CRN, NPA Ask FDA to Take Action on Melatonin Baked Goods

Following a letter sent to FDA last week by U.S. Senator Dick Durbin (D-IL) asking the agency to clarify its position on allowing additives such as melatonin in baked goods, associations representing the dietary supplements industries have released statements also asking the agency for clarity on the matter. The associations emphasize that the supplements industry at large does not condone the addition of unapproved additives in food. []

Steve Mister, CRN’s president and CEO, stated: “Conventional food products, including cakes and brownies, that are fortified with a dietary ingredient, such as melatonin, are not dietary supplements despite being labeled that way; they are mislabeled conventional foods.”

“A dietary ingredient is intended to do just that-supplement the diet,” Mister stated. “Products labeled or marketed as being part of the diet-as a ‘cake’ or ‘brownie’ would be-are conventional foods, not supplements. For a conventional food product to include a dietary ingredient, a company must either seek approval as a food additive or achieve generally recognized as safe (GRAS) status for the ingredient.”

He concluded: “FDA’s authority to distinguish between conventional foods and dietary supplements is well established, as demonstrated by its guidance last year on beverages fortified with dietary ingredients, and FDA has ample tools to enforce the law. CRN has reached out to the agency and encouraged it to take swift action against these products.”

John Gay, executive director and CEO of NPA, also added his comments: “The current controversy over certain baked goods claiming to be dietary supplements demands clarity and action.

“First, clarity. The Natural Products Association believes the products in question-brownies containing melatonin-are conventional foods falsely labeled as supplements. Simply calling a product a ‘dietary supplement’ does not make it so. There are specific rules for what qualifies as a supplement as opposed to what qualifies as conventional food.

“Second, action. We urge the Food and Drug Administration to take quick action on these or any products masquerading as a dietary supplement. In fact, the FDA has taken such action before, and we urge them to do so again….We again endorse FDA to hold accountable those who violate the law by marketing products they claim are supplements but, in reality, do not qualify as supplements.”