NEW YORK— Ullman, Shapiro & Ullman LLP submitted comments to FDA urging the agency to reconsider its apparent intent to classify products marketed as dietary supplements as conventional foods simply due to product packaging. The law firm expressed concern that such action by FDA would violate the Congressional intent behind the Dietary Supplement Health & Education Act (DSHEA), and potentially force many otherwise legally marketed supplements off the market.
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 addition new determinative factors, the firm stated, 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 supplements.
The comments further noted if FDA intends to use packaging or form of a product as determinative of its status as a dietary supplement or conventional food, FDA could extend its analysis to such items as “bar” dietary supplements packaged similarly to candy bars, powdered dietary supplements packaged similarly to breakfast drinks, or “gummy” vitamins that look like candy.
Shapiro added: “I find this reminiscent of the Traco and Oakmont black currant oil cases of the 1980s, which lead to the enactment of DSHEA in the first place. Here, as in those cases, rather than addressing a perceived ingredient issue ‘head on,’ the agency is attempting to manipulate the classification of products under the Food and Drug Act so as to be able to use the pre-approval provisions applicable to ‘food additives,’ instead of the provisions actually applicable under the Act. This seems to be yet another attempt by the agency to circumvent DSHEA as opposed to actually implementing and enforcing DSHEA.”
