The maker of the melatonin-laced ‘relaxation’ brownies at the center of a debate over where a dietary supplement ends and a food begins says it will make “all necessary changes to market and sell the product as a supplement”.
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.”
Source: Nutraingredients USA