Docket Management
Comment Number: EC -262

Accepted - Volume 4

Comment Record
Commentor Mr. Reed Hamilton Date/Time 2002-07-29 14:47:50
Organization Mr. Reed Hamilton
Category Dietary Supplement Industry

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? Yes there are. Drugs have a lethal dose limit, dietary supplements do not and are inherently safe. The DSHEA Law recognizes the safety of nutritional supplements and the value they have in reducing health care costs and their benefits to health. No speech needs to be regulated for dietary supplements beyond the limitations of the DSHEA. Nutritional supplements, being food substances, do not warrant any other restraints on speech, they should be able to be promoted and described by any person. It would make no sense to regulate conversations on broccoli, onions or other food substances. Furthermore, the body is created to run on food, not drugs, and if the food supply cannot supply the proper nutrients to let the body run properly (as evidenced by the disease rate), then no restraint is appropriate. The FDA could sustain a position, however, regarding promotional spech about chemical drugs that speech is misleading by allowing the promotion to contend that the drug is all that is needed without also mentioning that the condition of the body should first be bolstered through proper nutrition and supplements as determined by the person before relying on a drug to mask deeper problems.
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? The contention of this question is that the FDA or some body has to assure you previent any misconceptions on the part of consumers. That is not a possible goal, no matter how well things are explained. The FDA's actions should be to assure access to information is preserved and freely available so people can check out claims or contentions. Dietary supplements have labelling limits passed unanimously by both houses of the legislative branch in the DSHEA law. That will should not be thwarted or re-visited, unless to provide for the freer flow of information to an inquiring, interested public.
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? The FDA should not require warnings or consider placing warnings unless you have documented, peer reviewed, publicly available information that warrants the warning. A warning immediately sets up a fear and confusion. If the FDA has no evidence of harm, then no warning is appropriate, not even a label that says no detrimental evidence is available.
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? People should have no restraint to what off-label uses a product may be applied to. To try to restrain speech on the basis of approved uses puts the FDA in charge of limiting sharing of experiences that go beyond what you have evidence for. The body doesn't solve or address problems or conditions on the same basis as specific research studies might. So a restraint on speech that was limited to what you have on file would say that the FDA controls the body of knowledge. People will experience benefits from nutritional dietary supplements far beyond what the FDA or researchers can imagine because the body is a system and it compensates for problems as long as it can until the deficiency becomes so great that the problem surfaces to the point of being a symptom. You can't limit speech to only things you recognize as valid through your limited input.

EC -262