Sen. Dick Durbin wants FDA to issue guidance clarifying the agency's authority to regulate foods containing dietary ingredients as additives.

In his May 18 letter to Commissioner Margaret Hamburg, the Illinois Democrat highlights melatonin-containing baked goods with brand names like Lazy Cakes, Kush Cakes and Lulla Pies that are marketed as dietary supplements claiming to provide a harmless way to promote relaxation.

FDA has not approved melatonin as a food additive, the senator points out. If the agency determines these snack cakes are foods containing a dietary ingredient additive, "the manufacturers would be responsible for determining that melatonin is generally recognized as safe or failing this, the FDA would have to approve or reject melatonin as a food additive," Durbin adds.

The agency in 2010 said melatonin is not generally recognized as safe as a food additive as it took enforcement action against Innovative Beverage Group for its drank liquid supplement ([A#0518010004].

FDA has not yet determined whether the products at issue are a food or dietary supplement, and will respond directly to the senator, an agency spokesman said.

The distinction between supplements and foods with dietary additives "is not always clear, leaving room for some food products to be marketed as dietary supplements in order to circumvent the safety standards required for food additives," Durbin adds in the letter.

Durbin has been an outspoken critic of supplements and the Dietary Supplement Health & Education Act, but he also worked in concert with industry on the mandatory adverse event reporting law passed in 2006 (Also see "Bigger Stage Expected For Durbin’s Supplement Industry Criticism" - Pink Sheet, 10 November, 2008.).

"This isn't a dietary supplement," attorney Marc Ullman emphasized in an interview. "It's a food. It might be adulterated, but it's a food."

Firms marketing these products should "at a minimum" get a warning letter advising them they are marketing "an adulterated, misbranded food" and demanding corrective action in 15 days, said Ullman, a partner with the New York firm Ullman, Shapiro and Ullman.

"I'd like to see this operation shut down," he said, adding, "I think the product is completely out of compliance and the marketing makes it potentially dangerous."

The Council for Responsible Nutrition also called for regulatory action against the products, emphasizing that products "labeled or marketed as being part of the diet," as a brown or cookie would be, are conventional foods.

By Carolyn B. Phenicie

Melatonin Snacks Prompt Durbin Questions On Dietary Ingredients in Food

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