Memphis-based HBB, LLC, which makes Lazy Larry chocolate brownies (formerly Lazy Cakes) containing the neurohormone melatonin, received a warning letter from the Food and Drug Administration (FDA) on July 28.
This claimed that the brownies were being marketed as conventional foods but contained ingredients without the necessary regulatory approvals for use in food (melatonin is not an approved food additive or considered GRAS - generally recognized as safe).
HBB: Taking immediate steps to achieve compliance
But HBB chief executive Terry Harris said he was confident that with some changes to the packaging and marketing, the product would comply with the law.
He added: “We are taking immediate steps to address the concerns expressed in the [FDA’s] letter, all of which stem from the way the product is packaged, labeled and marketed.
“To be clear, there has never been any suggestion by anyone that the product itself is unsafe in any way. We look forward to continuing to work closely with the FDA to immediately remedy these concerns, and to ensure compliance with FDA’s dietary supplement regulations.”
As melatonin has been sold in dietary supplements for many years, it is considered ‘grandfathered in’ under the 1994 Dietary Supplement Health and Education Act (DSHEA) and HBB would not have to submit fresh regulatory filings to sell it as a supplement, assuming it can prove it was sold as a dietary supplement before 1994.
Stores encouraged to stock brownies alongside energy shots or with other supplements
The firm, which markets its products as “a dietary supplement to aid adults who lead a stressful energy-drink fueled lifestyle to wind down and relax”, said it had sold “more than 2 million units” in just over six months.
It added: “While in-store placement is the decision of each individual storeowner or manager, HBB encourages stores to place these products alongside the energy shots or with other dietary supplements that are also produced for adult consumption.”
CRN: FDA action should take wind out of Sen Durbin’s sails…
Council for Responsible Nutrition (CRN) chief executive Steve Mister told NutraIngredients-USA that the swift FDA action should take the wind out of the sails of Senator Durbin, who recently wrote to the FDA complaining that the cakes were “marketed in ways that are inconsistent with federal law”.
In a letter to FDA commissioner Margaret Hamburg, Durbin said: “The distinction between dietary supplements and foods with dietary ingredient additives is not always clear.”
But Mister said: “The FDA’s December 2009 guidance on liquid dietary supplements vs conventional beverages is very instructive as to what FDA is thinking on this and could as easily apply to cakes and snacks as beverages. You can sell nutrition bars as dietary supplements but they must be clearly marketed as supplements and positioned next to other supplements, not on the counter as a snack.
“The FDA is concerned that while foods have serving sizes, there will be people that will eat three at a time, whereas when you know something is a supplement, you see the dosage and you stick with it. You can have too much melatonin.”
Food or supplement?
In its warning letter to HBB, the FDA said the fact that HBB had used the term ‘dietary supplement’ and included a supplement facts panel on pack did “not make your product a dietary supplement, because your Lazy Larry product is represented for use as a conventional food”.
However, the legal dividing line between dietary supplements and conventional foods and beverages has been the subject of much debate.
And draft guidance issued by the FDA in December 2009 has only added to the controversy, with several lawyers claiming it contradicts the legislation it was designed to clarify.
Indeed, scores of products currently on the market are in breach of the guidance, according to New York-based lawyer Steven Shapiro, who was speaking to NutraIngredients-USA at the Supply Side East show in May.
Serious consequences for industry
Historically, argued Shapiro, the FDA had advised industry that it didn’t matter if a liquid dietary supplement was packaged like a conventional beverage, as long as it was labeled as a supplement.
However, the recent guidance appeared to throw this on its head by arguing that where a dietary supplement was merchandised, what it looked like, how much liquid was in it and whether it physically resembled a conventional food/drink product did matter, he said.
“If the FDA suddenly decides to start enforcing this guidance, which runs contrary to dietary supplements legislation and to its own previous advice, there could be serious consequences for industry.”
The FDA, meanwhile, said feedback it had received about the guidance had raised “several complex legal questions that we are considering”.