Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -153

Accepted - Volume 4

Comment Record
Commentor Mrs. Christie D. Michas Date/Time 2002-07-19 11:50:24
Organization Mrs. Christie D. Michas
Category Individual

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? FDA should not put a disclaimer on nutritional supplements because such a statement discourages consumers from products that can have a very beneficial effect on their health.
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? Some consumers are being misled by the FDA's disclaimer into thinking that there is something wrong with the product because it has such a disclaimer. That is more harmful to health because many people are discouraged from trying a nutritional supplements that may be beneficial to their health.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? First Amendment allows for the presentation of information that helps the consumer understand what the product is for, including health issues. I have a right for this information to be freely available to me, and withholding such information violates the First Amendment.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? No, the FDA's current approach with regard to nutritional supplements does not in any way advance the public health concerns they are designed to address. In fact, the FDA is working against the public health concerns by requiring an FDA disclaimer, which is often misunderstood and misinterpreted by the consumer. The FDA disclaimer is very confusing and misleading to a large percentage of consumers.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? YES! Do not require the FDA disclaimer on nutritional products. And allow information about the benefits of nutritional supplements to be stated on the products and provided in other materials so the public is informed to make their own choices, just as is allowed with other products in the marketplace.

EC -153