Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1215

Accepted - Volume 326

Comment Record
Commentor Mr. Gregory Cumberford Date/Time 2003-04-02 13:49:19
Organization Gaia Herbs, Inc.
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments While Gaia Herbs, Inc., a liquid herbal extract manufacturer based in Western North Carolina, does not manufacture any ephedra-containing extracts, we are nevertheless concerned about recent ephedra-related events spilling over and causing Congress to expand FDA's legislative mandate unnecessarily. We applaud FDA's recent promulgation of 21 CFR 111 Dietary Supplement GMPs. These GMPs, coupled with FDA's existing regulatory and enforcement powers authorized under DSHEA, provide ample basis for FDA to properly regulate our industry and assure that unsafe, illegal, or poorly made dietary supplements leave the consumer supply chain. No additional legislative authority from Congress is needed. To be sure, the existing regulatory framework that DSHEA originally authorized FDA to utilize still needs more time and resources to be effectively implemented. But given the extremely low adverse events history of dietary supplements other than ephedra-containing products, when compared to many classes of pharmaceutical drugs and even food products, proper enforcement actions under FDA's existing authority should suffice to control ephedra-related risks. Herbal dietary supplements like valerian, echinacea, black cohosh, red clover, and hawthorn continue to prove their efficacy, safety, and value to thousands of health-conscious consumers seeking real supplementation to their diets without need for costly pharmaceutical drugs. DSHEA strongly affirmed the right of American citizens to make healthy, informed choices about their diets while protecting them from unscrupulous marketers and manufacturers. Please affirm the adequacy of FDA's authority to regulate dietary supplements under existing law.




EC -1215