Marco Moran, President
Dewmar International BMC, Inc.
101 Convention Center Drive, Suite 700
Las Vegas, Nevada 89109
Dear Mr. Moran:
The Food and Drug Administration (FDA) has reviewed the regulatory status of the ingredients declared on the label of your beverage products, Lean Slow Motion…Potion (Easta Pink, Purp, and Yella varieties) and has determined your products are adulterated under Section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(2)(C)] because they bear or contain an unsafe food additive. Specifically, the products contain melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4), which is a neurohormone and is an unapproved food additive under Section 409 of the Act [21 USC 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations, Part 170 (21 CFR 170).
Additionally, based on our review of your product labels, your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 of the Act [21 USC 343]. You may find the Act and FDA regulations through links at FDA’s Internet home page at www.fda.gov.
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are represented for use as conventional foods, and accordingly are not dietary supplements, as defined under Section 201(ff) of the Act [21 USC 321(ff)]. The Act excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 USC 321(ff)(2)(B)]. Your use of the term “dietary supplement” below the Nutrition Facts panel on your product labels does not make your products dietary supplements, because your Lean Slow Motion…Potion products are represented for use as conventional foods. Examples of factors and information that establish that the products are represented for use as conventional foods are as follows:
Unapproved Food Additive
Any substance added to a conventional food, such as your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) beverage products, must be used in accordance with a food additive regulation, unless the substance is the subject of a prior sanction or is generally recognized as General Recognized As Safe (GRAS) among qualified experts for its use in foods [21 CFR 170.30(g)]. There is no food additive regulation that authorizes the use of melatonin. We are not aware of any information to indicate that melatonin is the subject of a prior sanction (see 21 CFR 181). As explained below, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.
FDA's regulations in 21 CFR 170.30(a)-(c) describe criteria for eligibility for classification of a food ingredient as GRAS. General recognition of safety must be based only on the views of qualified experts. The basis of such views may be either (1) scientific procedures, or (2) in the case of a substance used in food prior to January 1, 1958, through experience based on common use in food. In addition, general recognition of safety requires common knowledge about the substance throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food.
We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958. Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders. In assessing the GRAS status of melatonin for use in a conventional food such as “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella),” we considered the criteria described above. FDA is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods. On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns about effects on blood glucose homeostasis (References 1- 4), and effects on the reproductive/developmental (References 5- 11), cardiovascular (References 12- 18), ocular (References 19- 21) and neurological systems (References 22, 23). Therefore, the use of melatonin in your “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella)” products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exemption from the food additive definition that would apply to melatonin for use as an ingredient in a conventional food, such as your beverage product. Therefore, melatonin added to a conventional food is a food additive under Section 201(s) of the Act [21 USC 321(s)] and is subject to the provisions of Section 409 of the Act [21 USC 348]. Under Section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Melatonin is not approved for use in any food, including beverages. Therefore, your “Lean Slow Motion…Potion (Easta Pink, Purp, and Yella)” products are adulterated within the meaning of Section 402(a)(2)(C) of the Act [21 USC 342(a)(2)(C)].
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)]. As discussed above, the products are represented for use as conventional foods, however, below the Nutrition Facts panel, the labels state: “DIETARY SUPPLEMENT.”
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403 (i)(1) of the Act [21 USC 343(i)(1)] because they fail to bear a statement of identity in accordance with 21 CFR 101.3.
Your Lean Slow Motion…Potion (Easta Pink, Purp, and Yella) products are misbranded within the meaning of Section 403(q) of the Act [21 USC 343(q)] because the nutrition information is not in an appropriate format, as specified in 21 CFR 101.9. For example:
This letter is not intended to be an all-inclusive list of violations in your products. It is your responsibility to ensure all of your products comply with the Act and other applicable regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure or injunction.
You should respond in writing within 15 working days from the date you receive this letter. Your response should include specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned correction will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact Ms. Dutzek at (615) 366-7826.
Patricia K. Schafer
New Orleans District