DIETARY SUPPLEMENT ADVERSE REACTION LABELING IN REP. COLLINS' BILL
This article was originally published in The Tan Sheet
DIETARY SUPPLEMENT ADVERSE REACTION LABELING IN REP. COLLINS' BILL would "unfairly discriminate" against dietary supplement companies, the Council for Responsible Nutrition maintained in a summary of the Dietary Supplement Consumer Protection Act of 1993 (HR 2923) introduced by Rep. Cardiss Collins on Aug. 6 ("The Tan Sheet" Aug. 16, p. 4). HR 2923 instructs supplement firms to state on the product label "the level, if any, at which a dietary supplement can cause adverse effects and the specific nature of any adverse effects and shall identify segments of the population" that may be affected. CRN pointed out that this provision would require the "same type of labeling as prescription drugs about possible side effects and adverse reactions." CRN claimed that this provision "would unfairly discriminate against supplements, which would become the only class of foods subject to such a requirement." CRN raised objections to six areas in Collins bill. Overall, the trade association said it "strongly opposes HR 2923, which would give FDA inappropriate authority to remove safe dietary supplements from the market and to choke off the flow of valuable health information to consumers." CRN asserted that the Collins bill would "further discriminate against supplements by subjecting dietary supplement manufacturers to an unprecedented requirement that they notify FDA whenever they have knowledge "which reasonably supports the conclusion that a dietary supplement may be adulterated or misbranded.'" This requirement, CRN argued, "goes well beyond even the adverse reactions reporting requirements to which new drugs are subject, where the regulations specifically provide that the report [of adulteration or misbranding] will not constitute an admission of a violation of" the FD&C Act. Regarding the safety provisions of HR 2923, CRN asserted that the bill "would leave FDA free to continue to misapply the [FD&C Act's] food additive provisions to essential nutrients and other dietary ingredients." In addition, CRN complained, the bill "would give FDA even more powers to remove safe dietary supplements from the market." The Collins legislation would mandate that FDA conduct a comprehensive safety review of all supplements on the market before Aug. 5, 1993, drawing predominantly on evidence of an ingredient's safety "through either scientific procedures or experience based on common use in a dietary supplement." CRN said that "historically, it takes tens of millions of dollars and several years of effort to assemble the data necessary to satisfy FDA that this test is met. Yet under HR 2923," the summary continues, "all supplements would have to be removed from the market until that showing can be made, without regard to their long history of safe use." Based on the definition of dietary supplements in the legislation, CRN charged that HR 2923 would "severely limit both the ingredients included in supplements and the forms in which dietary supplements may be sold." For example, the definition of dietary supplements in HR 2923 is a "vitamin, mineral or herb or other similar nutritional substance." While the bill does not define the term "nutritional," CRN said, FDA "defines that term very narrowly as meaning only those substances that are necessary to promote growth, replace essential nutrients or provide energy." This definition, the group asserted, "excludes other dietary ingredients (including some antioxidants) that play an important role in helping to protect the body against disease." In addition, CRN argued that by omitting amino acids from the list of ingredients specified in the definition, "the bill would leave that entire class of essential nutrients in the regulatory limbo to which they have been consigned" by FDA's June 18 advance notice of proposed rulemaking on dietary supplement regulation, which called for data on amino acids ("The Tan Sheet" June 21, p. 1). Finally, CRN criticized the Collins bill's limitation of dietary supplement dosage forms to tablets, capsules and other similar delivery systems. This provision, CRN claimed, will "make it more difficult for supplement manufacturers to offer supplements in other forms (such as lozenges) which many consumers prefer." The association also objected to the bill's provision that FDA establish good manufacturing practices and "quality factor requirements." This provision, CRN said, ignores "the work that [the U.S. Pharmacopeia], with the industry's cooperation, has put into developing voluntary guidelines in this area and [does not give] these voluntary guidelines an opportunity to be implemented."
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