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The agency has now posted a warning letter it sent in December to a company called Revolt Distribution Inc.
FDA has censured another maker of melatonin-containing food products. Last July, the agency sent a warning letter to melatonin-brownie maker Lazy Larry. The agency has now posted a warning letter it sent in December to a company called Revolt Distribution Inc., stating that the company’s “Wownie Relaxation Brownie” and “Slowtivate Relaxation Drink” are conventional foods, not dietary supplements, and are therefore prohibited from including melatonin, an unapproved, non-GRAS-sanctioned additive for food.
The agency pointed out that the melatonin-containing products are packaged and marketed to appear to be conventional food.
“You market your “Slowtivate Relaxation Drink” product as a dietary supplement; however, it does not meet the definition of a dietary supplement because you represent it as a beverage, which is a type of conventional food,” FDA’s warning letter states. “Your use of a ‘Supplement Facts’ panel for nutrition labeling does not make your product a dietary supplement because you represent the product as a conventional food by using the term ‘drink’ in the statement of identity on the product label and marketing the ‘Slowtivate Relaxation Drink’ in a single serving can similar in size, shape, and appearance to those in which single servings of beverages like soda, fruit juice, and iced tea are sold.”
The agency had similar criticisms of “Wownie Relaxation Brownie,” stating: “Additionally, the use of terms such as ‘cookie’ or ‘brownie’ in the product’s statement of identity, the appearance and packaging of the product as a cookie (including the round cookie shape and clear plastic packaging), and the use of a combination of ingredients that includes sugar, flour, and cocoa (typical ingredients of brownies or cookies) establish that your ‘Wownie Relaxation Cookie’ is a conventional food.”
Nutritional Outlook thanks the American Herbal Products Association for the tip.