Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -676

Accepted - Volume 322

Comment Record
Commentor Dr. Emanuel Goldman Date/Time 2003-03-26 13:51:37
Organization New Jersey Medical School
Category Academic

Comments for FDA General
1. General Comments Dockets Management Branch Food & Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dear Sir/Madam, No additional legislative authority is needed. There is only so much that the government can do to prevent people from doing idiotic things. Many products taken in excess can be harmful, but that doesn't mean those products should be removed from the marketplace. People can kill themselves with aspirin too, but the benefits from having aspirin available far outweigh that risk. I have used ephedra ('Ma Huang') in moderation to control upper respiratory congestion in the common cold, and have found it a safe an effective supplement, superior to many OTC decongestants such as Contac. The use of ephedra for weight loss is a relatively new application of this herb, and appropriate warning labels should be sufficient precaution. This is well within your current legislative authority. 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.

EC -676