COLLEGE PARK, Md.—After months of industry outcry for FDA action, the agency warned HBB LLC d.b.a. Baked World, Memphis, TN, that its Lazy Larry (formerly “Lazy Cakes") brownies are adulterated because they contain melatonin, an unapproved food additive. The product, although the package says it is a dietary supplement, is represented for use as a conventional food, according to a letter FDA send to Terry Harris at HBB.
This issue was much debated among industry experts on the SupplySide Community, where the consensus was that these products were marketed as foods despite the product label. It appeared the company was trying to get around regulations for food products by labeling the product as supplements, a practice some feared would taint the entire industry.
Indeed, a month after a New York Times article on Lazy Cakes and similar products, Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) introduced the Dietary Supplement Labeling Act (S. 1310) to target products that blur the line between dietary supplement and food/beverage. The supplement industry criticized the bill as redundant, saying the products that drove the creation of the bill—namely melatonin-containing baked goods—are already covered in existing regulations. “With continued pressure from people like Senator Durbin and his new bill, FDA may ramp up the efforts to 'regulate' supplements and identify products posing as supplements for what they really are," said Justin J. Prochnow, attorney and shareholder, Greenberg Traurig LLP.
"It’s an important letter because it demonstrates that FDA has the tools to address these kinds of concerns in the marketplace and that they are willing to use them," said Steve Mister, president and CEO, Council for Responsible Nutrition (CRN). "When you have issues that are so high profile, being covered in the New York Times and getting Sen. Durbin exercised, those are certainly issues that FDA needs to step in and do something."
Mister added that the warning letter shows how Sen. Durbin's bill is unecessary. "Sen. Durbin introduced legislation in June and cited this incidence as a reason that we needed to give FDA more authority to clarify differences between foods and supplements. The FDA already has the authority; we don’t need more legislation. This warning letter demonstrates that they do have the authority, and they can use it."
In FDA’s July 28 warning letter to Harris, it said “Lazy Larry" products are adulterated under section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 342(a)(2)(C)] because melatonin (5-methoxy-N-acetyltryptamine, CAS Reg. No. 73-31-4) is a neurohormone and is an unapproved food additive under section 409 of the FDCA [21 U.S.C. § 348].
FDA noted the product is considered a food and not a supplement because:
- The product is marketed alongside snack foods;
- The name of a URL, MyLazyCakes.com (accessed July 14, 2011), that directs people to the product website, refers to a conventional food (cake);
- The product is described on the website (accessed July 14, 2011) as having “the same ingredients your mother uses to make brownies," which is a conventional food;
- The use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg and salt, in order of predominance by weight);
- The appearance and packaging of the product as a brownie.
- As previously sold as “Lazy Cakes," the product was represented for use as conventional food, for example, by the use of the words “cakes" in the product name and use of the word “brownie" in the statement of identity on the package label.
"It’s a good reminder to industry that FDA likes clean compartments for its legislation," Mister said. "Either you’re a conventional food or you’re a supplement. If you straddle that line, you’ve got to commit one way or the other."
Prochnow said this is the first letter that reflects the action that FDA , in a 2009 Draft Guidance, said it might take regarding liquid supplements that it really considers to be beverages, even though this product is a food. “I would not be surprised to see more letters like this pop up in the near future," he said. “I think the letter could be an indication that FDA is intending to be more aggressive about going after companies that are selling products as supplements solely to take advantage of greater perceived leeway with respect to ingredients and claims."
In response to this warning letter, Prochnow said liquid supplement companies should take a hard look at how their products are marketed and pay close attention to serving and container size, directions of use, etc. “If FDA believes the product is really replacing normal beverage intake, it could take similar action against liquid supplements."
Prochnow further noted FDA sent a warning letter to Innovate Beverages for Drank in January 2010 regarding the use of melatonin in a beverage, but the agency did not follow up on that letter nor on the 2009 Draft Guidance for Industry on liquid supplements vs. beverages. “It will be interesting to see whether this is an isolated incident or the sign of increased regulation in this area," he said. “I will be interested to see whether FDA sends out any letters to beverage/supplement companies next."
Regarding how this letter may affect the liquid supplement market, Mister said, "I don’t think you can’t sell these products, but it’s a reminder that FDA is active in this area. So, as a company, you need look at your products, look at the guidance and be sure you can defend why you’ve chosen the route that you chose."
Any substance added to a conventional food must be used in accordance with a food additive regulation or be GRAS (generally recognized as safe) according to 21 CFR 170.30(g). Melatonin, FDA pointed out in the letter to HBB, is not a food additive nor considered GRAS.
Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders, FDA said, adding reports in the scientific literature have raised safety concerns about the use of melatonin. Among these are concerns are effects on blood glucose homeostasis, and effects on the reproductive/developmental, cardiovascular, ocular and neurological systems. “Therefore, the use of melatonin in your ‘Lazy Larry’ product does not satisfy the criteria for GRAS status under 21 CFR 170.30," FDA wrote.
FDA gave HBB 15 days from the receipt of the warning letter to provide the specific steps it has taken to correct the violation and to assure that similar violations do not occur in the future .