All of the negative publicity generated by Lazy Cakes and other “relaxation” foods and beverages is drawing the attention of the FDA. In fact, a spokesperson for the agency, Stephanie Yao, wrote in an e-mail to the New York Times that any food product containing melatonin “as an additive may be subject to regulatory action.”

The FDA also recently issued a letter to food and beverage manufacturers outlining its rules for the use of novel ingredients in food and beverage products. According to the letter, “food additives require pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition, ordinarily by the producer. A substance is exempt from the definition of a food additive and thus, from pre-market approval, if, among other reasons, it is generally recognized as safe (GRAS) by qualified experts under the conditions of intended use.”

The agency said it issued the communiqué because of trepidation over the growing number of food and beverage products containing novel ingredients, such as herbal extracts, that have not been used as food additives in the past.

“The FDA is concerned that some of the herbal and other botanical ingredients that are being added to conventional foods may cause the food to be adulterated because these added ingredients are not being used in accordance with an approved food additive regulation and may not be GRAS for their intended use,” the agency wrote.