Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -367

Accepted - Volume 307

Comment Record
Commentor Mr. Christopher Grell Date/Time 2003-03-19 20:50:13
Organization Law Offices of Christopher E. Grell
Category Individual

Comments for FDA General
Questions
1. General Comments To: The FDA From: Chris Grell Re: Dietary Supplement Industry Form letter The following is a form letter that the dietary supplement industry group NNFA is encouraging its members to send to the FDA. Hopefully, when considering these form letters you will verify that in fact the sender is who he or she claims they are and that in fact, the sender's customers have in fact expressed the concerns mentioned in the form letter. The form letter is as folllows: Date: 19 Mar 2003 23:03:34 -0000 From: NNFA | This is Spam | Add to Subject: NNFA Action Alert! National Nutritional Foods Association 3931 MacArthur Blvd., Suite 101 Newport Beach, CA 92660 ph: (800) 966-6632 fax: (949) 622-6266 e-mail: nnfa@nnfa.org FDA Seeks Comments that Could Change Supplement Law Act Today to Protect DSHEA—You Now Have Only 16 Days to Take Action! As first reported to NNFA members on March 5, 2003, in a proposed rule published that day, the U.S. Department of Health & Human Services (HHS), which oversees the Food & Drug Administration, asked for public comment regarding the safety of ephedra and the potential addition of warning labels to products containing the herb (see February 28 NNFA Alert). Significantly, the FDA is asking what additional legislative authority it might need to effectively address this issue. What is troubling is that any change in FDA's legislative authority would be the result of amending the Dietary Supplement Health and Education Act (DSHEA) and apply to the entire supplement category—not just ephedra. What will happen if DSHEA is amended? It could mean that new dietary supplement products will need to go through a lengthy approval process before being sold. This would mean fewer products, reduced innovation and less variety. It would also result in a less competitive marketplace since only the largest manufacturers could afford to do business. It would take the industry back to pre-DSHEA days when products could be taken off the shelves with little evidence that they might do harm. We don't want to go back to 1993! That's why it's still imperative that every member of this industry—every person concerned about access to a wide variety of safe and beneficial supplements—go on the record with the FDA within the next 16 days in support of the Dietary Supplement Health and Education Act. To protect DSHEA and all supplements, it is vitally important that you submit your comments in writing to the FDA. To help you do this, NNFA is providing you with a sample letter that emphasizes the three key points you should make—in your own words or ours. You must submit these comments by April 5, 2003 for them to count. Here are the key points: 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 & 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 as well as recently issuing a proposed rule on good manufacturing practices for supplements. Give these efforts a chance to work. You can submit your comments in two easy ways: Internet - http://www.fda.gov/dockets/ecomments (Choose 95N-0304 when asked to select a docket for comment) Regular Mail - Write to: Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Please send us a copy of your comments via fax, e-mail, or regular mail to the address and number above. -------------------------------------------------------------------------------- Sample Letter - Use Your Own Words or Ours March 5, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Dear Sir/Madam, I own/work for a health food store/dietary supplement company in Anytown, USA, and have been in the natural products industry for several years. Both my customers 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 concerned that FDA has only just begun to implement key sections of DSHEA. For instance, the agency recently released its proposed good manufacturing practices for the industry, and yet is immediately calling for suggestions for increased legislative authority in order to better regulate the supplement industry. Shouldn't you first give DSHEA a chance to work as it was intended to before calling for new laws? Please also don’t overlook that DSHEA actually increased FDA's enforcement powers. FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury. In addition, the government can stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. In sum, I agree with the former FDA commissioner, Dr. Jane Henney, that DSHEA provides FDA with the necessary legal authority to protect public health. DSHEA 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, Your Name Address




EC -367