Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -291

Accepted - Volume 4

Comment Record
Commentor Mr. Earl Staelin Date/Time 2002-07-30 17:56:40
Organization Attorney at Law and Nutritional Consultant
Category Health Professional

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? Certainly there are strong arguments for regulating speech about drugs more strictly than speech about dietary supplements. In general, drugs are likely to have far more serious side effects and many more of them than dietary supplements. In addition, they generally only treat symptoms and do not address underlying causes, which should be required to be plainly disclosed to the public. They should also be required to disclose that there are relatively less toxic or non-toxic dietary and herbal alternatives that do address underlying causes for the symptoms or illness involved. I think it is a very bad practice to allow drug companies to market their products directly to consumers. The information is one-sided, and does not provide adequate information about contgraindications, side effects, or anything about alternatives. Such advertising should be strictly limited to health professionals. Instead we're becoming a nation on Prozac and Ritalin.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? For the reasons stated above, the FDA's current regulations lead to over-prescription of drugs. The most recent Center for Disease Control statistics show that 106,000 persons died last year due to reactions to legally prescribed drugs. That is 20 times the rate of death of soldiers during the entire Vietnamese war in Vietnam. THe FDA should be protecting the nation's health, and therefore should encourage the use of nutritional substances and herbs that have fewer side effects, an extremely low death rate, and actually address underlying causes of disease, consistent with the theory presented by Linus Pauling in 1968 in the journal _Science_, in which he stated that the approach to disease should be to restore the natural healthy biochemistry of the human cell and organism, for which he coined the term orthomolecular. The greatest impediment to the ability of doctors to give optimal medical advice or prescribe optimal treatment is the fact that medical doctors have virtually no education in the area of nutrition and health and therefore are totally incompetent to give advice to patients in how to address underlying nutritional or biochemical causes of diseases, and instead merely treat symptoms. For that the remedy is a national law that requires a minimum of 15 credit hours in the subject of nutrition and health, or what would be more difficult, laws in 50 states making such a requirement.
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? If there is credible scientific research that a nutrient or combination of nutrients is effective to treat or prevent a particular disorder it should be permissible to include such claims on the label. In weighing evidence for such claims, evidence should address conflicts of interest in research, and affecting any witnesses. I do think people are somewhat more likely to question dietary supplements than foods. However, for some people a highly regarded food, such as milk may be very harmful. And except for the influence of the dairy industry it might be argued that milk is not a recommended for most children (or adults) after weaning. But a food such as wheat can be a very harmful for many people also. The FDA has been no help in advising people on this subject, and the Department of AGriculture is often part of the problem because of the heavy influence of the food industry in its recommendations.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? I believe disclaimers should be in the same size print, unless describing of serious side effects, in which case the print should be larger and in red or other accented format. But I know of no research in this area.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think the FDA should try to restrict advertising of junk foods to young minor children, such as on cartoon shows. While this issue was addressed by the Supreme Court in an FTC case, I believe that decision was wrong and in any event could be reversed if adequate evidence were presented showing the harmfulness of such foods, and how such ads unfairly manipulate children who are not suffiently educated to evaluate such ads, and such ads contain no warmings of the harmful nutritional and health effects of consuming large quantities of such foods, e.g. refined sugar. The First Amendment was not designed to allow deceitful ads to persons who cannot protect themselves from the harm caused thereby. Otherwise, why not permit drug pushers to advertise drugs to minor children as a form of free speech?




EC -291