For Immediate Release: Nov. 19, 2010
Media Inquiries: Dick Thompson, 301-796-7566, Dick.Thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
October 22, 2007
Stimul Media and Rx Partners relation
Filed under: reviews — Crevete @ 6:51 am
Today I signed up for two pharmacy affiliate programs: Rx Partners and Stimul Cash (former known as Stimul Media). As you know, signing up for these two is quite hard these days and you are required to have invitation code plus webmaster approval to start making money with them. Here is a conversation with the approval guy (Mark from Rx-Partners):14:58:58 Me: Hello! I want to sign-up with stimul-media but the signup form does not appear. https://www.stimul-media.com/signup.html Please leave offline message if it’s the case.
11:32:00 stimul-media: please register here http://www2.stimul-cash.com/signup.html
13:18:31 Me: Hello! How can I sign-up on stimul-cash.com and give credit to a friend that reffered me? Is http://www2.stimul-cash.com/?partner=2331 going to work?
13:19:22 stimul-media: yes, it will work.
13:19:34 : ok, thanks
13:22:22 stimul-media: are you signing up in Rx-parterns as well?
13:22:38 Me: yes
13:22:51 Me: how did you know?
13:23:20 430886685: we run both programs
13:23:34 Me: I understand
13:23:42 430886685: can yo uplease tellme how exactly are you planning to advertisie our sites?
I will advertise on http://www.bubub.org/, search engine traffic.
13:25:15 430886685: I have apporved your account
13:25:23 Me: ok
13:25:31 Me: thank you
That’s a lot of money these dudes are making. Two of the top affiliate programs. Hope this shit will work for me. If you want to sign up with Rx Partners and need an invitation code please leave a comment, I will respond in less than an hour. Also if you need affiliate coaching don’t hesitate to
Address lookup
canonical name http://www.stimul-cash.com
aliases
addresses 72.52.4.173
Domain Whois record
Queried whois.internic.net with “dom stimul-cash.com”…
Domain Name: WWW.STIMUL-CASH.COM
Registrar: REALTIME REGISTER BV
Whois Server: whois.yoursrs.com
Referral URL: http://www.realtimeregister.com
Name Server: NS0.STIMULCASH.COM
Name Server: NS1.STIMULCASH.COM
Status: clientTransferProhibited
Updated Date: 24-sep-2010
Creation Date: 16-mar-2007
Expiration Date: 16-mar-2013
>>> Last update of whois database: Wed, 13 Oct 2010 20:26:41 UTC <<<
Queried whois.yoursrs.com with “stimul-cash.com”…
Domain Name:stimul-cash.com
Name Server:ns1.stimulcash.com
Name Server:ns0.stimulcash.com
Created On:2010-08-13
Last Updated On:2010-09-24
Expiration Date:2013-03-16
Dealer:stimul
Registrant ID:stimul
Registrant Name:Vitaly Petrov
Registrant Organization:STIMUL-MEDIA.COM
Registrant Street1:Petrozavodskaya st, 16
Registrant Street2:
Registrant Street3:
Registrant City:Moscow
Registrant State/Province:
Registrant Postal Code:125414
Registrant Country:RU
Registrant Phone:+7.9160248086
Registrant Fax:
Registrant Email:vitalypetrov76@yahoo.com
Admin ID:stimul
Admin Name:Vitaly Petrov
Admin Organization:STIMUL-MEDIA.COM
Admin Street1:Petrozavodskaya st, 16
Admin Street2:
Admin Street3:
Admin City:Moscow
Admin State/Province:
Admin Postal Code:125414
Admin Country:RU
Admin Phone:+7.9160248086
Admin Fax:
Admin Email:vitalypetrov76@yahoo.com
Billing ID:stimul
Billing Name:Vitaly Petrov
Billing Organization:STIMUL-MEDIA.COM
Billing Street1:Petrozavodskaya st, 16
Billing Street2:
Billing Street3:
Billing City:Moscow
Billing State/Province:
Billing Postal Code:125414
Billing Country:RU
Billing Phone:+7.9160248086
Billing Fax:
Billing Email:vitalypetrov76@yahoo.com
Tech ID:stimul
Tech Name:Vitaly Petrov
Tech Organization:STIMUL-MEDIA.COM
Tech Street1:Petrozavodskaya st, 16
Tech Street2:
Tech Street3:
Tech City:Moscow
Tech State/Province:
Tech Postal Code:125414
Tech Country:RU
Tech Phone:+7.9160248086
Tech Fax:
Tech Email:vitalypetrov76@yahoo.com
Network Whois record
Queried whois.arin.net with “n 72.52.4.173″…
NetRange: 72.52.0.0 – 72.52.63.255
CIDR: 72.52.0.0/18
OriginAS:
NetName: PROLEXIC
NetHandle: NET-72-52-0-0-1
Parent: NET-72-0-0-0-0
NetType: Direct Allocation
NameServer: NS2.PROLEXIC.NET
NameServer: NS1.PROLEXIC.NET
Comment: http://www.prolexic.com / NOC hours are 24/7
RegDate: 2005-07-11
Updated: 2007-06-27
Ref: http://whois.arin.net/rest/net/NET-72-52-0-0-1
OrgName: Prolexic Technologies, Inc.
OrgId: PROLE
Address: 1930 Harrison Street
City: Hollywood
StateProv: FL
PostalCode: 33020
Country: US
RegDate: 2004-07-15
Updated: 2009-10-16
Ref: http://whois.arin.net/rest/org/PROLE
OrgTechHandle: HOSTM528-ARIN
OrgTechName: Hostmaster
OrgTechPhone: +1-866-800-0366
OrgTechEmail: hostmaster@prolexic.com
OrgTechRef: http://whois.arin.net/rest/poc/HOSTM528-ARIN
RTechHandle: HOSTM528-ARIN
RTechName: Hostmaster
RTechPhone: +1-866-800-0366
RTechEmail: hostmaster@prolexic.com
RTechRef: http://whois.arin.net/rest/poc/HOSTM528-ARIN
DNS records
name class type data time to live
stimul-cash.com IN MX
preference: 10
exchange: mail.stimul-cash.com
600s (00:10:00)
stimul-cash.com IN A 72.52.4.173 600s (00:10:00)
stimul-cash.com IN SOA
server: ns0.stimulcash.com
email: root.stimulcash.com
serial: 2010824934
refresh: 3600
retry: 900
expire: 604800
minimum ttl: 1200
600s (00:10:00)
stimul-cash.com IN NS ns0.stimulcash.com 600s (00:10:00)
stimul-cash.com IN NS ns1.stimulcash.com 600s (00:10:00)
173.4.52.72.in-addr.arpa IN PTR unknown.prolexic.com 86400s (1.00:00:00)
— end —
IP address: 72.52.4.173
Host name: stimul-cash.com
Alias:
stimul-cash.com
72.52.4.173 is from United States(US) in region North America
TraceRoute to 72.52.4.173 [stimul-cash.com]
Hop (ms) (ms) (ms) IP Address Host name
1 53 41 30 72.249.128.5 –
2 23 14 8 8.9.232.73 xe-5-3-0.edge3.dallas1.level3.net
3 Timed out 41 Timed out 66.192.240.94 dal2-pr1-ge-5-0-0-0.us.twtelecom.net
4 26 37 23 157.238.224.193 xe-0-4-0-1.r07.dllstx09.us.bb.gin.ntt.net
5 24 46 11 129.250.3.66 ae-6.r20.dllstx09.us.bb.gin.ntt.net
6 63 41 42 129.250.6.87 as-0.r21.miamfl02.us.bb.gin.ntt.net
7 48 47 41 209.200.132.34 blackhole.prolexic.com
8 51 69 80 157.238.179.6 ge-4-12.r02.miamfl02.us.ce.gin.ntt.net
9 51 44 55 209.200.132.34 blackhole.prolexic.com
10 69 80 58 72.52.4.173 unknown.prolexic.com
Trace complete
Retrieving DNS records for stimul-cash.com…
DNS servers
ns0.stimulcash.com
ns1.stimulcash.com
Query for DNS records for stimul-cash.com failed: Timed out
Whois query for stimul-cash.com…
Query error: Timed out
Network IP address lookup:
Whois query for 72.52.4.173…
Results returned from whois.arin.net:
#
# The following results may also be obtained via:
# http://whois.arin.net/rest/nets;q=72.52.4.173?showDetails=true&showARIN=false
#
NetRange: 72.52.0.0 – 72.52.63.255
CIDR: 72.52.0.0/18
OriginAS:
NetName: PROLEXIC
NetHandle: NET-72-52-0-0-1
Parent: NET-72-0-0-0-0
NetType: Direct Allocation
NameServer: NS2.PROLEXIC.NET
NameServer: NS1.PROLEXIC.NET
Comment: http://www.prolexic.com / NOC hours are 24/7
RegDate: 2005-07-11
Updated: 2007-06-27
Ref: http://whois.arin.net/rest/net/NET-72-52-0-0-1
OrgName: Prolexic Technologies, Inc.
OrgId: PROLE
Address: 1930 Harrison Street
City: Hollywood
StateProv: FL
PostalCode: 33020
Country: US
RegDate: 2004-07-15
Updated: 2009-10-16
Ref: http://whois.arin.net/rest/org/PROLE
OrgTechHandle: HOSTM528-ARIN
OrgTechName: Hostmaster
OrgTechPhone: +1-866-800-0366
OrgTechEmail: hostmaster@prolexic.com
OrgTechRef: http://whois.arin.net/rest/poc/HOSTM528-ARIN
RTechHandle: HOSTM528-ARIN
RTechName: Hostmaster
RTechPhone: +1-866-800-0366
RTechEmail: hostmaster@prolexic.com
RTechRef: http://whois.arin.net/rest/poc/HOSTM528-ARIN
#
# ARIN WHOIS data and services are subject to the Terms of Use
# available at: https://www.arin.net/whois_tou.html
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
canonical name ed-meds.net.
aliases http://www.ed-meds.net
addresses 195.95.155.11
Domain Whois record
Queried whois.internic.net with “dom ed-meds.net”…
Domain Name: WWW.ED-MEDS.NET
Registrar: ENOM, INC.
Whois Server: whois.enom.com
Referral URL: http://www.enom.com
Name Server: NS1.SUSPENDED-DOMAINS.NET
Name Server: NS2.SUSPENDED-DOMAINS.NET
Name Server: NS3.SUSPENDED-DOMAINS.NET
Name Server: NS4.SUSPENDED-DOMAINS.NET
Status: clientTransferProhibited
Updated Date: 29-jun-2009
Creation Date: 29-jun-2009
Expiration Date: 29-jun-2010
Last update of whois database: Sat, 22 Aug 2009 17:07:24 UTC
Queried whois.enom.com with “ed-meds.net”…
Visit AboutUs.org for more information about ed-meds.net
AboutUs: ed-meds.net
Registration Service Provided By: –
Contact: director@climbing-games.com
Visit: http://www.ruler-domains.com
Domain name: ed-meds.net
Registrant Contact:
Ostap Bondarev ostapbondarev@mail.ru
Fax:
Novomytishchinskii prospekt, 80, 145
Mytishchi, 141000
RU
Administrative Contact:
Ostap Bondarev ostapbondarev@mail.ru
+79031827507
Fax:
Novomytishchinskii prospekt, 80, 145
Mytishchi, 141000
RU
Technical Contact:
Ostap Bondarev ostapbondarev@mail.ru
+79031827507
Fax:
Novomytishchinskii prospekt, 80, 145
Mytishchi, 141000
RU
Status: Locked
Name Servers:
ns1.suspended-domains.net
ns2.suspended-domains.net
ns3.suspended-domains.net
ns4.suspended-domains.net
Creation date: 29 Jun 2009 23:32:04
Expiration date: 29 Jun 2010 23:32:04
Get Noticed on the Internet! Increase visibility for this domain name by listing it at http://www.whoisbusinesslistings.com
Network Whois record
Queried whois.ripe.net with “-B 195.95.155.11”.
Information related to ‘195.95.155.0 – 195.95.155.255’
inetnum: 195.95.155.0 – 195.95.155.255
netname: MSKCOM-NET
descr: MoskvaCom Ltd
country: RU
org: ORG-ML114-RIPE
admin-c: PG5690-RIPE
tech-c: PG5690-RIPE
status: ASSIGNED PI
mnt-by: RIPE-NCC-HM-PI-MNT
mnt-lower: RIPE-NCC-HM-PI-MNT
mnt-by: MSKCOM-MNT
mnt-routes: MSKCOM-MNT
mnt-routes: AS2118-MNT
mnt-domains: MSKCOM-MNT
changed: dilotto@gmail.com 20090224
source: RIPE
organisation: ORG-ML114-RIPE
org-name: MoskvaCom Ltd
org-type: OTHER
address: Parusnyj pr. 49/2
address: Moscow, Russia
phone: +7 910 4311272
e-mail: dilotto@gmail.com
mnt-ref: MSKCOM-MNT
mnt-by: MSKCOM-MNT
changed: hostmaster@ripe.net 20090224
source: RIPE
person: Pavel Gorbunov
address: Parusnyj pr. 49/2
address: Moscow, Russia
phone: +7 910 4311272
e-mail: dilotto@gmail.com
nic-hdl: PG5690-RIPE
mnt-by: MSKCOM-MNT
changed: hostmaster@ripe.net 20090224
source: RIPE
% Information related to ‘195.95.155.0/24AS2118’
route: 195.95.155.0/24
descr: RusDesign Autonomous System
origin: AS2118
notify: noc@relcom.net
mnt-by: AS2118-MNT
changed: andreyss@relcom.net 20090303
source: RIPE
DNS records
DNS query for 11.155.95.195.in-addr.arpa returned an error from the server: NameError
name class type data time to live
http://www.ed-meds.net IN CNAME ed-meds.net 60s (00:01:00)
ed-meds.net IN SOA
server: ns1.nscontrol.com
email: root.ed-meds.net
serial: 2007100801
refresh: 28800
retry: 7200
expire: 604800
minimum ttl: 30
60s (00:01:00)
ed-meds.net IN NS ns2.nscontrol.com 60s (00:01:00)
ed-meds.net IN NS ns4.nscontrol.com 60s (00:01:00)
ed-meds.net IN NS ns3.nscontrol.com 60s (00:01:00)
ed-meds.net IN NS ns1.nscontrol.com 60s (00:01:00)
ed-meds.net IN NS ns5.nscontrol.com 60s (00:01:00)
ed-meds.net IN A 195.95.155.11 60s (00:01:00)
— end —
Domains on Nameserver ns2.nscontrol.com
Entries 1 – 40 of 162 next page
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
Date: November 16, 2009
TO: Andrey Petroff
ul.Radionova 2-192
Nishny Nogorod, NN 601000
Russian Federation
79056626390
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Andrey Petroff
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16,2009
WARNING LETTER
The United States Food and Drug Administration (FDA) has reviewed your websites at shrinkrapthemovie.com, bikekmba.org, dinnerdvrsLcom, myfleacircus.com, petpetcentral.com, sorasheart.com, and walona.com and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to “Ativan (Generic),” “Viagra (Brand),” “Xanax (Brand),” “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra.” We request that you immediately cease marketing violative products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321 (g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant” dispensed through your websites are “new drugs,” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).
You also offer “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” on your websites. Xanax, Ambien, and Viagra are approved drugs well-known for their intended use(s) to treat disease. Therefore, including these drug names causes “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” to be subject to regulation as drugs under Section 201 (g) of the Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. . Moreover, these products are new drugs, as defined by section 201 (p) of the Act, 21 U.S.C. § 321(p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your websites offer products, including, but not limited to Ativan (Generic),” “Viagra (Brand),” and “Xanax (Brand),” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Some of the products available on your website are also controlled substances; the sale of these products is particularly concerning because of the potential for abuse and dependency. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act, 21 U.S.C. §§ 331Ja), 331 (b), and 331 (k).
Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
In addition, you offer “Herbal Xanax,· “Herbal Ambien,· and “Herbal Viagra” for sale. These drugs are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs are false and misleading. The labeling are false and misleading because they erroneously suggest that the products contain Xanax, Ambien, and Viagra, which are the proprietary names for FDA-approved products containing the active pharmaceutical ingredients alprazolam, zolpidem, and sildenafil citrate. Regardless of whether your products contain Xanax, Ambien, or Viagra, the products you are offering for sale are not manufactured by the sponsors of the approved applications for Xanax, Ambien, or Viagra, and it is false and misleading to suggest that your products are manufactured by those sponsors.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act, 21 U.S.C. § 331(a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force atFDAInternetPharmacyTaskForceCDER@ fda.hhs.gov or (301) 796-3110.
Sincerely,
/s/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
For Immediate Release: January 18, 2010
Media Inquiries: Tom Gasparoli, 301-796-4737
thomas.gasparoli@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Warns Consumers about Counterfeit Alli
The counterfeit products contain controlled substance sibutramine
The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit).
Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.
Consumers began reporting suspected counterfeit Alli to GSK in early December 2009. GSK has determined that the counterfeit product has been sold over the internet. However, there is no evidence at this time that the counterfeit Alli product has been sold through other channels, such as retail stores.
The counterfeit Alli product looks similar to the authentic product, with a few notable differences. The counterfeit Alli has:
Consumers who believe they have received counterfeit Alli are asked to contact the FDA’s Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI Web site (http://www.fda.gov/OCI).
Health care professionals and consumers are encouraged to report adverse events that may be related to the use of these counterfeit products to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
Pictures of counterfeit Alli samples provided by GSK are shown below.
________________________________________
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
TO: Med Light LTD
37 Rectory Lane
PO Box 2063
Belize City, Belize
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Med Light LTD
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your websites at
and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Brand),” “Acomplia (Generic),” “Rimonabant,” “Viagra (Brand),” “Cialis (Brand),” and “Prozac (Generic).” We request that you immediately cease marketing violative products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321(g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states.
Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective. Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321(p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your websites offer product for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner, including, but not limited to “Viagra (Brand),” “Cialis (Brand),” and “Prozac (Generic).” Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331(b), and 331(k).
Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act, 21 U.S.C. § 331(a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
CC:
Chris Walsh c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.refill-rx-meds.com
http://www.brand-meds.com
http://www.rx-easy-pharmacy.com
Janis Larsen c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.buy-american-pharma.com
http://www.online-pharma-rx.com
Gordon Mcleod c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.first-american-pharmacy.com
http://www.secure-rx-refills.com
Katherine Wainscott c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.brand-pharma.com
PrivacyProtect.org
Domain Administrator
contact@privacyprotect.org
http://www.american-pharm.com
http://www.first-swiss-meds.com
Jacqueline Sockley c/o Dyndadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.rx-Iife.com
Domains by Proxy, Inc.
15111 N. Hayden Road
Ste 160 PMB 353
Scottsdale Arizona 85260
http://www.quickgeneric.com
canonical name | rx-life.com. |
aliases | |
addresses | 78.40.37.130 |
Queried whois.internic.net with “dom rx-life.com”…
Domain Name: RX-LIFE.COM Registrar: DYNADOT, LLC Whois Server: whois.dynadot.com Referral URL: http://www.dynadot.com Name Server: NS1.DOMAIN-ADMIN-CENTRAL.COM Name Server: NS2.DOMAIN-ADMIN-CENTRAL.COM Status: clientTransferProhibited Updated Date: 19-nov-2009 Creation Date: 11-jul-2007 Expiration Date: 11-jul-2010 Last update of whois database: Sun, 29 Nov 2009 14:55:34 UTC <<<
Queried whois.dynadot.com with “rx-life.com”…
Domain Name: rx-life.com Registered at http://www.dynadot.com Registrant: jacqueline shockley c/o Dynadot Privacy PO Box 701 San Mateo, CA 94401 United States Administrative Contact: jacqueline shockley c/o Dynadot Privacy PO Box 701 San Mateo, CA 94401 United States privacy@dynadot.com 1-650-585-1961 Technical Contact: jacqueline shockley c/o Dynadot Privacy PO Box 701 San Mateo, CA 94401 United States privacy@dynadot.com 1-650-585-1961 Record expires on 2010/07/11 UTC Record created on 2007/07/11 UTC Domain servers in listed order: ns1.domain-admin-central.com ns2.domain-admin-central.com Last update of whois database: 2009/11/29 06:52:07 PST <<<
Queried whois.ripe.net with “-B 78.40.37.130″…
% Information related to '78.40.37.128 - 78.40.37.135' inetnum: 78.40.37.128 - 78.40.37.135 netname: ASSIVA descr: Assiva UK Network country: GB admin-c: BL2095-RIPE tech-c: BL2095-RIPE status: ASSIGNED PA mnt-by: MNT-TAGADAB changed: olympus@tagadab.com 20091119 source: RIPE person: Benjamin Lawrie address: Twyver Place Brockworth Gloucestershire GL3 4AN phone: +448443575059 nic-hdl: BL2095-RIPE changed: steve@tagadab.com 20080831 source: RIPE % Information related to '78.40.32.0/21AS8426' route: 78.40.32.0/21 descr: TAGADAB-AGG1 origin: AS8426 mnt-by: AS8426-MNT mnt-by: MNT-TAGADAB changed: hostmaster@uk.clara.net 20070710 source: RIPE
name | class | type | data | time to live | |||||||||||||||
rx-life.com | IN | SOA |
|
300s | (00:05:00) | ||||||||||||||
rx-life.com | IN | NS | ns1.domain-admin-central.com | 300s | (00:05:00) | ||||||||||||||
rx-life.com | IN | NS | ns2.domain-admin-central.com | 300s | (00:05:00) | ||||||||||||||
rx-life.com | IN | A | 78.40.37.130 | 300s | (00:05:00) | ||||||||||||||
130.37.40.78.in-addr.arpa | IN | PTR | serverinstalled.udedi.com | 3600s | (01:00:00) |
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
TO: Med Light LTD
37 Rectory Lane
PO Box 2063
Belize City, Belize
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Med Light LTD
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your websites at
and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Brand),” “Acomplia (Generic),” “Rimonabant,” “Viagra (Brand),” “Cialis (Brand),” and “Prozac (Generic).” We request that you immediately cease marketing violative products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321(g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states.
Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective. Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321(p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your websites offer product for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner, including, but not limited to “Viagra (Brand),” “Cialis (Brand),” and “Prozac (Generic).” Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331(b), and 331(k).
Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act, 21 U.S.C. § 331(a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
CC:
Chris Walsh c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.refill-rx-meds.com
http://www.brand-meds.com
http://www.rx-easy-pharmacy.com
Janis Larsen c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.buy-american-pharma.com
http://www.online-pharma-rx.com
Gordon Mcleod c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.first-american-pharmacy.com
http://www.secure-rx-refills.com
Katherine Wainscott c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.brand-pharma.com
PrivacyProtect.org
Domain Administrator
contact@privacyprotect.org
http://www.american-pharm.com
http://www.first-swiss-meds.com
Jacqueline Sockley c/o Dyndadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.rx-Iife.com
Domains by Proxy, Inc.
15111 N. Hayden Road
Ste 160 PMB 353
Scottsdale Arizona 85260
http://www.quickgeneric.com
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
Date: November 16, 2009
TO: Ric Deleon
21 Villamor Street
Manila, Manila 2700
bastprices2000@yahoo.com
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Ric Deleon
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your websites at
247meds.com
24-7pills.com
24-7rx.com
bestdealrx.com
and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
These products include, but are not limited to, “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” “Herbal Viagra,” “Viagra (Brand),” “Xanax (Brand),” and “Valium (Brand).”
We request that you immediately cease marketing violative
products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321 (g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to Acomplia (Generic),”
“Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,· “Herbal Ambien,· and “Herbal Viagra.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same
assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts
among patients. Accordingly, the “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant,” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 .S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses.
You also offer “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” on your websites. Xanax, Ambien, and Viagra are approved drugs well-known for their intended use(s) to treat disease.
Therefore, including these drug names causes “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” to be subject to regulation as drugs under Section 201 (g) of the Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Moreover, these products are new drugs, as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved
application is in effect for it. Your sale of several products, including but not limited to “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra,” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your websites offer several products, including but not limited to “Viagra (Brand),” “Xanax (Brand),” and “Valium (Brand),” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Some of the products available on your website are also controlled substances; the sale of these products is particularly concerning because of the potential for abuse and dependency. Therefore, the drugs are misbranded under section
503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act, 21 U.S.C. §§ 331 (a), 331 (b), and 331 (k).
Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act.
Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
In addition, you offer “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” for sale. These drugs are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs are false and misleading. The labeling are false and misleading because they erroneously suggest that the products contain Xanax, Ambien, and Viagra, which are the proprietary names for FDA-approved products containing the active pharmaceutical ingredients alprazolam,
zolpidem, and sildenafil citrate. Regardless of whether your products contain Xanax, Ambien, or Viagra, the products you are offering for sale are not manufactured by the sponsors of the approved applications for Xanax, Ambien, or Viagra, and it is false and misleading to suggest that
your products are manufactured by that sponsor.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331 (a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
Date: November 16, 2009
TO: Pro West Marketing Ltd, Rue de
L’arc 45, Road Town, Tortola,
BVI VG1110
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Pro West Marketing Ltd
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your websites at
and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Viagra (Brand),” “Cialis (Brand),” “Prozac (Generic): and “Levitra (Brand).” We request that you immediately cease marketing violative products.
These products are drugs under section 201(g) of the Act, 21 U.S.C. § 321(g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unaporoved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant” dispensed through your websites are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321 (p).
Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant” without approved applications violates these provisions of the Act.
Misbranded Drugs
Many of your websites sell products, including but not limited to “Viagra (Brand),” “Cialis (Brand),” “Prozac (Generic),” and “Levitra (Brand)” without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331(b), and 331(k).
Further, most of your websites state that your products are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331(a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/s/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
Cc:
Protected Domain Services – Customer ID: NCR-1083643
125 Rampart Way, Suite 300
Denver, CO 80230
doctorphentermine.com@protecteddomainservices.com
doctorphentermine.com
Steven Rook
Regents Blvd
Union City, California 94587
redisonberg@gmail.com
trusted-tabs.us
Domains by Proxy, Inc., DomainsByProxy.com
15111 N. Hayden Rd., Ste 160, PMB 353
Scottsdale, Arizona 85260
United States
ONLINE-PHARMACY-NO-PRESCRIPTION.COM@domainsbyproxy.com
online-pharmacy-no-prescription.com
prescriptionsintl.com
WhoisGuard
8939 S. Sepulveda Blvd. #110 – 732
Westchester, CA 90045
US
365pharm.com
approved-pharm.com
value-drugstore.com
aprixe.com
buycanadianpharmacy.net
Scott Stiverson
XP Hosting and Design
1938 Eagle Crest Dr
Draper, UT 84020
US
info@xphostinganddesign.com
cheapphentermine.com
NameCheap.com NameCheap.com
8939 S. Sepulveda Blvd. #110 – 732
Westchester, CA 90045
6763d4f87c15430b92099daadd0d9f0a.protect@whoisguard.com
rx-giant.com
ESALES, LLC
One Commerce Center
1201 Orange Street, Suite 600
Wilmington, Delaware 19899
rampage76@cyber-rights.net
4cheaprx.com
Gregg Masters
MorMax, LLC
1644 Corte Verano
Oceanside, CA 92056
greggmasters@gmail.com
preferredpharma.com
Sergey Nikolaev
Chaykovskogo 28 apt 39
Nikolaev
Mykolaiv Oblast
54018
UA
nikolos00@gmail.com
terameds.org
Chris Walsh c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
dragon-rx.com
bestrxpharm.net
pharma-direct.com
buy-canadian-pharm .com
easy-pharm.com
Iicensed-medical.com
rxcalm.com
top-hotpills.com
top-uspharm.com
smsrx.net
total-pharma.com
James Riley c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
my-pharm.com
PrivacyProtect.org
Domain Admin
contact@privacyprotect.org
first-refill-c1ub.com
Gordon Mcleod c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
my-refill-drugstore.com
refill-rx-now.com
rxontv.com
Sergiy Nikolaev c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
my-pill.com
Janis Larsen c/o Dynadot Privacy PO Box 701 San Mateo, CA 94401 United States
pharma-discounts.com
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
Date: November 16, 2009
TO: Chris Walsh
c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Chris Walsh
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your website at trustmeds.com and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Viagra (Brand),” and “Prozac (Generic).” We request that you immediately cease marketing violative products.
These products are drugs under section 201(g) of the Act, 21 U.S.C. § 321(g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant” dispensed through your website are “new drugs,” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).
Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your website offers numerous products, including but not limited to “Viagra (Brand)” and “Prozac (Generic)” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331(b), and 331(k).
Further, your website offers products for sale and states that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a)of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act, 21 U.S.C. § 331(a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice. Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
TO: Med Light LTD
37 Rectory Lane
PO Box 2063
Belize City, Belize
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Med Light LTD
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your websites at
and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Brand),” “Acomplia (Generic),” “Rimonabant,” “Viagra (Brand),” “Cialis (Brand),” and “Prozac (Generic).” We request that you immediately cease marketing violative products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321(g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states.
Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective. Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321(p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your websites offer product for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner, including, but not limited to “Viagra (Brand),” “Cialis (Brand),” and “Prozac (Generic).” Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301(b), and 301(k) of such Act, 21 U.S.C. §§ 331(a), 331(b), and 331(k).
Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act, 21 U.S.C. § 331(a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
CC:
Chris Walsh c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.refill-rx-meds.com
http://www.brand-meds.com
http://www.rx-easy-pharmacy.com
Janis Larsen c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.buy-american-pharma.com
http://www.online-pharma-rx.com
Gordon Mcleod c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.first-american-pharmacy.com
http://www.secure-rx-refills.com
Katherine Wainscott c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.brand-pharma.com
PrivacyProtect.org
Domain Administrator
contact@privacyprotect.org
http://www.american-pharm.com
http://www.first-swiss-meds.com
Jacqueline Sockley c/o Dyndadot Privacy
PO Box 701
San Mateo, CA 94401
http://www.rx-Iife.com
Domains by Proxy, Inc.
15111 N. Hayden Road
Ste 160 PMB 353
Scottsdale Arizona 85260
http://www.quickgeneric.com
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
Date: November 16, 2009
TO: New Horizons LTD
Prol. Av. Independencia KM 20
Santo Domingo
Dominican Republic
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD.20903
TO: New Horizons LTD
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your websites at
and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Viagra (Brand),” “Cialis (Brand),” “Prozac (Generic),” and “Levitra (Brand).” We request that you immediately cease marketing violative products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321 (g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated
sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts
among patients. Accordingly, the”Acomplia (Generic),· Acomplia(Brand),· and “Rimonabant”
dispensed through your websites are “new drugs,” as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Generic), “Acomplia (Brand),” and “Rimonabant” without approved applications violates these provisions of the Act.
Misbranded Drugs
Many of your websites sell products, including but not limited to “Viagra (Brand),” “Cialis (Brand)”, “Prozac (Generic),” and “Levitra (Brand)” without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301(a), 301 (b), and 301(k) of such Act, 21 U.S.C. §§ 331 (a), 331(b), and 331(k).
Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act.
Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331 (a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@ fda.hhs.govor (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
Cc:
Chris Walsh c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
top-drugstore. net
John Ruben c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
us-rx-meds.com
PrivacyProtect.org
Domain Admin
contact@privacyprotect.org
american-pharma.com
approved-swiss-pharm.com
approved-swiss-pharma.com
approved-swiss-pharmacy.com
first-swiss-dru gstore.com
first-swiss-pharm .com
first-swiss-pharmacy.com
mexican-pharma.com
Gordon Mcleod c/o Dynadot Privacy
PO Box 701
San Mateo, CA 94401
United States
central-rx-refill.com
Piter Krasnikov
745 Ushakova
Petersburg, 23987
Russian Federation
midas ua@yahoo.com
cheapdrugsmd.com
Domains by Proxy, Inc., DomainsByProxy.com
15111 N. Hayden Rd., Ste 160, PMB 353
Scottsdale, Arizona 85260
PHARMACYTOUCH.COM@domainsbyproxy.com
pharmacytouch.com
WhoisGuard
8939 S. Sepulveda Blvd. #110 – 732
Westchester, CA 90045
lion-rx.com
mypillshop.com
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
TO: Ric Deleon
21 Villamor Street
Manila, Manila 2700
bastprices2000@yahoo.com
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Ric Deleon
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your websites at
and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to, “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” “Herbal Viagra,” “Viagra (Brand),” “Xanax (Brand),” and “Valium (Brand).” We request that you immediately cease marketing violative products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321 (g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,· “Herbal Ambien,· and “Herbal Viagra.” FDA
is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts
among patients. Accordingly, the “Acomplia (Generic),” “Acomplia (Brand),” and “Rimonabant,” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses.
You also offer “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” on your websites. Xanax, Ambien, and Viagra are approved drugs well-known for their intended use(s) to treat disease.
Therefore, including these drug names causes “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” to be subject to regulation as drugs under Section 201 (g) of the Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Moreover, these products are new drugs, as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including but not limited to “Acomplia (Generic),” “Acomplia (Brand),” “Rimonabant,” “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra,” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your websites offer several products, including but not limited to “Viagra (Brand),” “Xanax (Brand),” and “Valium (Brand),” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Some of the products available on your website are also controlled substances; the sale of these products is particularly concerning because of the potential for abuse and dependency. Therefore, the drugs are misbranded under section
503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act, 21 U.S.C. §§ 331 (a), 331 (b), and 331 (k).
Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act.
Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
In addition, you offer “Herbal Xanax,” “Herbal Ambien,” and “Herbal Viagra” for sale. These drugs are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs are false and misleading. The labeling are false and misleading because they erroneously suggest that the products contain Xanax, Ambien, and Viagra, which are the proprietary names for FDA-approved products containing the active pharmaceutical ingredients alprazolam,
zolpidem, and sildenafil citrate. Regardless of whether your products contain Xanax, Ambien, or Viagra, the products you are offering for sale are not manufactured by the sponsors of the approved applications for Xanax, Ambien, or Viagra, and it is false and misleading to suggest that
your products are manufactured by that sponsor.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331 (a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
lookup failed | 247meds. com |
Could not find an IP address for this domain name. |
Queried with “247meds. com”…
Query error: NoWhoisServerForDomain
Don’t have an IP address for which to get a record
DNS query for 247meds. com returned an error from the server: NameError
No records to display
— end —
IP address: 66.115.142.93
Host name: 247meds.com
Alias:
247meds.com
66.115.142.93 is from United States(US) in region North America
TraceRoute to 66.115.142.93 [247meds.com]
Hop (ms) (ms) (ms) IP Address Host name
1 30 61 57 72.249.128.5 –
2 52 35 11 8.9.232.73 xe-5-3-0.edge3.dallas1.level3.net
3 7 18 30 4.69.145.244 ae-93-90.ebr3.dallas1.level3.net
4 55 26 36 4.69.134.22 ae-7-7.ebr3.atlanta2.level3.net
5 32 31 26 4.69.148.254 ae-73-73.csw2.atlanta2.level3.net
6 33 28 28 4.69.150.68 ae-22-52.car2.atlanta1.level3.net
7 29 26 25 4.78.211.162 nationalnet.atlanta1.level3.net
8 30 35 44 66.115.128.114 gig2-10.tr1.atl4.national-net.com
9 62 57 42 66.115.142.93 pillcart.com
Trace complete
Retrieving DNS records for 247meds.com…
DNS servers
ns2.nationalnet.com
ns1.nationalnet.com
Answer records
247meds.com NS ns1.nationalnet.com 900s
247meds.com A 66.115.142.93 900s
247meds.com SOA
server: ns1.nationalnet.com
email: dnsadmin@nationalnet.com
serial: 2008042501
refresh: 28800
retry: 7200
expire: 604800
minimum ttl: 86400
900s
247meds.com NS ns2.nationalnet.com 900s
Authority records
Additional records
ns1.nationalnet.com A 216.201.81.254 900s
ns2.nationalnet.com A 216.201.87.28 900s
Whois query for 247meds.com
Results returned from whois.internic.net:
Domain Name: 247MEDS.COM
Registrar: GODADDY.COM, INC.
Whois Server: whois.godaddy.com
Referral URL: http://registrar.godaddy.com
Name Server: NS1.NATIONAL-NET.COM
Name Server: NS2.NATIONAL-NET.COM
Status: clientDeleteProhibited
Status: clientRenewProhibited
Status: clientTransferProhibited
Status: clientUpdateProhibited
Updated Date: 20-dec-2010
Creation Date: 11-mar-2003
Expiration Date: 11-mar-2012
Last update of whois database: Thu, 13 Jan 2011 11:43:14 UTC
Registrant:
Ric Deleon
Registered through: GoDaddy.com, Inc. (http://www.godaddy.com)
Domain Name: 247MEDS.COM
Domain servers in listed order:
NS1.NATIONAL-NET.COM
NS2.NATIONAL-NET.COM
For complete domain details go to:
http://who.godaddy.com/whoischeck.aspx?Domain=247MEDS.COM
Network IP address lookup:
Whois query for 66.115.142.93
Results returned from whois.arin.net:
The following results may also be obtained via:
http://whois.arin.net/rest/nets;q=66.115.142.93?showDetails=true&showARIN=false
NationalNet, Managed Services NATNET-MANAGED-VL255-BLK14 (NET-66-115-142-0-1) 66.115.142.0 – 66.115.142.255
NationalNet, Inc. NATIONALNET-1 (NET-66-115-128-0-1) 66.115.128.0 – 66.115.191.255
ARIN WHOIS data and services are subject to the Terms of Use
available at: https://www.arin.net/whois_tou.html
Results returned from whois.arin.net:
The following results may also be obtained via:
http://whois.arin.net/rest/nets;handle=NET-66-115-142-0-1?showDetails=true&showARIN=false
NetRange: 66.115.142.0 – 66.115.142.255
CIDR: 66.115.142.0/24
OriginAS: AS22384
NetName: NATNET-MANAGED-VL255-BLK14
NetHandle: NET-66-115-142-0-1
Parent: NET-66-115-128-0-1
NetType: Reassigned
RegDate: 2010-04-21
Updated: 2010-04-21
Ref: http://whois.arin.net/rest/net/NET-66-115-142-0-1
CustName: NationalNet, Managed Services
Address: 1130 Powers Ferry Place SE
City: Marietta
StateProv: GA
PostalCode: 30067
Country: US
RegDate: 2010-04-21
Updated: 2010-04-21
Ref: http://whois.arin.net/rest/customer/C02472880
OrgNOCHandle: NNO76-ARIN
OrgNOCName: NationalNet Network Operations
OrgNOCPhone: +1-678-247-7000
OrgNOCEmail: noc@nationalnet.com
OrgNOCRef: http://whois.arin.net/rest/poc/NNO76-ARIN
OrgTechHandle: IA88-ARIN
OrgTechName: IP Administrator
OrgTechPhone: +1-678-247-7000
OrgTechEmail: ipadmin@nationalnet.com
OrgTechRef: http://whois.arin.net/rest/poc/IA88-ARIN
OrgAbuseHandle: NAC69-ARIN
OrgAbuseName: NationalNet Abuse Contact
OrgAbusePhone: +1-678-247-7000
OrgAbuseEmail: abuse@nationalnet.com
OrgAbuseRef: http://whois.arin.net/rest/poc/NAC69-ARIN
RTechHandle: IA88-ARIN
RTechName: IP Administrator
RTechPhone: +1-678-247-7000
RTechEmail: ipadmin@nationalnet.com
RTechRef: http://whois.arin.net/rest/poc/IA88-ARIN
ARIN WHOIS data and services are subject to the Terms of Use
available at: https://www.arin.net/whois_tou.html
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
Date: November 16, 2009
TO: William Wynne
billandsveta@hotmail.com
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: William Wynne
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16, 2009
The United States Food and Drug Administration (FDA) has reviewed your websites at andersenpharmacy.com and dukepharmacy.com and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to “Acomplia (Brand),” “Acomplia (Generic) “Rimonabant,” “Herbal Ambien,” “Herbal Xanax,” “Valium (Brand),” “Valium (Generic),” and “Prozac (Generic).” We request that you immediately cease marketing violative products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321 (g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers many unapproved new drugs including, but not limited to “Acomplia (Brand),” “Acomplia (Generic),” “Rimonabant,” “Herbal Ambien,” and “Herbal Xanax.” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts among patients. Accordingly, the “Acomplia (Brand),” “Acomplia (Generic),” and “Rimonabant” dispensed through your websites are “new drugs,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).
You also offer “Herbal Ambien,” and “Herbal Xanax,” on your websites. Ambien and Xanax are approved drugs well-known for their intended use(s) to treat disease. Therefore, including these drug names causes “Herbal Ambien” and “Herbal Xanax” to be subject to regulation as drugs under Section 201 (g) of the Act because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, these products are new drugs, as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Brand),” “Acomplia (Generic),” “Rimonabant,” “Herbal Ambien,” and “Herbal Xanax” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your websites offer numerous products, including but not limited to “Valium (Brand),” “Valium (Generic),” and “Prozac (Generic),” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Some of the products available on your website are also controlled substances; the sale of these products is particularly concerning because of the potential for abuse and dependency. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act, 21 U.S.C. §§ 331 (a), 331 (b), and 331 (k).
Further, your websites offer products for sale and state that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act. Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
In addition, you offer “Herbal Ambien” and “Herbal Xanax” for sale. These drugs are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because their labeling is false and misleading. The labeling is false and misleading because it erroneously suggest that the products contain Ambien or Xanax, which are the proprietary names for FDA-approved products containing the active pharmaceutical ingredient zolpidem and alprazolam. Regardless of whether your products contain Ambien or Xanax, the products you are offering for sale are not manufactured by the sponsors of the approved applications for Ambien and Xanax, and it is false and misleading to suggest that your products are manufactured by those sponsors.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331 (a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDA lnternet Pharmacy TaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at AlnternetPharmacyTaskForceCDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
lookup failed | andersenpharmacy.com |
Could not find an IP address for this domain name. |
Queried whois.internic.net with “dom andersenpharmacy.com”…
Domain Name: ANDERSENPHARMACY.COM Registrar: WILD WEST DOMAINS, INC. Whois Server: whois.wildwestdomains.com Referral URL: http://www.wildwestdomains.com Name Server: NS1.SUSPENDED-FOR.SPAM-AND-ABUSE.COM Name Server: NS2.SUSPENDED-FOR.SPAM-AND-ABUSE.COM Status: clientDeleteProhibited Status: clientRenewProhibited Status: clientTransferProhibited Status: clientUpdateProhibited Updated Date: 17-nov-2009 Creation Date: 29-oct-2005 Expiration Date: 29-oct-2010 Last update of whois database: Sun, 22 Nov 2009 08:53:01 UTC
Queried whois.wildwestdomains.com with “andersenpharmacy.com”…
Registrant: OMR Registered through: JoJoDomains.com Domain Name: ANDERSENPHARMACY.COM Domain servers in listed order: NS1.SUSPENDED-FOR.SPAM-AND-ABUSE.COM NS2.SUSPENDED-FOR.SPAM-AND-ABUSE.COM For complete domain details go to:
Don’t have an IP address for which to get a record
DNS query for andersenpharmacy.com failed: WouldBlock
No records to display
— end —
“The Canadian Pharmacy, Canadian/European Pharmacy”, “Canadian Healthcare” and “US Drugstore” are brands of one of the most disgusting illegal online pharmacy group well organized CRIMINAL OPERATION of all times. “GREED” is the driving force behind this operation. Don’t let them fool you. They will never send you any genuine drugs. If they ever send anything at all, it may consist of literally anything from sugar to wall plaster, and they certainly don’t care that you will endanger your health by taking those dangerous counterfeit drugs.
Today a shadowy, transnational network of illicit drug manufacturers, traders, doctors, Web site operators, spammers and criminals makes up the online pharmacy world.
There are many options out there when it comes to buying medication online. We have looked at websites after websites. Some sites feature offshore pharmacies that do not require a prior prescription. Others feature licensed pharmacies that do require a prescription from your doctor.
Before making a purchase that can effect your health, we strongly recommend that you consult your physician & DO NOT self-medicate. Ordering medication online can be a safe, money-saving experience. When done through licensed online pharmacies that require a prescription, you can be assured that the medication you get is exactly what you need to treat your ailments.
From: FDA Center for Drug Evaluation and Research
FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov
Date: November 16, 2009
Food and Drug Administration
TO: Eugene Lefter
peachpiefordiabetics@gmail.com
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
ROCKVILLE, MD 20903
TO: Eugene Lefter
FROM: Food and Drug Administration Internet Pharmacy Task Force
RE: Internet Marketing of Unapproved and Misbranded Drugs
DATE: November 16,2009
The United States Food and Drug Administration (FDA) has reviewed your website at wellknowndrugs.com and has determined that you are offering products for sale in violation of the Federal Food, Drug, and Cosmetic Act (the Act). These products include, but are not limited to “Acomplia (Generic),” “Valium (Brand),” and “Xanax (Generic).” We request that you immediately cease marketing violative products.
These products are drugs under section 201 (g) of the Act, 21 U.S.C. § 321 (g), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. Your marketing and distribution of these drugs violate various provisions of the Act, as described below:
Unapproved New Drugs
Your firm offers unapproved new drugs including, but not limited to “Acomplia (Generic).” FDA is taking this action against your firm because of the inherent risk in buying unapproved prescription drugs. Unapproved drugs from unregulated sources do not have the same assurance of safety and effectiveness as drugs subject to FDA oversight and have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. For drugs that are regulated by FDA, FDA protections include rigorous scientific standards for prescription drug approval and label review for accuracy and completeness, manufacturing procedures and testing performed under closely controlled conditions at FDA registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public from unregulated sources may not be safe and effective.
Rimonabant (also marketed under the name Acomplia) was specifically rejected for FDA approval because it did not meet the statutory requirements for safety and effectiveness. In June 2007, the FDA Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted not to recommend approval of the drug because of increased risk of neurological and psychiatric side effects including seizures, depression, anxiety, insomnia, aggressiveness, and suicidal thoughts
among patients. Accordingly, the “Acomplia (Generic)” dispensed through your website is a “new drug,” as defined by section 201 (p) of the Act, 21 U.S.C. § 321 (p).
Under sections 301 (d) and 505(a) of the Act, 21 U.S.C. §§ 331 (d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of several products, including “Acomplia (Generic),” without approved applications violates these provisions of the Act.
Misbranded Drugs
Your website offers products, including but not limited to “Valium (Brand)” and “Xanax (Generic)” for sale without requiring that the products be dispensed under a prescription from a duly licensed practitioner. Some of the products available on your website are also controlled substances; the sale of these products is particularly concerning because of the potential for abuse and dependency. Therefore, the drugs are misbranded under section 503(b)(1) of the Act, 21 U.S.C. § 353(b)(1), and are marketed in violation of sections 301 (a), 301 (b), and 301 (k) of such Act, 21 U.S.C. §§ 331 (a), 331(b), and 331(k).
Further, your website offers products for sale and states that they are FDA-approved. As noted above, your products are not FDA-approved and are offered for sale in violation of the Act.
Therefore, these products are misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), because the labeling of the drugs is false and misleading.
The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301 (a) of the Act, 21 U.S.C. § 331 (a).
This letter is not intended to identify all of the ways in which your activities might be in violation of United States law. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action, including but not limited to, seizure and/or injunction without further notice.
Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to FDAlnternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries concerning this letter to FDA’s Internet Pharmacy Task Force at FDAlnternetPharmacyTaskForceCDER@fda.hhs.gov or (301) 796-3110.
Sincerely,
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
lookup failed | wellknowndrugs.com |
Could not find an IP address for this domain name. |
Queried whois.internic.net with “dom wellknowndrugs.com”…
Domain Name: WELLKNOWNDRUGS.COM
Registrar: MONIKER ONLINE SERVICES, INC.
Whois Server: whois.moniker.com
Referral URL: http://www.moniker.com/whois.html
Name Server: No nameserver
Status: clientDeleteProhibited
Status: clientHold
Status: clientTransferProhibited
Updated Date: 17-nov-2009
Creation Date: 31-dec-2008
Expiration Date: 31-dec-2009
Last update of whois database: Sun, 22 Nov 2009 08:41:15 UTC
Queried whois.moniker.com with “wellknowndrugs.com”…
Domain Name: WELLKNOWNDRUGS.COM
Registrar: MONIKER
Registrant [1913944]:
Eugen Lefter peachpiefordiabetics@gmail.com
Student 17/1
Ch
Ch
3001
MD
Administrative Contact [1913944]:
Eugen Lefter peachpiefordiabetics@gmail.com
Student 17/1
Ch
Ch
3001
MD
Phone: +373.79656020
Billing Contact [1913944]:
Eugen Lefter peachpiefordiabetics@gmail.com
Student 17/1
Ch
Ch
3001
MD
Phone: +373.79656020
Technical Contact [1913944]:
Eugen Lefter peachpiefordiabetics@gmail.com
Student 17/1
Ch
Ch
3001
MD
Phone: +373.79656020
Domain servers in listed order:
NS1.ALLSITESDNS.COM
NS2.ALLSITESDNS.COM
Record created on: 2008-12-31 10:29:27.0
Database last updated on: 2009-10-07 16:17:56.33
Domain Expires on: 2009-12-31 10:29:28.0
Don’t have an IP address for which to get a record
DNS query for wellknowndrugs.com returned an error from the server: NameError
No records to display