- Delivery Method:
- VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
- Dietary Supplements
Recipient NameDavid Lovatt
- New York Nutrition Company
- American Metabolix
11427 W I 70 Frontage Rd
Wheat Ridge, CO 80033
- Issuing Office:
- Center for Food Safety and Applied Nutrition (CFSAN)
Dear Mr. Lovatt:
This letter concerns your products Lean Muscle For Her and Lean Muscle, which are labeled as dietary supplements. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the products are adulterated dietary supplements. You can find the FD&C Act through links on FDA’s website at https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-andcosmetic-act-fdc-act and the FDA regulations at https://www.ecfr.gov/current/title-21.
Adulterated Dietary Supplement: Unsafe Food Additive
The labels of your products Lean Muscle for Her and Lean Muscle declare 5a-Hydroxy-Laxogenin, an abbreviated name for 5-alpha-hydroxy-laxogenin,1 as a dietary ingredient; however, 5-alpha-hydroxylaxogenin is not a dietary ingredient. Under section 201(ff)(1) of the FD&C Act [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories. 5-alphahydroxy-laxogenin does not qualify as a dietary ingredient under section 201(ff)(1) of the FD&C Act because it is not a vitamin; a mineral; an amino acid; an herb or other botanical; a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any dietary ingredient from the preceding categories.
If a substance is not generally recognized as safe (GRAS) by qualified experts for its intended use in food and does not qualify for any of the other exemptions from the food additive definition, it is a food additive. Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. Adulterated foods cannot be legally imported or marketed in the United States.
Section 201(s) of the FD&C Act [21 U.S.C. § 321(s)] exempts dietary ingredients used in dietary supplements from the food additive definition. However, non-dietary ingredients intended for use in dietary supplements, such as the 5-alpha-hydroxy-laxogenin used in your products, are not exempt from the food additive definition and must meet the same requirements as substances added to conventional foods. In other words, a non-dietary ingredient added to a dietary supplement must be used in accordance with a food additive regulation or be GRAS for its intended use, unless it qualifies for another exception to the food additive definition.
5-alpha-hydroxy-laxogenin is not generally recognized as safe under its conditions of use in your dietary supplement products. Because 5-alpha-hydroxy-laxogenin does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your Lean Muscle For Her and Lean Muscle products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act because they contain an unsafe food additive. The introduction or delivery for introduction into interstate commerce of any food that is adulterated is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Aaron Dotson, Compliance Officer, via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Ann M. Oxenham
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration