Ullman, Shapiro &Ullman, LLP Submits Comments to the FDA Concerning the Draft Guidance for
Industry: Factors that Distinguish Liquid Dietary Supplements From Beverages, Considerations
Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods
Contact: Steven Shapiro or Marc Ullman --212-571-0068
February 1, 2010 (New York, New York) --This afternoon New York City 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, which specializes in Food & Drug Law and represents numerous companies in the dietary supplement/natural products field, expressed concern that such action by FDA would violate the Congressional intent behind OSHEA and potentially force many otherwise legally marketed supplements off the market.
The Comments observe that FDA's stated purpose in issuing the draft guidance is the concern over "an increase in the marketing of beverages as dietary supplements" and the purported "growth in the marketplace of beverages and other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." The FDA does not, however, actually address ingredient safety issues in its draft guidance.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 of a conventional beverage."
In adding new determinative factors, the firm argues, 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 the FDA must perceive as less onerous that the "significant or unreasonable" safety standard that applies to dietary supplement ingredients.
The comments further note that If FDA intends to use packaging or form of a product as determinative of its status as a dietary supplement or conventional food, then FDA can extend its analysis right down the slippery slope to such things as "bar" dietary supplements that are packaged similarly to candy bars, powder dietary supplements that are packaged similarly to breakfast drinks or "gummy" vitamins that look like candy. There is a reason that packaging has not been a factor in making this determination and FDA should not finalize a guidance that would make it a determinative factor now.
According to Steve Shapiro, "I find this reminiscent of the Traco and Oakmont Black currant oil cases of the 1980's, 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."