Fleminger Inc v. US Dept of Health and Human Svcs et al
Filing
43
ORDER granting in part and denying in part 36 Motion for Summary Judgment; granting in part and denying in part 37 Motion for Summary Judgment. See attached memorandum of decision. The Clerk is directed to close the file. Signed by Judge Vanessa L. Bryant on 2/23/2012. (Fernandez, Melissa)
UNITED STATES DISTRICT COURT
DISTRICT OF CONNECTICUT
FLEMINGER, INC.,
PLAINTIFF,
:
:
: CIVIL ACTION NO. 3:10cv855 (VLB)
:
v.
: FEBRUARY 23, 2012
:
U.S. DEPARTMENT OF HEALTH AND :
HUMAN SERVICES, ET AL.,
:
DEFENDANTS
:
MEMORANDUM OF DECISION GRANTING IN PART AND DENYING IN PART
PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT AND GRANTING IN PART AND
DENYING IN PART DEFENDANTS’ CROSS MOTION FOR SUMMARY JUDGMENT
[Dkt. ## 36, 37]
Plaintiff, Fleminger, Inc. (“Fleminger”), a manufacturer and retailer of green
tea brings this action against the U.S. Department of Health and Human Services
(“DHHS”), Kathleen Sebelius in her official capacity as Secretary of DHHS, the
U.S. Food and Drug Administration (“FDA”), and Margaret Hamburg, M.D., in her
official capacity as Commissioner of the FDA. Fleminger filed a petition with the
FDA for authorization of certain qualified health claims regarding green tea on its
products labeling. The FDA exercised its enforcement discretion requiring
Fleminger to include a modified disclaimer to its qualified health claim that
drinking green tea “may reduce the risk of breast or prostate cancer.” Fleminger
alleges that Defendants violated its commercial speech rights under the First
Amendment by requiring Fleminger to include the modified disclaimer to its
health claim. Both Fleminger and Defendants have moved for summary
judgment. For the foregoing reasons, Plaintiff’s motion for summary judgment is
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granted in part and denied in part and Defendants’ cross motion for summary
judgment is granted in part and denied in part.
I.
Background
The current case challenging the FDA’s regulation of marketing claims
regarding the health benefits for food under the First Amendment is closely
related to a progression of similar cases challenging the FDA’s regulation of
health claims for dietary supplements under the First Amendment in the District
of Columbia. In response to these cases, the FDA has developed a system for
considering so called “qualified health claims” which it applies to both food
products and dietary supplements. [Dkt. #37, Def. Mem. at 6].
This is a case of first impression in this Circuit as neither party cites and
this Court has not found any Second Circuit authority on point analyzing the
FDA’s qualified health claim process under the First Amendment. The D.C.
Circuit and district court cases provide the most pertinent analysis and guidance
on this rather unique issue. Before turning the particular facts and issues in
dispute in the present case, it is necessary to first review these prior D. C. Circuit
and district court cases as well as the statutory and regulatory framework
underlying the FDA’s power to regulate such health claims.
i.
Legal Standard for Evaluating Commercial Speech Claims
Since health claims regarding both food products and dietary
supplements are commercial speech, the FDA’s regulation of such claims is
evaluated under the multi-step framework established in Central Hudson Gas &
2
Elec. Corp. v. Public Serv. Comm’n of New York, 447 U.S. 557 (1980) and as later
elaborated in Thompson v. Western States Medical Center, 535 U.S. 357 (2002).
As a “threshold matter,” the Court must determine “whether the commercial
speech concerns unlawful activity or is misleading. If so, then the speech is not
protected by the First Amendment.” Western States, 535 U.S. at 367.
However, if the speech is lawful and not misleading or is only potentially
misleading, the Court must ask “whether the asserted governmental interest in
regulating the speech is substantial.” Id. (quoting Central Hudson, 447 U.S. at
566). If the government interest is substantial, then the Court must determine
“whether the regulation directly advances the governmental interest asserted”
and finally “whether [the regulation] is not more extensive than is necessary to
serve that interest.” Id. (quoting Central Hudson, 447 U.S. at 566). The last step
requires an evaluation of “whether the fit between the government’s end and the
means chosen to accomplish those ends is not necessarily perfect, but
reasonable.” Pearson I, 164 F.3d at 656 (internal quotation marks and citation
omitted). A “reasonable fit” is not a “least restrictive means” test, Clear Channel
Outdoor, Inc. v. City of New York, 594 F.3d 94, 104 (2d Cir. 2010), and thus courts
do not ask where there is “no conceivable alternative” but instead require that the
“regulation not burden substantially more speech than is necessary to further the
government’s interests.” Bd. of Trs. of the State Univ. of N.Y. v. Fox, 492 U.S.
469, 478 (1989). “[I]f the Government c[an] achieve its interests in a manner that
does not restrict speech, or that restricts less speech, the Government must do
so.” Western States, 535 U.S. at 371. The “government has the burden of
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showing that the regulations on speech that it seeks to impose are ‘not more
extensive than is necessary to serve’ the interests it attempts to advance.”
Alliance II, 786 F.Supp.2d at 13 (quoting Western States, 535 U.S. at 371).
Plaintiff argues that the Supreme Court’s recent decision in Sorrell v. IMS
Health Inc., 131 S.Ct. 2653 (2011) altered or modified the traditional framework for
evaluating commercial speech. See [Dkt. # 41, Pl. Opposition Mem. at 9, 9 n.5].
Plaintiff argues that under Sorrell the government must demonstrate more than
just a reasonable fit between the government’s ends and the means chosen to
accomplish those ends and suggests that Sorrell overturned the Supreme Court’s
prior holding in Fox. In Fox, the Supreme Court expressly rejected the
proposition that government restrictions on commercial speech need to be the
absolute least restrictive means to achieve the desired end and instead held that
such restrictions require only a reasonable fit. Fox, 492 U.S. at 477-78. Plaintiff
bases its argument solely on the fact that the majority in Sorrell never used the
word “reasonable” in connection with its analysis of the fit between the
government’s means and ends and at one point noted that the statute at issue “at
least” must directly advance the substantial government interest. [Dkt. #41, Pl.
Opposition Mem at 0, 9 n.5].
The Court is not persuaded that the Supreme Court’s decision in Sorrell
altered the traditional scrutiny applied under the Central Hudson framework and
overturned Fox’s holding. The majority’s opinion in Sorrell expressly relied on
the Supreme Court’s prior articulation of the standard for evaluating commercial
speech claims in Central Hudson, Western States and Fox. See Sorrell, 131.Ct. at
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2667-68 (“To sustain the targeted, content-based burden § 4631(d) imposes on
protected expression, the State must show at least that the statute directly
advances a substantial government interest and that the measure is drawn to
achieve that interest. There must be a ‘fit between the legislature’s ends and the
means chosen to accomplish those ends.’”) (quoting Fox, 492 U.S. at 480). The
majority in Sorrell cited to Fox for the proposition that “there must be a fit
between the legislature’s end and the means chosen to accomplish those ends.”
Sorrell, 131 S.Ct. at 2667-68. The fact that the majority did not use the word
“reasonable” when it cited to Fox for the proposition that there must be a fit
between the government’s means and ends does not indicate that the Supreme
Court mutely overturned well-established and long standing precedent.
Moreover, the Sorrell court’s focus was on the subject restrictions lack of
neutrality and lack of any fit reasonable or otherwise with its stated purpose.
Further, under the traditional framework as articulated in Central Hudson,
Western States and Fox, the government’s restriction on speech must directly
advance the governmental interest asserted. The use of the words “at least” by
the majority in Sorrell does not alter or change any part of the traditional
commercial speech analysis under this long standing precedent. See Fox, 492
U.S. at 474 (noting that under Central Hudson, the Court “must determine whether
the regulation directly advances the governmental interest asserted”). Moreover,
it is unlikely that the Supreme Court would directly overturn a prior holding and
drastically alter the level of scrutiny afforded under a foundational constitutional
analysis without a thorough and comprehensive discussion heralding such an
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elemental change to the long standing and well-established constitutional
framework. The decision in Sorrell did not impact the traditional framework for
evaluating commercial speech under the First Amendment and accordingly the
government must demonstrate a reasonable fit between its ends and the means
chosen to accomplish those ends. The government is therefore not obligated to
demonstrate that its restriction is the least restrictive means to achieve its ends.
ii.
Statutory and Regulatory Framework
To determine the disputed issues, the Court must consider the statutory
and jurisprudential context in which they arise. In 1990, Congress enacted the
Nutrition Labeling and Education Act of 1990 (“NLEA”) Pub. L. No. 101-535, 104
Stat. 2353 (1990) (codified as amended at 21 U.S.C. §§ 301, 321, 337, 343, 34-1,
345, 371) which amended the Food, Drug and Cosmetic Act (“FDCA”) to provide
the FDA with authority to regulate health claims on food including dietary
supplements. Before NLEA was enacted, a food intended for use in the
diagnosis, cure, mitigation, treatment or prevention of a disease would fall within
the FDCA’s definition of a drug and become subject to the FDA’s requirements
for drug approval and labeling. See Pearson v. Shalala, 164 F.ed 650, 652-3 (D. C.
Cir. 1999) (“Pearson I”); 21 U.S.C. § 321 (g)(1)(B). NLEA created a “safe harbor”
from drug designation for foods labeled with health claims. See Alliance for
Natural Health U.S. v. Sebelius, 714 F.Supp.2d 48, 41 (D.D.C. 2010) (“Alliance I”);
see also 21 U.S.C. § 343(r)(1). “Under NLEA, a manufacturer may make a health
claim on a food without FDA new drug approval if the FDA determines that
‘significant scientific agreement,’ based on the totality of publicly available
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scientific evidence supports the claim.” Alliance for Natural Health U.S. v.
Sebelius, 786 F.Supp.2d 1, 4 (D.C.C. 2011) (“Alliance II”) (quoting 21 U.S.C. §
343(r)(3)(B)(i)). The FDA subsequently promulgated a regulation adopting NLEA’s
“significant scientific agreement” standard for food health claims to dietary
supplement claims. Id. (citing 21 C.F.R. §101.14(c)).
Under the FDCA, a food labeled with an unauthorized health claim may be
considered a misbranded food. See 21 U.S.C. § 343(r)(1)(B) (providing that a food
shall be deemed to be misbranded if its “(1) labeling is false or misleading in any
particular, or (2) in the case of a food to which section 350 of this title applies, its
advertising is false or misleading in a material respect or its labeling is in
violation of section 350(b)(2) of this title.”). A product labeled with a claim that is
false or misleading is subject to seizure and the FDA may enjoin the product’s
distribution or seek criminal penalties against its manufacturer. See Alliance II,
786 F.Supp.2d at 5 (citing 21 U.S.C. §§ 331(a), 332, 334, 352(a)).
iii.
Pearson I
After enactment of NLEA, the FDA declined to authorize petitions for health
claims that did not meet the significant scientific agreement (“SSA”) standard.
The FDA reasoned that if a health claim was not supported by significant
scientific agreement such claim was “inherently misleading and thus entirely
outside the protection of the First amendment” as commercial speech. See
Pearson I, 164 F.3d at 655. The D.C. Circuit in Pearson I considered whether the
FDA had violated the First Amendment because it had precluded “the approval of
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less-well supported claims accompanied by a disclaimer.” Id. at 654. The FDA
had declined to consider the alternative of requiring corrective disclaimers for
claims that did not meet the SSA standard arguing that even if the proposed
disclaimers were only potentially misleading under Central Hudson the
government was “not obligated to consider requiring disclaimers in lieu of an
outright ban on all claims that lack significant scientific agreement.” Id. at 655.
Applying the commercial speech test set forth in Central Hudson, the
Pearson I Court concluded that there was not a reasonable fit between the
government’s goals of protecting public health and preventing consumer fraud
and the “means chosen to advance those goals” which was the rejection of a
proposed health claim without consideration of a corrective disclaimer. Pearson
I, 164 F.3d at 656-58. The D.C. Circuit’s rationale was based on its conclusion that
under the commercial speech doctrine there “was a preference for disclosure
over outright suppression” and for the “less restrictive and more precise means”
of regulating commercial speech. Id. at 656-58. In analyzing recent Supreme
Court precedent in similar arenas, the Pearson I court concluded that
“disclaimers [were] constitutionally preferable to outright suppression.” Id. at
657.
The FDA was therefore required under the First Amendment to consider the
adequacy of possible disclaimers which would have the effect of preventing
consumer confusion and present claims in a way that was not deceptive. Id. at
656-60. The court concluded that well-drafted disclaimers could remedy any
supposed weakness in the proposed claims.
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The Pearson I court proposed several examples of such corrective
disclaimers in connection with the appellants’ proposed claims at issue in
Pearson I. Appellant’s first proposed claim was that “[c]onsumption of
antioxidant vitamins may reduce the risk of certain kinds of cancer.” Id. at 658.
The FDA had determined that this claim lacked significant scientific agreement
“because existing research had examined only the relationship between
consumption of foods containing these components and the risks of these
diseases. The FDA logically determined that the specific effect of the component
of the food constituting the dietary supplement could not be determined with
certainty.” Id. (emphasis in the original). The court suggested that this concern
could be accommodated by “adding an appropriate disclaimer to the label along
the following lines: ‘The evidence is inconclusive because existing studies have
been performed with foods containing antioxidant vitamins, and the effect of
those foods on reducing the risk of cancer may result from other components in
those foods.’” Id.
The Pearson I court also suggested a clarifying disclaimer for appellants’
fourth proposed claim that “‘0.8 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’” which the FDA had concluded was not supported by
significant scientific agreement because “‘the scientific literature does not
support the superiority of any on source [of folic acid] over others.’” Id. at 658-9.
The Pearson I court stated that they “suspect[ed] that a clarifying disclaimer
could be added to the effect that ‘The evidence in support of this claim is
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inconclusive.’” In addition, the court suggested that if the FDA is concerned that
the “consumers might assume that a claim on a supplement's label is approved
by the government” then the FDA might “require the label to state that ‘The FDA
does not approve this claim.’” Id.
However, the D.C. Circuit did not create a safe harbor. Instead it stated that
it did not “presume to draft precise disclaimers” for the proposed claims itself
and instead expressly left that “task to the agency in the first instance.” Id. at
660. The court also recognized that “where evidence in support of a claim is
outweighed by evidence against the claim, the FDA could deem it incurable by a
disclaimer and ban it outright.” Id. at 659. In addition, it saw “no problem with the
FDA imposing an outright ban on a claim where evidence in support of the claim
is qualitatively weaker than evidence against the claim.” Id. at 659 n. 10.
Lastly, the court considered whether the Administrative Procedures Act
(“APA”) required the FDA to “explain why it rejects [] proposed health claims
[and whether] to do so adequately necessarily implies giving some definitional
content to the phrase ‘significant scientific agreement.’” Id. at 660. The court
concluded that “[i]t simply will not do for a government agency to declare-without
explanation-that a proposed course of private action is not approved” and held
that the “FDA must explain what it means by significant scientific agreement, or
at minimum what it does not mean.” Id. at 661.
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iv.
Pearson II
After considering the Pearson I decision, the FDA issued a guidance
document regarding significant scientific agreement. The FDA also issued a
subsequent decision stating that it would not authorize a proposed folic acid
claim even with clarifying disclaimers because it had found the claim to be
inherently misleading as the weight of scientific evidence was against the claim.
See Pearson v. Shalala, 130 F.Supp.2d 105, 107 (D.D.C. 2001) (“Pearson II”). In
Pearson II, the court found that the FDA had failed to comply with the
constitutional guidelines outlined in Pearson I when it concluded that the weight
of evidence was against the proposed claim and could not be corrected by an
appropriate disclaimer. Id. at 112,114. After reviewing the scientific data, the
court concluded that the proposed claim was not inherently misleading since
“[t]he mere absence of significant affirmative evidence in support of a particular
claim ... does not translate into negative evidence ‘against’ it.” Id. at 115. Lastly,
the court indicated that the “question that must be answered under Pearson [I] is
whether there is any ‘credible evidence’” in support of the proposed claim. Id. at
114, 118. The court reasoned that if there was any “credible evidence” unless
such evidence was “outweighed by evidence against the claim” or is
“qualitatively weaker” than evidence against the claim, the claim could “not be
absolutely prohibited.” Id. at 114-15. The court therefore found that the FDA’s
conclusion that the proposed claim could not be remedied by appropriate
disclaimers was arbitrary and capricious and remanded the case to the FDA to
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“draft one or more appropriately short, succinct, and accurate disclaimers.” Id. at
120.
v.
Whitaker v. Thompson
In June 2001, the plaintiffs in Pearson filed another lawsuit challenging the
FDA’s decision to not authorize an antioxidant claim that had been at issue in
Pearson I. Whitaker v. Thompson, 248 F.Supp.2d 1 (D.D.C. 2002). The FDA had
concluded that “the weight of the scientific evidence against the relationship
[between cancer and and antioxidant vitamins] was greater than the weight of
evidence in favor of the relationship.” The FDA reasoned that such claim was
therefore “inherently misleading” and could not be cured with a disclaimer. Id. at
7. After reviewing the relevant scientific data, the court found that the proposed
claim was not “inherently misleading” and that the “FDA ha[d] failed to carry its
burden of showing that suppression of Plaintiffs' Antioxidant Vitamin Claim is the
least restrictive means of protecting consumers against the potential of being
misled by the Claim.” Id. at 8. The Whitaker Court suggested that “any complete
ban of a claim would be approved only under narrow circumstances, i.e., when
there was almost no qualitative evidence in support of the claim and where the
government provided empirical evidence proving that the public would still be
deceived even if the claim was qualified by a disclaimer.” Id. at 11. The Court
directed the FDA to “draft and submit one or more alternative disclaimers, one of
which may be selected by designers, sellers and manufacturers of dietary
supplements containing antioxidant vitamins” noting that the FDA’s decision to
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entirely suppress the claim did not “comport with the First Amendment’s clear
preference for disclosure over suppression of commercial speech.” Id. at 8, 15.
vi.
The FDA’s Response to Pearson I, Pearson II and Whitaker
In response to the decisions rendered in Pearson I, Pearson II and
Whitaker, the FDA developed a system for evaluating proposed health claims.
Under this system, the FDA first determined whether the proposed health claim
was supported by significant scientific agreement. If it was, the FDA considered
the claim to be “unqualified” and it approved the claim without requiring the
addition of any corrective disclaimers. However, if the claim was not supported
by significant scientific agreement, but there was credible evidence in support of
the claim, the FDA considered the claim to be “qualified” and would require the
addition of corrective disclaimers to the claim to reflect the scientific record.
Since the FDA is only authorized to approve claims that are supported by
significant scientific agreement under NLEA and the FDA’s regulations, it does
not “approve” qualified health claims but instead “exercises enforcement
discretion” to allow such claims to made with the additional of corrective
disclaimers. See [Dkt. #37, Def. Mem. at 6].
The FDA also issued a guidance document which describes its process for
evaluating the scientific support for both qualified and unqualified health claims.
See Guidance for Industry: Evidence-Based Review System for the Scientific
Evaluation for Health Claims (Jan. 2009) (“Guidelines”).1 According to the
1
Available at http://www.fda.gov/Food/GuidanceComplianceRegulatory
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Guidelines, the FDA employs an evidence-based review system for the scientific
evaluation of health claims. See Guidelines at §III.A. “After assessing the totality
of the scientific evidence, FDA determines whether there is SSA to support an
authorized health claim or credible evidence to support a qualified health claim.”
Id. “When the evidence for a substance-disease relationship is credible but does
not meet the SSA standard, then the proposed health claim for the relationship
should include qualifying language that identifies limits to the level of scientific
evidence to support the relationship.” Id. at III.H. The Guidelines indicate that the
“health claim language should reflect the level of scientific evidence with
specificity and accuracy. However, gaps in the scientific evidence may
sometimes limit the information that can be included in the claims. For example,
when the scientific evidence is limited but credible, it may not be possible for the
qualified health claim to identify an amount of the substance that is associated
with a reduced risk of the disease.” Id.
vii.
Alliance I
In Alliance I, the plaintiffs challenged the FDA’s rejection of certain health
claims regarding cancer risk and selenium supplements. 714, F.Supp.2d at 57.
The FDA outright banned several of plaintiffs’ claims concluding there was no
credible scientific evidence to support them and then exercised its enforcement
discretion to permit modified versions of the claims that were supported by some
credible evidence. Id. at 57-78.
Information/GuidanceDocuments/FoodLabelingNutrition/ucm073332.htm
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In connection with the FDA’s decision to entirely ban certain health claims,
the court reviewed the record to determine whether the FDA’s determination that
those claims at issue were not supported by credible scientific evidence was
arbitrary and capricious. The Court concluded that while it was “obligated to
conduct an independent review of the record and must do so without reliance on
the Agency's determinations as to constitutional questions” that it should afford
“deference to the Agency’s interpretation of scientific information, provided such
interpretation is reasoned and not arbitrary and capricious.” Id. at 60. The Court
found that certain aspects of the FDA’s determinations were arbitrary and
capricious while other aspects were not and remanded those back to the FDA for
reevaluation and drafting of disclaimers where appropriate. Id. at 65, 72.
The plaintiffs also argued that the FDA’s decision to modify one of their
proposed claims by entirely replacing the proposed language with its own
language violated the Supreme Court’s mandate there be a reasonable fit
between the government’s goal and the restrictions it imposes on commercial
speech. The plaintiffs had proposed the following claim “Selenium may reduce
the risk of prostate cancer. Scientific evidence supporting this claim is
convincing but not yet conclusive.” Id. at 57. The FDA rejected this claim
“because it found the characterization of the evidence in support of the claim as
‘convincing but not yet conclusive’ to be false and misleading.” Id. at 70-71.
Consequently the FDA, in exercising its enforcement discretion, modified the
claim to the following “‘Two weak studies suggest that selenium intake may
reduce the risk of prostate cancer. However, four stronger studies and three
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weak studies showed no reduction in risk. Based on these studies, FDA
concludes that it is highly unlikely that selenium supplements reduce the risk of
prostate cancer.’” Id.
The court agreed with the plaintiffs that there was not “a reasonable fit”
because the “Agency has not drafted a precise disclaimer designed to qualify
plaintiffs’ claim while adhering to the First Amendment preference for disclosure
over suppression as mandated.” Id. at 71 (internal quotation marks and citation
omitted). The Court emphasized that the FDA had “replaced the plaintiffs’ claim
entirely. And the Agency’s qualification effectively negates any relationship
between prostate cancer risk and selenium intake. Indeed, the FDA’s language is
an example of a disclaimer that contradicts the claim and defeats the purpose of
making it in the first place.” Id. (internal quotation marks and citation omitted).
The Court suggested that where there is some credible evidence for a substancedisease relationship the FDA “is obligated to at least consider the possibility of
approving plaintiffs’ proposed language with the addition of ‘short, succinct, and
accurate disclaimers.’” Id. (quoting Pearson II, 130 F.supp. 2d at 120).
Consequently, the FDA was found to have “completely eviscerated plaintiffs’
claim, with no explanation as to why a less restrictive approach would not be
effective.” Id.
The Alliance I Court suggested the better approach might have been to
alter the “convincing but not yet conclusive” portion of the proposed claim to
“more accurately reflect[] the strength of the scientific evidence at issue. Such
qualification would be a ‘far less restrictive means’ than negation of the plaintiffs’
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claim.” Id. In sum, the Court found that the “FDA's replacement of plaintiffs'
claim with different and contradictory language is inconsistent with the spirit, if
not the letter, of Pearson I” and that the “FDA ha[d] failed to justify the complete
substitution of new language for plaintiffs' proposed claim, especially since it
appears that the Agency's central objection to the claim concerns the nature of
the qualifying language, not the underlying relationship claim.” Id. at 72. This
claim was consequently remanded to the FDA for the purpose of drafting one or
more short, succinct, and accurate disclaimers.
viii.
Alliance II
The same plaintiffs in Alliance I raised a substantially identical challenge to
the FDA’s rejection of several different proposed health claims and the FDA’s
rewording of two of their proposed claims. The court in Alliance II again noted
that since it “is not in the position, nor is it the Court’s role, to independently
assess, whether the scientific evidence evaluated by the FDA constitutes credible
evidence in support of plaintiffs’ claims,” the court’s inquiry into the propriety of
the FDA’s ban on several proposed claims was limited to “an assessment of
whether the FDA’s evaluation was inconsistent with its own standards, irrational
or arbitrary and capricious.” Alliance II, 786 F. Supp. 2d at 16. The Court
concluded that the FDA’s conclusion that plaintiffs proposed claims were not
supported by credible evidence was reasonable and not arbitrary and capricious.
As was the case in Alliance I, the FDA had completely reworded and
replaced two of plaintiffs’ qualified health claims in an identical manner to the
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claims at issue in Alliance I. The court found these modified claims failed for the
same reasons as articulated in Alliance I. The Alliance II court emphasized that
the FDA’s replacement and complete rewording of Plaintiffs’ claims made it
“difficult to tell what the original health claims are and appears to disavow the
FDA's own conclusions that those claims are supported by credible evidence.”
Id. at 24.
The court interpreted Pearson and its progeny as standing for the
proposition that “[w]here the evidence supporting a claim is inconclusive, the
First Amendment permits the claim to be made; the FDA cannot require a
disclaimer that simply swallows the claim.” Id. The court suggested that in such
cases where there is some credible evidence supporting a possible substancedisease relationship that the FDA should allow the claim regarding the
substance-disease relationship to be made. The FDA’s role and focus should
then be directed to drafting or modifying a disclaimer “regarding the strength or
nature of the evidentiary support for [the] health claim.” Id. at 24 n.22.
II.
Factual and Procedural History
Fleminger originally submitted a health claim petition to the FDA dated
January 27, 2004 which was supplemented on May 21, 2004 requesting the FDA to
authorize the following health claim: “Daily consumption of 40 ounces of typical
green tea containing 710 µg/ml of natural (-) -epigallocatechin gallate (EGCG) may
reduce the risk of certain forms of cancer. There is scientific evidence
18
supporting this health claim although the evidence is not conclusive.” See
(Administrative Record (“AR’”) at 1, 2102).
On June 30, 2005, the FDA issued a response letter informing Fleminger
that after its review it would exercise its enforcement discretion for qualified
health claims regarding the consumption of green tea and a reduced risk of
breast and prostate cancer. The FDA concluded that there was not “credible
evidence to support a claim with respect to all other types of cancer.” (AR 22162235).
In the response letter, the FDA evaluated the strength of the scientific
evidence to support the substance-diseases relationship. With respect to breast
cancer, the FDA explained that three studies provided information about whether
green tea may reduce the risk of breast cancer. The FDA noted that “[a]lthough
two Japanese cohort studies found no association between green tea
consumption and breast cancer… one-case control study reported that, with
green tea consumption, there was a reduction in breast cancer risk in AsianAmericans from California.” (AR 2229). On the basis of these studies, the FDA
concluded there was “very limited credible evidence for a qualified health claim
specifically for green tea and breast cancer.” The FDA noted that the reported
findings of the one-case control study “had not been replicated” and explained
that “replication of scientific findings is important to substantiate results.” In
addition, the FDA noted that “consistency of findings among similar and different
study designs is important for evaluating the strength of scientific evidence.”
(Id.). The FDA also indicated that “prospectively designed studies provide
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stronger evidence for an association than case-control studies since there are
fewer forms of bias.” (Id.). Based on its review of the “strength of the total body
of publicly available scientific evidence for a claim about green tea and reduced
risk of breast cancer, FDA rank[ed] this evidence as the lowest level for a
qualified health claim” and concluded that it was “highly unlikely that green tea
reduces the risk of breast cancer.” (AR 2230).
With respect to prostate cancer, the FDA explained that two studies
provided information about whether green tea may reduce the risk of prostate
cancer. (Id.). The FDA noted that these studies involved two case-control studies
from China and Japan and each of the studies “were small (fewer than 150 cases
each) in size and both received high methodological quality ratings.” (Id.). The
Japanese study reported no association while the Chinese study “reported a
decrease in prostate cancer risk with green tea intake.” (Id.). Based on these two
studies the FDA concluded there was “very limited credible evidence for a
qualified health claim specifically for green tea and prostate cancer.” (Id.). The
FDA noted that the reported findings of the Chinese study have not been
replicated and that prospectively designed studies provide for stronger evidence
for an association than case-control or retrospectively designed studies since
“there are fewer forms of bias.” (Id.). Based on its review of the “strength of the
total body of publicly available scientific evidence for a claim about green tea and
reduced risk of prostate cancer, FDA rank[ed] this evidence as the lowest level
for a qualified health claim” and concluded that it was “highly unlikely that green
tea reduces the risk of prostate cancer.” (Id.).
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The FDA informed Fleminger that it would consider exercising enforcement
discretion for the following qualified health claims:
(i) Two studies do not show that drinking green tea reduces the risk of
breast cancer in women, but one weaker, more limited study suggests that
drinking green tea may reduce this risk. Based on these studies, FDA
concludes that it is highly unlikely that green tea reduces the risk of breast
cancer; and
(ii) One weak and limited study does not show that drinking green tea
reduces the risk of prostate cancer, but another weak and limited study
suggests that drinking green tea may reduce this risk. Based on these
studies, FDA concludes that it is highly unlikely that green tea reduces the
risk of prostate cancer.
(AR 2235).
In response, Fleminger sought administrative reconsideration on August 5,
2005 pursuant to 21 C.F.R. §10.33 asking the FDA to consider the following two
qualified health claims:
(i) Drinking green tea equivalent to that consumed by Asian Americans may
reduce the risk of breast cancer in women. There is credible evidence
supporting this claim although the evidence is limited; and
(ii) Drinking green tea equivalent to that consumed by the residents living
in Hangzhou, China may reduce the risk of prostate cancer. There is
credible evidence supporting this claim although the evidence is limited.”
(AR 2473).
The FDA responded to Fleminger on August 19, 2008 denying his petition
for reconsideration concluding that the petition did “not satisfy the requirements
for reconsideration because none of the issues raised in [Fleminger’s] petition
demonstrates that the agency failed to consider or adequately consider relevant
information or views contained in the administrative record as required by 21
CFR §10.33(d)(1).” (AR 2495-2503).
21
On September 10, 2008, Fleminger responded in writing to the FDA’s denial
of its petition for reconsideration noting its disagreement with the FDA’s
determination. (AR 2504-2505). Fleminger indicated in its letter that it recognized
that the clarification of the “FDA ruling reiterates a qualified green tea health
claim language for the Agency’s discretion enforcement consideration for the
time being as follows: Green tea may reduce the risk of cancer of the break and
the prostate. There is credible evidence supporting this claim although the
evidence is limited.” (Id.). However, Fleminger’s response was not a formal
submission seeking FDA authorization of the new claim and consequently the
FDA did not consider or authorize Fleminger’s new claim. [Dkt. # 37, Def. Mem. at
10].
On February 22, 2010, FDA issued a warning letter advising Fleminger that
its websites contained marketing in violation of the FDCA including amongst
other items the marketing of several unauthorized health claims. (AR 2590-93).
The letter informed Fleminger that the use of unauthorized health claims which
were false and misleading rendered the company’s products misbranded and that
failure to correct the identified violations could lead to enforcement action. (Id.).
Fleminger responded to the warning letter explaining that it believed the claim
“Green tea may reduce the risk of cancer of the breast and the prostate. The FDA
has concluded that there is credible evidence supporting this claim although the
evidence is limited” had been properly submitted to the FDA in its September 10,
2008 letter. Fleminger explained that since “[t]here have been no objections from
the FDA or the FTC in the past 4.5 years since the letters were sent. The
22
undersigned believe[d] the language used in this claim is fully in compliance with
the conclusions of the FDA.” (AR2594-95).
Subsequently on May 27, 2010, the United States District Court for the
District of Columbia issued its decision in Alliance I finding that the FDA’s
modified health claim violated the First Amendment. See supra Part I.vii. Since
the modified health claim at issue in Alliance I was substantially similar to the
modified health claim the FDA had authorized in the instant case, the Alliance I
decision prompted the FDA to reconsider Fleminger’s prior claim. After such
reconsideration, the FDA issued an amended response on February 24, 2011.
(AR 2617-50). In the amended response, the FDA concluded that the “scientific
support between green tea and reduced risk of breast cancer is negligible, as is
the scientific support for a relationship between green tea and reduced risk of
prostate cancer.” (AR 2637). In light of the recent Alliance I decision, FDA
informed Fleminger that it would revise the qualified claim language it had
previously authorized. The FDA found that Fleminger’s proposed disclaimer that
“There is credible evidence supporting this claim although the evidence is
limited” did “not accurately convey the weakness of the scientific evidence
regarding a relationship between green tea and a reduced risk of breast or
prostate cancer.” (AR 2638).
The FDA also explained that based on the presence of the claim “Drinking
green tea may reduce the risk of breast or prostate cancer” in food labeling, the
FDA was concerned that “consumers are likely to assume that FDA has endorsed
the claim and that the claim is supported by reliable scientific evidence.” (Id.).
23
The FDA pointed to its 2002 study which found that “35% to 57% of consumers,
with or without use experience with dietary supplements, mistakenly believe that
the government regulates the manufacturing and pre-approves the marketing of
these products.” (Id.). The FDA concluded that “this risk of consumer deception
is particularly acute where, as here, the scientific support for the claim is scant,
and thus there is a very low likelihood that the substance actually may reduce the
risk of the disease. Under these circumstances, a strong disclaimer is essential
in order to make clear that the FDA does not endorse the claim and that there is
very little scientific evidence for the claim.” (AR 2639). The FDA indicated that
the proposed disclaimer which “characterizes the evidence as ‘credible’ but
‘limited’ is misleading because it suggests that the evidence is stronger than it
really is.”
Consequently, the FDA considered exercising its enforcement discretion
for the following claim: “Green tea may reduce the risk of breast or prostate
cancer. FDA does not agree that green tea may reduce the risk because there is
very little scientific evidence for the claim.” The FDA then explained the rationale
for its proposed disclaimer language. The FDA indicated that the language “FDA
does not agree” will prevent “consumers from erroneously assuming that the
health claim reflects FDA’s determination that scientific evidence, taken as a
whole, shows that green tea is likely to reduce the risk of breast or prostate
cancer.” (AR 2640). In addition, the language “there is very little scientific
evidence” according to the FDA “accurately conveys the strength of the scientific
evidence because it helps consumers distinguish among claims that are
24
supported by different levels of scientific evidence. To be effective, the
disclaimer must enable consumers to distinguish between the very limited level
of scientific support for the green tea qualified health claim and the stronger level
of scientific support for many other qualified health claims, and for health claims
that FDA authorizes by regulation.” (Id.).
After the FDA issued its amended response, Fleminger filed the instant
action in federal court alleging that the FDA violated the First Amendment when it
rejected Fleminger’s proposed health claim that “Green tea may reduce the risk
of breast and prostate cancers. The FDA has concluded2 that there is credible
evidence supporting this claim although the evidence in limited” and instead
modified the claim to the following “Green tea may reduce the risk of breast or
prostate cancers. FDA does not agree that green tea may reduce that risk
because there is very little scientific evidence for the claim.”
III.
Legal Standard
Pursuant to Federal Rule of Civil Procedure 56, the Court will grant a
motion for summary judgment “if the movant shows that there is no genuine
2
In the FDA’s amended response, the FDA considered the version of Fleminger’s
proposed disclaimer that was presented by Fleminger in its response to the
FDA’s denial of its petition for reconsideration. See (AR 2504-05). The Court
notes that Fleminger presented a slightly different version of the disclaimer in
response to the FDA’s warning letter. See (AR 2594-95). The main difference
between the two versions is that the version presented in response to the
warning letter includes the additional language that the “FDA has concluded”
there is credible evidence supporting this claim although the evidence is limited.
Fleminger’s motion for summary judgment is predicated on the version of the
proposed disclaimer which contains the additional language. Since the Court’s
analysis is not materially impacted by this additional language, the Court will
consider Fleminger’s disclaimer with the additional language.
25
dispute as to any material fact and the movant is entitled to judgment as a matter
of law.” Fed. R. Civ. P. 56(a). In this case, there are no disputed issues of fact as
each party seeks judgment as a matter of law based on the facts provided in the
administrative record.
Although Fleminger states in its complaint, that it brings this action under
the APA, Fleminger alleges a single cause of action for violation of the First
Amendment. See [Dkt. #1, Compl.]. Fleminger argues in its memorandum in
opposition to Defendants’ cross motion for summary judgment that this case
should not be evaluated under the APA’s arbitrary and capricious standard and
clarifies that its sole cause of action arises under the First Amendment. [Dkt. #42,
Pl. Opposition Mem. at 7]. Further, Fleminger never argues that the FDA’s
conclusion that “there is very little scientific evidence” for the proposed health
claim was arbitrary or capricious, it merely argues that its proposed language
that “there is credible evidence supporting this claim although the evidence is
limited” is better and more preferable and therefore the FDA’s preclusion of its
right to make the claim violates the First Amendment.
If Fleminger had argued that the FDA’s determination that “there was very
little scientific evidence” for the health claim that drinking green tea may reduce
the risk of breast or prostate cancer was erroneous that challenge would be
properly analyzed under Section 706(2) of the APA which provides that final
agency action may only be set aside if arbitrary, capricious and an abuse of
discretion. However, since Fleminger has not challenged the merits of the FDA’s
26
assessment of the strength of scientific evidence supporting the proposed health
claim, there is no question presented under the APA.
As described above, the Court’s analysis with respect to whether the FDA
violated Fleminger’s commercial speech rights under the First Amendment is
evaluated under the analytical framework articulated in Central Hudson and later
elaborated by Western States. See supra Part I.i. As the Alliance I court
acknowledged, the Court is “obligated to conduct an independent review of the
record and must do so without reliance on the Agency’s determinations as to
constitutional questions … But it would be inconsistent with binding precedent
and wholly inappropriate to evaluate the voluminous scientific studies at issue in
this case without some deference to the FDA’s assessment of that technical
data.” 714, F.Supp.2d at 60 (citations omitted).
The Court is not in the position, nor is it the Court’s role, to independently
assess the highly technical scientific data to determine what amount of scientific
evidence supports the proposed health claim at issue. Such a determination falls
squarely within the ambit of the FDA’s expertise and therefore the Court must
give deference to the FDA’s assessment of the strength of the scientific data at
issue. See e.g., Marsh v. Or. Natural Res. Council, 490 U.S. 360, 377 (1989)
(“Because analysis of the relevant documents requires a high level of technical
expertise, we must defer to the informed discretion of the responsible federal
agencies.”); Baltimore Gas & Electric Co. v. NRDC, 462 U.S. 87, 103 (1983)
(“reviewing court must generally be at its most deferential” when examining
“scientific determination [s]” by administrative agency “within its area of special
27
expertise”); City of New York v. United States Department of Transportation, 715
F.2d 732, 645 (2d Cir. 1983) (citing Baltimore Gas as defining the “standards
circumscribing our role”); Smith v. Potter, 187 F.Supp.2d 93, 97 (S.D.N.Y. 2001)
(“‘It is not the court’s role to second-guess scientific judgments of’ a
governmental agency that is responsible for protecting public health) (quoting
Mazur v. Merck & Co., 964 F.2d 1348, 1350 n.1 (3d Cir. 1992)).
Although the Court is obligated to give deference to the FDA’s assessment
of the strength of the scientific evidence for the proposed health claim, such
deference does not extend to the determination of whether the FDA’s modified
disclaimer violated Fleminger’s commercial speech rights.
IV.
Analysis
Fleminger principally argues that the FDA violated its commercial speech
rights because the FDA’s interests in regulating its speech are not substantial.
Fleminger argues that there are two asserted governmental interests at stake the
first being the interest in “accurately conveying the strength of the scientific
evidence” and second in “preventing the mistaken assumption that the FDA
endorses the claim.” See [Dkt. # 36, Pl. Mem. at 8]. Fleminger alternatively
suggests that there is not an appropriate fit between the government’s goal and
the restriction it imposed on its commercial speech which in this case is the
FDA’s revised disclaimer language. Defendants argue that the FDA has a
substantial interest in preventing consumer confusion and protecting public
health and that the fit between the restriction it imposed on Fleminger’s
28
commercial speech and its interest in preventing consumer confusion and public
health was reasonable.
i.
Analysis of whether the government’s interests are substantial
a. FDA has a substantial interest in preventing consumer confusion
and protecting public health
Fleminger argues that the FDA’s interest in “accurately conveying the
strength of scientific evidence” is not substantial in this case because its
proposed disclaimer that “[t]here is credible evidence supporting this claim
although the evidence is limited” does accurately convey the strength of
scientific evidence. See [Id. at 10]. However this particular argument is
misplaced and reflects a misunderstanding of the Central Hudson framework.
The argument that Fleminger’s proposed language does accurately convey the
strength of the scientific evidence rather relates to whether there is a reasonable
fit between the government’s interest in accurately conveying the strength of
scientific evidence and the means chosen to accomplish that end as opposed to
whether the asserted governmental interest is substantial in the first place. If
Fleminger’s proposed language already appropriately advanced the asserted
governmental interest then the restriction of replacing Fleminger’s proposed
language with the FDA’s modified language is more extensive than necessary to
serve that interest. Consequently, Fleminger’s argument that the governmental
interest in accurately conveying the strength of scientific evidence is not
substantial is unpersuasive as it is really an argument that goes to the fit between
the government’s ends and the means chosen to accomplish those ends.
Accordingly, the Court will consider Fleminger’s argument that its proposed
29
disclaimer accurately conveys the strength of scientific evidence in its analysis of
whether there is a fit between the FDA’s ends and the means chosen to
accomplish such ends.
Although, Fleminger’s characterizes the interest as “accurately conveying
the strength of the scientific evidence” this interest is more commonly
characterized as preventing consumer confusion and protecting public health. It
is beyond doubt that the FDA’s interest in preventing consumer confusion and
protecting public health is a substantial interest which justifies the FDA’s
imposition of appropriate disclaimers in connection with qualified health claims.
The D.C. Circuit in Pearson I found that the FDA’s substantial interests in
protecting public health and preventing consumer fraud were “undeniable” and
noted that the “significant questions under Central Hudson” concerned the fit
between the government interest asserted and the means chosen to accomplish
the end. Pearson I, 164 F.3d at 656.
The FDA’s substantial interests in preventing consumer confusion and
protecting public health are underscored by the legislative history of NLEA in
which Congress expressly granted the FDA authority to approve health claims
made on food which were supported by “significant scientific agreement.”
Congress specifically identified three main governmental interests underlying
NLEA: (i) prevention of consumer fraud; (ii) improving public health; and (iii)
ensuring that substance-disease claims were supported by significant scientific
agreement. Congress expressly stated that the “need for legislation regarding
health claims on foods is equally compelling” and noted that “during the mid30
1980's, companies began making health claims on foods, even though the FDA
had not approved the claims through the drug approval process” which led to a
plethora of “unfounded health claims in the marketplace.” H.R.Rep.No. 101-538,
at 3338-9 (1990). Congress concluded that “legislation with respect to health
claims is [] both desirable and necessary.” Id. Such legislation was desirable
and necessary because there was “a great potential for defrauding consumers if
food is sold that contains inaccurate or unsupportable health claims.” 136
Cong.Rec. H12951-02, 12953 (statement of Rep. Waxman).
The Court finds that the FDA has asserted a substantial interest in
ascertaining the validity and truthfulness of health-related claims on food and in
drafting appropriate disclaimers which reflect the level of scientific evidence for a
particular health claim in order to prevent consumer confusion and protect public
health. The FDCA’s and NLEA’s express grant of authority to the FDA to ensure
that only truthful and accurate health claims supported by reliable scientific
evidence are permitted in the marketplace reflects the substantial interest the
government has in regulating such claims and in ensuring that such claims not
supported by significant scientific agreement contain succinct disclaimers which
accurately convey the strength of scientific evidence. Consequently, the Court
finds that the government has asserted an interest in preventing consumer
confusion and protecting public health which is undeniably substantial.
b. FDA has a substantial interest in preventing the assumption that the
FDA endorses the claim
31
Fleminger also argues that the FDA’s concern that consumers might
mistakenly believe that the FDA endorses the qualified health claim is speculative
and unfounded. Fleminger suggests that since the FDA does not as extensively
regulate the sale of food as it does with drugs, its concern that consumers will
assume that FDA approves health claims made on food is unfounded. The
Federal Circuit has embraced this notion. See Pearson I, 164 F.3d at 659
(acknowledging the FDA’s “general concern, given the extensiveness of
government regulation of the sale of drugs, consumers might assume that a
claim on a supplement’s label is approved by the government”).
Indeed, Fleminger’s argument is contrary to our longstanding laws and
regulations and the FDA’s longstanding practice. The FDA has for over seventy
years been empowered by Congress to regulate the sale and marketing of foods
that were intended for use in the diagnosis, cure, mitigation, treatment or
prevention of a disease. See FDCA 21 U.S.C. §§ 301. For over twenty years
Congress has mandated that the FDA approve only those health claims made on
food which were supported by “significant scientific agreement.” See NLEA Pub.
L. No. 101-535, 104 Stat. 2353 (1990). The FDA has therefore historically and
extensively regulated any food which bears a substance-disease related
marketing claim. Contrary to Fleminger’s arguments, a claim on a box of Quaker
Oats indicating that “Oatmeal can reduce cholesterol” is exactly the type of
health claim that has for over seventy years fallen squarely within the parameters
of the FDA’s regulatory authority as mandated under the FDCA and then later
under NLEA. See [Dkt. # 41, Pl. Opposition Mem. at 13 n.8]. Since the statutory
32
and regulatory framework for health claims made on food is pervasive and long
established, the Court finds that the FDA’s concern that consumers might
mistakenly assume that the FDA approves such health claims to be more than
well founded. A consumer would likely assume that the FDA approves such
claims by the virtue of the fact that Congress has indeed legislated that the FDA
only approve health claims made on food which are supported by significant
scientific agreement.
Fleminger also argues that FDA has little evidence that consumers will
mistakenly believe that FDA approves health claims regarding food. Fleminger
emphasizes that the 2002 study the FDA cited in its amended response which
indicated that “35% to 57% of consumers, with or without use experience with
dietary supplements, mistakenly believe that the government regulates the
manufacturing and pre-approves the marketing of these products” is not relevant
or applicable to food claims since it only analyzed dietary supplements. See (AR
2638). The Court agrees that since the 2002 study focused on dietary
supplements it is not as relevant to establishing the significance of the FDA’s
purported concern and interest with respect to food claims. However as
discussed above, the statutory and regulatory framework mandating the FDA to
approve health claims made on food products amply establishes the fact and
significance of this interest.
Fleminger, relying on the Supreme Court’s decisions in Edenfield v. Fane,
507 U.S. 761. 771 (1993) and Ibanez v. Fla. Dep’t of Bus. & Prof’l Regulation, 512
U.S. 136, 146 (1994), suggests that the government must provide empirical
33
evidence establishing that its asserted interest is substantial and real. However
Fleminger’s reliance on these cases is misplaced. In Edenfield, the Supreme
Court recognized that the government’s asserted interest in protecting
consumers from fraud was substantial but found that there was no reasonable fit
between the government’s ends in preventing fraud and the means chosen,
namely the total prohibition of truthful speech. 507 U.S. at 762, 769. The
Supreme Court’s concern that there were no studies or anecdotal evidence
factored into the Court’s analysis of the fit between the government’s ends in
preventing fraud and the means chosen to pursue that end. Ultimately, the
Supreme Court held that the restriction on speech at issue in Edenfield did not
directly advance any of the state’s substantial interests. Id. at 762, 771.
Similarly in Ibanez, the Supreme Court suggests without expressly stating
that the state has a substantial interest in preventing consumer fraud but found
that the restriction at issue, once again the articulation of undeniably truthful
statements on a mere suspicion that the statements were made for an improper
purpose, did not directly serve that interest. 512 U.S. at 137, 144 (reasoning that
“[a]s long as Ibanez holds an active CPA license from the Board we cannot
imagine how consumers could be misled by her truthful representation to that
effect” and finding that “[o]n the bare record made in this case, the Board has not
shown that the restrictions burden no more of Ibanez' constitutionally protected
speech than necessary”). The Supreme Court’s admonishment that the we
cannot allow rote invocation of the words ‘potentially misleading’ to supplant the
Board's burden to demonstrate that the harms it recites are real and that its
34
restriction will in fact alleviate them to a material degree does not suggest as
Plaintiff contends that the government must present empirical evidence
establishing that its asserted interest is substantial. Instead, the Supreme Court’
admonishment is more aimed at the analysis with respect to the reasonable fit
between the government’s ends and the means chosen by the government to
advance those ends. Moreover, in Ibanez the court noted the absence of both
empirical or anecdotal evidence.
Lastly, the Court notes that Fleminger’s proposed disclaimer includes a
positive statement that “The FDA has concluded that there is credible evidence
supporting this claim although the evidence is limited.” [Dkt. #36, Pl. Mem. at 4]
(emphasis added). Fleminger’s proposed invocation of FDA approval creates the
very substantial interest in the accuracy of the claim Fleminger challenges.
In addition, the FDA is authorized by legislation to only approve those
health claims made on food which meet the SSA standard. To imply that the FDA
has approved a particular health claim where the claim is not supported by
significant scientific evidence would run afoul of NLEA’s mandate to the FDA.
Accordingly, this Court finds that the FDA has a substantial interest in preventing
consumers from assuming the FDA has approved the qualified health claim.
Further, it would be wholly inappropriate for the Court to command the
FDA to allow a disclaimer in which its name and reputation were expressly
invoked where it did not agree with the content of the disclaimer. Fleminger
cannot use the auspices of the First Amendment to put words into the mouth of
35
the FDA. For a marketing claim to include a specific reference to the “FDA’s
conclusions” the content of that claim must come from the FDA itself. If not,
such a claim would undoubtedly be misleading and false and would arguably fall
outside the protection of the First Amendment altogether. Absent the FDA’s
express agreement, a proposed health claim cannot include specific reference to
the “FDA” in its marketing.
ii.
Analysis of fit between the government’s end and the means chosen to
accomplish those ends
a. Fleminger’s proposed disclaimer is misleading and inaccurate
Fleminger’s argument that its proposed disclaimer that “[t]he FDA has
concluded that there is credible evidence supporting this claim although the
evidence is limited” accurately conveys the strength of scientific evidence is
really an argument regarding reasonable fit and whether the speech restriction
advances the asserted governmental interests. Essentially, Fleminger’s
argument is that since its proposed disclaimer accurately conveys the strength of
scientific evidence the FDA’s replacement of its disclaimer with its own version
cannot possibly advance the FDA’s interest in preventing consumer fraud and
protecting public health. Fleminger has carefully avoided challenging the FDA’s
conclusion that “there is very little scientific evidence” for the claim and instead
simply argues that its articulation of the level of scientific evidence supporting
the green tea health claim is appropriate.
As discussed above the assessment of the level of scientific evidence in
support a substance-disease relationship falls squarely within the ambit of the
36
FDA’s expertise and the Court must give deference to both the FDA’s own
assessment and articulation of the level of scientific evidence supporting the
green tea claim and the FDA’s determination that Fleminger’s articulation of the
level of scientific evidence was inaccurate and misleading. See e.g., Federal
Power Commission v. Florida Power & Light Co., 404 U.S. 453, 463 (1972)
(“Particularly when we consider a purely factual question within the area of
competence of an administrative agency created by Congress, and when
resolution of that question depends on ‘engineering and scientific’
considerations, we recognize the relevant agency's technical expertise and
experience, and defer to its analysis unless it is without substantial basis in
fact.”); Schering Corp. v. FDA, 51 F.3d 390, 399 (3d Cir. 1995) (finding that FDA's
“judgments as to what is required to ascertain the safety and efficacy of drugs
fall squarely within the ambit of the FDA's expertise and merit deference from
us”), cert. denied, 516 U.S. 908 (1995).
In both the FDA’s original response letter and its amended response letter,
the FDA explained its rationale for concluding that Fleminger’s proposed
disclaimer that there was credible but limited scientific evidence for both the
prostate and breast cancer claim was inaccurate and misleading. See (AR 22162235, 2627-50). With respect to breast cancer, there was only one study that
found an association between drinking green tea and a reduction in the risk of
breast cancer. (AR 2229). That study’s result have not been replicated and
utilized a scientific methodology, a case-control study method, which the FDA
considered to be weaker as it is susceptible to more forms of bias then
37
prospectively designed studies. (Id.). The FDA also identified two cohort studies
which found no association between drinking green tea and a reduction in the
risk of breast cancer and noted that these studies utilized the stronger
prospectively designed methodology. (Id.).
Considering that two stronger
studies found no association and only one weaker non-replicated study found an
association, the FDA concluded that the level of scientific evidence for the breast
cancer claim was “very little” and that Fleminger’s assessment of the scientific
evidence as credible but limited was not accurate and therefore misleading. The
Court agrees with the FDA’s conclusion that “credible but limited evidence”
signals to consumers a higher level of scientific support then is accurately
reflected by a single non-replicated study whose results were undermined by two
stronger studies finding no association.
The word “credible” is defined as “offering reasonable grounds for being
believed.” Merriam Webster Online Dictionary, http://www.merriam-webster.com/
dictionary/credible (last visited January 17, 2012). An average consumer would
likely then interpret “credible but limited evidence” to mean evidence which
offers a reasonable ground for believing that a purported health claim is true.
The Court agrees with the FDA’s assessment that one weaker un-replicated study
finding a positive association between drinking green tea and a reduced risk of
breast cancer and two stronger studies finding no such association does not
offer a reasonable ground for believing that the proposed health claim is true.
Since the weight of scientific evidence for the breast cancer claim does not offer
38
a reasonable ground for believing the claim to be true, it would be misleading to
label the level of evidence in support of such claim as “credible but limited.”
Similarly, the Court agrees with the FDA’s conclusion that “credible but
limited evidence” is an inaccurate and misleading description of the level of
scientific evidence in support of the proposed prostate cancer claim. The FDA
identified two studies relevant to whether drinking green tea may reduce the risk
of prostate cancer. (AR 2230). Both studies were smaller case-control studies.
One study found a positive association between drinking green tea and a reduced
risk of prostate cancer while the other study found no association. (Id.). The one
study finding a positive association has not been replicated. (Id.). For the same
reasons as the proposed breast cancer claim, the Court agrees with the FDA’s
assessment that one relatively weak and un-replicated study finding a positive
association and another relatively weak study finding no association does not
provide a reasonable ground for believing the claim to be true. Since the weight
of scientific evidence for the prostate cancer claim also does not offer a
reasonable ground for believing that claim to be true, it would be likewise
misleading to label the level of evidence in support of such claim as “credible but
limited.”
The Court acknowledges that in Pearson II the D.C. District court
concluded that “[t]he mere absence of significant affirmative evidence in support
of a particular claim ... does not translate into negative evidence ‘against’ it” and
therefore found that the proposed folic acid claim was not inherently misleading.
Pearson II, 130 F.Supp.2d at 115. The court in Pearson II was considering
39
whether the FDA’s assessment of the level of scientific data supported the
outright suppression of the proposed health claim. Unlike in Pearson II, the FDA
in the instant matter has concluded that it cannot outright suppress the proposed
health claim entirely on the basis of the one case-control study finding an
association with the reduced risk of breast cancer and the one case-control study
finding an association with the reduced risk of prostate cancer. Therefore, the
Pearson II court’s analysis is not fully applicable to these particular facts and
circumstances. Moreover unlike in Pearson II, in the present case there were
three studies which affirmatively found no association between drinking green
tea and the reduced risk of breast or prostate cancer which undermined the two
studies that did find such an association. The application of Pearson II court’s
reasoning to the facts of the present case only suggests that the FDA cannot
outright suppress the green tea health claim in the first instance, which the FDA
has acknowledged that it cannot do. The Pearson II court instructed that the
appropriate response under the First Amendment was to allow the folic acid claim
at issue to be made with the inclusion of appropriate disclaimers that “could cure
the alleged misleading nature of the Folic Acid Claim” which is exactly what
Defendants have tried to do in the present case. Id. at 119.
Fleminger also argues that its proposed disclaimer of “credible but limited
evidence” is accurate because it tracks the language of the FDA’s own Guidelines
for finding a “qualified health claim.” Fleminger points out that the FDA will only
exercise its enforcement discretion to permit a qualified health claim when it
finds that “there is credible evidence to support” such a claim. See Guidelines at
40
§III.H. Fleminger essentially argues that since the FDA has found that the
proposed health claim should be considered a qualified claim it has necessarily
found there to be credible evidence in support of the proposed claim and
therefore its disclaimer is accurate and not misleading. Fleminger suggests that
if there wasn’t credible evidence in support of the proposed claim, then the FDA
would have outright banned the claim in its entirety which it has not done.
However, the FDA’s use of the term “credible evidence” within the context
of the FDA’s Guidelines and its regulatory framework has a unique and technical
meaning which is substantially different from the meaning of “credible evidence”
within a consumer marketing context. As discussed above within a consumer
marketing context “credible evidence” connotes that there is a reasonable basis
to believe that the claim is true. Here the FDA has made clear that it does not
interpret “credible evidence” within its regulatory framework to mean that there is
a reasonable basis to believe that proposed health claim is true, but rather it
appears the lower threshold namely that there is some nominal or even negligible
support that the claim might be true. For example although the FDA concluded
there was “credible evidence” to support the classification of Fleminger’s
proposed health claim as “qualified,” the FDA also explained that on the basis of
this so called “credible evidence” that it concludes, based on the totality of the
scientific evidence, that it was “highly unlikely” that green tea reduces the risk of
breast or prostate cancer. See (AR 2229-30). Consequently, the meaning of
“credible evidence” within the FDA’s regulatory context cannot be translated over
into the consumer marketing context as Fleminger suggests is appropriate. The
41
classification of a claim as “qualified” does not reflect the FDA’s determination
that the evidence in support of such “qualified claim” provides a reasonable
basis for believing that claim to be true.
In fact, the determination that there is a reasonable basis for believing that
a proposed health claim is true appears to be better aligned with the FDA’s
classification of unqualified health claims under the “significant scientific
agreement” standard rather than its classification of qualified health claims under
its “credible evidence” standard. The FDA has indicated that “[s]ignificant
scientific agreement refers to the extent of agreement among qualified experts in
the field. On the continuum of scientific evidence that extends from very limited
to inconclusive evidence, SSA lies closer to consensus. FDA's determination of
SSA represents the agency's best judgment as to whether qualified experts would
likely agree that the scientific evidence supports the substance/disease
relationship that is the subject of a proposed health claim. The SSA standard is
intended to be a strong standard that provides a high level of confidence in the
validity of the substance/disease relationship.” Id. at §III G. Therefore the
“significant scientific agreement” standard and not the “credible evidence”
standard as articulated in the Guidelines better reflects the FDA’s assessment of
what is a reasonable basis for believing that a proposed health claim is true.
Consequently, the Court finds that the Fleminger’s proposed language that there
is “credible but limited” evidence is misleading as the FDA’s “credible evidence”
standard for classification of qualified health claims does not comport with a
consumer’s common sense understanding of the term “credible evidence.”
42
If the Court adopted Fleminger’s argument that the description of “credible
but limited” is appropriate on the basis of the FDA’s Guidelines and the FDA’s
invocation of its Guidelines in its response letter to Fleminger then the FDA
would be obligated to label the level of scientific support as “credible” for every
qualified health claim for which it exercised its enforcement discretion. This
would undermine the public interest in food labeling. As the FDA indicated in its
amended response to Fleminger for the disclaimers to be effective in preventing
consumer confusion and protecting the public health the “disclaimer must enable
consumers to distinguish between the very limited level of scientific support for
the green tea qualified health claim and the stronger level of scientific support for
many other qualified health claims, and for health claims that FDA authorizes by
regulation.” (AR 2640). The FDA must have the ability to draft specific
disclaimers tailored to the particular health claim at issue in order to allow the
FDA to advance the public’s interests in preventing consumer confusion and
protecting public health in a manner which does not burden substantially more
speech than is necessary to further those interests. In fact, the FDA Guidelines
indicate that the “health claim language should reflect the level of scientific
evidence with specificity and accuracy.” See Guidelines at III.H. The First
Amendment therefore requires that the FDA draft specific disclaimers tailored to
the particular health claim at issue which reflects the specific level of scientific
support for that health claim.
Since Fleminger’s proposed disclaimer is inaccurate and misleading, under
the applicable FDA nomenclature, the FDA is not obligated under the First
43
Amendment to allow Fleminger to use such language in its marketing. Instead
the FDA is obligated to draft short, succinct and accurate disclaimers “regarding
the strength or nature of the evidentiary support for [the] health claim.” Alliance
II, 786 F. Supp. 2d at 24 n.22.
b. The FDA is not required to provide empirical evidence demonstrating
the Fleminger’s proposed language is misleading or that consumers
will assume the FDA approves health claims made on food on the
bases asserted by the Plaintiff
Fleminger argues that under Ibanez and Edenfield the FDA is required
under the First Amendment to prove empirically that Fleminger’s proposed
disclaimer language is misleading and that consumers will assume that the FDA
approved the health claim in order to justify its modification of the disclaimer.
The Supreme Court’s admonishment in Ibanez that “[w]e cannot allow rote
invocation of the words ‘potentially misleading’ to supplant the Board's burden to
“demonstrate that the harms it recites are real and that its restriction will in fact
alleviate them to a material degree,” 512 U.S. at 146, and its concern in Edenfield
that there must be some basis for validation of the government’s supposition that
the restriction on speech advances its interests in any direct and material way,
507 U.S. at 771, do not stand for the proposition that the government is obligated
to conduct an empirical analysis to justify its restrictions. These Supreme Court
cases do not require empirical data. Instead, they really stand for the proposition
that there must be some actual or real validation that the speech restriction does
in fact advance the government’s interest. In fact, the Supreme Court noted in
Edenfield that this basis for validation does not require empirical evidence but
rather could be predicated on anecdotal evidence. 506 U.S. at 771 (“The Board
44
has not demonstrated that, as applied in the business context, the ban on CPA
solicitation advances its asserted interests in any direct and material way. It
presents no studies that suggest personal solicitation of prospective business
clients by CPA's creates the dangers of fraud, overreaching, or compromised
independence that the Board claims to fear. The record does not disclose any
anecdotal evidence, either from Florida or another State, that validates the
Board's suppositions.”) (emphasis added).
Conversely, the statutory and regulatory framework mandating FDA
approval for health claims made on food and the FDA’s expert assessment and
analysis of the level of scientific evidence at issue provide a sufficient basis for
validation that meets the Supreme Court’s edicts in Edenfield and Ibanez. First,
the FDA’s conclusion that Fleminger’s proposed disclaimer is inaccurate and
misleading is validated by the FDA’s expert analysis and assessment of the level
of scientific evidence at issue which was thoroughly articulated in the FDA’s
response and amended response to Fleminger’s petition. See (AR 2216-35, 261750). This expert analysis provides real validation that the restriction on speech
actually advances the FDA’s interests in preventing consumer confusion and
protecting public health.
The case at bar is inapposite to both Edenfield and Ibanez. In both of those
cases, relied upon by the Plaintiff, the speech sought to be precluded was
undeniably truthful. This is not the case here. In the case at bar there are three
relevant scientific studies on which the FDA formed its opinion. One was a
limited study supporting Fleminger’s claim and two were more efficacious
45
studies tending to undermine Fleminger’s claim. Thus the factual support for the
FDA’s restriction on Fleminger’s speech is more than anecdotal if not empirical.
If the FDA like the defendants in Ibanez and Edenfield had merely stated
without explaining the basis for its conclusion that Fleminger’s proposed
disclaimer was inaccurate and misleading that would have been the “rote
invocation of the words ‘potentially misleading’ that the Supreme Court warned
against. However the FDA did not merely rely on the rote invocation of these
words. Instead, it relied upon and provided a thorough review and analysis of all
of the scientific evidence at issue and a comprehensive articulation of its
rationale in concluding that Fleminger’s proposed disclaimer was inaccurate and
misleading. Consequently, the FDA has more than provided a real and not
speculative basis for the Court to find that the FDA’s restriction in modifying the
disclaimer to accurately reflect the level of scientific support for the claim
advanced the public’s interests.
Second as discussed above, the FDA’s concern that consumers will
assume it approved the health claim is validated by the long standing statutory
and regulatory framework authorizing the FDA to only approve health claims on
food that are supported by significant scientific agreement. Consequently, the
statutory and regulatory framework provide a real and not speculative basis for
finding that the FDA’s restriction in modifying the disclaimer to convey that the
FDA has not approved the health claim advanced its interests.
46
The Court also notes that the Pearson I and Whitaker courts considered the
issue of empirical evidence. In Pearson I, the D.C. Circuit stated that “while we
are skeptical that the government could demonstrate with empirical evidence that
disclaimers similar to the ones we suggested above would bewilder consumers
and fail to correct for deceptiveness, we do not rule out that possibility.” 164 F.3d
at 659-60. The Whitaker court interpreted Pearson I to stand for the proposition
that “any complete ban of a claim would be approved only under narrow
circumstances, i.e., when there was almost no qualitative evidence in support of
the claim and where the government provided empirical evidence proving that the
public would still be deceived even if the claim was qualified by a disclaimer.” 248
F.Supp.2d at 11. However, both the Pearson I and Whitaker courts only
considered the need for empirical evidence in connection with the government’s
outright ban of the proposed health claim as opposed to the FDA’s prerogative to
draft short, succinct and accurate disclaimers as to the level of scientific support
for a qualified health claim. The Pearson I and Whitaker court’s analysis should
therefore be confined to the circumstances where the government is seeking to
outright ban the proposed health claim entirely as opposed to the present
circumstance where the government allows the health claim to be made but
drafts an appropriate disclaimer to remedy the weaknesses in the proposed
claim. Accordingly, the First Amendment does not require the FDA in every case
to conduct an empirical study in connection with a petition for a qualified health
claim demonstrating that the petitioners’ proposed disclaimer language is
47
misleading or inaccurate or that consumers will mistakenly believe that the FDA
approved the proposed health claim.
c. The portion of the FDA’s disclaimer stating there is “very little
scientific evidence” strikes a reasonable fit between the
government’s ends and the means chosen to accomplish those ends
As the Alliance I and II court concluded the First Amendment requires that
where there is some evidence supporting a possible substance-disease
relationship, as is the case here, the FDA should allow the claim to be made in the
first instance, which the FDA has done in the present case. The FDA’s role then
should be directed toward drafting or modifying a disclaimer “regarding the
strength or nature of the evidentiary support for [the] health claim.” Alliance II,
786 F. Supp. 2d at 24 n.22. Here, the FDA has followed the Alliance court’s
direction allowing the proposed health claim to be made in the first instance but
also modifying a disclaimer which conveys “the strength or nature of the
evidentiary support for the health claim.” Id.
The portion of the FDA’s modified disclaimer stating that “there is very
little scientific evidence” for the proposed health claim reflects a reasonable fit
between the FDA’s goal of preventing consumer confusion and protecting public
health and the means chosen to accomplish that end as it permits the claim to be
made while disclosing to the consumer contrary sound scientific evidence. As
discussed above, the Court defers to the FDA’s assessment of the strength of
scientific evidence at issue as “very little” and notes that Fleminger has not
argued that the FDA’s assessment is arbitrary and capricious. In accord with
Pearson and its progeny, the First Amendment requires that the FDA allow
48
Fleminger’s claim that “drinking green tea may reduce the risk of breast or
prostate cancer” be made with the addition of short, succinct and accurate
disclaimers as to the level of scientific support for the proposed health claim. As
discussed above since Fleminger’s proposed disclaimer is inaccurate and
misleading, the FDA is not obligated to permit the disclaimer to be made under
the First Amendment. Instead the FDA has the obligation to draft a short,
succinct and accurate disclaimer which reflects the strength or nature of the
evidentiary support for the health claim. Since the drafting of disclaimers
regarding the strength or nature of evidentiary support for a health claim falls
well within the ambit of the FDA’s expertise as well as its statutory and regulatory
authority, the Court must necessarily defer to its analysis and judgment. As
explained above, any challenge to the FDA’s analysis and judgment as to the
level of scientific support for a proposed claim is rather properly asserted under
the APA as opposed to the First Amendment.
Since the portion of the FDA’s modified disclaimer stating that “there is
very little scientific evidence” accurately conveys the strength of the scientific
evidence supporting the proposed health claim, it directly advances the FDA’s
interest in preventing consumer confusion and protecting public health. It also
does not burden substantially more speech than is necessary to further that
interest as the FDA has permitted the health claim to be made in the first instance
thereby adhering to the First Amendment’s “preference for disclosure over
outright suppression” as well as the preference for the use of disclaimers over
outright suppression. See Pearson I, 164 F.3d at 656-58. In addition, the fit is
49
reasonable because Fleminger’s proposed disclaimer undermines the interest in
preventing consumer confusion and protecting public health as it unequivocally
did not accurately convey the strength of the scientific evidence for the proposed
claim. Accordingly, the Court finds that the portion of the FDA’s modified
disclaimer stating that “there is very little scientific evidence” is an accurate
statement of the scientific evidence and thus does not violate the First
Amendment.
d. The portion of the FDA’s disclaimer stating that the “FDA does not
agree that green tea may reduce that risk” does not strike a
reasonable fit between the government’s ends and the means
chosen to accomplish those ends
Although the portion of the FDA’s disclaimer conveying the strength of
scientific evidence supporting the health claim is appropriate under the First
Amendment, the portion of the disclaimer stating that the “FDA does not agree
that green tea may reduce that risk” suffers from the same constitutional
infirmities as the modified disclaimers at issue in Alliance I and II. The placement
of this language immediately after Fleminger’s claim that “drinking green tea may
reduce the risk of breast or prostate cancer” has the effect of negating any
relationship between green tea and the reduction of breast or prostate cancer and
therefore effectively swallows the entire claim. The negation of the proposed
health claim with this portion of the disclaimer represents an impermissible
restriction on Fleminger’s commercial speech.
Here the portion of the FDA’s disclaimer stating that “there is very little
scientific evidence” sufficiently cures or remedies the weaknesses inherent in
50
Fleminger’s proposed disclaimer as to the level of scientific support for the claim.
Since the FDA’s interest in preventing consumer confusion and protecting public
health is sufficiently advanced by the portion of the disclaimer accurately
conveying the strength of the scientific evidence, the portion of the disclaimer
stating that the “FDA does not agree that green tea may reduce that risk” is
rendered somewhat superfluous. Accordingly, the portion of the disclaimer
stating that the “FDA does not agree that green tea may reduce that risk” does
not directly advance the government’s interest in preventing consumer confusion
and protecting public health. Consequently, the inclusion of this language
burdens more speech then is necessary to remedy the weaknesses of
Fleminger’s health claim with respect to its interests in preventing consumer
confusion and protecting public health.
While the FDA does have a substantial interest in preventing the
assumption that it has approved the health claim, the FDA’s language burdens
substantially more speech than is necessary to further that interest since the
language effectively negates the substance-disease relationship claim altogether.
There are less burdensome ways in which the FDA could indicate in a short,
succinct and accurate disclaimer that it has not approved the claim without
nullifying the claim altogether. As the Supreme Court instructed “[I]f the
Government c[an] achieve its interests in a manner that does not restrict speech,
or that restricts less speech, the Government must do so.” Western States, 535
U.S. at 371. As the Pearson I court suggested the “agency could require the label
to state that ‘the FDA does not approve this claim.’” Pearson I, 164 F. 3d at 659.
51
Such a disclaimer would not have the same effect of negating Fleminger’s
proposed health claim in the first instance and would therefore allow the FDA to
achieve its interest in a manner that restricts less speech.
The Court also suspects that the FDA’s concern that consumers will
assume it has approved the health claim could also be accommodated by
changing the disclaimer along the following lines: “Green tea may reduce the risk
of breast or prostate cancer although the FDA has concluded that there is very
little scientific evidence to support the claim.” Such a disclaimer would not have
the effect of negating the substance-disease claim and would therefore represent
a lesser restriction on Fleminger’s commercial speech but also accommodate the
FDA substantial interest in preventing the assumption that it has approved the
claim. Accordingly, the portion of the disclaimer stating that the “FDA does not
agree that green tea may reduce that risk” does not strike a reasonable fit
between the Governments ends and the means chosen to accomplish those ends
and therefore violates the First Amendment.
As the Pearson I court acknowledged it is not the role of the courts to draft
precise declaimers but instead “leave[s] that task to the agency in the first
instance.” Pearson I, 164 F.3d at 659. The Court accordingly remands
Fleminger’s health claim to the FDA for the purpose of drafting appropriate
disclaimers consistent with this Memorandum Opinion.3
3
Defendants encourage the Court to take into consideration the settlement
reached in Alliance I in which the parties agreed to a disclaimer which stated that
“Selenium may reduce the risk of prostate cancer. Scientific evidence
52
Although the Court has found that the portion of the disclaimer stating that
the “FDA does not agree that green tea may reduce that risk” constitutes an
impressible restriction on Fleminger’s commercial speech rights, the Court
questions whether this portion of the disclaimer might be permissible under
certain circumstances. For example, Fleminger had affirmatively advertised on
his website the health claim that “Green tea may reduce the risk of breast and
prostate cancers. The FDA has concluded that there is credible evidence
supporting this claim although the evidence in limited” which the FDA had not
authorized. Considering that Fleminger had essentially advertised that the FDA
had agreed with its claim that green tea may reduce the risk of breast and
prostate cancer, the FDA might have an interest in requiring a retraction in the
form of a disclaimer that rectified or clarified that it did not agree with that claim.
Rectifying false advertisement may justify the imposition of the additional speech
restriction. However Defendants have not argued that this language in the
disclaimer was needed to ameliorate any consumer confusion that was caused by
Fleminger’s publication of the unauthorized health claim on its website and
accordingly the Court need not decide this issue.
concerning this claim is inconclusive. Based on its review, FDA does not agree
that selenium may reduce the risk of prostate cancer.” Although the Court
recognizes the FDA’s interest in using consistent disclaimer language, this
disclaimer was not the subject of any court’s review under the First Amendment
and is not identical to the disclaimer at issue, and therefore the Court does not
find the Alliance I settlement disclaimer to be relevant to its analysis in the
present case.
53
Conclusion
For the foregoing reasons, the Plaintiff’s motion for summary judgment is
GRANTED IN PART AND DENIED IN PART [Dkt. #36] and Defendants’ cross
motion for summary judgment [Dkt. #37] is GRANTED IN PART AND DENIED IN
PART. Fleminger’s qualified health claim is remanded to the FDA for further
action consistent with this Memorandum Opinion and the other relief sought by
the Plaintiff is denied. The Clerk is directed to close the file.
IT IS SO ORDERED.
_______/s/________
Hon. Vanessa L. Bryant
United States District Judge
Dated at Hartford, Connecticut: February 23, 2012
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