Here's the FDA Warning Letter:
The 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).
The 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:
- Your products are described as beverages on the information panels of the cans.
- The “Products” page on your website describes your Yella product as for people who like “pineapple-based Fanta” carbonated soft drink, your Purp product as for people who “like it raw mixed with Sprite” carbonated soft drink and your Easta Pink product as inspired by “Sprite Easta Pink.”
- The homepage of your website, www.slowmotionpotion.com, refers to your line of products as, “#1 relaxation beverage” and “the most potent relaxation drink.”
- The “Products” page on your website describes the flavor of your Yella product as having a “hint of red Jolly Rancher flavor” and “unique flavor combination that is ranked number 1 in blind taste tests.” The page describes the flavor of your Purp product as including “grape Jolly Rancher candy.” The page describes the flavor of your Easta Pink product as “a secret flavor combination” that “creates the sweetest of the Leans.”
- Your products, sold in single-serving pop-top aluminum cans, have the appearance and packaging of carbonated soft drinks.
- Your products contain a Nutrition Facts label.
- Your products are comprised of typical ingredients for carbonated soft drinks (carbonated water, sugar, citric acid, natural flavor, potassium sorbate, sodium benzoate) plus melatonin and extracts.
- The president’s message on your company website at www.dewmarinternational.com/presidents-message/ refers to your products as “relaxation beverages” and a “beverage brand.”
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.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390967.htm
