Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -79

Accepted - Volume 1

Comment Record
Commentor Dr. Jeffrey Maehr Date/Time 2002-05-30 17:19:44
Organization Dr. Jeffrey Maehr
Category Health Professional

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? Proper dietary supplements ARE foods, or should be. In the case of whole food supplements, no FDA involvement is warranted. In the case of fractionated vitamins, minerals and other similar types of supplements, a clear statement should be on the label stating that the product is NOT a whole food supplement. Proper health is NOT supported by a fractionated vitamin, mineral or herb any more than eating only 1 type of food from the food groups and ignoring the rest. There ARE many types of harmful health products on the market which act like drugs in the body simply because they are isolated (fractionated) components and are missing the whole elements that create the effectiveness that the natural system provides. Let's stay with the facts on the labels and not get into big brother manipulation of our freedoms to benefit big business.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? FDA over-reach and the bed fellow relationship with the drug companies and medical profession aside, the natural system... Nature provides the perfect nutrition pattern, and hundreds, even thousands of years of using this pattern for foods and medicines has served mankind well. Proper (natural) food and health product production is our safest means to good health. Labeling products with all the do's and don'ts any particular product is designed for is ludicrous. The FDA, drug companies and Medical profession all stand to gain by the FDA's stifling of possible health benefits of natural health products. What could be a clearer case of restriction of free speech for selfish and financial purposes? Isn't that somewhat of a monopoly in certain consumer areas?
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Labels that state basic facts regarding a product, such as basic warnings, if necessary, and practical applications as accepted by the respective sciences, and fine. Eliminate FDA control over natural, nutritional/medicinal elements (except perhaps for quality) and establish an oversight group consisting of practitioners of all the health sciences (including medical, but not controlled by the AMA) and allow them to collectively determine the scope of labeling that would be in the public's best interest.

EC -79