Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1164

Accepted - Volume 326

Comment Record
Commentor Mr. Terry Darwin Date/Time 2003-04-01 13:12:08
Organization Nutrition West
Category Health Professional

Comments for FDA General
1. General Comments Dockets Management Branch Food & Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dear Sir/Madam, Considering that thousands are killed each week by medical mistakes in hospital and thousands more are killed by drug reactions weekly, I would call your attention away from the FDA's effort to regulate nutrition and to more serious problems. Nutritional supplementation is is the one thing that gives us all hope in an epidemic deteriation of the food supply. Please stop wasting time and tax payer money attempting to regulate the nutrition industry and focus on really evident problems. We'd really hate for nutrition to end up like the over-regulated health care industry. Millions of consumers contacted Congress in 1993/94 urging support for the regulatory framework, the Dietary Supplement Health & Education Act (DSHEA) in order to provide important health information and products to consumers and to ensure the safety of these products. The unanimous passage of the law reflected the overwhelming number of constituents demanding access to nutritional supplements. DSHEA gives considerable powers to the federal government to assure the safety of supplements and the accuracy of health claims. Specifically, DSHEA provides FDA with the authority to: Stop any company from selling a dietary supplement that is adulterated or misbranded. Stop the sale of a dietary supplement that makes false or unsubstantiated claims. Take action against any dietary supplement that poses a significant or unreasonable risk of illness or injury. Stop any company making a claim that a product cures or treats a disease. Require dietary supplements companies to meet strict manufacturing standards, including potency, cleanliness and accurate labeling. Former FDA commissioner Dr. Jane Henney, in fact, testified before Congress that DSHEA provides FDA with the necessary legal authority to protect the public health. The request in this request for comments to consider additional legislative authority is troubling. The FDA has enough legislative authority to regulate the supplement market, including products containing ephedra, but examining its history shows how slow they have been to implement the law. The FDA has just recently taken steps to use the authority they were granted 9 years ago. Guidelines for Good Manufacturing Practices, mandated by DSHEA in 1994, were just released for comment March 7th, 2003. Steps were only recently taken to address unsubstantiated claims. I urge the FDA to focus on fully implementing DSHEA and to adhere to the original intent of the law as mandated by hundreds of thousands of consumer voices. Sincerely, Terry Darwin Nutrition West

EC -1164