“Guidance or no guidance, this warning letter is a no-brainer,” Marc Ullman, partner at New York-based food and drug law firm Ullman, Shapiro & Ullman, told NutraIngredients-USA. “This company labeled the product as a dietary supplement on the principal display panel and also had a Nutrition Facts display! It’s a no-brainer.”
In addition to contradictory on-pack labeling, the product—available in Easta Pink, Purp and Yella varieties—is also referred to as a relaxation drink in marketing materials (contains melatonin), is sold in single-serving, pop top cans and comprises "typical" soft drink ingredients (carbonated water, sugar, citric acid, sodium benzoate, etc), according to the March 27 FDA letter (read full text here ). Moreover, in the products section of its website, Dewmar describes Yella as a product for people who like the "pineapple-based Fanta" carbonated soft drink, and likens Purp's flavor to “Sprite and grape Jolly Rancher candy".
“The guidance really made it very clear that the FDA would take a holistic approach,” Ullman added. “When you couple a supplement label with descriptions of the product as a beverage ... or when you compare some of the products to a soft drink and call it a 'relaxation drink', you’re presenting it as a conventional food.”
FDA case-specific approach not black and white for manufacturers
Based on the parameters set forth by the guidance, “companies really have that choice of which way they want to do it," noted attorney Justin Prochnow, shareholder in Greenburg Traurig LLP, who specializes in beverage. "The number-one thing is, they have to be consistent. If you label your product as a supplement, then you should provide supplement facts on the label.”
That said, targeting “low-hanging fruit” like this suggests that the agency is sending warning shot to the industry at large, he added.
“It’s a case of as long as you’re fairly consistent, it’s unlikely FDA will come after you,” he said. “I expect we’ll see a few more warning letters come out and maybe even to a few large companies. In general that’s been the trend of the FDA after a guidance comes out just to tell the industry, we are going to be looking to make sure companies are complying within these general parameters.”
Still, Prochnow said that the FDA’s case-by-case approach to the issue of beverages versus supplements leaves many operating in a large gray area. “It’s interesting; the number-one question I get from new clients is, ‘Should I sell as a beverage or supplement?' It’s a topic that comes up an awful lot,” he said.
Melatonin warrants even more scrutiny
Also at issue with Dewmar? The products' inclusion of melatonin , which lacks the necessary regulatory approvals for use in food. “Once you present the product as a conventional food, every ingredient has to be either an approved food additive or GRAS [generally recognized as safe], and melatonin is neither,” Ullman noted.
Melatonin has often been a focus in the debate over where food ends and a supplement begins. The neurohormone, which has been sold in dietary supplements for many years, is grandfathered in under the 1994 Dietary Supplement Heath and Education Act.
“The FDA has issued three or four warning letters regarding melatonin, so it’s clearly an ingredient the FDA has concerns about,” Prochnow said. “So if you’re a company selling a supplement with melatonin, you have to be even more careful than others, since the FDA will look at those types of products to make sure they’re following the parameters of a supplement.”
Above all, Ullman said, companies like Dewmar are taking market share from those firms working to comply with the FDA’s guidance, which he says reinforced the FDA’s action, particularly because there's no private right of enforcement in this case.
“We shouldn’t be seeing a lot of these letters, because the guidance is pretty straightforward,” he said. “It’s appropriate for FDA to act in situations like this, where agency needs to step in and protect those companies that are working to comply from having market share stolen from them by unscrupulous marketers.”