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Alliance for Natural Health U.S. v. Sebelius
Alliance for Natural Health U.S. v. Sebelius 714 F.Supp.2d 48 (2010) is a civil action case brought by plaintiffs Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship against the Food and Drug Administration (FDA) for violating their First Amendment rights for commercial speech. The plaintiffs sought a review of the FDA’s decision to deny their petition for the authorization of qualified health claims for their selenium based dietary supplements. The plaintiffs sought a declaratory judgment, consistent with both the circuit and district court opinions, declaring the FDA’s denial of their petition invalid and asked for a permanent injunction enjoining the FDA from preventing them from using their selenium health claims. The court granted the plaintiffs’ motion for summary judgment for certain claims and denied the defendants’ cross-motion for summary judgment. The Court ruled that the FDA must use the least restrictive means for meeting its goal of protecting the public from fraud or confusion. The court mandated the FDA to consider qualifying disclaimers for claims backed with scientific evidence. Alternatively, the FDA can ban claims outright only where they can prove that disclaimers will fail to prevent confusion or deception. Some of the plaintiffs from this case subsequently filed suit against the FDA regarding their antioxidant health claims. The FDA again was required to draft qualifying disclaimers or prove that they would be ineffective for their goal of protecting the public. In Fleminger, inc. v U.S. Dept. of Health and Human Servs the Court found several of the plaintiff’s health claims to be misleading and the FDA’s restriction. The Court, however, found that the FDA’s proposed disclaimer stating that the FDA does not support a specific claim to be unreasonable. The FDA again was required to draft a more appropriate disclaimer.

=Prior to the Case= The Federal Food, Drug, and Cosmetic Act (FFDCA) requires manufacturers desiring to sell a new drug to submit to a “strict and demanding” process for the purpose of consumer safety and product usefulness in order for the FDA to approve the product for interstate commerce. Before 1984 the FDA considered a food to be a “drug” if it was stated to cure or prevent a particular disease. Therefore, the FDA could ban the sale of certain foods until a new drug was approved. By the mid-1980s the FDA allowed companies to make “health claims” on foods without approval for a new drug. Health claims are any claims for foods or supplements claiming a relationship of any substance to a particular disease. In response, Congress passed the Nutrition Labeling and Education Act of 1990 (NLEA). This act amended the FFDCA to allow the FDA to regulate health claims thereby extending their authority.

The NLEA allowed manufacturers to make health claims on foods, without the approval of a new drug, as long as the FDA determined that there was “significant scientific agreement” based all the available scientific evidence. Conversely, Congress passed on giving the same procedure for dietary supplement health claims. Instead, Congress left it up to the FDA to create an approval “procedure and standard”. The FDA enacted a regulation requiring significant scientific agreement based on the totality of scientific evidence, similar to the requirement for food claims. Consequently, the FDA may consider dietary supplements with improper health claims a misbranded food, a misbranded drug, or an unapproved drug. Any dietary supplement with unauthorized health claims are subject to seizure and the FDA may enjoin the product’s sale or bring criminal charges against its manufacturer.

=Prior Cases= In 1995, several dietary supplement manufacturers sued the FDA on First Amendment grounds concerning the use of health claims on their dietary supplements (Pearson v. Shalala). The manufacturer’s health claims suggested a relationship between their dietary supplements and particular diseases. The FDA, using their significant scientific agreement standard, reasoned that the evidence for these health claims was inconclusive, thus lacking significant scientific agreement. The FDA deemed these health claims to be “inherently misleading”, and not guaranteed under the First Amendment as commercial speech. The FDA also denied the manufacturers their alternate proposal of allowing the claims with clarifying disclaimers. The manufacturers argued that the FDA’s significant scientific agreement standard was ambiguous and allowed a virtual ban on health claims in violation of the First Amendment.

The district court rejected the manufacturer’s request for summary judgment and was then reversed by the D.C. Circuit. The court used the commercial speech test devised in Central Hudson Gas & Electric Corporation v. Public Service Commission of New York and found that the FDA’s chosen means of protecting the public health, rejecting the plaintiff’s proposed disclaimers, to be unreasonable. The Court stated that the First Amendment commercial speech doctrine values disclosure over suppression. This requires that the means of regulating commercial speech be “less restrictive” and “more precise”. The court reasoned that the FDA’s refusal to allow claims with disclaimers was not the “less restrictive” means for protecting the public health. The FDA was ordered to determine whether disclaimers could prevent consumer confusion, and if so, how they should be constructed. In addition, the Court found that the APA requires the FDA to define its significant scientific agreement standard. It decided that suppressing commercial speech without explanation is arbitrary and capricious. The Court gave the FDA permission to ban proposed health claims in cases where supporting evidence is outweighed by contradictory evidence. The Court added that the FDA has the burden of proof for a restriction on free speech is justified.

In 2000, several of the plaintiffs from Pearson I along with several other dietary manufacturers sued the FDA for restricting their folic acid health claims (Pearson v. Shalala II). After the Court’s decision in Pearson I the FDA issued “Guidance for the industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements.” The FDA reviewed the scientific data for the manufacturer’s folic acid health claims in accordance with their significant scientific agreement standard and found the claims to be “inherently misleading”. It would not authorize these claims even with corrective disclaimers. The plaintiffs’ argued that the FDA misapplied the standard set in Pearson I and violated the First Amendment. They asked for a preliminary injunction enjoining the FDA from preventing the use of their folic acid health claims.

The district court found that the FDA was not in compliance with the guidelines established in Pearson I as it failed to explain why the claim was inherently misleading or why it could not be corrected with a disclaimer. The Court reviewed the scientific evidence and concluded that a lack of significant evidence in support of a claim does not equate to evidence against it. In accordance with Pearson I, the FDA must determine whether there is any supportive evidence. If there is supporting evidence, and it is not outweighed by contradictory evidence, then the claim may not be prohibited. Since the Court found evidence in support of the claim it determined that the FDA’s rejection of the claim with disclaimers was “arbitrary and capricious”. The court granted the plaintiff’s preliminary injunction and ordered the FDA to draft one or more simple and accurate disclaimers. In response to the preliminary injunction, the FDA countered that the district court gave undue weight to one study while failing to consider the scientific evidence in its entirety. The court denied the motion, citing the FDA’s failure to accurately explain the scientific evidence in relation to their arguments. The Court reiterated the ruling from Pearson I requiring the FDA to demonstrate with empirical evidence how disclaimers would fail to prevent confusion or deception and reaffirmed the heavy burden of proof needed for suppression of health claims.

In 2001, the plaintiffs in Whitaker v. Thompson sued the FDA when it decided not to authorize their antioxidant health claim. Upon reviewing the antioxidant-cancer studies the FDA failed to find significant scientific agreement relating antioxidant vitamin use and cancer prevention. It reasoned that the antioxidant health claim was inherently misleading and therefore could not be remedied with a disclaimer. The court ruled that the FDA failed to use the least restrictive means standard, from the Supreme Court’s decision in Western States, for meeting its goals. It added that the FDA failed to show empirical evidence proving that a proposed health claim would still be deceptive if used with a disclaimer.

Upon reviewing over 150 studies regarding the relationship between antioxidant-vitamins and cancer the court found that almost one-third supported the plaintiffs’ health claim. The court decided that it was unreasonable for the FDA to reject the plaintiffs’ health claim as its decision was not supported by all the available evidence. The court concluded that since one-third of the evidence supported the plaintiffs’ health claim and that the FDA failed to provide empirical evidence as to why a disclaimer wouldn’t correct for any deception, the FDA did not meet the standard for banning misleading claims set forth in Pearson I. The court ruled that the FDA’s suppression of the plaintiffs claim violated the First Amendment and remanded the case to the FDA to develop simple and effective disclaimers.

=Background of the Case= In 2002, Wellness Lifestyles, Inc. submitted two health claims suggesting a relationship between selenium intake and cancer risk to the FDA. The FDA allowed the use of qualified versions for these two health claims. In 2007, the FDA reevaluated the scientific evidence used for these claims to determine whether or not they still supported the qualified claims. The plaintiffs protested the FDA’s decision to reevaluate their health claims. Additionally, the plaintiffs submitted an authorization request for ten new qualified health claims relating to selenium to cancer. They submitted over 150 scientific articles searching for a relationship between selenium and cancer.

In 2009, the FDA, upon completing a comprehensive review, found that scientific evidence does support the qualified health claims relating selenium intake to bladder, prostate, and thyroid cancer. Conversely, it determined that the evidence does not support the qualified claims relating selenium intake to urinary tract, lung and respiratory tract, colon and digestive tract, brain, liver, and breast cancers. The FDA concluded that claim 1, “Selenium may reduce the risk of certain cancers”, and claim 2, “Selenium may produce anticarcinogenic effects in the body” were overly broad, left out material facts, and were, therefore misleading. The FDA denied claims 1, 2,5,6,8,9,10 while allowing adapted versions of claims 3, 4, and 7.

=Opinion of the Court= On August 4, 2009, Alliance for Natural Health and other plaintiffs filed suit against the FDA for violating the First Amendment with its denial of claims 1, 2, 5, and 6. They added that the FDA violated their First Amendment rights with its onerous and negating qualification for their prostate claim. They believed that this equated to suppression of their claim. The plaintiffs also contended that the FDA’s qualification for claim 3 was “unreasonably long and burdensome” to include on their product labels. They argued that this violates Central Hudson requiring reasonable means be used for achieving government’s goals. The plaintiffs sought a declaratory judgment invalidating the FDA’s denial of their petition and a permanent injunction, enjoining the FDA from interfering with their use of claims 1, 2, 3, 4, and 5.

The plaintiffs brought their claims against the FDA under the First Amendment. From Poett v. United States, the Court’s review of Constitutional challenges to agency actions should be considered de novo .This requires that the Court make an “independent assessment” when reviewing claims of Constitutional right under agency decision-making. The plaintiffs argued that because a Constitutional issue was raised that review by an agency cannot be arbitrary or capricious, instead a more stringent standard is necessary. The FDA countered that because this case did not deal with a broad ban on a category of misleading speech, and instead on specific speech concerning the scientific evidence of the plaintiffs’ claims, that an arbitrary and capricious standard should apply. In Whitaker, the court granted deference to an agency’s expert evaluation of scientific evidence; however, the court required that an agency is still obligated to demonstrate that their decisions are reasonable, non-arbitrary, just and lawful. Applying this standard, the court found that the reasoning for the FDA’s denial of the plaintiffs’ health claims was unreasonable as it did not consider all the available scientific evidence. The Court decided that under the circumstances it is necessary to conduct an independent review of the record. The court acknowledged, however, that it would be irresponsible to evaluate the mountain of scientific studies without some reliance on the FDA’s expert evaluation. In Pearson I, the court did not define how the FDA should evaluate scientific data. Instead, it gave the FDA guidelines for regulating health claims upon assessment of the data. If the evidence in support of a claim was outweighed by evidence against a claim the FDA would not be required to consider a disclaimer.

The Court classified the plaintiffs’ health claims as commercial speech. Because it is commercial speech, the Court reasoned that the FDA’s suppression of these claims should be evaluated under the analytical test developed in Central Hudson. The Supreme Court has ruled that the government does not have absolute power to suppress or regulate speech. Alternatively, the Court ruled that “inherently misleading” speech could be banned outright. While potentially misleading speech could not be absolutely prohibited if the information could be presented in a non-deceptive way. The FDA banned four of the plaintiffs’ health claims in full. From Central Hudson and Pearson I, The FDA may suppress health claims only if they are “inherently misleading” or “potentially misleading” if, when qualified with a disclaimer, they would still be deceptive. Under Whitaker, an absolute ban would only be allowed when only negligible qualitative evidence supported a claim or when an agency could prove that a disclaimer would not keep the public from being deceived. The court considered each of the plaintiffs’ prohibited claims to decide whether or not the FDA met its burden of proof for banning these claims. Plaintiffs proposed health claims that "Selenium may reduce the risk of certain cancers. Scientific evidence supporting this claim is convincing but not yet conclusive" and "Selenium may produce anticarcinogenic effects in the body. Scientific evidence supporting this claim is convincing but not yet conclusive". The FDA determined that the plaintiffs’ “certain cancers” and “anticarcinogenic” claims were incomplete and misleading because they failed to reveal the individual cancers. The concern is that a consumer may purchase selenium to prevent a cancer for which there is no evidence supporting a relationship to risk reduction. The FDA adds that the language used in this claim suggests that all cancers are the same disease and therefore implies that selenium intake can prevent all cancers. The FDA determined that the claim “anticarcinogenic” is ambiguous as its meaning refers to both the treatment of cancer and the prevention of cancer. The FDA concluded that claims about treatment or prevention of disease are equal to drug claims and therefore could not be made non-misleading if supported by qualifying disclaimers. The court ruled that the FDA failed to provide empirical evidence showing that consumers would still be misled by the two claims if they were qualified with disclaimers. The court stated that the plaintiffs’ certain cancers claim was true for three cancers of which there is credible evidence supporting their relation to selenium intake. The FDA has not provided evidence showing that including these certain cancers on the labels would alleviate confusion as to which cancers selenium intake has an effect on. The Supreme Court and Pearson I set precedent requiring the FDA to at the very least consider “less restrictive” means for preventing misleadingness before considering suppression. The Court remanded the claims to the FDA to write one or more disclaimers or provide empirical evidence showing that a disclaimer would fail to correct for apparent misleadingness. Plaintiffs proposed a health claim that "Selenium may reduce the risk of lung and respiratory tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive". The FDA reviewed the scientific evidence for the plaintiffs’ lung and respiratory tract cancers and concluded that only four of the studies were useful for evaluating their claims. From these four studies, the FDA did not find credible evidence supporting a relationship between selenium intake and lung or respiratory cancer reduction. It also cited studies suggesting no relationship. The plaintiffs countered that many of the studies excluded by the FDA provide credible evidence in support of their claim. In Pearson I the Court granted the FDA permission to ban claims outright when evidence in support of the claim was outweighed by evidence against it. Where credible evidence supported a claim, however, a qualifying disclaimer could be used. It was necessary for the Court to determine what the FDA qualifies as credible evidence.

At the time the FDA used an “evidence-based review system” for evaluating evidence used for a claim. Among the criteria for review are the quality of the study, consistency, sample size, replication, and relevance to the U.S. population. The FDA reviews all available scientific evidence to decide whether there is “significant scientific agreement” or “credible evidence” for a health claim. The FDA failed to define “credible”; however, it defined its criteria for prioritizing different types of evidence. The FDA ranks randomized controlled trials the highest while excluding “research synthesis studies” and “review articles”. For intervention or observational studies the FDA looks at where they were taken, the type of information collected, and the type of disease biomarkers being measured. The FDA excludes studies it believes have flaws preventing reasoned scientific conclusions. Using these criteria, the FDA excluded the studies the plaintiffs cited as providing credible evidence for their lung and respiratory claim. The FDA excluded the van den Brandt and Knekt studies as they tested Dutch and Finnish populations. These populations appeared to have a selenium deficiency compared to the U.S. population. The Court found that the exclusion of these studies was rational as the reduction of the disease may be the result of correcting a nutrient deficiency.

The FDA justified its exclusion of the Zhuo publication because it is only a review article and therefore does not provide credible scientific evidence to support the plaintiffs’ claim. And the FDA normally excludes review studies as they do not sufficiently describe the studies being reviewed for scientific conclusions. The Court evaluated the review article and concluded that its exclusion was not “arbitrary” and “capricious”. The FDA excluded the SU. VI.MAX study as it could not conclude that the study included only subjects free of cancer prior to testing. The study, however, stated that it screened participants for diseases that may limit their participation for five years. Throughout the study, participants were routinely examined and were asked about their health. Any medical problems or diseases were recorded. The court concluded that the FDA’s reason for excluding the study was inconsistent with the study’s records. Under Pearson I, the FDA must consider disclaimers to address its concern about the limitations of a study. The lung and respiratory claims were remanded to the FDA to draft a qualifying disclaimer to address the claim’s limitations. Plaintiffs proposed a health claim that "Selenium may reduce the risk of colon and digestive tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive". The FDA rejected the plaintiffs’ colon and digestive tract cancers claim as it concluded that the claim is not supported by credible evidence. The FDA excluded multiple studies which the plaintiffs used to support their claim. It found three studies that reported no determinable relationship between selenium and colon cancer. The plaintiffs contested the FDA’s conclusions based on one of the studies and cited some of the studies it argued were wrongly excluded by the FDA. In response, the FDA reasoned that the Peters study did not give evidence in support of a relationship between selenium and colon cancer because there wasn’t a significant difference in the frequency of adenomatous colorectal polyps between the serum selenium quantiles. The Court found that the FDA’s claim that this study does not provide significant evidence is contrary to the conclusions of the study. The study found that higher serum selenium levels were inversely related to a decreased risk of colon cancer. The Court found that the FDA’s exclusion of the study for lack of significant evidence was unreasonable. The FDA excluded several “retrospective” studies as they measured selenium use after the subjects were already diagnosed with cancer. The FDA reasoned that it was impossible to tell whether low levels of selenium in these subjects were caused by cancer or a nutrient deficiency. The Court found that the exclusion of one of these studies, the Ghadrian study, was inconsistent with the FDA’s reasoning. The study measured toenail selenium which they claimed was the best method of measuring dietary selenium over a long-term. They argued that because toenails were mostly collected before final diagnosis that toenail selenium represents dietary selenium before diagnosis. The study found a significant negative relationship between toenail selenium levels and colon cancer. The Court ruled that exclusion of this study because it was retrospective was unreasonable. The FDA excluded several review studies consistent with its Guidance Report. The Court questioned the FDA’s exclusion of the review studies that it used in its decision to exclude in its evaluation of some of the other plaintiffs’ claims. The Criqui and Willet studies found an inverse relationship between selenium and gastrointestinal cancer. The FDA excluded them, however, because they didn’t provide information on the specific gastrointestinal cancers. The Court used the National Institutes of Health’s National Cancer Institute’s (NCI) definition of gastrointestinal cancers as “digestive tract cancers”. Further, the NCI classifies gastrointestinal cancers as a sub –group of digestive tract cancers. Therefore, a reduced risk of gastrointestinal cancers equates to a reduced risk of digestive tract cancers. The Court found the FDA wrongly excluded these studies as they provided significant evidence in support of the plaintiff’s claims. The Court concluded that there is credible evidence in support of the plaintiff’s colon and digestive tract claim. It ruled that the FDA’s complete ban on the plaintiff’s claim for lack of evidence was unreasonable in light of the available evidence. The Court remanded the claim to the FDA for reconsideration and, if necessary, coming up with a qualifying disclaimer. Plaintiffs made a health claim that "Selenium may reduce the risk of prostate cancer. Scientific evidence supporting this claim is convincing but not yet conclusive” . The FDA considered eight studies proposed by the plaintiffs and found that two of them may support their claim. Upon evaluating the evidence, the FDA rejected the prostate claim “convincing but not yet conclusive” to be misleading. The FDA exercised its enforcement discretion and proposed a claim qualified with “FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.” The Court found that the FDA’s proposal to be inconsistent with the requirement of a “reasonable fit” between government’s goals and restrictions on commercial speech. The Court found that the FDA replaced the plaintiffs’ claim completely and its qualification essentially negates the proposed selenium and prostate cancer relationship altogether. As there is significant evidence in support of the plaintiffs’ claim the FDA must at least consider the proposed claim with a qualifying disclaimer. The FDA has not elaborated on how their concern for misleadingness cannot be alleviated with qualifying language. Negating the plaintiffs’ claim would not be the “less restrictive” means for the government’s goal. The Court found that the FDA failed to justify completely replacing the plaintiffs’ claim. The Court remanded the claim to the FDA to reconsider the scientific evidence and to come up with simple and accurate disclaimers based on its review. The Court granted the plaintiffs’ motion for summary judgment in part and denied the defendant’s cross-motion for summary judgment. The Court remanded the case to the FDA to draft disclaimers for the plaintiffs’ certain cancers, anticarcinogenic, and prostate claims, draft a suitable disclaimer for the plaintiffs’ lung and respiratory tract claim under review of the SU.VI.MAX study, and reconsider the colon and digestive tract claim and draft an appropriate disclaimer. The Court denied the plaintiffs’ motion for enjoining the FDA from preventing them from using health claims with their dietary supplements. The Court determined that it could not rule out the possibility that the FDA could show with empirical evidence that disclaimers would fail to prevent confusion or deception. The Court remanded the indicated claims to the FDA for further review and to develop the necessary disclaimers. The Court was limited in its ability to mandate by a specific date; however, it expected the FDA to act with reasonable speed.

=Subsequent Jurisprudence= On August 4, 2009, several dietary supplement designers and industry groups brought suit against the FDA challenging its decision to deny their qualified health claims for their vitamin C and vitamin E enriched dietary supplements. This case involves some of the plaintiffs from Alliance I. The cases are similar except that they involve different health claims.

The plaintiffs challenged the FDA’s ruling on six of their proposed health claims. These claims linked Vitamin C and Vitamin E to reduced risk of certain cancers. The plaintiffs’ proposed that Vitamin C could help reduce the risk of lung cancer, colon cancer, and gastric cancer. They also proposed that Vitamin E could reduce the risk of lung cancer, gastric cancer, and bladder cancer. The FDA banned claims 1, 2, 3, and 4 and allowed claim five (Vitamin C-gastric cancer) and six (Vitamin E-bladder cancer) with qualifying language contradicting a relationship with cancer risk. The plaintiffs argued that the FDA’s denial violated their First Amendment rights. The plaintiffs requested a declaratory judgment making the FDA’s order invalid and a permanent injunction enjoining the FDA from preventing the use of plaintiffs’ proposed health claims. The plaintiffs reasoned that this would be consistent with both the circuit and district court opinions for similar claims.

Similar to Alliance I, the Court ruled that the FDA’s proposed disclaimer is inconsistent with the Supreme Court’s mandate requiring a reasonable fit between government’s goals and its restrictions on commercial speech. Further, the Court referred to a “First Amendment preference for disclosure over suppression”. The Court reasoned that the FDA’s disclaimers effectively refute any relationship between vitamin intake and risk of cancer. Further, the FDA’s alterations obscure what the original claims are and undermine the fact that the FDA concluded that those claims were backed with credible evidence. The Court argued that the First Amendment allows claims to be made even when its supporting evidence is inconclusive. The Court found that the FDA failed to draft precise disclaimers to properly qualify the plaintiffs’ claims or explain why a less restrictive approach would be ineffective.

The Court granted in part the plaintiffs motion and denied the defendant’s cross-motion for summary judgment. The court ruled that the FDA’s decision to ban the plaintiffs’ vitamin C-lung cancer claim, vitamin C-colon cancer claim, vitamin E-lung cancer claim, and vitamin E-gastric cancer claim to be consistent with its established evaluation criteria and rationally justifiable based on the available evidence. The Court remanded the plaintiffs’ vitamin E-bladder cancer and vitamin C-gastric cancer claims to the FDA to draft one or more appropriate disclaimers.

In February 2012, (FLEMINGER, INC. v. U.S. DEPT. OF HEALTH AND HUMAN SERVS 854 F.Supp.2d 192 (2012) Fleminger, Inc., a manufacturer and retailer of green tea sued the U.S. Department of Health and Human Services (DHHS) and the FDA for violating their First Amendment rights . The plaintiff requested an authorization from the FDA for use of qualified health claims on its green tea labeling. The FDA required the plaintiff to add a modified disclaimer to its qualified health claim relating green tea and reduced risk of breast or prostate cancer. Plaintiff argued that requiring the modified disclaimer violated its commercial speech rights under the First Amendment because the FDA’s reason for this regulation in this case was not warranted. The plaintiff implied that there isn’t an appropriate fit between the government’s goal of preventing consumer confusion and protecting public health and its restriction on commercial speech. The restriction, in this case, is the FDA’s requirement to include its modified disclaimer. The defendants countered that the government’s strong interest in preventing consumer confusion and protecting public health is reasonable justification for its restriction on the plaintiffs’ commercial speech. Both the plaintiff and the defendants requested a summary judgment.

Upon review of the available scientific evidence, the court found that the plaintiff’s proposed disclaimer “inaccurate and misleading” under the FDA’s guidelines. Therefore, the First Amendment does not obligate the FDA to allow the plaintiff’s chosen language in its marketing. Instead, the court ordered that the FDA draft short and precise disclaimers addressing the strength of the evidence in support of the claim. The plaintiff argued that the FDA is required under the First Amendment to show with empirical evidence why their proposed claim is misleading and that consumers will consider it approved by the FDA. In response, the court ruled that the FDA is not always required under the First Amendment to conduct an empirical study to demonstrate how a proposed disclaimer is misleading or inaccurate or give the appearance that the FDA supports the claim.

The court found that the plaintiff’s proposed disclaimer did not accurately express the strength of the evidence in support of the claim. Thus it is inconsistent with the government’s goal of protecting public health and preventing consumer confusion. The Court found that part of the FDA’s proposed disclaimer reading “there is very little scientific evidence” is consistent with the scientific evidence and does not violate the First Amendment. Conversely, the Court found that the part of the FDA’s proposed disclaimer stating that the “FDA does not agree that green tea may reduce that risk” is not a reasonable fit between the government’s goal of protecting the public health and the chosen means.

The Court granted in part the plaintiff’s motion for summary judgment and granted in part the defendant’s cross motion in part and denied in part. The Court remanded the qualified health claim to the FDA to draft a more appropriate disclaimer.

=References=