Court Strikes Down FDA Ban on Selenium/Cancer Health Claims – Alliance for Natural Health U.S. v. Sebelius
Kelley Drye Client Advisory
June 15, 2010

On May 27, 2010, the U.S. District Court for the District of Columbia issued a decision in Alliance for Natural Health U.S. v. Sebelius, Civ. Action No. 09-10470 (ESH) (D.C. Dist. May 27, 2010) ("Natural Health")Relying on a string of earlier decisions, including Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) ("Pearson I"), the court ruled that the Food and Drug Administration's ("FDA") refusal to grant several health claims characterizing the disease prevention benefits of selenium consumption violated First Amendment standards that protect freedom of expression in commercial speech.  The earlier cases also held that FDA policies restricting the use of health claims in food labeling failed to satisfy First Amendment standards. 

Alliance for Natural Health U.S. v. Sebelius

In Alliance for Natural Health, plaintiffs challenged, on First Amendment grounds, the FDA's rejection of the following claims:

  • "Selenium may reduce the risk of certain cancers. Scientific evidence supporting this claim is convincing but not yet conclusive."

  • "Selenium may produce anticarcinogenic effects in the body. Scientific evidence supporting this claim is convincing but not yet conclusive."

  • "Selenium may reduce the risk of lung and respiratory tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive."

  • "Selenium may reduce the risk of colon and digestive tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive."




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FDA had refused to authorize any of the above claims and had authorized a health claim characterizing the potential benefit of selenium in reducing the risk of prostate cancer only when accompanied by the following prescribed disclaimer language:

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. 

Plaintiffs challenged the disclaimer, arguing that it imposed an undue burden on the freedom of expression in commercial speech in violation of the First Amendment.

In Natural Health, the Court rejected the government's argument that the restrictions FDA imposed on the selenium health claims satisfied First Amendment standards because the claims proposed by Plaintiffs were "inherently misleading."  The Court relied on Pearson I and subsequent cases which have made clear that where health claims are supported by "credible evidence," FDA must carry a significant burden of proof to justify a complete ban of the health claim language proposed by a petitioner.    For instance, in its review of FDA's refusal to approve Plaintiff's health claim characterizing the benefit of selenium consumption in reducing the risk of lung and respiratory tract cancers, the court rejected the government's position that FDA could ban the health claim, stating

"Here, [FDA] 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" .  Therefore, the proper inquiry is what qualifies as "credible evidence" and is there any such evidence to support the lung and respiratory tract claim?"

Applying this standard, the court concluded that none of the FDA determinations concerning the selenium-related health claims satisfied First Amendment standards.  With respect to the single selenium health claim FDA had authorized in modified form concerning prostate cancer, the court held that the FDA prescribed disclaimer language could not be justified on First Amendment grounds because it "contradict[ed] the claim and defeat[ed] the purpose of making [it] in the first place."  The court ultimately concluded that the FDA disclaimer "completely eviscerated plaintiffs' claim, with no explanation as to why a less restrictive approach would not be effective."

The Court remanded all five of Plaintiff's selenium/cancer health claims to FDA for further review in accordance with the instructions summarized in the chart below:

"Selenium may reduce the risk of certain cancers.  Scientific evidence supporting this claim is convincing but not yet conclusive."

 

Remanded to FDA for further review.  FDA is required either to (1) develop an alternative disclaimer, or (2) establish, based on empirical evidence, that disclaimers would fail to prevent consumer deception.

"Selenium may produce anticarcinogenic effects in the body. Scientific evidence supporting this claim is convincing but not yet conclusive."

Remanded to FDA for further review.  FDA is required either to (1) develop an alternative disclaimer, or (2) establish, based on empirical evidence, that disclaimers would fail to prevent consumer deception.

"Selenium may reduce the risk of lung and respiratory tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive."

Remanded to FDA for further review.  FDA is required to draft an appropriate disclosure in light of a positive study that the court found had been disregarded in violation of FDA's guidance on substantiation for health claims.

"Selenium may reduce the risk of colon and digestive tract cancers.  Scientific evidence supporting this claim is convincing but not yet conclusive."

Remanded to FDA for further review.  FDA is required to reconsider the claim in light of several positive studies that the court found that had been disregarded in violation of FDA's guidance; FDA is required to draft appropriate disclosures, as necessary.

"Selenium may reduce the risk of prostate cancer.  Scientific evidence supporting this claim is convincing but not yet conclusive."

Remanded to FDA for further review.  FDA is required to "reconsider[] the scientific literature and draft[] one or more short, succinct, and accurate disclaimers in light of that review."

Natural Health lends considerable weight to the already significant body of case law that has developed since Pearson I.  That case law makes clear that any restrictions FDA imposes on the freedom of expression with respect to diet/disease relationships in commercial speech must satisfy First Amendment standards.  While the Natural Health decision, like the earlier string of cases, concerns health claims intended for use in dietary supplement labeling, the First Amendment standards upon which the court's holding relies apply to equally to health claims for conventional food and beverage products, and to health claims presented in forms of commercial speech that may not constitute "labeling" (e.g., advertising ).  Accordingly, the Natural Health decision offers significant support for more flexible FDA standards concerning health claim approval and FDA food labeling enforcement policies that are more protective of health-related claims that are supported by credible evidence.

Kelley Drye & Warren LLP

Kelley Drye's team of Food and Drug lawyers strives to integrate our clients' business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients' goals without running afoul of regulatory requirements. With close knowledge of FDA's enforcement priorities and deep experience with the FTC's regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.

For more information about this client advisory, please contact:

Sarah Roller
(202) 342-8582
sroller@kelleydrye.com

Katie Bond
(202) 342-8807
kbond@kelleydrye.com