The brownies contain melatonin. The FDA wrote: 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
Here is the letter:
The Food and Drug Administration (FDA) has reviewed the regulatory status of your product, “Lazy Larry” (formerly “Lazy Cakes”). Your “Lazy Larry” product is adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 342(a)(2)(C)] because it bears or contains an unsafe food additive. Specifically, it contains 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 FDCA [21 U.S.C. § 348]. The regulations pertaining to the general provisions for food additives are located in Title 21, Code of Federal Regulations (21 CFR), Part 170. You can find copies of the FDCA and these regulations through links on FDA’s home page at http://www.fda.gov.
Your “Lazy Larry” product is represented for use as a conventional food, and accordingly is not a dietary supplement, as defined under Section 201(ff) of the FDCA [21 U.S.C. § 321(ff)]. The FDCA 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 U.S.C. § 321(ff)(2)(B)]. Your use of the term “dietary supplement” in the statement of identity and your use of a “Supplement Facts” panel for nutrition labeling do not make your product a dietary supplement, because your “Lazy Larry” product is represented for use as a conventional food. Examples of factors and information that establish that the product is represented as a conventional food are as follows:
- the product is marketed alongside snack foods;
- the name of a URL, www.mylazycakes.com (accessed 7-14-11), that directs people to your product website, refers to a conventional food (cake);
- the product is described on your website (accessed 7-14-11) as having “the same ingredients your mother uses to make brownies,” which is a conventional food;
- the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight);
- the appearance and packaging of the product as a brownie.
As previously sold, your “Lazy Cakes” product additionally was represented for use as conventional food, for example, by the use of the words “cakes” in the product name and use of the word “brownie” in the statement of identity on the package label.