Alliance for Natural Health US v. Sebelius ( 2010 )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
__________________________________________
)
ALLIANCE FOR NATURAL HEALTH US, )
et al., )
Plaintiffs, )
)
v. ) Civil Action No. 09-01470 (ESH)
)
KATHLEEN SEBELIUS, et al., )
)
Defendants. )
__________________________________________)
MEMORANDUM OPINION
Plaintiffs Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and Coalition to
End FDA and FTC Censorship have sued the Food and Drug Administration (“FDA” or
“Agency”) and other defendants, 1 seeking review of the Agency’s decision to deny plaintiffs’
petition for authorization of qualified health claims regarding selenium-containing dietary
supplements. Invoking both circuit and district court opinions that have addressed similar
claims, plaintiffs seek a declaratory judgment that the FDA’s final order denying plaintiffs’
petition is invalid and a permanent injunction enjoining the Agency from “taking any action that
would preclude [plaintiffs] from placing [their proposed selenium] health claims on [dietary
supplement] labels.” (Compl. at 29.) Before the Court are 1) plaintiffs’ motion for summary
judgment and 2) defendants’ cross-motion for summary judgment. For the reasons set forth
herein, the Court will grant plaintiffs’ motion in part and deny defendants’ motion.
1
The other defendants named in the complaint are Kathleen Sebelius, Secretary, United States
Department of Health and Human Services (“DHHS”); DHHS; Margaret A. Hamburg, M.D.,
Commissioner, FDA; and the United States.
1
BACKGROUND
I. STATUTORY AND REGULATORY FRAMEWORK
A “dietary supplement” is a “product (other than tobacco) intended to supplement the diet
that bears or contains” one or more of certain dietary ingredients, including vitamins, minerals,
herbs or botanicals, amino acids, concentrates, metabolites, constituents, or extracts. 21 U.S.C. §
321(ff)(1)(A)-(F). A dietary supplement is deemed to be “food,” id. § 321(ff), which is defined
in part as “articles used for food or drink for man or other animals,” id. § 321(f)(1), except when
it meets the definition of a “drug,” which is defined in part as “articles intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Id. §
321(g)(1)(B). (See also Defs.’ Cross-Mot. for Summ. J. & Opp’n to Pls.’ Mot. for Summ. J.
[“Defs.’ Mot.”] at 3 n.2). A “health claim” is “any claim made on the label or in labeling of a
food, including a dietary supplement, that expressly or by implication . . . characterizes the
relationship of any substance to a disease or health-related condition.” 21 C.F.R. § 101.14(a)(1);
see also 21 U.S.C. § 343(r)(1)(A)-(B).
Under the Federal Food, Drug, and Cosmetic Act (“FFDCA”), manufacturers wishing to
market a new drug must undergo a “strict and demanding” process designed to ensure consumer
safety and product efficacy in order to obtain FDA approval before introducing the product into
interstate commerce. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 618-19
(1973); see also 21 U.S.C. § 355(a); Pearson v. Shalala, 164 F.3d 650, 652 (D.C. Cir. 1999)
(“Pearson I”). “Prior to 1984, the FDA took the position that a statement that consumption of a
food could prevent a particular disease was ‘tantamount to a claim that the food was a drug . . .
and therefore that its sale was prohibited until a new drug application had been approved.’”
Pearson I, 164 F.3d at 653 (quoting H.R. Rep. No. 101-538, at 9 (1990), reprinted in 1990
2
U.S.C.C.A.N. 3336, 3338). But in the mid-1980s, companies began making health claims on
foods without seeking new drug approval, a practice the FDA supported. Id. Congress
subsequently enacted the Nutrition Labeling and Education Act of 1990 (“NLEA”), Pub. L. No.
101-535, 104 Stat. 2353 (1990) (codified as amended at 21 USC §§ 301, 321, 337, 343, 343-1,
345, 371), amending the FFDCA to provide the FDA with authority to regulate health claims on
food. Pearson I, 164 F.3d at 653.
The NLEA created a “safe harbor” from the “drug” designation for foods and dietary
supplements labeled with health claims. Pearson v. Shalala, 130 F. Supp. 2d 105, 107 (D.D.C.
2001) (“Pearson II”); see also 21 U.S.C. § 343(r)(1). Under the Act, 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 scientific evidence,” supports
the claim. 21 U.S.C. § 343(r)(3)(B)(i). For dietary supplement health claims, however,
Congress declined to establish an authorization process and instead left the creation of an
approval “procedure and standard” to the FDA. Id. § 343(r)(5)(D). The FDA subsequently
promulgated a regulation adopting the NLEA’s standard for food health claims (i.e., “significant
scientific agreement”) for dietary supplement health claims. 21 C.F.R. § 101.14(c) (“FDA will
promulgate regulations authorizing a health claim only when it determines, based on the totality
of publicly available scientific evidence . . . that there is significant scientific agreement . . . that
the claim is supported by such evidence.”). The FDA may consider a dietary supplement
labeled with an unauthorized health claim to be a misbranded food, 21 U.S.C. § 343(r)(1)(B); a
misbranded drug, id. § 352(f); and/or an unapproved new drug. Id. § 355(a). A dietary
supplement labeled with such a claim, or a claim that is false or misleading, is subject to seizure,
3
and the Agency may enjoin the product’s distribution or seek criminal penalties against its
manufacturer. Id. §§ 331(a), 332, 334, 352(a); see also Def.’s Mot. at 3.
II. PEARSON V. SHALALA AND SUBSEQUENT CASE LAW
A. Introduction
Plaintiffs’ lawsuit is the latest in a series of disputes between dietary supplement
designers and the FDA regarding the Agency’s regulation of health claims regarding dietary
supplements after the passage of the NLEA. Pearson, Shaw, and other individuals and groups
affiliated with the production, sale, and use of dietary supplements have, since 1995, sought
judicial review of FDA decisions denying a variety of proposed health claims. The first of these
lawsuits, challenging the FDA’s rejection of the plaintiffs’ proposed claims on First Amendment
grounds, resulted in an invalidation of the Agency’s regulations regarding health claim review by
the D.C. Circuit. Pearson I, 164 F.3d at 661. Since then, the FDA has struggled to balance its
concerns for consumer protection and dietary supplement manufacturers’ First Amendment
commercial speech rights as defined by Pearson I. An abbreviated summary of these cases
follows.
B. Pearson I
In 1995, a group of dietary supplement manufacturers 2 filed suit against the FDA and
other defendants under the First Amendment, challenging the FDA’s rejection of four health
claims 3 that the manufacturers sought to include on certain dietary supplements. Pearson v.
2
Two of these plaintiffs, Pearson and Shaw, are plaintiffs in the instant case.
3
Pearson I concerned the FDA’s rejection of the following health claims: (1) “Consumption of
antioxidant vitamins may reduce the risk of certain kinds of cancers”; (2) “Consumption of fiber
may reduce the risk of colorectal cancer”; (3) “Consumption of omega-3 fatty acids may reduce
4
Shalala, 14 F. Supp. 2d 10, 14 (D.D.C. 1998). The claims characterized a relationship between
dietary supplements and the risk of particular diseases. Id. The Agency, applying the
“significant scientific agreement” standard set forth in 21 C.F.R. § 101.14, determined that the
evidence concerning the supplements “was inconclusive . . . and thus failed to give rise to
‘significant scientific agreement.’” Pearson I, 164 F.3d at 653. The Agency therefore declined
to authorize the claims, finding them to be “inherently misleading and thus entirely outside the
protection of the First Amendment” as commercial speech. Id. at 655 (emphasis in original).
The FDA also declined to consider the proposed alternative of “permitting the claim[s] while
requiring . . . corrective disclaimer[s],” arguing that even if the proposed claims were only
“potentially misleading,” it had no obligation under the First Amendment to consider a
“disclaimer approach,” as opposed to suppression, where the claims at issue lacked significant
scientific agreement. Id. at 654, 655, 657. The manufacturers sued, arguing that the FDA’s
“significant scientific agreement” standard was unconstitutionally vague and was tantamount to a
blanket ban on commercial speech in violation of the manufacturers’ First Amendment rights. 4
Pearson, 14 F. Supp. 2d at 14.
After the district court denied the manufacturers’ motion for summary judgment, the D.C.
Circuit reversed. The Court, applying the commercial speech test set forth in Central Hudson
the risk of coronary heart disease”; and (4) “.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.” Pearson I, 164 F.3d at 652.
4
The manufacturers also argued that the “significant scientific agreement” standard for dietary
supplement health claims generally and as applied to the four claims proposed by plaintiffs
violated the NLEA and the Administrative Procedure Act (“APA”). Pearson, 14 F. Supp. 2d at
14.
5
Gas & Electric Corporation v. Public Service Commission of New York, 447 U.S. 557 (1980), 5
held 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,” namely,
the rejection of plaintiffs’ proposed health claims without consideration of disclaimers. Pearson
I, 164 F.3d at 656-58. Specifically, the Court held that under the First Amendment commercial
speech doctrine, there is a “preference for disclosure over outright suppression” and for “less
restrictive and more precise means” of regulating commercial speech. Id. at 657-58. The
Agency’s rejection of disclaimers without a showing that they were insufficient to meet the
government’s goal of avoiding consumer confusion demonstrated a disregard for “less
restrictive” means of speech regulation that violated the First Amendment. The Court remanded
the case to the district court with instructions to remand it to the Agency to consider whether
disclaimers could sufficiently prevent consumer confusion and, if so, the content of those
disclaimers. Id. at 659. The Court also held that the APA requires the FDA to “giv[e] some
definitional content to the phrase ‘significant scientific agreement,’” because to “declare-without
explanation-that a proposed course of private action is not approved” is arbitrary and capricious.
Id. at 660-61.
In requiring the Agency to consider the adequacy of possible disclaimers accompanying
the manufacturers’ proposed health claims, the Court recognized that “where evidence in support
of a claim is outweighed by evidence against the claim, the FDA could deem it incurable by a
5
The Central Hudson analysis, as clarified by the Supreme Court in Thompson v. Western States
Medical Center, 535 U.S. 357 (2002), consists of four parts: 1) “whether ‘the speech concerns
lawful activity and is not misleading;’” 2) if the speech is protected, “whether the asserted
government interest [in regulation] is substantial;” 3) “whether the regulation directly advances
the governmental interest asserted;” and 4) “whether [the regulation] is not more extensive than
is necessary to serve that interest.” Whitaker v. Thompson, 248 F. Supp. 2d 1, 8-9 (D.D.C. 2002)
(quoting Western States, 535 U.S. at 367; Pearson I, 164 F.3d at 657).
6
disclaimer and ban it outright.” Id. at 659. Similarly, the Court “s[aw] 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. However, the Court stated that the
Agency “must still meet its burden of justifying a restriction on speech,” and a “conclusory
assertion” as to misleadingness is inadequate. Id. (citing Ibanez v. Fla. Dep’t of Bus. & Prof’l
Regulation, 512 U.S. 136, 146 (1994) (“If the protections afforded commercial speech are to
retain their force, we cannot allow rote invocation of the words ‘potentially misleading’ to
supplant the [government’s] burden to demonstrate that the harms it recites are real and that its
restriction will in fact alleviate them to a material degree.”) (citations and internal quotation
marks omitted)).
C. Pearson II
In late 2000, several of the plaintiffs from Pearson I and other dietary supplement
designers, sellers, and manufacturers 6 filed a second lawsuit to challenge the Agency’s decision
prohibiting plaintiffs from including on their dietary supplements’ labels a health claim
concerning folic acid. 7 Pearson v. Shalala, 130 F. Supp. 2d 105, 107 (D.D.C. 2001) (“Pearson
6
The plaintiffs in Pearson II were Durk Pearson; Sandy Shaw; American Preventive Medical
Association; Julian M. Whitaker, M.D.; Pure Encapsulations, Inc.; and XCEL Medical
Pharmacy, Ltd. Pearson II, 130 F. Supp. 2d at 107 n.1.
7
The folic acid health claim at issue in Pearson II was the same folic acid claim at issue in
Pearson I, which stated that “.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.”
Pearson I, 164 F.3d at 652. With respect to this claim, the Court of Appeals in Pearson I
“strongly suggested, without declaring so explicitly” that the claim “was only ‘potentially
misleading,’ not ‘inherently misleading,’ and therefore the FDA’s refusal to authorize [the claim]
(or to propose a disclaimer to accompany the [c]laim) violated the First Amendment.” Pearson
II, 130 F. Supp. 2d at 110; see also Pearson I, 164 F.3d at 659 (“[I]t appears that credible
evidence did support [the folic acid claim], and we suspect that a clarifying disclaimer could be
added to the effect that ‘The evidence in support of this claim is inconclusive.’” (citation
omitted)).
7
II”). After the decision in Pearson I, the FDA published a notice requesting submission of
scientific data concerning the four health claims at issue in that case, including the folic acid
claim. Id. at 110. The Agency also issued “Guidance for the Industry: Significant Scientific
Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.” 8
Id. at 111. After reviewing the newly submitted scientific data and applying the “significant
scientific agreement standard” described in its guidance document and modified by an October 6,
2000 rule, 9 the Agency issued a decision stating that it would not authorize the manufacturers’
folic acid claim, even with clarifying disclaimers, because it found the claim to be inherently
misleading. Id. The plaintiffs argued that the Agency’s decision “fundamentally misread and
misapplied the legal standard articulated” in Pearson I and violated the First Amendment, the
FFDCA, and the APA. Id. at 107, 112. They sought a preliminary injunction “enjoining the
FDA from taking any action which would prevent Plaintiffs from using their desired folic acid
health claim.” Id. at 107.
The district court agreed with the plaintiffs, finding that the FDA “failed to comply with
the constitutional guidelines outlined in Pearson [I]” when it concluded, without explanation,
8
The current FDA guidance regarding evaluation of health claims, issued in 2009, is entitled
“Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health
Claims” [hereinafter “Guidance Document”]. (Administrative Record [“AR”] 003508.)
9
On October 6, 2000, the FDA published a notice stating that “[r]ather than denying all petitions
that do not meet the significant scientific agreement standard pending completion of the general
rulemaking,” it would instead “exercise enforcement discretion in appropriate circumstances,”
such as when “the scientific evidence in support of [a] claim outweighs the scientific evidence
against the claim, the claim is appropriately qualified, and all statements in the claim are
consistent with the weight of the evidence . . . .” 65 Fed. Reg. 59855, 59856 (Oct. 6, 2000).
8
that the “weight of the evidence is against both aspects 10 of the proposed [folic acid] claim” and
that the claim was therefore “inherently misleading” and not susceptible to correction by
disclaimer. Id. at 112, 114. Although the court deferred to the Agency’s “method of dissecting”
and reading the folic acid claim per the APA, id. at 114 n.24, it disagreed with the FDA’s
weighing of the scientific data and found “as a matter of law that [the folic acid claim] is not
‘inherently misleading.’” Id. In coming to this conclusion, the court analyzed the scientific data
regarding folic acid and concluded that “[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. Moreover, the court held that the “question which must be answered under Pearson [I] is
whether there is any ‘credible evidence’” in support of the claim. Id. at 114, 118 (quoting
Pearson I, 164 F.3d at 658). If so, unless that evidence is “outweighed by evidence against the
claim” or is “qualitatively weaker” than evidence against the claim, the claim “may not be
absolutely prohibited.” Id. at 114-15.
Because the court found that there was credible evidence to support the folic acid claim,
it held that the FDA’s determination that the folic acid claim was “inherently misleading” and
could not be cured by disclaimers was “arbitrary and capricious” under the APA and that the
FDA had not “undertake[n] the necessary analysis required by Pearson [I].” Id. at 119. The
court granted the plaintiffs’ motion for a preliminary injunction and remanded the case to the
FDA to “draft one or more appropriately short, succinct, and accurate disclaimers.” Id. at 120.
10
The court considered whether .8 mg of folic acid is superior to .4 mg and whether folic acid is
superior to folate found in foods in common form in preventing neural tube defects. Pearson II,
130 F. Supp. 2d at 115, 117.
9
D. Pearson III
After the preliminary injunction was entered in Pearson II, the FDA filed a motion for
reconsideration, arguing that the district court had “assign[ed] undue weight to a particular
clinical study and fail[ed] to consider the relevant scientific evidence in totality” and “creat[ed] a
legal standard which is inconsistent with [Pearson I].” Pearson v. Thompson, 141 F. Supp. 2d
105, 108 (D.D.C. 2001) (“Pearson III”). The district denied the motion, pointing to the FDA’s
“fail[ure] to fully and accurately describe the record evidence” and “speculative” arguments. Id.
at 109. The district court also restated the holdings in Pearson I, which included 1) the
obligation of the Agency to “demonstrate with empirical evidence that disclaimers . . . would
bewilder consumers and fail to correct for deceptiveness,” id. at 112 (quoting Pearson I, 164
F.3d at 659-60, and 2) the establishment of “a very heavy burden which Defendants must satisfy
if they wish to totally suppress a particular health claim.” Id.
E. Whitaker v. Thompson
In June 2001, the plaintiffs 11 filed another lawsuit to challenge the Agency’s decision not
to authorize the antioxidant claim at issue in Pearson I. 12 Whitaker, 248 F. Supp. 2d at 2, 7. The
Agency, after reviewing the antioxidant-cancer relationship studies submitted at its request
subsequent to Pearson I, “found a lack of significant scientific agreement as to the relationship
between antioxidant vitamin intake and reduction in the risk of developing cancer.” Id. at 7. The
FDA concluded “that the weight of the scientific evidence against the relationship [between
cancer and antioxidant vitamins] was greater than the weight of evidence in favor of the
11
The plaintiffs in Whitaker were Julian M. Whitaker, M.D.; Durk Pearson; Sandy Shaw;
American Association for Health Freedom; Wellness Lifestyles, Inc.; and Pure Encapsulations,
Inc. Whitaker v. Thompson, 248 F. Supp. 2d 1, 2 n.1 (D.D.C. 2002).
12
The claim at issue was that “Consumption of antioxidant vitamins may reduce the risk of
certain kinds of cancers.” Whitaker, 248 F. Supp. 2d at 2; see also Pearson I, 164 F.3d at 652.
10
relationship” and, similar to its analysis of the folic acid claim in Pearson I and II, it determined
that the plaintiffs’ antioxidant claim was therefore “inherently misleading and c[ould not] be
made non-misleading with a disclaimer or other qualifying language.” Id.; see also Pearson II,
130 F. Supp. 2d at 111-12. Plaintiffs argued that the Agency had again misapplied the standard
articulated in Pearson I in violation of the First Amendment, and the district court agreed. Id. at
7-8.
Citing the Supreme Court’s then-recent decision in Western States, the court held that the
Agency had not met its “burden . . . to prove that its method of regulating speech [wa]s the least
restrictive means of achieving its goals.” Id. at 9 (citing Western States, 535 U.S. at 371-73).
Specifically, the court held that the FDA had failed to present evidence that the proposed
antioxidant claim, “if accompanied by a disclaimer, would be deceptive or unlawful.” Id. In
coming to its conclusion, the court reviewed the Agency’s analysis of the claim in light of
Pearson I, noting that “[t]he deference due to an agency’s expert evaluation of scientific data
does not negate ‘the duty of the court to ensure that an agency . . . conduct a process of reasoned
decision-making.” Id. at 11 (quoting K N Energy, Inc. v. F.E.R.C., 968 F.2d 1295, 1303 (D.C.
Cir. 1992)). As such, the court reviewed over 150 intervention and observational studies
regarding the relationship between antioxidant vitamins and cancer relied upon by the FDA in
reaching its conclusions and found that nearly one-third of the studies “supported” the
antioxidant/cancer relationship. Id. The court determined that the FDA had “failed to follow its
own [Guidance] Report and give appropriate weight” to these studies. Id. at 12. Furthermore,
the court held that the FDA had improperly emphasized and de-emphasized the import of certain
studies, directly contrary to the protocol it established in the Guidance Report. Id. In short, the
court concluded that the “basic finding” on which the FDA rested its denial of the proposed
11
claim was “unreasonable because it [wa]s not supported by an overall review of the available
evidence or the FDA’s own Guidance Report.” Id. at 13. The court then found that the
circumstances under which the Agency might ban a claim as misleading, described in Pearson I,
were not present because 1) one-third of the evidence examined supported the claim; and 2) the
FDA failed to provide “empirical evidence that an appropriate disclaimer would confuse
customers and fail to correct for deceptiveness.” Id. As a result, the court granted a preliminary
injunction after concluding that the Agency’s decision to suppress the claim did not “comport
with the First Amendment’s clear preference for disclosure over suppression of commercial
speech.” Id. at 15, 17 (remanding case to FDA to draft “short, succinct, and accurate alternative
disclaimers”).
III. FACTUAL AND PROCEDURAL HISTORY
In July 2002, Wellness Lifestyles, Inc., one of the plaintiffs in Whitaker, submitted to
the FDA two proposed health claims regarding the relationship between selenium and cancer
risk. On February 21, 2003, the FDA exercised enforcement discretion with respect to two
“qualified” 13 versions of the health claims. 14 (Pls.’ Statement of Uncontested Material Facts
13
“Qualified health claims” are health claims that include one or more disclaimers designed to
eliminate potentially misleading assertions. They were created in response to the D.C. Circuit’s
holding in Pearson I. (See FDA, Guidance for Industry: Evidence-Based Review System for the
Scientific Evaluation of Health Claims [“2009 Guidance Document”], at FDA 003510.)
14
The original proposed health claims were 1) “Selenium may reduce the risk of certain
cancers;” and 2) “Selenium may produce anticarcinogenic effects in the body.” (Petition for
Health Claims: Selenium and Reduction in the Risk of Certain Cancers; Selenium and
Anticarcinogenic Effects (July 10, 2002), available at
http://www.fda.gov/ohrms/dockets/dailys/02/Oct02/101802/800330ab.pdf (last visited May 25,
2010). The FDA concluded that the petition “d[id] not meet the ‘significant scientific agreement
standard’” but ultimately exercised enforcement discretion with respect to qualified versions of
the claims that stated as follows: 1) “Selenium may reduce the risk of certain cancers. Some
scientific evidence suggests that consumption of selenium may reduce the risk of certain forms
of cancer. However, FDA has determined that this evidence is limited and not conclusive;” and
12
[“Pls.’ SMF”] ¶ 10.) In December 2007, the FDA, in response to an Agency for Healthcare
Research and Quality (“AHRQ”) study, announced its intention to “reevaluate the scientific
evidence on these two qualified health claims and determine if the scientific evidence continues
to support the qualified health claim, and if so, whether the qualified health claim language
should be modified to reflect a stronger or weaker relationship.” 72 Fed. Reg. 72738, 72739
(Dec. 21, 2007). The Agency commenced a public comment period on this issue, and plaintiffs
filed extensive comments in opposition to the FDA’s proposed re-evaluation of the two selenium
claims. (Pls.’ SMF ¶ 14.) 15
In addition to opposing the FDA’s planned re-evaluation of the qualified selenium health
claims, plaintiffs submitted a health claim petition seeking authorization of ten new qualified
health claims (collectively, “qualified selenium health claims”) 16 concerning the purported
2) “Selenium may produce anticarcinogenic effects in the body. Some scientific evidence
suggests that consumption of selenium may produce anticarcinogenic effects in the body.
However, FDA has determined that this evidence is limited and not conclusive.” (Pls.’ SMF ¶
10; Selenium and Certain Cancers (Qualified Health Claim: Final Decision Letter) (Docket No.
02P-0457) (Apr. 28, 2003), available at
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072780.ht
m (last visited May 25, 2010)).
15
Plaintiffs’ opposition was not addressed by the Agency in its response to plaintiffs’ petition
(Letter from Barbara O. Schneeman, Director, Office of Nutrition, Labeling and Dietary
Supplements, Center for Food Safety and Applied Nutrition, FDA to Jonathan W. Emord (June
19, 2009) [“FDA Resp.”] at AR 001959), nor is it a subject of plaintiffs’ complaint.
16
Plaintiffs proposed the following claims:
1. Selenium may reduce the risk of certain cancers. Scientific evidence supporting this
claim is convincing but not yet conclusive.
2. Selenium may produce anticarcinogenic effects in the body. Scientific evidence
supporting this claim is convincing but not yet conclusive.
3. Selenium may reduce the risk of prostate cancer. Scientific evidence supporting this
claim is convincing but not yet conclusive.
13
relationship between selenium and cancer. (Petition for Qualified Health Claims: Selenium and
the Reduction in the Risk of Site-Specific Cancers [“Petition”] at AR 000001, 000022.)
Plaintiffs’ submission included over 150 scientific articles purporting to examine one or more
aspects of the relationship between selenium and cancer, which supplemented the 17 articles
previously submitted to the FDA during the public comment period. 17 (See FDA Resp. at AR
001967-001968.)
After conducting a comprehensive review of the petition and posting it on the FDA
website for a 60-day comment period, the Agency responded in June 2009. (FDA Resp. at AR
001957-002012.) The FDA concluded that while scientific evidence supports qualified health
claims concerning the relationship between selenium intake and a reduced risk of bladder,
4. Selenium may reduce the risk of bladder and urinary tract cancers. Scientific evidence
supporting this claim is convincing but not yet conclusive.
5. Selenium may reduce the risk of lung and respiratory tract cancers. Scientific evidence
supporting this claim is convincing but not yet conclusive.
6. Selenium may reduce the risk of colon and digestive tract cancers. Scientific evidence
supporting this claim is convincing but not yet conclusive.
7. Selenium may reduce the risk of thyroid cancer. Scientific evidence supporting this
claim is convincing but not yet conclusive.
8. Selenium may reduce the risk of brain cancer. Scientific evidence supporting this claim
is convincing but not yet conclusive.
9. Selenium may reduce the risk of liver cancer. Scientific evidence supporting this claim
is limited and applies only to hepatitis B virus-induced forms of the disease.
10. Selenium may reduce the risk of breast cancer. Scientific evidence supporting this claim
is convincing but not yet conclusive.
(Petition at AR 000045.)
17
Plaintiffs also submitted three supplements to their petition including “recent publications on
selenium and cancer chemoprevention” and “an analysis and opinion of a recent publication of
the National Cancer Institute (NCI) Selenium and Vitamin E Prevention Trial.” (FDA Resp. at
AR 001958.)
14
prostate, and thyroid cancer, no such evidence exists to support a relationship between selenium
intake and a reduced risk of urinary tract (other than bladder), lung and other respiratory tract,
colon and other digestive tract, brain, liver, and breast cancers. (Id. at AR 001959.) The Agency
also concluded that proposed Claims 1 and 2, regarding selenium intake and certain cancers and
anticarcinogenic effects, “are misleading because they are overbroad, fail to disclose material
information, and are not supported by the scientific evidence the agency reviewed . . . .” 18 (Id.)
Accordingly, the FDA denied Claims 1, 2, 5, 6, 8, 9, and 10 and stated that it would exercise
enforcement discretion with respect to modified versions of Claims 3, 4, and 7. 19 (Id. at AR
001992-001993.)
Plaintiffs filed the instant lawsuit on August 4, 2009, claiming a violation of the First
Amendment as a result of the FDA’s denial of Claims 1 (“certain cancers claim”); 2
(“anticarcinogenic effects claim”); 5 (“lung/respiratory tract claim”); and 6 (“colon/digestive
18
In its response letter, the Agency also summarized the process by which it reviewed plaintiffs’
petition (id. at AR 001959-001960); the weight it accords certain types of scientific studies (id. at
AR 001960-001962); its definition of the term “cancer” and its application to Claims 1 and 2 (id.
at AR 001962-001965); its safety review of selenium (id. at AR 001965-001976); its assessment
of the various studies submitted in support of the various claims in the petition (id. at AR
001968-001987); the strength of the scientific evidence (id. at AR 001987-001990); other
enforcement discretion factors (id. at AR 001990-001992); its consideration of disclaimers or
qualifying language (id. at AR 001992); and its conclusions (id. at AR 001992-001994).
19
The Agency stated that it would consider the exercise of its enforcement discretion for the
following qualified health claims: 1) “One study suggests that selenium intake may reduce the
risk of bladder cancer in women. However, one smaller study showed no reduction in risk.
Based on these studies, FDA concludes that it highly uncertain that selenium supplements reduce
the risk of bladder cancer in women;” 2) “Two weak studies suggest that selenium intake may
reduce the risk of prostate cancer. However, four stronger studies and three 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;” and 3) “One weak, small study
suggests that selenium intake may reduce the risk of thyroid cancer. Based on this study, FDA
concludes that it is highly uncertain that selenium supplements reduce the risk of thyroid
cancer.” (FDA Resp. at AR 001993.)
15
tract claim”). (Compl. ¶¶ 56-63). Plaintiffs also maintain that the FDA’s modification of Claim
3 (“prostate claim”) violates their First Amendment rights because it “constructively suppress[es]
[this] claim with the imposition of an onerous, value laden set of qualifications that only allow
Plaintiffs to propound a false, negatively value-laden, and inaccurate claim to the public.” (Id. ¶
67.) Plaintiffs also oppose the FDA’s proposed qualifications of Claim 3 as being “unreasonably
long and burdensome for Plaintiffs and other industry members to include on their dietary
supplement labels,” thereby violating Central Hudson’s requirement that the governments means
of accomplishing its goals be reasonable. (Id. ¶ 67.) They seek: 1) a declaratory judgment that
the FDA’s June 19, 2009 final order denying plaintiffs’ petition is invalid; 2) an order that the
FDA “refrain from taking any action” precluding plaintiffs from placing Claims 1, 2, 3, 4, and 5
on selenium dietary supplement labels; and 3) a permanent injunction, enjoining the FDA from
taking any action precluding plaintiffs from placing Claims 1, 2, 3, 4, and 5 on selenium dietary
supplement labels. (Id. at 28-29.)
ANALYSIS
I. LEGAL STANDARD
A. Scope of Review
Plaintiffs raise their claims under the First Amendment to the United States
Constitution.20 (Compl. ¶¶ 56-67). “[A] Court’s review of ‘constitutional challenges to agency
20
The Court “has the authority to examine and rule on any actions of a federal agency that
allegedly violate the Constitution,” apart from the power of review granted by the Administrative
Procedure Act (“APA”). Rydeen v. Quigg, 748 F. Supp. 900, 905 (D.D.C. 1990), aff’d mem.,
937 F.2d 623 (Fed. Cir. 1991) (citing Porter v. Califano, 592 F. 2d 770, 780 (5th Cir. 1979)).
However, the APA “also provides for the Courts to make an independent assessment of
constitutional issues,” and the role of the Court is the same “whether the plaintiff sues directly
under the Constitution or under [the APA].” Id. at 905 n.8 (citing 5 U.S.C. § 706(2)(b)).
16
actions . . . is de novo.’” Poett v. United States, 657 F. Supp. 2d 230, 241 (D.D.C. 2009)
(quoting Cullman Reg’l Med. Ctr. v. Shalala, 945 F. Supp. 287, 293 (D.D.C. 1996)). The Court
shall make “an independent assessment of [the plaintiffs’] claim of constitutional right when
reviewing agency decision-making,” Porter, 592 F.2d at 780, and it need not accord deference to
the agency’s “pronouncement on a constitutional question.” J.J. Cassone Bakery, Inc. v. NLRB,
554 F.3d 1041, 1044 (D.C. Cir. 2009) (quoting Lead Indus. Ass’n Inc. v. EPA, 647 F.2d 1130,
1173-74 (D.C. Cir. 1980) (emphasis added)).
The parties disagree as to which standard the Court should apply in reviewing the
Agency’s decision to deny the majority of plaintiffs’ qualified selenium health claims. Plaintiffs
maintain that “[r]eview of an agency action does not default to arbitrary and capricious review
when a constitutional issue is raised even if it is raised under the APA,” (Pls.’ Mem. in Reply and
Opp’n to Def.’s Opp’n to Pls.’ Mot. for Summ. J. and Cross-Mot. for Summ. J. [“Pls.’ Reply”] at
13), and therefore a more stringent standard applies, “not the deferential Chevron U.S.A., Inc. v.
Natural Resources Defense Council, 467 U.S. 837 (1984) or [APA] standards.” (Pls.’ Mem. in
Supp. of Mot. for Summ. J. [“Pls.’ Mot.”] at 18.) The Agency contends that because “this case
does not involve a challenge to a regulation broadly prohibiting an entire category of misleading
speech” and instead involves “particularized findings concerning the scientific evidence relating
to plaintiffs’ specific health claims,” the “APA’s deferential [arbitrary and capricious] standard
applies here.” (Defs.’ Mot. at 22.) This disagreement has been ongoing since Pearson I was
decided. See Pearson II, 130 F. Supp. 2d at 115 n.25. In Pearson II, the district court decided it
need not reach this issue because it found that the Agency’s decision in that case violated both
standards. Id. In Whitaker, the court did not address the disagreement directly. Instead, it
acknowledged the “deference due to an agency’s expert evaluation of scientific data” but
17
concluded that such deference did not negate the court’s obligation to ensure that the agency
engaged in reasoned decision-making and that its reasoning was not “‘arbitrary, capricious, an
abuse of discretion, or otherwise not in accordance with law.’” 248 F. Supp. 2d at 11 (quoting 5
U.S.C. § 706(2)(A)). The court went on to review the scientific evidence evaluated by the FDA
and concluded that the FDA’s finding on which it rested its decision to deny plaintiffs’ proposed
health claim was “unreasonable” because that finding was “not supported by an overall review of
the available evidence or the FDA’s own Guidance Report.” Id. at 13.
The Court concludes that it 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.
See J.J. Cassone Bakery, Inc., 554 F.3d at 1044 (constitutional challenges to agency actions are
“entertain[ed] . . . de novo”). 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. 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.”) (internal citation and quotations omitted); Serono Labs., Inc. v. Shalala, 158 F.3d
1313, 1320 (D.C. Cir. 1998) (agency “evaluations of scientific data within its area of expertise”
are “entitled to a high level of deference”) (internal quotations omitted); A.L. Pharma, Inc. v.
Shalala, 62 F.3d 1484, 1490 (D.C. Cir. 1995) (“[C]ourts give a high level of deference to an
agency’s evaluations of scientific data within its area of expertise.”); see also J.J. Cassone
Bakery, Inc., 554 F.3d at 1044 (distinguishing between “other aspects of a[n agency] decision,
which we review deferentially” and “a constitutional question,” to which “a reviewing court
owes no deference”). Moreover, deference to the Agency’s interpretation of scientific
18
information, provided such interpretation is reasoned and not arbitrary or capricious, is consistent
with the test set forth in Pearson I. By instructing the FDA to employ less restrictive means of
regulating speech and to provide greater empirical support for its regulatory decisions, the D.C.
Circuit did not purport to tell the Agency how to assess scientific data. Rather, it provided the
Agency with guidelines for developing regulations once it had evaluated the evidence before it.
See, e.g., Pearson I, 164 F.3d at 659 (“[W]here 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.”).
This is not, however, to say that where the FDA’s conclusions are contrary to its
purported evaluation standards or are otherwise arbitrary, as the court concluded they were in
Pearson II and Whitaker, a reviewing court should not overturn the Agency. See, e.g., Int’l
Fabricare Inst. v. EPA, 972 F.2d 384, 389 (D.C. Cir. 1992) (agency’s decision may be
overturned where it has “failed to respond to specific challenges that are sufficiently central to its
decision”); Ethyl Corp. v. EPA, 541 F.2d 1, 36 (D.C. Cir. 1976) (court has duty to give “close
scrutiny” to technical evidence and to “hold[] agencies to certain minimal standards of
rationality.”). But “[t]he enforced education into the intricacies of the problem before the agency
is not designed to enable the court to become a superagency that can supplant the agency’s
expert decision-maker. To the contrary, the court must give due deference to the agency’s ability
to rely on its own developed expertise.” Id.B. Regulation of Commercial Speech
Because the qualified selenium health claims are commercial speech, the FDA’s refusal
to authorize them must be evaluated under the analytical framework established in Central
Hudson, discussed by the D.C. Circuit in Pearson I, and elaborated upon by the Supreme Court
19
in Western States. Whitaker, 248 F. Supp. 2d. at 8; see also Pearson I, 164 F.3d at 655 (“Under
Central Hudson, we are obliged to evaluate a government scheme to regulate potentially
misleading commercial speech by applying a three-part test.”). The Supreme Court has “rejected
the ‘highly paternalistic’ view that government has complete power to suppress or regulate
commercial speech.” Central Hudson, 447 U.S. at 562 (quoting Virginia Pharmacy Bd. v.
Virginia Citizens Consumer Council, 425 U.S. 748, 770 (1976)). Moreover, it has distinguished
between “inherently misleading” speech and “potentially misleading” speech. “[Actually or
inherently m]isleading advertising may be prohibited entirely.” In re R.M.J., 455 U.S. 191, 203
(1982). “But the States may not place an absolute prohibition on certain types of potentially
misleading information . . . if the information also may be presented in a way that is not
deceptive.” Id. Moreover, “[t]he First Amendment does not allow the FDA to simply assert that
[a plaintiff’s c]laim is misleading in order to ‘supplant its burden to demonstrate that the harms it
recites are real and that its restriction will in fact alleviate them to a material degree.’” Whitaker,
248 F. Supp. at 9 (quoting Ibanez, 512 U.S. at 146). Indeed, in Pearson I, the D.C. Circuit
rejected the FDA’s contention that health claims lacking “significant scientific agreement” are
inherently misleading as “almost frivolous.” Pearson I, 164 F.3d at 655. Even when it finds
“that speech is misleading, the government must consider that ‘people will perceive their own
best interests if only they are well enough informed, and . . . the best means to that end is to open
the channels of communication rather than to close them.’” Whitaker, 248 F. Supp. 2d at 9(quoting Virginia Pharmacy Bd., 425 U.S. at 770).
Central Hudson established a multi-step analysis of speech regulation. “As a threshold
matter,” the Court must determine “whether the commercial speech [being regulated] concerns
unlawful activity or is misleading.” Western States, 535 U.S. at 367. If so, the speech is not
20
protected. Id. But 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 it is, the Court then ascertains
“whether the regulation [at issue] directly advances the governmental interest asserted” and
“whether [the regulation] is not more extensive than is necessary to serve that interest.” Id.(quoting Central Hudson, 447 U.S. at 566.) This last step requires the Court to evaluate
“whether the fit between the government’s ends and the means chosen to accomplish those ends
is . . . reasonable.” Pearson I, 164 F.3d at 656 (citation omitted).
The government has the burden of 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.
Western States, 535 U.S. at 371 (quoting Central Hudson, 447 U.S. at 566). “[I]f the
Government c[an] achieve its interests in a manner that does not restrict [commercial] speech, or
that restricts less speech, the Government must do so.” Id. Therefore, the Court in Pearson I
noted that disclaimers are “constitutionally preferable to outright suppression,” Pearson I, 164
F.3d at 657, and that generally, “the preferred remedy is more disclosure, rather than less.” Id.
(quoting Bates v. State Bar of Arizona, 433 U.S. 350, 376 (1977)); see also Pearson II, 130 F.
Supp. 2d at 113 (“[M]ore disclosure rather than less is the preferred approach, so long as
advertising is not inherently misleading.”). For this reason, the Court in Pearson I concluded
that “when government chooses a policy of suppression over disclosure-at least where there is no
showing that disclosure would not suffice to cure misleadingness-the government disregards a
far less restrictive means.” Pearson I, 164 F.3d at 658 (quotations omitted).
21
II. FDA’S COMPLETE BAN OF PLAINTIFFS’ CLAIMS
In its response to plaintiffs’ petition, the Agency denied four of the proffered claims
outright. (FDA Resp. at AR 001963, 001965, 001992-001993.) Under Central Hudson and
Pearson I, the FDA may refuse to consider disclaimers for health claims (i.e., prohibit their use
completely) only if such health claims are inherently misleading, Whitaker, 248 F. Supp. at 9, or
are potentially misleading but the Agency has deemed the claim “incurable by disclaimer.”
Pearson I, 164 F.3d at 659. The court in Whitaker arguably went even further than Pearson I,
holding 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.” 21 Whitaker, 248 F. Supp. 2d at 11 (emphasis added);
see also Pearson I, 164 F.3d at 659-60 (suggesting that government might completely ban health
claim where “evidence in support of a claim is outweighed by evidence against the claim” or
where it “demonstrate[d] with empirical evidence that disclaimers . . . would bewilder consumers
and fail to correct for deceptiveness”). The Court considers each of plaintiffs’ claims to
21
The FDA argues that Whitaker “strayed from Pearson I by suggesting that [the Agency] is
required, under the First Amendment, to present empirical evidence about the misleading nature
of a claim even where there is no evidence supporting the claim or the evidence in support of the
claim is qualitatively weaker than the evidence against the claim.” (Defs.’ Reply in Supp. of Its
Cross-Mot. for Summ. J. and In Opp’n to Pls.’ Mot. for Summ. J. [“Defs.’ Reply”] at 7.).
Plaintiffs maintain that “no doctrinal or legal difference of any decisional significance between
Pearson I and Whitaker” exists. (Pls.’ Surreply to Defs.’ Reply in Supp. of Defs.’ Cross-Mot.
for Summ. J. and In Opp’n to Pls.’ Mot. for Summ. J. at 7.) Despite extensive debate, the Court
need not decide whether Whitaker has improperly increased the government’s burden, because it
concludes that the FDA has not shown that there is no credible or only qualitatively weaker
evidence in support of plaintiffs’ claims or that the claims are “incurable by disclaimer.” See
Pearson I, 164 F.3d at 659.
22
determine whether the FDA has met its burden with respect to those claims it has banned
outright. 22
A. Plaintiffs’ “Certain Cancers” and “Anticarcinogenic Effects” Claims
The FDA asserts that claims that selenium may reduce the risk of certain cancers and
may produce anticarcinogenic effects are “misleading on their face,” “independent of the
proffered scientific evidence.” (Defs.’ Mot. at 23.) Specifically, the Agency concluded that the
certain cancers claim “is incomplete and misleading because it fails to reveal the individual
cancer(s) that selenium may have an effect on,” thus leading a consumer to purchase selenium in
hopes of preventing a cancer for which there is no evidence of risk reduction from selenium
intake. (FDA Resp. at AR 001963.) The FDA also argues that by “referring in general terms to
‘certain cancers,’ the requested claim language . . . suggests that cancers at different sites are
essentially the same disease and that it is not important to distinguish between them.” (Id.)
Similarly, the anticarcinogenic effects claim “falsely implies that [selenium] can protect against
all cancers,” when in fact cancer “is not a single disease” but a “collective term for a large
number of individual diseases that differ with respect to risk factors, etiology, methods of
22
The Court considers only the first sentence of each of plaintiffs’ proposed claims, not the
suggested disclaimer in the second sentence (i.e., that the “[s]cientific evidence supporting this
claim is convincing but not yet conclusive”). (FDA Resp. at AR 001957-001958.) To the extent
the FDA denied these claims outright, it did so on the basis of the claimed relationship between
selenium dietary supplements and various cancers, not because of the disclaimer. (See, e.g.,
Defs.’ Mot. at 23 (FDA concluded that certain cancers and anticarcinogenic effects claims were
misleading “independent of the proffered scientific evidence”)). Specifically, where the FDA
banned a claim entirely because it found “no credible evidence of a risk reduction relationship”
or believed the claim was inherently misleading, it concluded that the proposed disclaimer was
“clearly false” without further assessment of its merits. (FDA Resp. at AR 001993.) To the
extent the Court overturns the Agency’s findings as to the substance of the health claims, it must
allow the FDA to consider plaintiffs’ proposed disclaimer and/or alternate disclaimers in the first
instance. See, e.g., Pearson I, 164 F.3d at 659 (“We do not presume to draft precise disclaimers
for each of appellants’ . . . claims; we leave that task to the agency in the first instance.”).
23
diagnosis and treatment, and mortality risk.” (Id. at AR 001964; see also Defs.’ Mot. at 23.)
Moreover, the Agency argues that the phrase “anticarcinogenic effects” is ambiguous because
“anticarcinogenic” might mean both the “treatment and mitigation of existing cancer as well as
the reduction of risk of getting cancer in the first place.” (Def.’s Mot. at 24.) Since “[c]laims
about treatment or mitigation of disease are classified as drug claims, not health claims,” the
FDA “believes that no qualified claim based on that phrase would be truthful and non-
misleading.” (FDA Resp. at AR 001965.)
The Court concludes that the FDA’s position fails under Pearson I. The Agency has not
provided any empirical evidence, such as “studies” or “anecdotal evidence,” that consumers
would be misled by either of plaintiffs’ claims were they accompanied by qualifications. See
Pearson I, 164 F.3d at 659 (government’s “conclusory assertion” of misleadingness insufficient
to meet burden); see also Edenfield v. Fane, 507 U.S. 761, 771 (1993) (rejecting restriction of
commercial speech where government “present[ed] no studies” and “record d[id] not disclose
any anecdotal evidence . . . that validates the [government’s] suppositions” that unregulated
speech would cause “fraud and overreaching”). Moreover, the explanation the FDA offers to
demonstrate that plaintiffs’ claims are misleading—that the claims leave out pertinent
information—is not support for banning the claims entirely, but rather favors the approach of
remedying any potential misleadingness by the disclosure of additional information.
The FDA’s position is particularly troubling in light of its admission that plaintiffs’
certain cancers claim “is literally true . . . in that there is credible evidence that selenium may
reduce the risk of at least three cancers” and that the anticarcinogenic effects claim “is true to the
extent that it refers to reducing the risk of . . . three cancers[.]” (Defs.’ Reply at 10 n.8.) As the
Circuit Court in Pearson I made clear, “the government’s interest in preventing the use of labels
24
that are true but do not mention [material information] would seem to be satisfied-at least
ordinarily-by inclusion of a prominent disclaimer setting forth [that information].” 164 F.3d at
659 (emphasis added). Here, the FDA has not provided any evidence that completing plaintiffs’
certain cancers claim by “reveal[ing] the individual cancer(s) that selenium may have an effect
on” and explaining that cancers at different sites are different diseases and respond differently to
treatments would not eliminate the consumer confusion it fears. And, the FDA’s argument that
“disclaimer language defining ‘anticarcinogenic’ as reducing the risk of, rather than treating or
mitigating, cancer would not cure the misleading nature” of the claim because it “would still fail
to specify the disease at issue” (Defs.’ Mot. at 27) begs the question why an additional
disclaimer, specifying the disease[s], would not remedy the purported problem. 23
23
In its reply, the FDA appears to answer this question by arguing that qualifying language
would “merely add more information [to the certain cancers and anticarcinogenic effects claims]
without solving the problem created by the inherently misleading language of the claim itself.”
(Defs.’ Reply at 11.) Specifically, it maintains that a disclaimer defining the phrase
“anticarcinogenic effects” and specifying the cancers at issue would “undercut the claim and
create confusion as to why the broad ‘anticarcinogenic effects’ statement appears on the product
if the evidence only supports risk reduction for three cancers.” (Id. at 11-12.) It then contends
that
appending qualifying language such as ‘specifically prostate,
bladder, and thyroid cancer’ to the ‘certain cancers’ claim to
inform consumers of the cancers for which there is credible
evidence of possible risk reduction would not be sufficient to
prevent deception because the broader ‘certain cancers’ language
would still incorrectly suggest a possible protective effect against
other unnamed cancers, and the inconsistency between the broader
language of the claim and the narrower language of the disclaimer
would create confusion and uncertainty as to the scope of the
claimed benefit.
(Defs.’ Reply at 12.) But these conclusory contentions are insufficient to meet the Agency’s
burden under the commercial speech doctrine. See Edenfield, 507 U.S. at 770-71 (government’s
obligation to “demonstrate that the harms it recites are real and that its restriction will in fact
alleviate them to a material degree” “is not satisfied by mere speculation or conjecture”). The
Agency offers no support for its claim that limiting the type of “protective effect” and “risk
25
Supreme Court precedent and Pearson I obligate the FDA to, at a minimum, consider
“less restrictive” means of correcting that misleadingness before it turns to suppression. Pearson
I, 164 F.3d at 657-58; see also Bates, 433 U.S. at 374-75 (rejecting notion that “the public is
better kept in ignorance than trusted with correct but incomplete information”). Because the
Agency has not done so here, the Court will remand the claims relating to certain cancers and
anticarcinogenic effects to the FDA for the purpose of drafting one or more disclaimers or,
alternatively, setting forth empirical evidence that any disclaimer would fail to correct the
claims’ purported misleadingness.
reduction” claimed would insufficiently prevent consumers from assuming that selenium may
also lower the risk of other cancers. It also fails to explain what “confusing contradiction” would
result from such disclaimers. On the contrary, it acknowledges that the claims are true because
of, not in spite of, evidence that selenium may reduce the risk of particular cancers. (Defs.’
Reply at 10 n.8.)
The FDA’s reliance on International Dairy Foods Association v. Boggs, No. 08-628,
2009 WL 937045, at *5 (S.D. Ohio Apr. 2, 2009), which involved a state regulation that
prevented sellers of dairy products made from cows not treated with rbGH from advertising their
products as “rbGH free,” is unavailing. There, the court held that the phrase “rbGH free” was
inherently misleading because it implied that there was a “compositional difference between
those products that are produced with rbGH and those that are not,” when in fact no such
difference exists. Id. at *6. The restricted claims in Boggs are different from plaintiffs’ claims.
The “rbGH free” claim, while literally true, sent a message—that rbGH free milk is different
from milk produced by cows given rbGH—that was completely false. Here, by contrast, the
FDA concedes that plaintiffs’ anticarcinogenic and certain cancers claims “contain a kernel of
truth,” but are overly broad. (Defs.’ Reply at 10 n.8.) Yet, the FDA rejects disclaimers
explicitly limiting the scope of plaintiffs’ proposed claim to those circumstances supported by
credible evidence, arguing that such disclaimers would “defeat the purpose of making the
claim[s] in the first place.” (Id. at 12 (quoting Boggs, 2009 WL 937045, at *7).) The Court fails
to see how limiting a claim so that it accurately reflects the evidence in support of the claim
defeats the purpose of making the claim at all. Nor is this situation analogous to United States v.
Kasz Enterprises, Inc., 855 F. Supp. 534, 542-43 (D.R.I. 1994), where the disclaimers at issue
were clearly inconsistent with the message defendants sought to convey and therefore effectively
served to undo the original claims. See Pearson I, 164 F.3d at 659 (where evidence in support of
claim is outweighed by evidence against it, disclaimer that “no evidence supports this claim”
would not cure claim’s misleadingness). Absent evidence that consumers are unable to read
qualified versions of plaintiffs’ claims without assuming that selenium prevents diseases not
stated by the claims, the FDA has not demonstrated that disclaimers would be ineffective and
that suppression of these claims is thus warranted.
26
B. Plaintiffs’ Lung and Respiratory Tract Claim
In contrast to the certain cancers and anticarcinogenic effects claims, the FDA considered
the scientific evidence proffered by plaintiffs and concluded that it could draw scientific
conclusions from only four of those studies concerning plaintiffs’ lung/respiratory tract claim. 24
(FDA Resp. at AR 001985.) Because all of those studies reported “no significant difference in
mean serum levels” between control cases and lung cancer cases, the Agency concluded that
“there is no credible evidence for a claim about selenium supplements and reduced risk of lung
cancer or other respiratory tract cancers.” (Id. at AR 001985, 001989.) Plaintiffs contend that a
number of the studies discounted by the FDA provide sufficient credible evidence of a positive
relationship between selenium intake and a lowered risk of lung and respiratory tract cancers.
(Pls.’ Mot. at 34-36; Pls.’ SMF ¶¶ 37-39.)
As an initial matter, the FDA’s determination regarding the lung and respiratory tract
claim is not inconsistent with Pearson I, in which the Court allowed for the possibility 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.” 164 F.3d at 659. Here, the Agency
claims that there is no evidence in support of the proposed claim and cites studies suggesting that
there is no relationship between selenium intake and reduced lung cancer risk. However, the
Court in Pearson I also suggested that when “‘credible evidence’ supports a claim, that claim
may not be absolutely prohibited.” Whitaker, 248 F. Supp. 2d at 10; see also Pearson I, 164
F.3d at 658-59 (where “credible evidence” supported a proposed claim, “a clarifying disclaimer
24
The only studies relied upon by the FDA for this claim concerned the relationship between
selenium and lung cancer, as opposed to other respiratory tract cancers. (FDA Resp. at AR
001985.)
27
could be added” to note that the evidence was inconclusive). Therefore, the proper inquiry is
what qualifies as “credible evidence” and is there any such evidence to support the lung and
respiratory tract claim?
In its latest Guidance Document, the FDA states that it uses an “evidence-based review
system” to evaluate the strength of the evidence in support of a statement. The process
involves a series of steps to assess scientific studies and other data,
eliminate those from which no conclusions about the
substance/disease relationship can be drawn, rate the remaining
studies for methodological quality and evaluate the strength of the
totality of scientific evidence by considering study types,
methodological quality, quantity of evidence for and against the
claim (taking into account the numbers of various types of studies
and study sample sizes), relevance to the U.S. population or target
subgroup, replication of study results supporting the proposed
claim, and overall consistency of the evidence. After assessing the
totality of the scientific evidence, FDA determines whether there is
[significant scientific agreement] to support an authorized health
claim, or credible evidence to support a qualified health claim.
(Guidance Document at AR 003512 (emphasis added).) While the document does not define
“credible,” it does set forth threshold questions and categorizations the Agency uses to prioritize
certain types of evidence over others. For example, it states that “[r]andomized, controlled trials
offer the best assessment of a causal relationship between a substance and a disease.” (Id. at AR
003513.) In contrast, “research synthesis studies” and “review articles” “do not provide
sufficient information on the individual studies reviewed” to determine critical elements of the
studies and/or whether those elements were flawed. (Id. at AR 003517.) The FDA also explains
the questions it considers in determining whether scientific conclusions can be drawn from an
intervention or observational study, such as where the studies were conducted (i.e., on what type
of population); what type of information was collected; and what type of biomarker of disease
risk was measured. (Id. at AR 003518-003522.) If the FDA concludes that the elements of a
28
study are flawed such that it is impossible to draw scientific conclusions from the study, it
eliminates that study from further review. (Id. at AR 003518.)
Using the above procedure, the FDA disregarded the studies plaintiffs cite as “credible
evidence” in support of their proposed lung/respiratory tract claim: the van den Brandt et al.
study; the Knekt et al. study; the Zhuo et al. review article; and the “SU.VI.MAX” study. 25
(Pls.’ Mot. at 34-36.) The Agency states that it eliminated the van den Brandt and Knekt studies
because they were conducted on Dutch and Finnish populations whose average baseline
selenium levels (53.9 to 62.5 µg/L in blood and .5 µg/g in toenail clippings, respectively) are
significantly lower than the levels observed in the “vast majority of the U.S. population.” 26 (FDA
Resp. at AR 001979.) Indeed, it appears that the van den Brandt and Knekt studies focused on
populations whose members suffer from a selenium deficiency, since “nutritional adequacy of
25
Plaintiffs cite four studies as “credible evidence” supporting the lung/respiratory tract claim
that were improperly discounted by the FDA. (Pls.’ Mot. at 34-36.) However, plaintiffs
maintain that this is not a “comprehensive list of articles” they submitted in support of this claim
and urge the Court to review the Administrative Record for all such materials. (Id. at 34 n.47.)
In reviewing the nearly 4,000-page record, the Court encountered multiple articles that evaluated
or discussed a possible relationship between selenium and lung cancer. But the Court is not in
the position, nor is it the Court’s role, to independently assess whether these publications, many
of which are highly technical and discuss interactions at a bio-molecular level (see, e.g., AR
001844 (Poerschke et al., Modulation of redox status in human lung cell lines by
organoselenocompounds: Selenazolidines, selenomethionine, and methylseleninic acid, 22
Toxicology in Vitro 1761-1767 (2008)), constitute “credible evidence” in support of plaintiffs’
claim. As such, the Court will limit its consideration to the four articles relied on by plaintiffs to
assess whether the Agency’s evaluation is inconsistent with the standards outlined in its current
Guidance Document, irrational, and/or arbitrary and capricious. See Whitaker, 248 F. Supp. 2d
at 11 (reviewing FDA’s evaluation of scientific evidence to ensure Agency conducted a “process
of reasoned decision-making” and that decision was not arbitrary and capricious).
26
By comparison, according to a 2003 study, blood serum selenium concentrations in the U.S.
population range from 91 µg/L (1st percentile) to 168 µg/L (99th percentile). (FDA Resp. at AR
001977.) From this, the FDA concluded that “populations [with] blood selenium concentrations
of less than 90 µg/L are not applicable to the general U.S. population.” (Id.) Similarly, studies
from 1995 and 1998 indicate that toenail selenium concentration in the U.S. population is around
.86 µg/g, with the lowest quintile ranging from .66 to .72 µg/g. (Id. at AR 001978.)
29
selenium is defined as the amount of selenium that is needed to saturate selenium enzyme
activities; this occurs at blood selenium concentrations of 70-90 µg/L.” (Id. at AR 001977.) The
Agency’s elimination of the van den Brandt and Knekt studies is thus consistent with the 2009
Guidance Document, which states that “[s]cientific conclusions cannot be drawn from studies
conducted in countries or regions where inadequate intake of the substance is common since a
response to the intake of the substance may be due to the correction of a nutrient deficiency for
which health claims are not intended.” (Guidance Document at AR 3521.) In fact, the Knekt
study noted that “the serum selenium level of the present population was about 60 percent of the
levels generally observed in other Western countries” and found only that “individuals with a
low serum selenium concentration had an elevated risk of lung cancer.” (AR 001569-001570.)
The study further noted that “[h]igher serum selenium was associated with a reduced risk only at
low alphatocopherol levels.” (AR 001570.) Similarly, the van den Brandt found an inverse
association between toenail selenium content and the risk of lung cancer, but it noted that
selenium levels in the Netherlands are “intermediate between those reported from New Zealand
and the United States.” (AR 003170.) As such, the FDA’s decision not to extrapolate from these
studies to the U.S. population is both rational based on the studies’ conclusions and consistent
with the Agency’s evaluation criteria.
The FDA contends that it eliminated the Zhuo publication from its evaluation because the
article “only reviewed lung cancer studies” and did not purport to provide “scientific evidence”
in support of plaintiffs’ claim. (Defs.’ Mot. at 41.) Moreover, the Agency generally excludes
such review articles because they “‘do not contain sufficient information on the individual
studies reviewed’ from which scientific conclusions can be drawn.” (Id. (quoting FDA Resp. at
AR 001968).) Based on its review of the article, the Court concludes that the Agency’s decision
30
to exclude the article from its evaluation was not arbitrary and capricious. While the article
discusses 16 studies (some of which are also included in the record), it is not apparent from the
article that the Agency had sufficient information from the Zhuo article to determine whether
these studies contained design flaws. Moreover, many of the populations studied have low
selenium levels that may not be the case in the U.S. population. (AR 003799.) Indeed, the
article concludes that “[w] e found evidence that selenium could have protective effects;
however, based on this analysis and other evidence, these effects apparently occur primarily in
populations where overall selenium levels are low.” (AR 003803.) The FDA’s findings
regarding the van den Brandt and Knekt studies suggest that even had the Agency considered the
Zhuo article as providing scientific evidence, that evidence is not sufficiently credible to support
plaintiffs’ claim.
Finally, the Agency rejected the SU.VI.MAX study because the study “did not confirm
that all subjects were free of the cancers of interest prior to the intervention” and therefore may
have involved subjects who already had cancer at the time the study began. (FDA Resp. at AR
001971.) Because of this omission, the FDA stated that it could not draw scientific conclusions
from the study. (Id.) However, the SU.VI.MAX study states that one of the criteria for
participation in the study was “lack of disease likely to hinder active participation or threatened
[sic] 5-year survival.” (AR 001660.) The study participants were intermittently examined, and
participants were asked to report any health events monthly. (Id.) Whenever a possible adverse
event, including “cancer of any kind,” was reported from whatever source, records were
collected and included in study data. (Id.) The Agency also appears to have overlooked a later
report on the SU.VI.MAX study population concerning prostate cancer, which noted that three
participants were excluded at the start of the study because they had prostate cancer, indicating
31
that some sort of cancer screening process was conducted at the study’s outset. (AR 001669.)
As such, the Agency’s stated reason for its disregard of the study is unsupported by the record.
And the FDA provided no response to the plaintiffs’ argument regarding the results of the study,
namely that “in men, the incidence of respiratory cancers was reduced from 88 per 100,000 for
the control group to 37 per 100,000 for the supplemented group,” while in women, the
“incidence of respiratory tract cancers was reduced from 21 per 100,000 in the control group to
only 12 per 100,000 in the supplemented group.” (Pls.’ Mot. at 31; AR 01665.)
In sum, while the Court concludes that the Agency’s exclusion of the van den Brandt,
Knekt, and Zhuo publications on the basis of its Guidance Document was not irrational or
arbitrary and capricious, the exclusion of the SU.VI.MAX study on the basis that it did not
screen participants for cancer is not supported by the record. To the extent that the FDA is
concerned about possible limitations of the SU.VI.MAX study protocol and/or results, it must
remedy such limitations with disclaimers. See Pearson I, 164 F.3d at 658 (suggesting disclaimer
for antioxidant claim to address Agency’s concerns about study limitations). Accordingly, the
Court remands the lung/respiratory tract claim to the Agency to determine an appropriate
disclaimer in light of the SU.VI.MAX study.
C. Plaintiffs’ Colon and Digestive Tract Claim
As with the lung/respiratory tract claim, the FDA concluded that there is no credible
evidence for a claim about selenium supplements and reduced risk of colon or other digestive
tract cancers. (FDA Resp. at AR 001989; Defs.’ Mot. at 43.) After eliminating various studies
from which it determined no scientific conclusions could be drawn, including studies it relied
upon in the evaluation of other of plaintiffs’ claims, the FDA reviewed three prospective
observational studies that it found reported no significant relationship between selenium
32
concentration and the risk of colorectal cancer. (FDA Resp. at AR 001983-001985.) Plaintiffs
challenge the FDA’s conclusions regarding one of these studies (the Peters et al. study) and cite
additional publications they contend were wrongly excluded from the FDA’s evaluation of their
colon and digestive tract claim: the Clark et al. study; the Ghadirian et al. study; the Fernandez-
Banares et al. study; the Jaskiewicz et al. study; the Das et al. review article; the Schrauzer et al.
study; and the Wei et al. study. (Pls.’ Mot. at 36-38.)
In its response to plaintiffs’ petition, the Agency stated that the Peters study was of “high
methodological quality” (FDA Resp. at AR 001984), which is the highest ranking the FDA gives
to human intervention and observational studies, which in turn are the two types of studies the
Agency considers most reliable. (Id. at AR 001961; see also AR 003523-003526.) However, the
Agency concluded that because “[t]here was no significant difference in the overall incidence of
adenomatous colorectal polyps (a surrogate endpoint for colorectal cancer) between the five
quintiles of serum selenium [levels],” the study did not provide evidence of a relationship
between selenium and a reduced risk of colorectal cancer. (FDA Resp. at AR 001984.) Upon
review of this study, the Court concludes that the FDA’s determination that this study does not
constitute credible evidence in support of plaintiffs’ claim is unreasonable and unsupported by
the findings of the study. The study concluded that “[o]verall, higher serum selenium levels
were inversely associated with reduced risk of advanced colorectal adenoma.” (AR 002910.) In
particular, the authors noted that men in “the highest quintile of selenium had 43% lower risk for
advanced colorectal adenoma compared with men in the lowest quintile.” (AR 002909.) The
authors later stated that “[f]indings from our study [and another study] particularly support
inverse association [between selenium and] advanced adenoma.” (AR 002912.) These findings
are squarely at odds with the FDA’s conclusion that the study showed no significant difference
33
in adenomas across the various levels of selenium. Therefore, the Court finds that the Peters
study was unreasonably discounted as credible evidence.
The Agency excluded several studies because they are “retrospective,” meaning that they
measured selenium intake after the subjects “had already been diagnosed with the disease.”
(Defs.’ Mot. at 43.) Because the health status of subjects can have an effect on selenium
measurements, the FDA concluded that it could not determine whether the lowered selenium
levels observed in these studies were caused by the cancer or by the participants’ nutrient intake.
(Id.) The Court defers to the FDA’s position with respect to retrospective studies generally and
its determinations regarding the Clark, Fernandez-Barnares, and Jasckiwicz studies, which
appear reasonable and consistent with the Agency’s Guidance Document. However, the
Agency’s explanation for exclusion is inapposite with respect to the Ghadrian study. There, the
authors measured toenail selenium because it is “the best measure of assessing long-term dietary
selenium.” (AR 003844.) They then noted that in their study, “toenail selenium represents the
dietary selenium intake prior to the diagnosis of cancer, as toenails were collected mainly before
the final diagnosis or major treatment.” (Id. (emphasis added).) The study found a “significant
inverse association . . . between toenail selenium levels and the risk of colon cancer.” (AR
003841.) The Court concludes that the FDA’s exclusion of this study from its evaluation of
plaintiffs’ claim because it is retrospective was unreasonable, given the clear representations in
the study as to the nature of the selenium intake observed.
The FDA’s rejection of the Schrauzer, Das, and Wei publications is consistent with the
Agency’s guidance, discussed previously, regarding review articles and studies of nutritionally-
deficient populations. However, it is difficult to discern the logic in the FDA’s decision to
exclude from its evaluation of plaintiffs’ digestive tract claim studies the Agency relied on for
34
scientific conclusions concerning other of plaintiffs’ claims (e.g., the Criqui et al. study; the
Ringstad et al. study, and the Willet et al. study). (FDA Resp. at AR 001983-001985.) Although
the Criqui and Willet studies showed an inverse relationship between selenium and
gastrointestinal cancer (AR 002248, 003278), the FDA excluded them from consideration of
plaintiffs’ claim because they do not include information about the site-specific gastrointestinal
cancers measured. (FDA Resp. at AR 001983-001984.) “Gastrointestinal” cancers are
“digestive tract” cancers, at least according to the National Institutes of Health’s National Cancer
Institute (NCI), on which the FDA relies heavily in defining and categorizing cancers. (See id. at
AR 001962 (“Cancer is categorized into different types based on specific organ and tissue sites
(National Cancer Institute).”) NCI defines “digestive tract” as “[t]he organs through which food
and liquids pass when they are swallowed, digested, and eliminated. These organs are the
mouth, esophagus, stomach, small and large intestines, and rectum and anus.” 27 NCI’s definition
of gastrointestinal (“[r]efers to the stomach and intestines”) 28 thus suggests that gastrointestinal
cancers are a subset of digestive tract cancers, meaning that a reduced risk of gastrointestinal
cancers necessarily constitutes a reduced risk of digestive tract cancers. Therefore, the failure of
the Criqui and Willet studies to specify the gastrointestinal cancers observed is irrelevant to
whether they are credible evidence in support of plaintiffs’ claim. 29 The Court therefore finds
that the FDA erred when it excluded these studies.
27
National Cancer Institute, Dictionary of Cancer Terms, available at
http://www.cancer.gov/dictionary/?CdrID=46447 (last visited May 26, 2010).
28
National Cancer Institute, Dictionary of Cancer Terms, available at
http://www.cancer.gov/dictionary/?CdrID=45692 (last visited May 26, 2010).
29
To the extent the Agency fears that consumers hoping to prevent a type of digestive tract
cancer other than a gastrointestinal cancer will be misled by the claim, qualifying language can
be used to limit the claim’s scope. See Pearson I, 164 F.3d at 659 (government’s interest in
35
In sum, based on its examination of the scientific literature and the FDA’s response to
plaintiffs’ petition, the Court finds that the FDA’s decision to ban plaintiffs’ colon and digestive
tract claim because there is no credible evidence in support of it “is unreasonable because it is
not supported by a review of the available evidence or the FDA’s own Guidance Report.” See
Whitaker, 248 F. Supp. 2d at 13. Indeed, it appears that credible evidence (e.g., the Peters,
Ghadrian, Criqui, and Willet studies) does support this claim. As such, complete suppression of
the claim is unwarranted. See Whitaker, 248 F. Supp. 2d at 10; see also Pearson I, 164 F.3d at
658-59; Pearson II, 130 F. Supp. 2d at 114. The Court will remand this claim to the Agency for
reconsideration and, if needed, appropriate qualifying language.
III. FDA’S QUALIFICATION OF PLAINTIFFS’ PROSTATE CLAIM
After reviewing the scientific literature submitted with plaintiffs’ petition, the FDA
concluded that it could draw scientific conclusions regarding plaintiffs’ prostate claim from eight
observational studies and one intervention study. (FDA Resp. at AR 001989.) Of these, the
Agency determined that two nested case-control studies suggested that selenium may reduce the
risk of prostate cancer. (Id. at AR 001989-001990.) However, the FDA rejected plaintiffs’
proposed 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 AR 001993.) Instead, the
Agency stated that it would exercise enforcement discretion with respect to the following
qualified health claim: “Two weak studies suggest that selenium intake may reduce the risk of
prostate cancer. However, four stronger studies and three weak studies showed no reduction in
preventing labels that do not include material information “would seem to be satisfied-at least
ordinarily-by inclusion of a prominent disclaimer”).
36
risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements
reduce the risk of prostate cancer.” (Id.)
The Court agrees with plaintiffs’ contention that the FDA’s proposed claim is at odds
with the Supreme Court’s mandate that there be a “reasonable fit” between the government’s
goal and the restrictions it imposes on commercial speech. See Pearson I, 164 F.3d at 656 n.5
(quoting State University of New York v. Fox, 492 U.S. 469, 480 (1989)). 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. Pearson I, 164 F.3d at
658-59. Rather, it has replaced 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 “contradict[s] the claim and defeats the
purpose of making [it] in the first place.” (Defs.’ Reply at 11.) While such language might be
appropriate were there no credible evidence in support of a positive relationship between prostate
cancer risk and selenium intake, the Agency concedes that there is such evidence. (FDA Resp. at
AR 001986, 001990.) As such, the FDA is obligated to at least consider the possibility of
approving plaintiffs’ proposed language with the addition of “short, succinct, and accurate
disclaimers.” Pearson II, 130 F. Supp. 2d at 120. Here, the FDA has completely eviscerated
plaintiffs’ claim, with no explanation as to why a less restrictive approach would not be
effective. For instance, to the extent that the FDA takes issue with the proposed “convincing but
not yet conclusive” claim, the Agency makes no attempt to demonstrate that this concern would
not be accommodated by altering this portion of the claim with language that more accurately
reflects the strength of the scientific evidence at issue. Such qualification would be a “far less
restrictive means” than negation of plaintiffs’ claim. Pearson I, 164 F.3d at 658.
37
Moreover, in light of its review of the scientific literature, the Court finds that the
Agency’s “disclaimer” is inaccurate. For example, the FDA concluded that the Li et al. study
showed “no significant difference in plasma selenium levels between cancer-free controls . . .
and prostate cancer cases” and “no significant relationship between plasma selenium levels and
prostate cancer risk.” (FDA Resp. at AR 001986.) Yet, the studies’ authors stated that they
“found a statistically significant inverse association between pre-diagnostic plasma selenium
levels and the risk of advanced prostate cancer.” (AR 001697.) Further, among men with
“increased PSA levels at baseline,” the authors found that “higher levels of selenium were
associated with a reduced risk of all prostate cancer.” (Id.) The FDA argues that the Li study
does not support plaintiffs’ claim because the statistically significant relationship between
selenium and cancer risk appeared only when the investigators “stratified the subjects into five
groups based on the pre-diagnostic plasma selenium levels and compared the highest group to
the lowest.” (Defs.’ Mot. at 38.) Yet, the purported absence of a significant difference in cancer
risk “between the five quintiles of serum selenium” was the very reason the Agency excluded a
study in the evaluation of plaintiffs’ colon and digestive tract claim. (FDA Resp. at AR 001984.)
Such inconsistency is unreasonable. Even if the FDA determines the study evidences only a
limited reduction in risk in certain subgroups (Defs.’ Mot. at 38), the Court concludes that the
Agency erred in finding that the study “show[s] no reduction in [prostate cancer] risk.”
In short, the FDA’s replacement of plaintiffs’ claim with different and contradictory
language is inconsistent with the spirit, if not the letter, of Pearson I. The FDA has 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. Additionally, although the Court has not
38
conducted a complete review of the Agency’s analysis of the scientific evidence submitted in
support of this claim, 30 the Agency’s replacement claim mischaracterizes at least one study (Li et
al), suggesting that the FDA’s proposed claim is inaccurate. As such, the Court will remand
plaintiffs’ prostate claim to the FDA for the purpose of reconsidering the scientific literature and
drafting one or more short, succinct, and accurate disclaimers in light of that review.
CONCLUSION
Plaintiffs’ motion for summary judgment is granted in part and denied in part, and
defendants’ cross-motion for summary judgment is denied. This case is remanded to the FDA
for the purpose of 1) drafting one or more disclaimers to accompany plaintiffs’ certain cancers,
anticarcinogenic, and prostate claims, or, alternatively, setting forth empirical evidence that any
disclaimer would fail to correct the claims’ purported misleadingness; 2) determining an
appropriate disclaimer to accompany plaintiffs’ lung and respiratory tract claim in light of the
SU.VI.MAX study; and 3) reevaluating plaintiffs’ colon and digestive tract claim and drafting
one or more disclaimers.
The Court denies plaintiffs’ motion to the extent it seeks an order enjoining the FDA
from precluding plaintiffs from placing their proposed health claims on dietary supplement
labeling. (Pls.’ Mot. at 43.) It is not for this Court to pass judgment on the validity of plaintiffs’
proposed qualifying language in the first instance, see Pearson I, 164 F.3d at 659, nor can the
Court rule out the possibility that “the government could demonstrate with empirical evidence
that disclaimers . . . would bewilder consumers and fail to correct for deceptiveness.” Id. at 659-
60. To that end, the Court remands the claims at issue to the Agency for further review and
30
Because the Court remands this claim to the FDA on the basis of the Agency’s complete
substitution of plaintiffs’ proposed claim, it did not need to review all of the studies excluded or
relied on by the FDA in evaluating plaintiffs’ claim.
39
action consistent with this Memorandum Opinion. Although the Court is limited in its ability to
mandate that the Agency act by a specific date, see Consumer Fed’n of Am. and Pub. Citizen v.
United States Dep’t of Health and Human Servs., 83 F.3d 1497, 1506-07 (D.C. Cir. 1996), the
Court expects that the FDA will act with reasonable speed in reviewing the proposed claims and
drafting disclaimer language. See Whitaker, 248 F. Supp. 2d at 17 n.20.
/s/
ELLEN SEGAL HUVELLE
United States District Judge
DATE: May 27, 2010
40