Finds FDA Rejection of Truthful Health Claims Unconstitutional
January 15, 1999, the U.S. Court of Appeals held that the FDA acted
unconstitutionally in its rejection of four specific health claims
that dietary supplement manufacturers Durk Pearson and Sandy Shaw
wanted to place on their products' labels.
does this decision really mean? Are manufacturers now free to make
any kind of health claim they wish as long as they include appropriate
in this article is based on the published court opinion.
speech and advertising
U.S. Court of Appeals stated that "truthful advertising related
to lawful activities is entitled to the protection of the First
Amendment." However, government can impose restrictions when advertising
is potentially misleading. Since almost any statement can be potentially
misleading, the question becomes: What kinds of restrictions are
allowable, under the law? At least three laws and many court decisions
affect the kinds of restrictions that the government can place.
Health claims: Who can make them?
health claim is a statement that a particular substance has an impact
upon a disease. Until the mid-1980s, only drugs were allowed to
make such a claim -- and any product that did make such a claim
was automatically categorized as a drug. (According to legislative
definition, any product that is "intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease" is a drug.)
the past, the FDA took a very stringent position on health claims.
Statements that a food could prevent a particular disease were viewed
as a claim that the food was a drug -- and the FDA said it would
prohibit sale of that food until a new drug application had been
approved. Thus, the question of whether a particular product is
a drug or a dietary supplement has very significant consequences,
both for the manufacturer and the consumer.
the mid-80s, however, companies began making health claims on food
without seeking new drug approval -- and in 1987, the FDA issued
regulations that sanctioned this practice. In 1990, Congress passed
the Nutrition Labeling and Education Act (NLEA), which allowed health
claims on foods if these claims were certified by the FDA as supported
by "significant scientific agreement." The Dietary Supplement Health
and Education Act (DSHEA) of 1994 created a similar niche for allowing
health claims by dietary supplements.
for approval of health claims
specifically allows dietary supplements to make "structure/function"
claims. However, in order to print a health claim on the label of
a dietary supplement, that claim must be submitted to the FDA for
preapproval. The FDA approves only those claims that have "significant
scientific agreement" among experts that the claim is supported
by the available evidence. (The FDA has approved only two such health
claims on dietary supplements.)
criteria are the FDA allowed to use for approving or rejecting these
health claims? This question lies at the heart of the Pearson and
Shaw lawsuit. Pearson and Shaw claimed that the criteria the FDA
used in rejecting their health claims was both unconstitutional
-- violating both the First and Fifth Amendments -- and illegal
under the Administrative Procedure Act (APA). The First Amendment
protects free speech. The Fifth Amendment and the APA require that
laws and regulations be clearly defined in order to be observable
the health claim inherently misleading?
decisions have held that advertising that is inherently misleading
can be prohibited altogether. The FDA argued that health claims
lacking "significant scientific agreement" are inherently misleading.
appeals court characterized the FDA's argument as saying that health
claims that lack significant scientific agreement have such an "awesome"
and "hypnotizing" influence on consumers that they become unable
to exercise any judgment at the point of sale, and therefore are
bound to be misled. The appeals court rejected this argument as
government prohibit health claims that are potentially misleading?
FDA also argued that health claims on dietary supplements are potentially
misleading for two reasons. Consumers would find it hard to verify
these claims on their own. Also, consumers might assume that the
government has approved such claims.
are often used in advertising to clarify or qualify statements that
are potentially misleading. For example, a statement that "The FDA
has not approved these health claims" might be an adequate disclaimer
for the second concern in the paragraph above.
and Shaw offered to use disclaimers with their health claims. The
FDA rejected this offer and argued in court that the government
is not required to accept disclaimers but can instead prohibit any
claims that lack "significant scientific agreement."
can government restrict commercial speech?
appeals court cited several court cases in stating that information
that is potentially misleading may not be prohibited altogether
"if the information can be presented in a way that is not deceptive."
particular, the Central Hudson case [477 U.S. 557, 566 (1980)] established
that government schemes for regulating commercial speech that is
potentially misleading must meet three specific guidelines.
the appeals court found that the FDA's choice of suppressing health
claims that lack "significant scientific agreement" was not a direct
advancement of consumer health -- although it could be considered
a direct advancement of protection against consumer fraud. But the
appeals court then said, "The difficulty with the government's consumer
fraud justification comes at the final Central Hudson factor: Is
there a reasonable fit between the government's goals and the means
chosen to advance those goals?"
the FDA's refusal to consider disclaimers a "reasonable fit"?
issue is whether the government is allowed to prohibit a potentially
misleading statement if providing additional information (such as
a disclaimer) will satisfy the requirement for a "reasonable fit"
between government ends and means. The FDA maintained that commercial
speech doctrine does not prefer disclosure over outright suppression
-- but the appeals court disagreed.
grounds for rejection of health claims found unconstitutional
appeals court cited several cases in which the Supreme Court "repeatedly
[pointed] to disclaimers as constitutionally preferable to outright
suppression." The Supreme Court has rejected the ideas that the
public is too unsophisticated to understand the limitations of advertising,
and that the public is better kept in ignorance than trusted with
correct but incomplete information. The Supreme Court has also said
that "the preferred remedy is more disclosure, rather than less."
these reasons, the appeals court found that the FDA's rejection
of these four health claims was unconstitutional.
the FDA now required to accept disclaimers?
appeals court did not conclude that the FDA would be required to
accept health claims with disclaimers. The appeals court said it
would not presume to draft appropriate disclaimers for the four
health claims, saying that this was the job of the agency.
appeals court also said that if evidence against a particular health
claim outweighed evidence supporting that claim, it was possible
that the FDA could decide that this potential confusion was incurable
by any disclaimer and might ban such a claim outright.
the appeals court was skeptical that the government could demonstrate
empirically that a particular disclaimer "would bewilder consumers
and fail to correct for deceptiveness," but they did not rule out
unarticulated standard of "significant scientific agreement"
speech was one of two major threads in the Pearson and Shaw lawsuit.
They also claimed that the FDA's failure to define "significant
scientific agreement" more specifically was an independent violation
of the Fifth Amendment of the Constitution. They claimed the FDA's
approach was so vague that it deprived them of liberty and property
without due process.
and Shaw also claimed that the Administrative Procedure Act (APA)
requires the FDA to develop a standard for acceptance or rejection
of health claims that is much more concrete and specific than "significant
appeals court did not consider the constitutional issue here because
it agreed with the appellants that the APA requires the agency to
explain why it rejected their proposed health claims. The appeals
court said that giving an adequate explanation "necessarily implies
giving some definitional content to the phrase significant scientific
the government is not allowed to engage in arbitrary and capricious
action. The appeals court stated, "It simply will not do for a government
agency to declare -- without explanation -- that a proposed course
of private action is not approved. To refuse to define the criteria
it is applying is equivalent to simply saying no without explanation.
It must be possible for the regulated [party] to perceive the principles
which are guiding agency action."
U.S. Court of Appeal's decision
reasons, the appeals court held the FDA's rejection of the four health
claims to be invalid. Fundamentally, this decision says that
the government could appeal this case to the Supreme Court, it seems
unlikely that this decision would be reversed. Two of the three judges
are considered to be experts in commercial speech jurisprudence.
FDA must reconsider the appellants' four health claims because
the reasons it gave for rejecting them are an unconstitutional
violation of the appellants' First Amendment rights of free speech.
FDA must also explain what it means by significant scientific
agreement (or at least what it does not mean).
decision of the appeals court to discuss the constitutional issue
was highly unusual. They stated that they did so because the appellants
might be entitled to make health claims with proper disclaimers
even if those claims did not meet the standard of a fuller and more
concrete definition of "significant scientific agreement". In other
words, even if the FDA were to define "significant scientific agreement"
more fully and specifically, Pearson and Shaw might still be entitled
to make health claims that did not meet this standard as long as
they used appropriate disclaimers.
decision is a clear victory for both producers and consumers. Producers
will be able to include on their labels and product literature fuller
information about the health benefits of their products. Consumers
will have access to better, more extensive information about the
scientific evidence about products they are considering. In the
long run, this decision helps empower consumers to take charge of
their own health.
of the four health claims links the consumption of a particular
supplement to the reduction in risk of a particular disease:
of antioxidant vitamins may reduce the risk of certain kinds
of fiber may reduce the risk of colorectal cancer."
of omega-3 fatty acids may reduce the risk of coronary heart
mg of folic acid in a dietary supplement is more effective in
reducing the risk of neural tube defects than a lower amount
in foods in common form."
rejecting the first three claims, the FDA said that the evidence
for these statements was based on consumption of foods containing
these substances, not on consumption of the substances alone. In
rejecting the fourth claim, the FDA merely stated that "the scientific
literature does not support the superiority of any one source over
three laws cited in this court case were the Administrative Procedures
Act (APA), the Nutrition Labeling and Education Act of 1990 (NLEA),
and the Dietary Supplements Health and Education Act of 1994 (DSHEA).
Central Hudson [477 U.S. 557, 566 (1980)] guidelines that must be
applied to government schemes for regulating commercial speech are:
asserted government interest must be "substantial".
On this point, the FDA presented two concerns: protection of
public health and prevention of consumer fraud. The Supreme
Court has said "there is no question that [the government's]
interest in ensuring the accuracy of commercial information
in the marketplace is substantial," and that government has
a substantial interest in "promoting the health, safety, and
welfare of its citizens."
regulation must "directly advance the governmental interest
The FDA did not claim that the dietary supplements in question
were any kind of threat to consumers' health and safety. Instead,
it argued that consumers' health is directly advanced by barring
any health claims that were not approved by the FDA.
The appeals court rejected this argument, saying that this strategy
was only an indirect advancement of public health at best, and
cited the Supreme Court's statement that "The First Amendment
directs us to be especially skeptical of regulations ... that
seek to keep people in the dark for what the government perceives
to be their own good."
The appeals court did find some merit in the idea that the FDA's
regulatory scheme was a direct protection against consumer fraud.
In essence, if some health claims on dietary supplements will
mislead consumers, then requiring FDA preapproval and setting
the standard extremely high (perhaps even impossibly high) will
definitely prevent any confusion among consumers.
fit between the government's ends and the means chosen to accomplish
those ends must be "not necessarily perfect, but reasonable."
However, the appeals court then said, "The difficulty with the
government's consumer fraud justification comes at the final
Central Hudson factor: Is there a reasonable fit between the
government's goals and the means chosen to advance those goals?"
This issue lies at the heart of Pearson and Shaw's constitutional
challenge to the FDA's action. If a disclaimer satisfies the
requirement for a "reasonable fit", then the more severe approach
of suppressing the information altogether is a violation of
the First Amendment protection of free speech.
source of this article was the published court decision of the following
December 1, 1998. Decided January 15, 1999
Durk Pearson and Sandy Shaw, American Preventive Medical Association,
and Citizens for Health, Appellants
Donna E. Shalala, Secretary, United States Department of Health
and Human Services, et al., Appellees
Appeals from the United States District Court for the District of
W. Emord argued the cause for appellants. With him on the briefs
were James S. Turner and Betsy E. Lehrfeld.
N. Kohl, Attorney, United States Department of Justice, argued the
cause for appellees. With her on the brief were Frank W. Hunger,
Assistant Attorney General, Wilma A. Lewis, United States Attorney,
and Douglas N. Letter, Attorney, United States Department of Justice.
Nancy T. Lord-Johnson was on the brief for amici curiae Direct Aids
Alternative Information Resources, et al. David C. Vladeck, Allison
M. Zieve, and Bruce Silverglade were on the brief for amici curiae
American Cancer Society, et al.
Wald, Silberman, and Garland, Circuit Judges