Mr. Jeffery R. Rose, President
Dear Mr. Rose:
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 1851 Florence Road, Mount Airy, MD, from April 27-29, 2010, and determined that your firm is a distributor, labeler, and relabeler of foods and dietary supplements and distributes these products in interstate commerce. During the inspection, our investigators collected samples of a number of products bearing the Natural Zing label. FDA collected additional samples of your products in July 2010. FDA also reviewed your website at www.naturalzing.com in December 2010 and has determined that this site is labeling within the meaning of section 201(m) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(m)]. Based on our review of your product labels and website, we have determined that your Goji Berries, Mesquite Pod Meal, Milk Thistle Seed Powder, Rice Bran Solubles, Acai Powder, and Yacon Syrup products are in violation of the Act and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links in FDA’s home page at www.fda.gov.
Unapproved New Drugs
FDA reviewed your website www.naturalzing.com
in December 2010 and has determined that your Milk Thistle Seed Powder, Rice Bran Solubles, Acai Powder and Yacon Syrup products are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your website include:
Milk Thistle Seed Powder (Raw, Organic) 8 oz webpage:
• “Virtually all parts of the plant have been used as both food and medicine at one time or another with no reports of toxicity.”
• “[A] remedy for snake bites. They [milk thistle seeds] are also used as a preventive-antidote to poisoning by death-cap mushroom.”
• “[M]ilk thistle is known for curing jaundice and other liver disorders.”
• “[M]ilk thistle also soothes and moistens the mucous membranes and skin, making it excellent for psoriasis.”
Tocotrienols (Rice Bran Solubles) 1 lb webpage:
• “Other studies indicate a possible role for tocotrienols in protecting against cancer (particularly breast and skin cancer).”
Acai Powder (Raw, Organic Fair-traded) 100 g webpage:
• “Experienced Benefits: Anti-Inflammatory; Antimutagenic; Anti-Bacterial . . .”
Yacon Syrup (Raw, Organic) 8 fl oz, webpage:
• ”[Y]acon . . . safeguards against colon cancer . . . .”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Unauthorized Nutrient Content Claims
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation promulgated by the Secretary (and, by delegation, FDA) authorizing the use of such a claim. The use of a term not defined by regulation in food labeling to characterize the level of a nutrient misbrands a product under section 403(r)(1)(A) of the Act.
Nutrient content claims that use the defined terms “rich in,” “excellent source,” or “high,” (“superb source” is an unauthorized synonym for “excellent source”) may be used in the labeling of a food only if the food contains 20 percent or more of the daily value (DV) of that nutrient per reference amount customarily consumed (RACC) [21 CFR 101.54(b)(1)]. Such claims may not be made about a nutrient for which there is no established DV. The labels of your Authentic Tibetan Goji Berries and Wildcrafted Mesquite Pod Meal products bear the following claims that must meet the requirements set forth in 21 CFR 101.54(b)(1):
Authentic Tibetan Goji Berries:
• “[Superb source of vitamin A . . . .”
• “[R]ich source of . . . germanium.”
• “[R]ich source of . . . selenium . . . .”
Wildcrafted Mesquite Pod Meal:
• “[R]ich in calcium . . . iron . . . .”
• “[R]ich in . . . lysine.”
• “[R]ich in . . . magnesium, potassium . . . zinc . . . .”
However, these claims are unauthorized nutrient content claims because they do not meet all of the requirements of 21 CFR 101.54(b)(1). Specifically, according to the product label, your Authentic Tibetan Goji Berries product does not contain 20 percent or more of the DV of Vitamin A, and your Wildcrafted Mesquite Pod Meal product does not contain 20 percent or more of the DV of calcium or iron. Further, a DV has not been established for germanium or lysine, so “rich” cannot be used to make a claim about these nutrients. Finally, your Authentic Tibetan Goji Berries product label does not provide information about the amount of selenium in the product, and your Wildcrafted Mesquite Pod Meal product label does not provide information about the amount of magnesium, potassium, or zinc in the product, which makes it impossible to determine whether these products contain a sufficient amount of the DV of these nutrients to make “rich” claims about the nutrients. Because the above nutrient content claims do not meet the requirements set forth in 21 CFR 101.54(b)(1), your Authentic Tibetan Goji Berries and Wildcrafted Mesquite Pod Meal products are misbranded under section 403(r)(1)(A) of the Act.
Your Authentic Tibetan Goji Berries product is further misbranded within the meaning of section 403(r)(1)(A) of the Act because the product label bears a “more” nutrient content claim that is not authorized by regulation. The label of your Authentic Tibetan Goji Berries product bears the following claim: “[M]ore beta carotene than carrots.” FDA has defined the nutrient content claim “more” and its authorized synonyms in 21 CFR 101.54(e). “More” nutrient content claims may be used on the label or in the labeling of foods to describe the level of nutrients, provided that (1) the food contains at least 10 percent more of the DV for the nutrient per RACC than an appropriate reference food; (2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20; and (3) the claim bears the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.54(e)(1)(iii). Beta carotene is a form of Vitamin A. The nutrition facts panel for this product declares the amount of vitamin A as 2% of the DV. Carrots contain approximately 280% of the DV per RACC. Because the label of this product does not indicate that the product contains at least 10 percent more of the DV of Vitamin A per RACC than the reference food, carrots, this claim does not meet the requirements for a “more” claim and misbrands the product.
Other Food Labeling Violations
Your Milk Thistle Seed Powder and Wildcrafted Mesquite Pod Meal products are misbranded under section 403(q)(1) of the Act [21 U.S.C. § 343(q)(1)] because their labels fail to declare the nutrition facts information in accordance with 21 CFR 101.9. Specifically, your Milk Thistle Seed Powder product label fails to declare any nutrition facts information as required by 21 CFR 101.9, and your Wildcrafted Mesquite Pod Meal product label fails to declare trans fat on the nutrition facts information panel as required by 21 CFR 101.9(c)(2)(ii).
Your Milk Thistle Seed Powder product is further misbranded under section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the label does not properly declare the statement of your place of business as required by 21 CFR 101.5(d).
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all products marked by your firm comply with the Act and its implementing regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as copies of the new labels for the products that your firm manufactures and distributes, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.