Liquid Should’s and Shouldn’ts

Recently, FDA sent a warning letter regarding the marketing and formulation of beverages as dietary supplements. The warning letter was sent to Innovative Beverage Group for its beverage product DRANK, an aluminum-canned 16-oz. liquid containing ingredients such as melatonin and valerian root, among other additives. The drink is marketed to “Slow your roll.” The regulatory issue, according to FDA, pertains to marketing the drink as a beverage (and therefore, according to FDA, a conventional food) such that, as a conventional food under existing laws, DRANK can only contain ingredients that are generally recognized as safe (GRAS) or ingredients that have prior sanctions for being acceptable food additives. Specifically, FDA noted, melatonin is not GRAS or previously sanctioned and thus cannot be included in a beverage; hence, the warning letter in which the agency offers several scientific studies corroborating their finding.

The overarching industry concern, here and in broader terms, relates to the difference between a beverage and a dietary supplement. As such, the issues raised in this particular case have immense implications for the industry: for instance, if DRANK marketed itself as a dietary supplement instead of a beverage (read: conventional food), would this issue of non-GRAS ingredients be moot? A dietary supplement, after all, can include melatonin because GRAS delineation only pertains to conventional foods, and, as current law states, a dietary supplement can contain non-GRAS ingredients if the ingredient is an old dietary ingredient (ODI)—which means an ingredient can be “grandfathered” into the legal, safe realm of ODI if it was used in a product sold before 1994. Melatonin happens to be an ODI.

So, instead of including the word “beverage” on its label, could DRANK merely replace it with “dietary supplement” to avoid the GRAS issue? Or is there something other than the printed word “beverage” that makes a liquid product a beverage, and not a dietary supplement—like its packaging, its serving size or its marketing?

FDA recently released a Guidance document addressing the same issue. Though still in draft form and open to input from consumers and industry insiders alike, that guidance, if finalized, will alter the environment in which dietary-supplement and beverage producers market and manufacture their products. As the guidance states, “Even when the label of a liquid product characterizes it as a dietary supplement, the product may not in fact be a dietary supplement.” Further, “FDA considers a liquid product’s name, packaging, serving size and recommended conditions of use … to be important determinants of whether the product is represented as a conventional food and may not be marketed as a dietary supplement.” DRANK—with its cola-like can, advertising, and serving size—looks to be luckless in this view.