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September 18, 2019

WARNING LETTER

19-HAFE4-WL-10/CMS No. 586947

VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED

Dear Mr. Thomas:

This letter concerns your products Elevate Smart Coffee, Choclevate, Elevate Nitro, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa, which are labeled and/or offered for sale as dietary supplements. The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 2231 Linwood Avenue in Naples, FL 34112-4737 on May 29-31, June 3, and June 10, 2019, during which we reviewed the product labels for these products that you manufacture. Our review of your product labels revealed that you declared the ingredient 2-amino-5 methylheptane and Octodrine as a dietary ingredient in several of the dietary supplements you manufacture, including Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa. The ingredients 2-amino-5 methylheptane and Octodrine are also called, among other names, 1,5-DMHA, 2-amino-6-methylheptane, 2-aminoisoheptane, 1,5-Dimethylhexylamine, 6- Amino-2-methylheptane, Amidrine, 2-Metil-6-amino-eptano, and 2-Isooctyl amine, 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 products, 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 ingredients 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 Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa 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 into 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.

Furthermore, during the inspection we reviewed the product label for the “CBD oil” (550mg) you distribute under the brand name “Green Roads.” This product is labeled as a dietary supplement; however, it cannot be a dietary supplement because it does not meet the definition of a dietary supplement under section 201(ff)(3)(B) of the Act [21 U.S.C. § 321(ff)(3)(B)]. FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) and (ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(i) and (ii)]. Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.2 FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.

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 Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa 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 Elevate Smart Coffee, Choclevate, Elevate Nitro, Revital U Smart Coffee, Valentus SlimRoast Optimum Dark Roast Coffee, and Valentus SlimRoast Optimum Cocoa 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 (15) 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.

Section 743 of the Act [21 USC § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 USC § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Your written reply should be directed to the Office of the District Director, U.S. Food and Drug Administration, San Juan District Office, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901. If you have questions regarding this letter, please contact Ms. Laura Kennedy, Compliance Officer, at (813) 915-7948, or via e-mail at: [email protected].

Sincerely,
/S/

Ramon A. Hernandez
District Director, San Juan District Office
Program Division Director,
Office of Human and Animal Food
Operations, Division IV East

_______________________

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.

2 CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations [21 CFR 312.2], unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the Act.