Hi Tech Pharmaceuticals - 560788 - 04/10/2019

WARNING LETTER

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

April 10, 2019

Jared Wheat, CEO & Founder

Hi-Tech Pharmaceuticals, Inc.

6015 B Unity Drive

Norcross, GA 30071-3575 US

Re: 560788

Dear Mr. Wheat:

This letter concerns your products Ultimate Orange, HydroxyElite, Lipodrene Elite, and Synadrene, which are labeled and/or offered for sale as dietary supplements. The Supplement Facts panel on your product labels declares 2-Aminoisoheptane HCl as a dietary ingredient. This ingredient is also called, among other names, 1,5-DMHA, 2-amino-6-methylheptane, 2-amino-5methylheptane, 1,5-Dimethylhexylamine, 2-Isooctyl amine, and Octodrine, and will be referred to hereinafter as DMHA.

The term “dietary supplement” is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)]. Given that you have declared DMHA as a dietary ingredient in the labeling of your product, we assume you have a basis to conclude that DMHA is a “dietary ingredient” under section 201(ff)(1) of the Act [21 U.S.C. § 321(ff)(1)]. If you have a basis to conclude that DMHA is a “dietary ingredient,” it would also be 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 Act [21 U.S.C. § 350b(d)].

Under section 413 of the Act [21 U.S.C. § 350b], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the 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 DMHA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient 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. Assuming DMHA is a dietary ingredient, in the absence of such information, DMHA would be subject to the notification requirement in section 413(a)(2) of the Act [21 U.S.C. § 350b(a)(2)] and 21 CFR 190.6. 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 Act [21 U.S.C. §§ 342(f) and 350b(a)].

Even if a new dietary ingredient notification had been submitted under section 413(a)(2) and 21 CFR 190.6, we know of no evidence that would establish that DMHA could be lawfully marketed as a new dietary ingredient in your Ultimate Orange, HydroxyElite, Lipodrene Elite, and Synadrene products. In the absence of a history of use or other evidence of safety establishing that DMHA, when used under the conditions recommended or suggested in the labeling as a dietary ingredient, will reasonably be expected to be safe, dietary supplements containing DMHA as a new dietary ingredient are adulterated under sections 402(f) and 413(a) of the Act because there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such products into interstate commerce is prohibited under sections 301(a) and (v) of the Act [21 U.S.C. § 331(a) and (v)]. To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that DMHA will reasonably be expected to be safe when used as a dietary ingredient.

We also note that we have questions about whether DMHA is, in fact, a dietary ingredient. If DMHA were not a dietary ingredient under section 201(ff)(1) of the Act, it would be an unsafe food additive. 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.[1] 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 Act [21 U.S.C. § 342(a)(C)(i)]. Adulterated foods cannot be legally imported or marketed in the United States.

Section 201(s) of the 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 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.

DMHA it is not generally recognized as safe under its conditions of use in your dietary supplement products. If DMHA is not a dietary ingredient under section 201(ff)(1) of the Act, dietary supplements containing DMHA would be adulterated under section 402(a)(2)(C)(i) of the Act because they would contain an unsafe food additive.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.

You should take prompt action to correct the violations addressed in this letter, as well as any other violations associated with your Ultimate Orange, HydroxyElite, Lipodrene Elite, and Synadrene products or other dietary supplement products marketed by your firm, including any that contain DMHA. We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered. Failure to immediately cease distribution of your products Ultimate Orange, HydroxyElite, Lipodrene Elite, and Synadrene, and any other products you market that contain DMHA, could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334].

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your written reply should be directed to Mr. Rob Genzel Jr., Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, you may also contact Mr. Genzel at rob.genzel@fda.hhs.gov.

Sincerely,

/S/

William A. Correll

Director

Office of Compliance

Center for Food Safety and Applied Nutrition

[1] Under section 201(s) of the Act [21 U.S.C. § 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the Act, the Poultry Products Inspection Act, or the Meat Inspection Act); (5) new animal drugs; and (6) dietary ingredients in or intended for use in a dietary supplement.

U.S. Food and Drug Administration

Hi Tech Pharmaceuticals MARCS-CMS 560788 — April 10, 2019