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FDA Seeks Public Comment on First Amendment Limits on Health Claims
Washington DC, 17 May 2002

The First Amendment of the Constitution protects commercial speech that is truthful and not misleading. The federal Food & Drug Administration (FDA) recently lost a Supreme Court decision regarding the way it restricts health claims. The FDA is now seeking public comments about its approach to health claims for foods, drugs, and dietary supplements.

(See also editorial: Too Good To Be True?)

The May 16 issue of the Federal Register (available at www.access.gpo.gov) contains a notice that seeks public comments on nine questions within 75 days (by July 30). These questions are:

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?

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?

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?

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?

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?

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?

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?

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?

9. Are there any regulations, guidance, policies and practices FDA should change, in light of governing First Amendment authority?

Send written comments to:

Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville MD 20852

Electronic comments can be made online at:


On that page, select [02N-0209 -- Request for Comment on First Amendment Issues] and click on continue.

Comments are due by July 30, 2002, and responses to those comments must be submitted by September 13, 2002.


FDA website, www.cfsan.fda.gov.

Natural Products Insider website news, www.naturalproductsinsider.com.end-of-story




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