Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -177

Accepted - Volume 4

Comment Record
Commentor Mr. Charles Hicks Date/Time 2002-07-25 15:52:26
Organization Mr. Charles Hicks
Category Individual

Comments for FDA General
Questions
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? The pharmaceutical industry produces toxic substances that are deemed to be too dangerous to be made available to the consumer directly, but must be prescribed by a physician. Pharmaceutical companies are able to obtain patents and are able to charge high prices for drugs once they are proven safe and effective. The FDA requires a high standard of proof because of the inherent danger of harm and/or addiction as a result of use of these drugs. Dietary supplements are usually non-toxic. There is no need for stringent requirements of proof of their safety at a particular dosage level because supplements are similar to food. At the same time there is not as much opportunity for large profits as there are for drugs, since supplements cannot usually be patented. Therefore supplement companies cannot hope to invest as much money either in lobbying the FDA or in proving whether their supplement actually works. The FDA's role with supplements should not prevent dissemination of information about supplements if that information is truthful. It should not require that supplements meet the same standards as drugs. This would have the perverse effect of eliminating any possibility of true and accurate information about supplements being communicated and making the public rely on more toxic, and more expensive drugs.
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? Although supplements are often made from food sources and are designed to supplement the nourishment gained from food, their purpose is diffent. Food is eaten to satisfy hunger, and to give us some nourishment. It is also chosen because of its taste. Supplements are usually taken to improve health or to provide a safe natural cure of a disease condition. Therefore a food label should give us information about the type of nourishment contained in the food and about any substances that might be harmful if we eat too much of it. Supplements provide a concentrated source of certain nutrients to which we may be deficient. It would be in the interest of all consumers to know if a case can be made that a particular supplement containing particular nutrients can help prevent or treat a disease condition. This type of information may not fit on a label, but consumers should have access to it. The DSHEA law provides for this opportunity. The FDA should not prohibit this information from being communicated.
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? I do not believe that government should prevent people from discovering new uses for natural supplements. It does have an interest in preventing false information from being communicated, but we should not have to wait for the government to tell us before we take our supplements
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? Neither the FDA or any other branch of government should be empowered to have the exclusive right to tell us what is good for us.




EC -177