Legal & Regulatory Briefs

Senator Michael Crapo, R-ID, introduced in Congress Oct. 19 the “Dietary Supplement Fairness in Labeling and Advertising Act,” or S1749. The legislation prevents FDA from moving forward with proposed restrictive labeling regulations and addresses gaps in the Federal Trade Commission’s (FTC) advertising guidelines for dietary supplements, according to Boulder, CO-based Citizens for Health.

A European Union (EU) effort to include the use of the “precautionary principle” in international food trade was defeated. The vote was held Oct. 15 at the Special Conference on International Food Trade—Beyond 2000, in Melbourne, Australia. The precautionary principle is a concept endorsed by the EU that allows restraint when there are concerns about insufficient evidence of food safety.

The CA Association of Naturopathic Physicians announced a campaign to license naturopathic doctors in the state. Eleven other states currently license naturopathic physicians.

Business Week Online says that while the $12 billion dietary supplements industry is asking the agency to require that companies meet good manufacturing practice rules, FDA only has 20 staffers attempting to

monitor the industry.

FDA announced in the Oct. 6 Federal Register a proposed survey of the manufacturing practices of dietary supplements makers. The survey will be given to approximately 717 dietary supplements manufacturers, out of 2,004 currently listed in the Research Triangle Institute’s Dietary Supplement Enhanced Establishment Database. Contact Peggy Schlosburg, Office of Information Resources Management (HFA-250), FDA, 5600 Fishers Lane, Rockville, MD 20857; or phone 301.827.1223. Written comments are due by Nov. 5.

Green Bay, WI-based Enzymatic Therapy has filed complaints in U.S. district court against Solaray Inc. and its parent Nutraceutical Intl. (NUTR), BNG Enterprises, Jarrow Formulas, Lifesource Naturals, and Water Pure Inc. alleging patent infringement, unfair competition and invasion of the right to privacy.