Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -47

Accepted - Volume 298

Comment Record
Commentor Ms. Patricia Sardell Date/Time 2003-03-06 03:12:02
Organization Country Vitamins
Category Individual

Comments for FDA General
Questions
1. General Comments In 1994, the Dietary Supplement Health and Education Act passed and provides guidelines for supplement restriction and regualtion. Ephedra should be examined by the guidelines already defined by this act. FDA already has enough legislative authority to regulate supplements. 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 passage of DSHEA increased FDA's enforcement powers. The FDA can already seize dietary supplements that pose an unreasonable or significant risk of illness or injury. The Department of Health and Human Services can also stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. FDA has finally started to fully implement the law by taking aggressive action against unsubstantiated dietary supplement claims. It has also said that good manufacturing practices for supplements are imminent. Give these efforts a chance to work.




EC -47