Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1219

Accepted - Volume 326

Comment Record
Commentor Mr. Edward McGinnis Date/Time 2003-04-02 15:10:40
Organization Contract Packaging Resources
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments The FDA has recently taken a strong stand on two issues which are extremely important to the health and safety of American consumers and the future of the dietary supplement business. These issues, the proposed increased regulation of ephedra and the institution of Good Manufacturing Practices in the industry, are simultaneously sensible and threatening to an industry unfamiliar with these actions. I am taking this opportunity, as one involved in several FDA regulated businesses over the last 25 years, to support your position and, hopefully, reduce unfounded fears, within the industry. It has been my experience that businesses directly involved in the health and safety of consumers need a “roadmap’ to maximize the probability that the products or services they provide meet predetermined criteria. The Good Manufacturing Practices (cGMP’s) are, to coin a phrase, “disciplined common sense”. Unfortunately, as the author Mark Twain once stated “common sense is an uncommon virtue”. The cGMP’s are the building blocks by which manufacturers institute, maintain, and develop their operations in a precise, controlled and quality conscious manner. The goals are clear: safety, purity, potency, and quality. They are met through a comprehensive, broad based program which: o Assures that only proper constituents are used o Provides clear labeling standards to enable proper product use o Prevents contamination o Assures that process capability matches intended use o Ensures the traceability of constituents and finished product should there be a problem o Ensures proper employee training o Mandates rigorous investigation of both production problems and customer complaints In conclusion, I wholeheartedly support the institution of cGMP’s in the dietary supplement industry and the establishment of consumer safety standards for ephedrine alkaloid based products. I sincerely hope that these can be instituted without delay.

EC -1219