New York, NY-based Ullman, Shapiro & Ullman, LLP submitted comments urging FDA to reconsider its apparent intent to classify products marketed as dietary supplements as conventional foods merely because of product packaging. The firm expressed concern that such action by FDA would violate the Congressional intent behind DSHEA and potentially force many otherwise legally marketed supplements off the market. The comments note that FDA’s stated purpose in issuing the draft guidance is concern over “an increase in the marketing of beverages as dietary supplements” and the purported “growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts.” FDA does not, however, actually address ingredient safety issues in its draft guidance. Rather, according to Steven Shapiro, a partner at the firm, “the guidance serves as an attempt by the FDA to announce a substantive change in the agency’s statutory and regulatory policy toward how the agency distinguishes dietary supplements from conventional foods and beverages. For the first time, in contradiction to 15 years of policy and public statements, the FDA is announcing that a product’s physical form and packaging, together with the volume of liquid consumed will now be determinative factors in whether a product will be regulated as a dietary supplement or a conventional beverage.”

In adding new determinative factors, the firm argued, it is FDA’s obvious intent to regulate more products as conventional beverages instead of dietary supplements. Thus, the ingredients in such products would be subject to “food additive” status and a safety standard, which FDA must perceive as less onerous than the “significant or unreasonable” safety standard that applies to dietary supplement ingredients.