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WARNING LETTER

UNITED PARCEL SERVICE SIGNATURE REQUIRED

May 4, 2022

RE: 622401

Dear Mr. Peterson:

This letter concerns your products Lipo Red and StimoVEX XT, 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 Act and FDA regulations through links on FDA’s website at https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and- cosmetic-act-fdc-act and the FDA regulations at https://www.ecfr.gov/current/title-21.

Adulterated Dietary Supplement: Unsafe Food Additive

The label of your product StimoVEX XT declares hordenine HCl as a dietary ingredient; however, hordenine HCl 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. Hordenine HCl 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 hordenine HCl used in your product, 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.

Hordenine HCl is not generally recognized as safe under its conditions of use in your dietary supplement product. Because hordenine HCl does not qualify as a dietary ingredient and is not GRAS or otherwise exempt from the food additive definition, your StimoVEX XT product is adulterated under section 402(a)(2)(C)(i) of the FD&C Act because it contains 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)].

Adulterated Dietary Supplement: New Dietary Ingredient

The label of your Lipo Red product declares octopamine as a dietary ingredient. Octopamine is a “dietary ingredient” under section 201(ff)(1)(F) of the FD&C Act [21 U.S.C. § 321(ff)(1)(F)] because it is a constituent of bitter orange and other botanicals. As explained below, octopamine is also a “new dietary ingredient” (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) under section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)].

Under section 413(a) of the FD&C Act [21 U.S.C. § 350b(a)], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the FD&C Act [21 U.S.C. § 342(f)] unless it meets one of two requirements:

1.    The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

2.    There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

To the best of FDA’s knowledge, there is no information demonstrating that octopamine was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that octopamine has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. Therefore, octopamine is subject to the premarket new dietary ingredient notification requirement in section 413(a)(2) of the FD&C Act [21
U.S.C. § 350b(a)(2)] and 21 CFR 190.6. FDA has not received any NDI notifications pertaining to the use of octopamine in dietary supplements. Products for which the manufacturer or distributor is required to submit a new dietary ingredient notification under section 413(a)(2) and 21 CFR 190.6, but for which the required notification has not been submitted, are adulterated under sections 402(f) and 413(a) of the FD&C Act [21 U.S.C. §§ 342(f) and 350b(a)]. The introduction of such adulterated dietary supplements into interstate commerce is prohibited under sections 301(a) and (v) of the FD&C Act [21 U.S.C. § 331(a) and (v)].

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 products are 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 [email protected]. If you have any questions, you may also email at [email protected].

 
Sincerely,
/S/
Ann M. Oxenham Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration