On March 27, within months of finalizing relevant guidance documents, FDA issued a warning letter to the maker of Lean Slow Motion...Potion for using an unapproved food additive in a product FDA considered to be a conventional food beverage, in spite of the manufacturer's labeling the product as a dietary supplement. In its first warning letter on this issue since the liquid dietary supplements guidance was finalized in January, FDA warned the manufacturer that the beverage drinks are adulterated under federal law because they contain melatonin, which is not approved for use in food. Any substance added to a food product must comply with a food additive regulation or be recognized as GRAS. FDA included in the warning letter a list of factors it evaluated to determine the product was represented for use as a conventional food and not a liquid dietary supplement, which reflected items presented in the guidance.
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