Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -175

Accepted - Volume 4

Comment Record
Commentor Mrs. Ida Flowers Date/Time 2002-07-25 15:48:23
Organization Mrs. Ida Flowers
Category Individual

Comments for FDA General
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? The FDA should not take any action which would reverse or weaken DSHEA. Congress passed this act with overwhelming public consumer support. Diatary supplements have proven through the years to be much safer than prescription durgs. Dietary supplement companies are allowed to publish research about natural products and consumers are free to educate themselves. My husband and I take dietary supplements and have had impressive results. My husband is now free from arthritic pain, regulates his blood sugar (with no need for drugs to control his diabetes), has healed a skin condition he had for 25 years, as well as helping with several other minor conditions. I use dietary supplements instead of HRT. Recent research on HRT will have many women looking for a substitute. Dietary supplements have been taken for years with no harmful side effects and the FDA should not discourage their use.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Dietary supplements should be required to contain the specified ingredients stated on the labels. Anything taken in excessive amounts has the potential to be harmful. Many natural supplements do not contain what is stated on their labels and consumers neede to know which companies take the time and money to assure their products are standardized.

EC -175