New York, NY—WholeFoods reported last month on the U.S. Food and Drug Administration’s (FDA) publication of draft guidelines concerning the distinction between beverages and liquid dietary supplements. Since then, as part of the commentary phase of the FDA guideline process, Ullman, Shapiro and Ullman, LLP have submitted a thorough response statement in opposition to the proposed FDA guidelines.
The FDA guidelines state that based on its packaging, among other factors, a liquid product can be considered a conventional food, and placed under the regulatory guidelines for food products. In other words, were these guidelines accepted, a product designated by its manufacturer as a dietary supplement may be considered a conventional beverage if it appears like one on a store shelf. If something is packaged in a bottle that might lead consumers to believe it is a regular drink, meant to quench thirst and be consumed all at once, then it may fall into the category of conventional beverage.
The comment from Ullman, Shapiro and Ullman says the FDA’s draft guidelines, at least in part, represent “radical new positions.” The main legal claim found in the comment is their opinion that the FDA’s language is in opposition to the Dietary Supplement Health and Education Act (DSHEA ) of 1994, which altered the state of regulatory law established earlier by the Federal Food, Drug, and Cosmetic Act.
They explain that DSHEA places emphasis on a product’s “representation for use” in determining whether it is a food or supplement product. So, they argue, a product that perhaps resembles a conventional food product, like a drink or snack bar, but represents itself as a supplement, should not be brought into the category of conventional food. They say this was the congressional intent of the bill, and that the FDA would be violating this statute. Neither should, the comment argues, the volume of liquid intended for consumption (serving size) determine a product’s status, as the FDA guidelines propose.
The attorneys’ commentary alleges that the FDA’s motivation in producing guidelines that would reclassify countless products as food is a sneak regulatory maneuver. It is, the comment says, an “end around” attempt to regulate the dietary supplement industry differently. If products formerly designated as dietary supplements become beverages, the FDA can regulate what were formerly “dietary ingredients,” subject to self-regulation by the manufacturer, as “food additives,” subject to FDA pre-market approval, or to being classified generally recognized as safe (GRAS). Under DSHEA, supplement ingredients must instead meet safety standards and not pose “a significant or unreasonable risk of illness or injury.”
To bolster their argument, they cite evidence, including published statements, indicating that FDA has previously taken a position acknowledging that a dietary supplement’s packaging can resemble conventional food. The comment also urges FDA to be explicit if it is implying, or otherwise intending to declare, that the packaging of all solid food products can determine their status (supplement versus food) as well.
Published in WholeFoods Magazine, March 2010