Friday, April 24, 2015 11:38:40 AM
WARNING LETTER NO. 2014-NOL-13
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).
...
http://www.fda.gov/iceci/enforcementactions/warningletters/ucm390967.htm
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