Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -390

Accepted - Volume 307

Comment Record
Commentor Mr. Ralph Lotz Date/Time 2003-03-20 10:52:51
Organization Alpha-Omega Nutrition
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments Dear Sir/Madam, I have been selling and using nutritional supplements for nearly forty years. In 1994 Congress passed the Dietary Supplement Health and Education Act with regard to protecting our right to choose how we take care of ourselves. After all of these years FDA has only just begun to implement key sections of DSHEA such as GMP for the industry. There is no basis for FDA being granted more legislative authority to regulate the dietary supplement industry since the increased enforcement powers under DSHEA are more than perfectly adequate. After all FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury.In addition there is statuatory authority already in place to stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. I agree with former FDA commissioner, Dr.Jane Henney, That DSHEA provides FDA with the necessary legal authority to protect public health. DSHEA has improved consumer access to dietary supplements and information about them, while increasing consumer protection against unsafe products and false and misleading claims. I strongly support DSHEA. Any other legislative authority is neither necessary nor warranted for FDA to regulate ephedra or any other supplement. Why does the FDA continue to go on wild goose chases after dietary supplements which are virtually non-toxic, while letting drugs such as tylenol which is responsible for 60% of all liver failure go untouched. Your efforts are misdirected and arbitrary at best. Your job is to protect the public, after all is it not? Sincerely, Ralph W. Lotz




EC -390