Dietary supplement point-of-sale material discussed in upcoming commission report.

DIETARY SUPPLEMENT POINT-OF-SALE LITERATURE ADDRESSED IN COMMISSION REPORT slated for release in draft form after June 9, President's Commission on Dietary Supplement Labels Executive Director Kenneth Fisher, PhD, said at the Food & Drug Law Institute's Food Regulatory Update '97, held June 2-3 in Washington, D.C. The draft report of the seven-member commission's recommendations for regulation of dietary supplement label claims and statements will be made available for a 45-day comment period, according to a June 3 Federal Register notice. The group is required to submit a final report to Congress and President Clinton under the Dietary Supplement Health & Education Act. It expects to do so on or before Sept. 30.

In the draft, "there is a discussion of one of the more difficult issues that the commission has addressed...and that is publications used in connection with a sale" of a supplement product, Fisher commented, adding, "that is one [area] where the commission would like some additional input."

The commission discussed the issue of third-party literature, as opposed to product package inserts, at several of its meetings ("The Tan Sheet" Sept. 23, 1996, p. 4). Under DSHEA, the use of third-party literature is permitted if it is not false or misleading, does not promote a particular brand, presents a balanced view of the scientific information and is physically separate from the supplement product. Package inserts, which are acknowledged as labeling by manufacturers, are product-specific and often restate the label claims of the product.

Commenting on the report in general, Fisher noted "there are a number of contentious issues in the report and the commission's approach to dealing with these has basically been to try and identify some recommendations to both the [HHS] secretary and also possibly some that would be taken up at a higher level on how to resolve several of the issues." Safety is one such issue, Fisher said, "in a sense that people are always concerned about safety, but data about safety and lack of safety of dietary supplements in general are very inconclusive, and in most cases quite absent."

The report includes comments on nutrition labeling of dietary supplements containing nutrients, Fisher said, as well as an "extensive" section on statements of nutritional support. "There also is a section which is on something dear to the heart of consumers and the industry on substantiation of labeling information and statements," he said, in addition to a section on botanical products focusing on those making preventive or therapeutic claims. "In addition, there are some general comments about the assessment of consumer education [and] third-party or other mechanisms for expert evaluation of label claims and then issues related to research," he added.

Fisher noted that the commission does not want to extend the 45-day comment period because the report "is one of the many steps in the long process to the implementation of DSHEA." He explained that the document "is going to answer some questions and raise some more," adding, "it is not going to be a report that answers all questions."

Commission member and Council for Responsible Nutrition Scientific & Regulatory Affairs Director Annette Dickinson, PhD, cautioned a May 22 symposium that the report does not provide answers to the numerous questions about DSHEA that were hoped for ("The Tan Sheet" May 26, p. 22).

CRN President and CEO John Cordaro presented at the FDLI meeting an update of the council's activities regarding dietary supplements, mentioning that the group is attempting to "work much more closely with FDA on implementation" of DSHEA, specifically in the areas of labeling, good manufacturing practices and substantiation of nutritional support statements.

CRN also is "addressing some of the anti-DSHEA bashing that is going on," Cordaro said. "We recognize there are some honest differences but we also recognize there is just some pure ignorance; people simply don't read the statute."