Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -530

Accepted - Volume 307

Comment Record
Commentor Mr. C Beeson Date/Time 2003-03-22 11:27:24
Organization Razzberry's
Category Company

Comments for FDA General
Questions
1. General Comments Dear Sir/Madam, I work at a health food store in Boone, NC, and have been in the natural products industry for fifteen years. Both my customers and I appreciate the significance of the Dietary Supplement Health and Education Act of 1994 with regard to protection our right to choose how we care for ourselves. I understand and appreiciate the concern of the FDA regarding the safety of ephedra and the potential addition of warning labels to products containing ephedra. However I am concerned that the FDA is asking what additional authority it may need to effectively address this issue. Former FDA commissioner Dr. Jane Henney has testified before Congress that the DSHEA provides the FDA with the necessary legal authority to protect the public health. The passage of DSHEA has increased FDA's enforcement powers. The FDA, under DSHEA has the power to seize dietary supplements that pose an unreasonable or significent risk of illness or injury. In addition the goverment can also stop the sale of an entire class of dietary supplements if they pose an immenent public health hazard. In sum, I agree with former FDA commisioner, Dr. Jane Henney, that DSHEA provides FDA with the necessary legal authority to protect public health. The FDA has finally started to fully implement DSHEA by taking aggressive action against unsubstantiated dietary supplement claims as well as recently issuing a proposed rule on good manufacturing practices for supplements. Lets give these efforts a chance to work. 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 and do not think any additional legislative authority is necessary for FDA to regulate ephedra or any other dietary supplement. Sincerely, C Beeson Razzberry's 2194 Blowing Rock RD Boone, NC




EC -530