Companies in the dietary supplement industry have danced on this labeling language tightrope for years. One example is to use words whose first letters, capitalized and printed in a different color, add up to an acronym for a disease condition. Another ploy could be to use bits of words like “medicine” woven into the very names of the products. Other examples could be the clever use of rhymes to tip off a consumer to what you really mean (wink, wink).
Interpreting the fine lines
None of these practices are expressly forbidden in the chapter and verse of regulation, and whether they cross the line into disease claim language is a matter of interpretation. In the warning letter that the US Food and Drug Administration sent to Biomin Industries of Tempe, AZ in mid October, the agency made the case that the company had fallen off that tightrope into the forbidden claims pitfall below.
FDA redacted the full names of the offending products, perhaps because Biomin is a contract manufacturer and another entity likely is involved in their distribution. FDA took Biomin to task for the labels of three products, one because “[T]he name of the product and its similarity to ‘allergies,’ and another, whose name in part was ‘Antibiotc,’ which the agency objected to because of “[T]he name of the product and its similarity to the drug category ‘antibiotic.’” The third contained what FDA has come to interpret as an outright disease claim: “Designed to eliminate inflammation.”
In other instances that involve products made by a contract manufacturer (which account for a large percentage—possibly a majority—of the dietary supplements in distribution in the US) FDA has made the case that the brand holder has the ultimate responsibility for how those products are manufactured, what the labels say and other aspects of regulatory compliance. But here the agency reiterates that that responsibility is in fact a shared one:
“To the extent that your firm manufactures, packages, and labels products on behalf of another firm that releases for distribution that product under their firm’s name, your firm nevertheless has an obligation to know whether that product’s label and labeling is in conformance with the Act. Although a firm may be under contract to perform certain manufacturing, packaging and labeling operations, it cannot contract out its ultimate responsibility to ensure that the products it places into commerce (or causes to be placed into commerce) comply with the Act,” the warning letter states.
What’s the intent?
Attorney Ivan Wasserman, who has advised many companies on labeling questions in his practice as a partner in the firm Amin Talati Upadhye, said that FDA will use all of the information available to determine what the company intends as the end use of the product. If you’re getting cute with the language, and seem to be suggesting that while you can’t mention a disease outright on the label, if consumers suffer from the disease you’re hinting at they might benefit from your product, the agency will take you at your word.
“FDA has I’m sure mentioned this before, but the name of a product can certainly be a claim and evidence of its intended use. If there is an implied claim, FDA can take the position that you are implying your product is intended for a drug use,” Wasserman told NutraIngredients-USA.
Wasserman said he’s sympathetic to the struggle brands have to differentiate their offerings and to build consumer loyalty. With so many seemingly identical products on the market, how do you stand out? Nevertheless, the effort can backfire if the regulators or others, like class action lawyers, see fit to get involved, he said.
“The effort is certainly fraught with peril. I’m reminded of the class action suit that was filed against the cereal Froot Loops, because it was alleged that the name implied there was real fruit in it. I always tell companies that if you are going to be aggressive in a product name to be extremely cautions in the copy associated with that product to make sure the express and implied claims are crystal clear,” he said.