Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1284

Accepted - Volume 326

Comment Record
Commentor Mr. Scott Rosenbush Date/Time 2003-04-03 13:51:11
Organization PL Thomas & Co., Inc
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments Dear Sir/Madam, I am an employee of P.L. Thomas & Co., Inc., and I have been a participant in the natural products industry for many years. Both my clients and I appreciate the significance of the Dietary Supplement Health and Education Act of 1994 with regard to protecting our right to choose how we care for ourselves. I am deeply concerned that FDA has only just begun to implement key sections of DSHEA. I note that the agency only just recently released its long-anticipated proposed good manufacturing practices for the industry, and yet FDA is immediately calling for suggestions for increased legislative authority in order to better regulate the supplement industry. I strongly recommend that FDA first give DSHEA a chance to work as it was intended before asking for enhanced legislative authority and the resulting complications. Under DSHEA, FDA can already seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury, and this power has certainly been utilized. The Government can stop the sale of an entire class of dietary supplements if theyare deemed to pose an imminent public health hazard. Former FDA commissioner, Dr. Jane Henney, has publicly stated that DSHEA provides FDA with the necessary legal authority to protect public health, and we strongly concur with that view. We believe that DSHEA has greatly benefited the consumer, enhancing his access to dietary supplements and information about them, while not eliminating the necessity of the provider to present truthful information about those supplements without unsubstantiated claims. FTC and FDA announcements have further clarified the essential details on these matters and are more than sufficient to address without the enactment of any further legislation. That also includes dealing with any dietary supplement product that becomes associated with adverse events; we believe the dietary supplement industry is an overall very strong supporter of the necessary steps to be taken within existing regulations to protect the consumer in such matters. Sincerely, Scott Rosenbush

EC -1284