Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -50

Accepted - Volume 1

Comment Record
Commentor Dr. Ken Miller Date/Time 2002-05-29 09:13:32
Organization Dr. Ken Miller
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? Drugs should be regulated differently than supplements because: 1. Generally, natural substances are much safer and more free of side effects than drugs. As a result, there is no compelling public interest in restricting its use and distribution as there is with drugs. 2. When a company creates a non-natural substance for ingestion, the burden of proof is on them to prove it is safe because the existence of that substance is attributable specifically to that company. Natural supplements, however, exist in nature, and its origin is not attributable to a specific company. Therefore, the burden of proof is not on the companies selling the supplements, any more than the burden of proof is on a food distributor for proving that potatoes or beans are safe. Of course, if there is exists conclusive scientific studies that demonstrate toxicity levels, side effects, or drug interactions for specific natural supplements, the FDA should require disclosure of those specific facts somewhere in the packaging of the product, but not necessarily on the bottle if space does not allow. 3. Drugs are patentable, and the reward for a successful patent is great, so speach about new products is not stymied by requiring millions of dollars in research prior to release. Natural substances are not patentable, and therefore any similar requirement on natural substances would create an insurmountable economic barrier to free speech. To tell a person that they cannot speak freely unless they spend tens of millions of dollars is the same as saying they cannot speak freely at all. 4. Just because modern pharmaceutical medicine has a virtual monopoly in the US does not justify taking away the free speech of those who subscribe to other philosophical approaches to health, nor should those ideas be subject to the approval or disapproval of those who subscribe to the modern pharmaceutical approach to health. Again, the only interest the FDA has with regard to natural supplements is requiring disclosure in a non-onorous way of specific health risks that may be associated with use or misuse of those supplements.
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? Conventional foods and natural substances should be treated similarly. In both cases, if substantial risk is associated with certain types or levels of use, the FDA should be able to require disclosure. However, the FDA should err on the side of allowing legitimate expression of ideas, requiring disclosure only when the risk is truly substantial and non-obvious. Milk producers like to say that 'Milk does a body good'. Many vegetarians take exception to that, and point out some downsides to milk consumption. In fact, there are pros and cons to milk consumption, and there is no substantial health risk that would warrant FDA restriction of those opposing viewpoints.
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? It would be possible for the FDA to require so much disclaimer and to require it on the outside of the box that, in effect, it makes it impossible to produce the supplement in a reasonable sized bottle. Requirements on type size are fine as long as they do not impose unreasonable constraints on normal packaging. One solution would be, for those products that require disclosure, require a short statement on the outside of the package that there are disclosures, and allow the full detail to be inside.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? First, disclosures should only be required when there is substantial risk. If some study shows benign side effects in only 1 percent of the population and only when taking large doses, this would not justify a disclaimer. The more selective the disclaimers, the more seriously they will be taken by the public.
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? The same free speech should be allowed in both cases, but if vitamin X produces symptoms of toxicity when more than 5 grams are taken per day, it is legitimate to require this disclosure on the label because the information is relevant to the purchase of the bottle of Vitamin X. If a book, on the other hand, touts the virtues of Vitamin X without listing the toxicity level, no harm is done because the information is not needed as immediately as with a label.
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? With regard to natural substances, the FDA should be mostly concerned with safety, not effectiveness. If a substance is safe but ineffective, little harm is done except that the user will only get the benefit of placebo. Because drugs normally have strong negative side effects, the creator of the drug should have to either prove that the side effects are minimal or they should have to prove the effectiveness of each use that they tout in any of their literature.




EC -50