Seeks Public Comment on First Amendment Limits on Health Claims
DC, 17 May 2002
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
also editorial: Too
Good To Be True?)
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:
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?
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
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?
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
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
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
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
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?
Are there any regulations, guidance, policies and practices FDA
should change, in light of governing First Amendment authority?
written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville MD 20852
comments can be made online at:
that page, select [02N-0209 -- Request for Comment on First Amendment
Issues] and click on continue.
are due by July 30, 2002, and responses to those comments must be
submitted by September 13, 2002.
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