# \[Docket No. 02N-0209\] {#docket-no.-02n-0209 .unnumbered}

*Citizens for Health* submits the following comments to the Food and
Drug Administration (FDA) in response to the Agency's Request for
Comment on First Amendment Issues, 67 Fed. Reg. 34943 (May 16, 2002),
available at wais.access.gpo.gov (last visited August 2002). *Citizens
for Health* is a non-profit organization representing over 120 million
Americans who regularly take dietary supplements, buy organic foods, or
visit alternative medicine practitioners.

**Comments of *Citizens for Health***

I.  *Introduction*

The Food and Drug Administration (FDA) regulates approximately 40% of
the United States gross national product using primarily the Food Drug
and Cosmetic Act of 1938, as amended. This legislation creates two
categories of illegal acts: adulteration and misbranding. Adulteration
concerns the nature of the product safety. Misbranding concerns what can
be said about the product in various forums. To date, the FDA focuses
almost exclusively on the nature of the products it regulates using the
misbranding sections of the act to make additional barriers to marketing
of apparently safe products that have not yet been shown to be
effective.

In reality, some products known to be safe, but not yet shown to be
effective under the FDA's relatively rigid standards of proof for
efficacy\-- rooted in the agency's unnecessarily narrow interpretation
of the "significant scientific agreement" standard - are severely
limited in, if not completely blocked from the marketplace. Thus there
is a category of products in the proverbial "grey" area, safe, but not
yet shown to be effective, which have emerging evidence of value. These
products are kept off, or limited within, the market by artificial
means. This is one aspect of the problem that, for the past decade, the
court seem to be addressing.

The 1990 Federal Trade Commission (FTC) cautions to the FDA about the
constitutional vulnerability of its misbranding regulations are even
more true today. The FTC urged the FDA to reconsider its policy of
requiring scientific consensus for health claims on food labels, and
recommended the FDA use a scientific substantiation requirement more
like the FTC's "reasonable basis" standard, which does not violate the
First Amendment. According to the FTC, the FDA's relatively more rigid
standard violates the First Amendment because it restricts too much
truthful speech.

######### Short Answers to Specific Questions 

> 1\. [The First Amendment protects all truthful, non-misleading
> commercial speech, regardless of whether such speech concerns drugs or
> dietary supplements, and regardless of the targeted audience. The very
> narrow inherently misleading category does not permit for prohibition
> of truthful, factual statements presented in a way that allows for "an
> opportunity for comparison and reflection.]{.underline}"[^1]

In response to previous comments on First Amendment issues, the FDA
argued that unapproved health messages on labels were inherently
misleading, and thus not entitled to First Amendment protection.[^2] In
its argument, the FDA relied on incorrect readings of several Supreme
Court cases. The Court has found certain types of commercial speech to
be "inherently misleading," but the reasoning applied would not apply to
truthful claims concerning food, dietary supplements, or drugs, that are
located in advertisements or on labels. See [Ohralik v. Ohio State Bar
Association]{.underline}, 436 U.S. 447, 456 (1978) (finding in person
solicitation by lawyers of accident victims to be inherently misleading
because of potential for exertion of pressure, distinguishing public
advertisements, which provide "an opportunity for comparison and
reflection"); see also [Friedman v. Rogers]{.underline}, 99 S.Ct. 887
(1978) (finding trade name advertising by optometrists to be inherently
misleading because the practice was shown to have been subject to abuse,
noting that restriction on use of trade names did not restrict
dissemination of "factual information"). The inherently misleading
doctrine was clarified in [In re R.J.M.]{.underline}, 455 U.S. 191, 203.
The Court indicated that the government "may not place an absolute
prohibition on certain types of potentially misleading information...
*if that information also may be presented in a way that is not
deceptive.* Id. at 203 (emphasis added). In [Pearson v.
Shalala]{.underline}, 164 F.3d 650, 676 (D.C. Cir. 1999), the court
found the FDA's argument that truthful unapproved messages were
inherently misleading to be "almost trivial." [Id.]{.underline} The
Supreme Court recently stated that restrictions on speech cannot be
justified based on a fear that people will make bad choices even when
given truthful information. See [Thompson v. Western Medical
Center]{.underline}, 122 S.Ct. 1497, 1507 (2002).

2.  [Direct-to-consumer (DTC) advertising should only be regulated to
    ensure that messages are not false or misleading]{.underline}.[^3]

The doctor-patient relationship has waned over the last decade, with the
shift from private practices to managed care plans. As a result,
consumers now take more responsibility for their own health and disease
management. In order to make optimal choices, consumers must be well
informed. The United States Supreme Court recently struck restrictions
on DTC advertising of compounded drugs. [Thompson v. Western Medical
Center]{.underline}, 122 S.Ct. 1497 (2002). The First Amendment does not
permit for restriction of truthful, non-misleading DTC advertising, for
the purpose of preventing over-prescription. In [Thompson]{.underline},
the government asserted only the interest of distinguishing between new
and compounded drugs for the purpose of exempting compounded drugs from
the new drug approval requirements, and failed to assert the interest of
preventing over-prescription. The Court spoke directly to the issue
anyway:

> Even if the Government had argued that the FDAMA's speech-related
> restrictions were motivated by a fear that advertising compounded
> drugs would put people who do not need such drugs at risk by causing
> them to convince their doctors to prescribe the drugs anyway, that
> fear would fail to justify the restrictions. Aside from the fact that
> this concern rests on the questionable assumption that doctors would
> prescribe unnecessary medications, this concern amounts to a fear that
> people would make bad decisions even of given truthful information
> about compounded drugs. [Id.]{.underline} at 1507.

The issue nearly split the Court, with Brennan, joined by Stevens,
Ginsburg, and Rehnquist, dissenting, because the non-speech alternatives
of distinguishing between new and compounded drugs offered by the Court
would not serve to the interest of preventing over-prescription.
[Id.]{.underline} at 1510-15. However, the reasoning employed in the
Court's majority opinion would apply to DTC advertising of all types of
prescription drugs.

> 3\. [The First Amendment protects all truthful, non-misleading
> commercial speech, regardless of whether such speech concerns dietary
> supplements or foods. The level of substantiation required by the FDA
> for health claims on food and drug labels unconstitutionally restricts
> truthful, non-misleading statements about scientific findings relating
> to the connection between diet and health.]{.underline}[^4] [Consumer
> interest in health claims for dietary supplements may be higher than
> for foods, because people buy dietary supplements for the sole purpose
> of improving their health.]{.underline}[^5]
>
> 4\. [Claims based on scientific findings should include an explanation
> of the scientific basis of the claim, as well as any disclaimer
> required by the FDA, so that consumers can make informed decisions for
> themselves. The explanation and disclaimer should be in the same size
> type as each other, and should be located together near the
> nutritional or supplemental facts. The claims themselves, however,
> should be placed on the front of the product, with a note such as "see
> explaination and disclaimer.]{.underline}"[^6]
>
> 5\. [Warnings should, to the greatest extent possible, provide not
> only information about potential adverse effects, but also provide
> information about which groups of people are most likely to experience
> specific adverse effects.]{.underline}[^7]

6.  [The First Amendment protects all truthful, non-misleading
    commercial speech, regardless of whether such speech appears in
    advertisements or on labels.]{.underline}[^8]

First Amendment case law does not provide a basis for giving the
government greater latitude in the regulation of labels than in the
regulation of advertisements. It may however, provide a basis for giving
labels greater First Amendment protection. When the Court originally
extended First Amendment protection to commercial speech, it defined
commercial speech as "speech that *does no more* than propose a
commercial transaction." [Virginia State Board of Pharmacy v. Virginia
Consumers Council]{.underline}, 425 U.S. 748, 762 (1976). Under
[Virginia Pharmacy]{.underline}, scientific findings on labels would
receive greater protection than that afforded pure commercial speech,
because labels do much more than propose a commercial transaction. They
also provide factual information about the product. The Court has,
however, expanded the definition of commercial speech, characterizing
the proposal of a commercial transaction as the test in [City of
Cincinnati v. Discovery Networks, Inc.]{.underline}, 597 U.S. 410, 423
(1993), and applying the commercial speech doctrine to beer and wine
labels in [Rubin v. Coors Brewing Co.]{.underline}, 514 U.S. 476, 481
(1995).

7.  [Speech concerning off-label uses should only be regulated to ensure
    that information is not false or misleading. The FDA may not use
    speech restrictions to encourage applications for approval of new
    drug uses, but the government does have non-speech related options
    for encouraging manufacturers to seek FDA approval for new
    uses.]{.underline}[^9]

In [Washington Foundation v. Henney]{.underline}. 56 F.Supp.2d 81
(D.D.C. 1999), the court determined that the First Amendment prohibits
the FDA from using revocation of First Amendment rights as a basis for
encouraging the filing of applications for approval of new uses.
[Id.]{.underline} at 87 (describing the requirement as "constitutional
blackmail" because failure to comply results in loss of First Amendment
rights). The Supreme Court has also struck "indirect" regulation of free
speech, with a determination that the FDA could not base the grant of a
government benefit such as an exemption from the drug approval process
on the surrender of the First Amendment right to advertise the product.
[Thompson v. Western Medical Center]{.underline}, 122 S.Ct. 1497 (2002).
These cases indicate that the First Amendment does not permit the FDA to
ban the advertisement of products or use of products that are on the
market, merely for the purpose of promoting its broader regulatory
scheme. The government could use non-speech related means to encourage
manufacturers to seek FDA approval of new drug uses. For example,
Congress could provide by statute for a common law defense to tort
claims in cases where the manufacturer sought FDA approval for the
advertised use.[^10]

> 8\. [To the extent that they restrict truthful, non-misleading speech,
> the FDA's regulations do not advance public health. The FDA could
> advance public health by alternatively regulating to prevent only
> false or misleading speech.]{.underline}[^11]

9.  [The level of scientific substantiation required for approval of
    health claims on food and dietary supplement labels
    unconstitutionally restricts too much truthful, non-misleading
    speech. Similarly, the level of scientific substantiation of
    efficacy for approval of drug uses also raises First Amendment
    issues.]{.underline}[^12]

The First Amendment requires that restrictions of commercial speech be
"narrowly tailored" to serve the asserted government interest. The
interest of protecting consumers from fraud could be served by less
stringent standards for scientific substantiation. The FDA could also
require explanations to ensure that potentially misleading statements
are not misleading.

###### The FDA's Restriction of Truthful Messages on Food and Dietary Supplement Labels is Unconstitutional.

The level of scientific substantiation required for FDA approval of
health claims on food and dietary supplement labels, combined with the
FDA's refusal to allow for health claims with disclaimers is
unconstitutional under First Amendment protections for commercial
speech. The First Amendment requires that restrictions on truthful,
non-misleading commercial speech be "narrowly tailored" to serve the
asserted government interest. [Board of Trustees of SUNY v.
Fox]{.underline}, 409 U.S. 469, 109 S.Ct. 3028, 3035 (1989). The purpose
of restricting health claims on labels is to protect consumers from
claims that are either false or misleading. In order to be "narrowly
tailored," restrictions on commercial speech must serve this purpose
"without at the same time banning or significantly restricting a
substantial quantity of speech that does not create the same evils." See
[Ward v. Rock Against Racism]{.underline}, 109 S.Ct. 2746, 2758 (1989).
The high level of scientific substantiation required by the FDA
significantly restricts the flow of truthful information that would help
consumers make informed decisions relating to their health. The FDA
could use less restrictive means to protect consumers from fraud.

######  {#section .unnumbered}

######## Background: The Developing Role of the FDA

The 1906 Pure Foods and Drugs Act marks the beginning of systematic,
national regulation of foods and drugs. The act did not require
preclearance of drugs, and it placed on the government the burden of
proving a claim both false and fraudulent.[^13] Misbranding provisions
applied only to labels, so health claims in advertisements tended to
escape the FDA scrutiny. The 1938 Federal Food, Drug and Cosmetic Act
(FDCA) introduced premarket review of drugs. 21 U.S.C. § 505, FDCA §
355.[^14] The term "labeling" was introduced, which extended the reach
of the FDA beyond product labels. 21 U.S.C. § 201(m), FDCA §
321(m).[^15] Under the FDCA, false claims were prohibited. 21 U.S.C §
502(a), FDCA § 352(a).[^16]

The 1962 Drug Amendments[^17] to the FDAC require premarket *approval of
drug safety and efficacy* for intended use, as opposed to premarket
review of only safety previously required by the 1938 FDCA. The approval
process placed the burden of proof for drug efficacy on the drug
sponsor. 21 U.S.C. § 505(a),(b),(c), FDCA 355(a),(b),(d).[^18] The
amendments authorize the FDA to approve drugs only if the agency finds
that there is "substantial evidence" that the drug will be effective for
proposed use. 21 U.S.C. § 505(d), FDCA § 355(d).[^19]

For several years, the FDA completely banned health claims on food and
dietary supplement labels, on the basis that such claims transformed
these products into unapproved drugs under the 1962 Drug Amendments.
During the 1970's and 1980's, scientific knowledge concerning the
relationship between health and diet increased significantly, but the
FDA continued to ban health claims. In 1990, Congress enacted the
Nutritional Labeling and Education Act (NLEA), which instructs the FDA
to allow on food labels health claims substantiated by "significant
scientific agreement," and instructs FDA to develop a standard for
health claims on dietary supplements. The FDA simply extended the food
label requirement to health claims on dietary supplement labels, and
chose for "significant scientific agreement," a stringent scientific
consensus standard. The 1994 Dietary Supplement Act directed the FDA to
reconsider its criteria for health claims, and the FDA chose to adhere
to the policy of applying the standards developed for health claims on
foods.[^20] The 1997 Food and Drug Administration Act added the
alternative of health claims based on an authoritative statement of a
scientific body of the U.S. government.

######## The Commercial Speech Doctrine

1.  *First Amendment protections apply to commercial speech.*

Under the Constitution of the United States, Congress has broad power to
regulate commerce, U.S. Const. art. 1, § 8, cl. 3, but the power to
regulate speech is limited by the First Amendment, which reads,
"Congress shall make no law... abridging the freedom of speech, or of
the press," U.S. Const. amend. I. The framers did not distinguish
between "commercial" and "political" speech, and the general
understanding of "freedom of the press" in colonial America included
commercial speech.[^21] However, until 1975, the Court refused to extend
protection commercial speech. [See]{.underline}, [e.g.]{.underline},
[Valentine v. Christnesen]{.underline}, 316 U.S. 52, (1942). The
distinction between commercial and political speech remains unclear, but
the Court has determined that "commercial" speech is entitled to limited
First Amendment protection. [See]{.underline}, [e.g.]{.underline},
[Virginia State Board of Pharmacy v. Virginia Consumers
Council]{.underline}, 425 U.S. 748 (1976); [Thompson v. Western Medical
Center]{.underline}, 122 S.Ct. 1497 (2002). Therefore, the broad power
to regulate commerce is limited by First Amendment protections for
commercial speech.

In 1975, The Supreme Court held that "purely factual information of
public interest" is entitled to First Amendment protection, even if the
information is within an advertisement. [Bigelo v.
Virginia]{.underline}, 421 U.S. 809 (1975). One year later, in [Virginia
Pharmacy]{.underline}, the Supreme Court struck a Virginia statute that
restricted price advertising for prescription drugs, finding that purely
commercial speech is entitled to protection under the First Amendment.
[Virginia State Board of Pharmacy v. Virginia Consumers
Council]{.underline}, 425 U.S. 748, 758-73 (1976). The Court also held
that the First Amendment affords potential recipients of information a
"reciprocal right to receive the advertising," granting to consumers
standing to challenge restrictions on advertisers. [Id.]{.underline} at
756-7. The First Amendment was adopted against a backdrop of common law
prohibition of fraud, so false or misleading speech is not entitled to
First Amendment protection.

######## The Central Hudson framework is used to determine whether restrictions on commercial speech are constitutional.

[Central Hudson]{.underline} provides the framework for determining
whether restrictions on commercial speech violate the First Amendment.
[Central Hudson Gas & Electric Corp. v. Public Serv. Comm'n of
N.Y.]{.underline}, 447 U.S. 557, 566 (1980). The four step analyses
begins with a determination of whether the speech is truthful and not
misleading. [Id.]{.underline} False and misleading speech is not
entitled to First Amendment protection. In order to regulate truthful
commercial speech, the government must assert a substantial interest.
[Id.]{.underline} The restriction must directly advance the asserted
interest, and the restriction must be no more extensive than necessary.
[Id.]{.underline} In [Central Hudson]{.underline}, New York Public
Commission regulations restricting advertising intended to promote
electricity were held to be unconstitutional because the Court found
that they restricted speech that did not impair the asserted interest of
energy conservation, and because the interest could be served by a less
restrictive means. [Id.]{.underline} The test for whether a restriction
is too extensive looks to whether there is a "reasonable fit" between
the asserted interest and the restriction. [Board of Trustees of the
State of New York v. Fox]{.underline}, 492 U.S. 469 (1989). The
restriction must be "narrowly tailored." [Id.]{.underline} The existence
of alternative, less restrictive, means of serving the interest is to be
considered. [Id.]{.underline}

###### The U.S. Supreme Court recently found sections of the FDAMA to be unconstitutional restrictions of commercial speech.

The U.S. Supreme Court recently reviewed provisions of the FDAMA in
[Thompson v. Western Medical Center]{.underline}, 122 S.Ct. 1497 (2002).
The provisions prohibited advertising and promotion of compounded drugs,
which are drugs combined or mixed to meet the needs of an individual
patient. Section 503A of the FDAMA exempts compounded drugs from the new
drug approval process, so long as they are not solicited, or advertised.
21 U.S.C. § 353a(a), (c) (as amended). The FDA asserted the interest of
distinguishing between newly manufactured and compounded drugs, in order
to require safety and efficacy testing only for new drugs.
[Id.]{.underline} at 1498. The regulations were found to be
unconstitutional, in an opinion by Justice O'Connor joined by Scalia,
Kennedy, Souter and Thomas. [Id.]{.underline} at 1509. The regulations
failed the [Central Hudson]{.underline} test because the asserted
interest could be accomplished by a non-speech means, and because the
regulations restricted beneficial speech. [Id.]{.underline} Justice
Breyer, in a dissent joined by Stevens, Ginsburg, and Rehnquist, found
that an interest of limiting distribution of compounded drugs to people
who not need them, would not be served by the alternatives offered by
the Court. [Id.]{.underline} at 1510-5. O'Connor addresses the dissent
by indicating that government did not introduce this interest in the
briefs, and statutes are only sustained on hypothesized justifications
when reviewed to determine whether rational. [Id.]{.underline} at 1597.

######## First Amendment Analysis of the FDA's Restriction of Health Claims on Food and Dietary Supplement Labels

Prior to the 1990 Nutritional Labeling and Education Act (NLEA), health
claims were completely banned on food and dietary supplemental labels.
The NLEA amended the FDCA to permit for approval of a food health claim
characterizing the relationship between a nutrient and health condition
if supported by "significant scientific agreement." 21 U.S.C. §
343(r)(1)(B), (3)(B)(i); FDAC § 403(r)(1)(B), (3)(B)(i). Congress gave
the FDA the discretion of determining the requirements for health claims
on dietary supplement labels, 21 U.S.C. § 343(r)(5)(D); FDAC §
403(r)(5)(D), and the FDA extended the food label requirement to dietary
supplements. The FDA chose as the standard for "significant scientific
agreement," a stringent scientific consensus standard:

> FDA will promulgate regulations authorizing a health claim only when
> it determines, based on the totality of publicly available scientific
> evidence (including evidence from well-designed studies conducted in a
> manner which is consistent with generally recognized scientific
> procedures and principles), that there is significant scientific
> agreement, among experts qualified by training and experience to
> evaluate such claims, that the claim is supported by such evidence. 21
> C.F.R. 101.14(c)

The 1997 Food and Drug Administration Modernization Act (FDAMA) amends
the FDCA to also allow for claims based on an authoritative statement
made by a "scientific body of the United States government with official
responsibility for public health or research directly relating to human
nutrition." 21 U.S.C. § 403 (r)(3)(C). Such claims must accurately
represent the statement and the relevance of the information in the
context of a total daily diet. Id.

Health claims for dietary supplements that relate a nutrient to a health
condition are also subject to either the 1990 NLEA "substantial
scientific agreement" requirement or the 1997 FDAMA authoritative
statement of a scientific body of the United States government. However,
the 1994 Dietary Supplement Health and Education Act (DSHEA) allows for
structure/function claims without FDA approval. U.S.C. § 343(r)(6); FDAC
§ 403(r)(6). Such claims must have substantiation, but need not present
substantiation to the FDA, U.S.C. § 343(r)(6)(B); FDAC § 403(r)(6)(B)
and 21 CFR § 101.93(a), and they must include the following disclaimer:
"This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure,
or prevent any disease," USC § 343(r)(6)(C); FDAC § 403(r)(6)(C).

######  {#section-1 .unnumbered}

###### Truthful Report of Scientific Findings on Food and Dietary Supplement Labels are at Least Entitled to the First Amendment Protections for Commercial Speech

####### The Supreme Court has not provided a clear framework for distinguishing between commercial speech, entitled to limited First Amendment protection, and pure informational speech, entitled to full protection. In [Virginia Pharmacy]{.underline}, commercial speech was defined as "speech that *does no more* than propose a commercial transaction." [Virginia State Board of Pharmacy v. Virginia Consumers Council]{.underline}, 425 U.S. 748, 762 (1976). The Court later expanded the definition to include speech that also does more. See [City of Cincinnati v. Discovery Networks, Inc.]{.underline}, 597 U.S. 410, 423 (1993) (characterizing the presence of proposal of a transaction as the test for identifying commercial speech). Food and dietary supplement labels are not clearly commercial speech under [Virginia Pharmacy]{.underline}, because they do more then propose a commercial transaction. They also provide facts about the product, and in some cases, facts about the relationship between diet and health. However, labels probably would pass the [Discovery Networks]{.underline} test, because they are a means of encouraging consumers to purchase the product. {#the-supreme-court-has-not-provided-a-clear-framework-for-distinguishing-between-commercial-speech-entitled-to-limited-first-amendment-protection-and-pure-informational-speech-entitled-to-full-protection.-in-virginia-pharmacy-commercial-speech-was-defined-as-speech-that-does-no-more-than-propose-a-commercial-transaction.-virginia-state-board-of-pharmacy-v.-virginia-consumers-council-425-u.s.-748-762-1976.-the-court-later-expanded-the-definition-to-include-speech-that-also-does-more.-see-city-of-cincinnati-v.-discovery-networks-inc.-597-u.s.-410-423-1993-characterizing-the-presence-of-proposal-of-a-transaction-as-the-test-for-identifying-commercial-speech.-food-and-dietary-supplement-labels-are-not-clearly-commercial-speech-under-virginia-pharmacy-because-they-do-more-then-propose-a-commercial-transaction.-they-also-provide-facts-about-the-product-and-in-some-cases-facts-about-the-relationship-between-diet-and-health.-however-labels-probably-would-pass-the-discovery-networks-test-because-they-are-a-means-of-encouraging-consumers-to-purchase-the-product. .unnumbered}

####### The Court has applied the [Central Hudson]{.underline} test to restrictions on labels for bear and wine. [Rubin v. Coors Brewing Co.]{.underline}, 514 U.S. 476, 481 (1995) ("both parties agree that the information on beer labels constitutes commercial speech"). Statements of scientific findings on food labels would also likely be considered commercial speech, even though such statements could alternatively be characterized as purely informational speech, which is afforded greater protection. There is no constitutional basis for affording scientific findings on labels any less protection than that given to scientific findings published in science journals, so the Court could alternatively determine that certain health claims are entitled to full First Amendment protection, as opposed to the lesser protection afforded commercial speech.  {#the-court-has-applied-the-central-hudson-test-to-restrictions-on-labels-for-bear-and-wine.-rubin-v.-coors-brewing-co.-514-u.s.-476-481-1995-both-parties-agree-that-the-information-on-beer-labels-constitutes-commercial-speech.-statements-of-scientific-findings-on-food-labels-would-also-likely-be-considered-commercial-speech-even-though-such-statements-could-alternatively-be-characterized-as-purely-informational-speech-which-is-afforded-greater-protection.-there-is-no-constitutional-basis-for-affording-scientific-findings-on-labels-any-less-protection-than-that-given-to-scientific-findings-published-in-science-journals-so-the-court-could-alternatively-determine-that-certain-health-claims-are-entitled-to-full-first-amendment-protection-as-opposed-to-the-lesser-protection-afforded-commercial-speech. .unnumbered}

In response to previous comments about First Amendment issues relating
to FDA regulation of health claims on foods, the FDA argued that such
regulation was incidental to its broad authority to regulate economic
activity surrounding foods, and is therefore not subject to First
Amendment limitations.[^22] The FDA has apparently abandoned this
position in regard to health claims for food and dietary supplements,
because in [Pearson v. Shalala]{.underline}, the FDA did not dispute the
application of the Central Hudson framework. [See]{.underline} [Pearson
v. Shalala]{.underline}, 164 F.3d. 650, 655 (D.C. Cir. 1999) ("It is
undisputed that FDA's regulations on appellants' health claims are
evaluated under the commercial speech doctrine). The arguments will,
however, be considered later in the section discussing approval of drug
uses, as those regulations are more closely associated with broader
regulation of commercial conduct. The Court's application of the
[Central Hudson]{.underline} test in [Thompson]{.underline} to
restrictions on advertising of compounded drugs indicates that the Court
will not let FDA restraints on speech to escape First Amendment scrutiny
based on the furtherance of a broader regulatory objective. [Thompson v.
Western Medical Center]{.underline}, 122 S.Ct. 1497 (2002).

######  {#section-2 .unnumbered}

###### Truthful reports of scientific findings on food and dietary supplement labels are not inherently misleading. 

The first prong of [Cental Hudson]{.underline} asks whether regulated
speech is truthful and not misleading. Speech that is either false or
deceptive is not entitled to First Amendment protection. The Court has
found certain types of communication to be "inherently misleading." See
[Ohralik v. Ohio State Bar Association]{.underline}, 436 U.S. 447, 456
(1978); see also [Friedman v. Rogers]{.underline}, 99 S.Ct. 887 (1978).
In [Ohralik]{.underline}, in person solicitation by lawyers of accident
victims was found to be inherently misleading because of the potential
for exertion of pressure. [Ohralik v. Ohio State Bar
Association]{.underline}, 436 U.S. at 468. The Court distinguished
public advertisements, on the basis that they provide "an opportunity
for comparison and reflection," so restrictions on health claims on
labels would not be upheld under [Ohralik]{.underline}. See id. at 457.

Health claims on food and dietary supplement labels would not be found
to be inherently misleading under other Supreme Court cases finding
speech to be inherently misleading. In [Friedman]{.underline}, the Court
found public advertisement of trade names by optometrists to be
inherently misleading because there had been a history of deception of
the public. [Friedman v. Rogers]{.underline}, 99 S.Ct. at 15-6. The
Court found the restrictions to be permissible because they would have
only an incidental effect on the content of advertisements, and would
still allow for the communication of the "factual information associated
with trade names." Id. at 15-6. The FDA's restriction of health claims
is more intrusive than the restriction validated in
[Friedman]{.underline}. The restrictions on health claims prevent
communication of factual information, and so would not be valid under
[Friedman]{.underline}.

Restriction of speech that has been shown to be subject to abuse was
also upheld in [In re R.J.M.]{.underline}, 455 U.S. 191, 203. The Court
clarified the "inherently misleading" aspect of the commercial speech
doctrine:

> Truthful advertising related to lawful activities is entitled to the
> protections of the First Amendment. But when the particular content or
> method of the advertising suggests that it is inherently misleading or
> when experience has proved that in fact such advertising is subject
> abuse, the \[government\] may impose appropriate restrictions.
> Misleading advertising may not be prohibited entirely. But the
> \[government\] may not place an absolute prohibition on certain types
> of potentially misleading information... *if that information also may
> be presented in a way that is not deceptive.* Id. at 203 (emphasis
> added).

The First Amendment therefore requires the FDA to allow potentially
misleading health claims, when they can be phrased in a way that is not
misleading, through the use of disclaimers, or otherwise.

In [Pearson v. Shalala]{.underline}, the FDA argued that people may not
be able to differentiate between approved and unapproved health claims,
regardless of the form of presentation, and that unapproved health
claims are therefore inherently misleading speech, which is not entitled
to First Amendment protection. [Pearson v. Shalala]{.underline}, 164
F.3d 650, 76 (D.C. Cir. 1999). The court found this argument to be
"almost frivolous" because it depended on an assumption that people are
not able to exercise any judgement at the point of sale. Id.

The First Amendment favors the use of disclaimers, or increased
disclosure, over a complete ban of speech, but the FDCA, as amended to
allow for health claims, does not allow for the use of disclaimers for
unapproved health claims. The FDCA is not, however, necessarily
unconstitutional. The FDA could have chosen a less rigorous approval
process for the FDCA "significant scientific agreement" standard for
health claims. The FDA could have instead chosen a standard that only
prohibits claims that lack scientific basis. Such claims are fraudulent
and therefore not protected by the First Amendment. The FDA could then
use disclaimers and explanations to clarify the level of substantiation
supporting potentially misleading approved claims.

In response to previous comments regarding First Amendment issues, the
FDA argued that unapproved claims are misleading because the FDCA, as
amended, defines foods with unapproved claims as misbranded. Fraudulent
claims are not protected by the First Amendment because they are
prohibited under common law doctrines. The government is not free to
define what is misleading and then regulate what they have defined. If
this were the case, the government could easily shield regulations from
First Amendment limitations. The FTC, which has jurisdiction over health
claims in food advertisements, has used the common law definition for
fraud and the commercial speech doctrine to tailor its scientific
substantiation requirement to these legal requirements. The FTC has
urged the FDA to use a similar scientific substantiation standard, in
order to bring FDA into compliance with the First Amendment, and also
for the purpose of consistency in federal regulation of foods.

###### The general interest of protecting consumers from fraud is substantial, as is the more specific interest of protecting consumer health. 

The second prong of [Central Hudson]{.underline} asks whether the
asserted governmental interests are substantial. Courts are deferential
in the determination of whether an asserted legislative interest is
substantial. See, e.g. [Greater New Orleans Broadcasting Association,
Inc. v. United States]{.underline}, 527 U.S. 173 (1999) (accepting as
"substantial" the asserted interest of reducing the social costs of
gambling, while recognizing that there are "coutervailing policy
considerations, primarily in the form of economic benefit"). In [Rubin
v. Brewing Co.]{.underline}, 514 U.S. 476, 486 (1995), the Court
rejected the Federal Alcohol Administration's asserted interest of
preserving state authority in regulation of alcohol under the
Twenty-first Amendment. The Court found that the federal government had
failed to show that states needed assistance in order to ban disclosure
of alcohol content within their borders. [Id.]{.underline} The
additional asserted interest of "promoting health, safety, and welfare"
by curbing strength wars was found to be substantial. [Id.]{.underline}
at 485. The FDA's asserted interest of promoting health, safety, and
welfare by preventing fraudulent health claims would also pass the
substantial government interest prong of [Central Hudson]{.underline}.

###### The scientific substantiation requirement for health claims serves the interest of protecting consumers from fraud, but may not serve the underlying interest of protecting public health.

######   {#section-3 .unnumbered}

###### The third prong of Central Hudson asks whether the regulations advance the asserted interest. See [Edenfeld v. Fane]{.underline}, 507 U.S. 761 (1993). The government bears the burden of showing that the challenged regulation advances the interest in a direct and material way. [Id.]{.underline} at 767. The FDA's regulation of health claims directly and materially serves the interest of protecting consumers from fraudulent health claims. However, the restrictions are for the most part overbroad, in that they also restrict truthful claims that would help consumers make better diet decisions. By banning claims that are substantiated by science, though not to the level required by the FDA, the FDA withholds valuable information from the consumer. The broader interest of protecting public health is therefore not served by the restrictions on health claims on food and dietary supplement labels.  {#the-third-prong-of-central-hudson-asks-whether-the-regulations-advance-the-asserted-interest.-see-edenfeld-v.-fane-507-u.s.-761-1993.-the-government-bears-the-burden-of-showing-that-the-challenged-regulation-advances-the-interest-in-a-direct-and-material-way.-id.-at-767.-the-fdas-regulation-of-health-claims-directly-and-materially-serves-the-interest-of-protecting-consumers-from-fraudulent-health-claims.-however-the-restrictions-are-for-the-most-part-overbroad-in-that-they-also-restrict-truthful-claims-that-would-help-consumers-make-better-diet-decisions.-by-banning-claims-that-are-substantiated-by-science-though-not-to-the-level-required-by-the-fda-the-fda-withholds-valuable-information-from-the-consumer.-the-broader-interest-of-protecting-public-health-is-therefore-not-served-by-the-restrictions-on-health-claims-on-food-and-dietary-supplement-labels. .unnumbered}

######   {#section-4 .unnumbered}

###### The restrictions on health claims are not narrowly tailored to restrict only fraudulent claims. 

The final prong of Central Hudson asks whether the speech restriction is
not more extensive than necessary to serve the asserted interest. The
First Amendment requires that restrictions on truthful, non-misleading
commercial speech be "narrowly tailored" to serve their objective.
[Board of Trustees of SUNY v. Fox]{.underline}, 409 U.S. 469 (1989). In
order to be narrowly tailored, there must be a reasonable fit between
the interest and the speech restrictions, with the scope of the means
"in proportion to the interest served." [Id.]{.underline} at 480. The
presence of less restrictive alternatives is a consideration.
[See]{.underline}, [e.g.]{.underline}, [Central Hudson Gas & Electric
Corp. v. Public Serv. Comm'n of N.Y.]{.underline}, 447 U.S. 557 (1980).
The purpose of restricting health claims on labels is to protect
consumers from claims that are either false or misleading, which serves
an underlying interest of protecting public health.

###### . {#section-5 .unnumbered}

The FDA could use less restrictive means to protect consumers from
fraud. Under existing legislation, the FDA could use scientific
substantiation standards tailored to restrict only fraudulent claims. In
addition, the FDA could utilize disclaimers to protect consumers from
potentially misleading information. The limited certainty of preliminary
research does not justify prohibiting claims and indications based on
such research. The First Amendment requires instead greater
communication, allowing consumers to make fully informed decisions for
themselves. See [Virginia State Board of Pharmacy v. Virginia Citizens
Consumer Council, Inc.]{.underline}, 425 U.S. 748, 772 (1975) ("people
will perceive their own best interests if only they are well enough
informed, and the best means to that end is to open the channels of
communication, rather than to close them").

The Federal Trade Commission (FTC) has urged the FDA to reconsider its
policy of requiring scientific consensus for health claims on food
labels.[^23] According to the FTC, the high level of substantiation
required raises First Amendment issues because it bans truthful
information along with the false.[^24] The FDA's scientific consensus
standard, applied to foods and dietary supplements, considers only the
potential harm that could result from allowing a claim that later turns
out to be incorrect. The FTC is concerned that the FDA's preapproval
process "may not be able to keep pace with the rapidly accumulating and
changing diet and health information."[^25] The FTC warns, "withholding
information from consumers where there is a substantial scientific basis
for it, but where a scientific consensus has not been reached, can also
cause consumer harm."[^26] Consider, for example, the harm that likely
resulted during the several years that the FDA refused to approve health
claims connecting cholesterol and fat with heart disease.

The FDA opposes a court order by refusing to allow for any unapproved
claims with disclaimers. In [Pearson v. Shalala]{.underline}, the United
States Court of Appeals for the District of Columbia reviewed the FDA's
rejection of four health claims for dietary supplements. [Pearson v.
Shalala]{.underline}, 164 F.3d 650 (D.C. Cir. 1999). The court held that
the FDA must consider whether a disclaimer would negate the potential of
a claim to mislead, and allow any claim that can be worded, with the
inclusion of disclaimers, or otherwise, in a way that is not misleading.
[Id.]{.underline} at 658-660 (finding that the government's concern that
consumers would be confused by each of the four health claims could be
accommodated by disclaimers). The court instructed the agency to draft
disclaimers for the four health claims challenged in
[Pearson]{.underline}. [Id.]{.underline} at 659 ("We do not presume to
draft precise disclaimers for the agency: we leave that task to the
agency in the first instance"). In opposition to the court's
instructions, the FDA continues to prohibit unapproved claims with
disclaimers.[^27]

The suppression of unapproved health claims for dietary supplements has
severe consequences because people buy dietary supplements for the
purpose of improving their health. To date, the FDA has authorized less
than twenty health claims, only one of which is likely to benefit
dietary supplements: a claim concerning the relationship between calcium
and osteoporosis. Between 1995 and 1997, purchase of dietary supplement
rose thirty percent.[^28] Allowing more health claims on dietary
supplement labels would help the consumers in this expanding market make
wise choices when purchasing supplements.

In addition, by suppressing the flow of information, and requiring that
health claims relate only to a specific nutrient, FDA regulations
squelch the market incentive to investigate potential health benefits of
food and dietary supplement products. Approval of health claims, which
must relate to a nutrient, requires a prohibitively expensive level of
scientific substantiation. Once approved, any qualified product can use
a health claim, which further reduces the market incentive to
investigate potential health benefits and seek approval for health
claims.

###### The Efficacy Requirement for Approval of Drug Uses Also Raises First Amendment Issues

The level of substantiation required by the FDA for approval of drug
efficacy also raises First Amendment issues. The 1962 Drug Amendments
require premarket approval of drug safety and efficacy for intended use.
Pub. L. No. 87-781, 76 Stat. 780 (1962) (amending 21 U.S.C. § 355(d),
FDAC § 505(d)). The efficacy testing phases are the most expensive
aspect of the drug approval process.[^29] Once a drug is on the market,
approval of new uses requires repeat of the efficacy testing.
Prescribing drugs for unapproved, or "off-label" uses is a generally
accepted practice, but the FDA restricts the dissemination of truthful
information regarding scientific testing of off-label uses. These
restrictions violate the First Amendment's protections for truthful,
non-misleading commercial speech.

As applied to drugs that are already on the market, the efficacy
requirement has been found to be unconstitutional. In 1998, the
Washington Legal Foundation challenged FDA guidance documents that
prohibited dissemination of information about off-label uses.
[Washington Legal Foundation v. Friedman]{.underline}, 13 F.Supp.2d 51
(D.D.C. 1998). Before the decision, which found the documents to be
unconstitutional, was handed down, Congress enacted the Food and Drug
Administration Act (FDAMA), which slightly changed the policy for
dissemination of information to physicians. The FDAMA allows for
dissemination of information about unapproved uses, but permits the FDA
to require a supplemental application for approval of the new use be
filed with the FDA prior to dissemination. The Washington Legal
Foundation challenged the FDAMA, and the court found the supplemental
application requirement to be unconstitutional because it allowed FDA to
use the revocation of a First Amendment right as a means for encouraging
the filing of approval applications. [Washington Foundation v.
Henney]{.underline}. 56 F.Supp.2d 81, 87 (D.D.C. 1999) (describing the
requirement as "constitutional blackmail" because failure to comply
results in loss of First Amendment rights).

The premarket efficacy approval requirement as applied by the FDA may be
also be an unconstitutional restriction of commercial speech. For drugs
that have dangerous side effects, efficacy testing is an important
counterpart to safety testing, because the determination of safety
requires consideration of potential risks and benefits.[^30] Efficacy
testing for drugs that do not have dangerous side effects, however,
merely provides fraud protection. This "premarket" speech restriction
should not be permitted to escape First Amendment scrutiny. The level of
scientific substantiation required for proof of efficacy of drug uses
may unconstitutional as applied to therapies that are already proven
safe. Consumer interest would be better served by increased regulation
of product safety and less restrictive regulation of speech.

###### Conclusion

> *Citizens for Health* concurs with Senator Reed's request that FDA
> hold a public meeting to discuss these important issues. *Citizens*
> respectfully requests that a meeting be held to consider the question
> of the FDA's authority and responsibility under the First Amendment.
>
> James S. Turner, Esq. *Representing Citizens for Health Board*
>
> Naomi A. Lundberg, *Citizens for Health law clerk*

[^1]: The FDA asked: Are there arguments for regulating speech about
    drugs more comprehensively than, for example 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]: Food and Drug Administration 21 C.F.R. Parts 20 and 101 Food
    Labeling; General Requirements for Health Claims for Food, 58 Fed.
    Reg. 2478, 2525 (Jan. 6, 1993).

[^3]: The FDA asked: Is the FDA's current position regarding direct-to
    consumer and other advertisements consistent with the 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 devises? 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? 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?

[^4]: See, supra, section III.

[^5]: The FDA asked: May the 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 way? 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?

[^6]: The FDA asked: Should disclaimers be required to be in the same
    (or smaller or larger) size type and given equal prominence with
    claims? Is there any relevant authority or social science on this
    issue?

[^7]: The FDA asked: 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?

[^8]: The FDA asked: 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?

[^9]: The FDA asked: 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 the FDA's ability to regulate
    speech about off-label uses?

[^10]: See Richard C. Ascroft, The Impact of the Washington Legal
    Foundation Cases on Pharmaceutical Manufacture Practices in the
    United States, 34 Ind. L. Rev. 95, 107 (2000).

[^11]: The FDA asked: 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?

[^12]: The FDA asked: Are there any regulations, guidance, policies, and
    practices FDA should change, in light of the governing First
    Amendment authority?

[^13]: The Sherley Amendment, Pub. L. No. 62-301, 37 Stat. 416 (1912).
    Applied to health claims for drugs. There was no corresponding
    provisions for foods, but a food making a therapeutic claim would
    fall within the act's "drug" definition: "... any substance or
    mixture of substances intended to be used for the cure, mitigation,
    or prevention of disease of either man or other animals." Pub. L.
    No. 59-384, § 6, 34 Stat. 768 (1906).

[^14]: Pub. L. No. 75-717, 52 Stat. at 1052-3 (1938).

[^15]: Pub. L. No. 75-717, 52 Stat. at 1041.

[^16]: [Id.]{.underline}

[^17]: Pub. L. No. 87-781, 76 Stat. 780 (1962).

[^18]: Pub. L. No. 75-717, 52 Stat. at 1052, as amended.

[^19]: Pub. L. No. 75-717, as amended.

[^20]: 58 Fed. Reg. at 33,702-3.

[^21]: See David A. Anderson, The Origins of the Press Clause 30 UCLA L.
    Rev. 455 (1983) (), and Verner W. Crane Benjamin Franklin's Letters
    to the Press, 1758-1775 xvi (1950) ("It was a commercial age, and it
    produced a commercial press").

[^22]: See, supra, note 2.

[^23]: "Comments of the Bureaus of Consumer Protection and Economics of
    the Federal Trade Commission," submitted to the Food and Drug
    Administration, Department of Health and Human Services In Response
    to a Request for Comments on its Proposal to Amend the Rules
    Governing Food Labeling; Health Messages and Label Statements;
    Reproposed Rule \[Docket No. 85N-0061\] 55 Fed. Reg. 5176, February
    13, 1990.

[^24]: The First Amendment and Food Health Claims, from the NAD Workshop
    II: Substantiating Food Health Claims in Advertising, November 14-15
    (1990) at 167.

[^25]: [Id.]{.underline} at 169.

[^26]: [Id.]{.underline}

[^27]: The agency has not yet allowed any of the four claims at issue in
    [Pearson]{.underline}, nor has it allowed for any other unapproved
    claims with disclaimers.

[^28]: Michael Higgins, Hard to Swallow, ABA J., June 1999, at 60.

[^29]: Richard A. Merrill, The Architecture of Government Regulation of
    Medical Products, 82 Va. L. Rev. 1753, 1853 n.316 (1996).

[^30]: *Drug Industry Antitrust Act: Hearing on S. 1552 Before the
    Subcomm. on Antitrust and Monopoly of the Comm. on the Judiciary*,
    87^th^ Cong. 2588 (1961) (statement of Abraham Ribikoff, Secretary,
    Department of Health Education and Welfare).