ELLEN SEGAL HUVELLE, District Judge.
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,
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,
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, 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.
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
In 1995, a group of dietary supplement manufacturers
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 Gas & Electric Corporation v. Public Service Commission of New York, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980),
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 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, 114 S.Ct. 2084, 129 L.Ed.2d 118 (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)).
In late 2000, several of the plaintiffs from Pearson I and other dietary supplement designers, sellers, and manufacturers
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, that the "weight of the evidence is against both aspects
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
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.
In June 2001, the plaintiffs
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, 122 S.Ct. 1497). 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,
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"
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")
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.
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 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 raise their claims under the First Amendment to the United States Constitution.
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, 104 S.Ct. 2778, 81 L.Ed.2d 694 (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 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
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, 109 S.Ct. 1851, 104 L.Ed.2d 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 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.
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 in Western States. Whitaker, 248 F.Supp.2d. at 8; see also Pearson I, 164 F.3d at 655
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, 122 S.Ct. 1497. If so, the speech is not 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, 100 S.Ct. 2343). 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, 100 S.Ct. 2343.) 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, 122 S.Ct. 1497 (quoting Central Hudson, 447 U.S. at 566, 100 S.Ct. 2343). "[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, 97 S.Ct. 2691, 53 L.Ed.2d 810 (1977)); see also Pearson II, 130 F.Supp.2d at 113 ("[M]ore disclosure rather
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.2d 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."
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 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, 113 S.Ct. 1792, 123 L.Ed.2d 543 (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 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
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.
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 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
(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 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.
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 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
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 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.
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 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 Ghadrian et al. study; the Fernandez-Banares et al. study; the Jaskiewicz et al.
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 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
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.
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 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, 109 S.Ct. 3028, 106 L.Ed.2d 388 (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.
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."
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 conducted a complete review of the Agency's analysis of the scientific evidence submitted in support of this claim,
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 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.
(Petition at AR 000045.)
(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, 113 S.Ct. 1792 (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 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.