Senator Dick Durbin (D-IL) has asked the FDA to clarify its regulatory position on dietary supplements and food additives on the back of widespread concerns about the marketing of melatonin-containing baked goods.
Melatonin supplements are widely marketed to promote sleep and can be bought over the counter in the United States, although they require a prescription in Europe. Melatonin-containing brownies and cakes, under brand names like Lazy Cakes, Kush Cakes and Lulla Pies, have made headlines in the past week, with two Massachusetts mayors calling for the products to be banned. They claim that the products appeal to children, even though Lazy Cakes’ website explicitly says that the brownies are intended for adults only.
Durbin claims marketing melatonin-containing foods as dietary supplements means that they “do not need to establish evidence of their products’ safety and effectiveness or require pre-market approval”.
In a letter to FDA commissioner Margaret Hamburg, Durbin wrote: “The website for Lazy Cakes claims their product is, ‘a delicious, chocolate alternative to medication and harmful narcotics to help you safely relax and fall asleep.’ These products appear to be promoting themselves as therapeutic alternatives to medications. As such, the products may be marketed in ways that are inconsistent with federal law.”
However, partner at food and drug law firm Ullman, Shapiro & Ullman, Marc Ullman told FoodNavigator-USA.com: “Senator Durbin’s letter is completely disingenuous.” He said that the brownies could pose a public health risk, but that if someone becomes ill or has an accident as a result of eating these products, the dietary supplements industry should not be implicated.
“A brownie is not a dietary supplement,” he said. “…At a minimum they are adulterated foods because I am unaware of anybody doing the work that melatonin – at any dose – is generally recognized as safe for use in snack foods…I am hopeful that the FDA will take some pretty swift action on this.”
Melatonin is also a common ingredient in relaxation drinks, which have managed to carve out a niche as the flip side to the energy drinks market. Research firm Zenith International groups the two categories together and said earlier this year that the global market for alertness and relaxation drinks has surpassed the $500m mark.
The United States is by far the biggest market, with regulatory hurdles holding them back in European countries, according to Zenith.
Ullman has previously warned that makers of relaxation beverages could face problems in light of the FDA’s draft guidance on the distinction between dietary supplements and beverages.
Indeed, last January the FDA issued a warning letter to the makers of relaxation beverage Drank, saying the melatonin it contains is an unapproved food additive. The issue remains unresolved.