HerbalEGram: Volume 7, Number 8, August 2010

Court Orders FDA to Amend Qualified Health Claims for Selenium

In May, the US District Court for the District of Columbia ordered the US Food and Drug Administration (FDA) to re-consider qualified health claims* for selenium and reduced risk of cancers, ruling that the FDA’s denial of certain claims and insistence on lengthy disclaimers for other health claims violated free speech rights under the First Amendment of the US Constitution.^1,2,3

The court held the claims backed by credible scientific evidence and that FDA’s disclaimers for the subset of claims the agency allowed violated the requirement that disclaimers be succinct and accurate.^1,2,3 The court further ruled that disclaimers could not contradict claims.

The suit, Alliance for Natural Health US, et. al. v. Sebelius, et. al., was filed by Jonathan Emord of Emord & Associates on behalf of the Alliance for Natural Health (ANH), a consumer lobby group dedicated to promoting sustainable health; Durk Pearson and Sandy Shaw, claimants in several previous Emord-led cases against FDA censorship of health claims; and the Coalition to End FDA and FTC Censorship, an organization with which Emord has been associated. It was initiated after the FDA denied a petition for several qualified health claims concerning the relationship between consumption of selenium and certain cancers. On First Amendment grounds, the plaintiffs in the case challenged FDA’s denial of claims relating to selenium and certain cancers, including cancers of the lung/respiratory tract and colon/digestive tract, as well as a claim concerning selenium’s anticarcinogenic effects. The plaintiffs also challenged FDA’s insistence on a long, overly broad disclaimer in connection with a qualified claim concerning selenium and reduced risk of prostate cancer.

FDA had argued that the plaintiffs’ claims were not supported by credible evidence or were misleading and left out pertinent information. The court, affirming earlier court decisions on the subject of qualified health claims, held that FDA cannot ban a claim for which credible supporting scientific evidence exists and must consider qualifying statements to correct any potentially misleading impressions. The court indicated that the correct action was to clear-up “potential misleadingness by disclosure of additional information.”^1,4

Additionally, the court noted that a decision by FDA that no qualifying language exists to correct a potentially misleading impression must be supported by empirical evidence. The court found that the FDA’s lengthy disclaimers to certain selenium claims were unconstitutional because they were not succinct or accurate and, in fact, contradicted the claims instead of qualifying them. The court ordered the FDA to reconsider all challenged claims and propose reasonable disclaimers to accompany them with “reasonable speed.”^1,4   

According to an article in Natural Products Insider, the Council for Responsible Nutrition (CRN), a leading industry trade association, noted that this court decision strongly reprimands FDA for its approach to reviewing qualified health claims, and it could lead to more favorable reviews of such petitions in the future.²

CRN’s Senior Vice President of Scientific and Regulatory Affairs Andrew Shao, PhD, was quoted as saying, “FDA has to go back to the drawing board to develop claim language that better reflects the state of the science but that is not misleading to consumers. This will take some time and effort. On the one hand, we already know from the agency’s own research (and from [International Food Information Council] too) that it is difficult to come up with qualifying language that is not confusing or misleading to consumers. On the other hand, we also know, for example, the statement that ‘there is no evidence that selenium reduces the risk of certain cancers’ (which is what FDA’s qualifying language basically amounts to) is also incorrect, because there is evidence, and some of it quite good, but it is conflicting. This is a huge challenge for FDA, and I’m not sure how they will go about striking this important balance.”²

Dr. Shao added that there is still the possibility that FDA might appeal the court’s decision.

An FDA spokesperson contacted for this article stated, “FDA is evaluating next steps in response to the court’s decision” (S. Cianci, e-mail to C. Cavaliere, July 22, 2010).

Alliance for Natural Health v. Sebelius is the seventh victory over the FDA for food and drug law attorney Jonathan Emord of Emord & Associates regarding allowable health claims for foods or dietary supplements.⁵ Previous cases in which the court ruled in Emord’s clients’ favor include: Pearson v. Shalala I, II, and III; Pearson v. Thompson, Whitaker v. Thompson; and Nutraceutical Corp. v. Crawford^.†

“These First Amendment victories are essential defenses for rights to speech against federal censorship by all agencies of the government,” said Emord (e-mail, June 22, 2010). “In an age of appropriate skepticism, when a massive and ever-growing government bureaucracy seems to violate rights with impunity, it is refreshing to see our federal courts upholding the First Amendment against government censorship.”

Emord’s victories started in 1999 with the groundbreaking Pearson v. Shalala.⁶ In that case, the court held that under the First Amendment, the FDA may not ban health claims simply because science supporting them is inconclusive or does not meet the “significant scientific agreement” standard established for health claims under the Nutrition Labeling and Education Act of 1990 (NLEA). The court stated that when health claims are only potentially misleading, FDA is obligated to use clear and accurate disclaimers to refrain from restricting speech instead of resorting to an outright ban.

Following the original Pearson v. Shalala, a second lawsuit was filed over the FDA’s refusal to authorize the plaintiffs’ folic acid/neural tube defect risk reduction claim (one of the claims that was the subject of the original lawsuit). The court held that the FDA violated the First Amendment by suppressing the claim rather than proposing a clarified disclaimer.^4,7 The court ordered the FDA to draft one or more “short, succinct, and accurate alternative disclaimers,” which could be selected by the plaintiffs to accompany their folic acid claim. In Pearson III, FDA filed a motion asking the court to reconsider its decision in Pearson II.^4,8 The court denied FDA’s motion. That case was dismissed after an agreement was reached that allowed the labels of dietary supplements containing folic acid to display the health claim with a disclaimer proposed by the FDA and chosen by the plaintiffs.  

“Ultimately after losing Pearson I, II, and III, FDA finally lifted its ban on a claim associating folic acid-containing dietary supplements with greater effectiveness in reducing the risk of neural tube defect [NTD] births,” said Emord. “Center for Disease Control tracking information reveals that since the lifting of the ban, the incidence of NTDs in the United States has gone down (as more women of childbearing age learn of the critical need to take folic acid supplements before they become pregnant).” 

In Whitaker v. Thompson (2002), Emord & Associates challenged the FDA’s renewed decision to prohibit dietary supplement labels from including an antioxidant vitamin/cancer risk reduction health claim.^4,9 The Pearson I court held that claim unconstitutionally suppressed. FDA refused to allow it until ordered a second time to do so in Whitaker I. Then, unilaterally, FDA reversed its decision to allow the claim and censored it again, leading Emord to sue the agency yet again. That case is still pending before the US District Court for the District of Columbia.

Emord remains committed to battling what he views as FDA censorship of commercial speech protected by the First Amendment. In addition, he has argued that the FDA, at least under previous administrations, is significantly biased toward the pharmaceutical industry, despite evidence of FDA’s forcing the removal of some problematic drugs off the market.

“As the Associate Director of FDA’s Office of Drug Safety, David Graham, has testified under oath, the FDA is beholden to the drug industry, views that industry as its ‘client,’ and assiduously protects that industry’s interests,” said Emord.^‡

“The FDA not only approves unsafe drugs to protect the economic interests of that industry over the public health, but it also censors truthful information about the therapeutic effects of nutrients, creating the false (and dangerous) consumer perception that drugs (often having serious side effects) are the only means to prevent disease when science supports therapeutic roles for food and food elements (yet FDA maintains an absolute prior restraint to block consumer receipt of that information),” he continued.

Emord intends to continue his First Amendment quest for health messaging on commercial food and supplement products, stating that “The war against FDA censorship is far from over, but so long as I am alive, I plan to fight each battle, and if FDA thinks the war will end with my death, it should think again because I am training lawyers in my firm to pick up the baton when I am no more.”

─Kelly E. Lindner

*Health claims are claims for conventional foods and dietary supplements that describe the relationship between a food or supplement ingredient and reduction of risk of a particular disease. Health claims are authorized under the Nutrition Labeling and Education Act of 1990 (NLEA) and must be pre-approved by the FDA. Under the NLEA, the FDA may approve a health claim for use in food and dietary supplement labeling only upon a finding that “significant scientific agreement” (SSA) exists to support the substance-disease relationship. Qualified health claims evolved out of case law based on First Amendment challenges to FDA’s refusal to authorize certain health claims that the agency determined did not meet the SSA standard. The first legal challenge, Pearson v. Shalala, gave rise to qualified health claims based on a lesser degree of scientific consensus than the SSA standard, and the use of qualifying language to correct any potentially misleading impression.  In 1997, the FDA Modernization Act authorized health claims whereby manufacturers could market foods and/or dietary supplements with health claims based on an official statement of a scientific body of the U.S. government with responsibility for public health protection or research relating to human nutrition, or the National Academy of Sciences. Health claims based on such an authoritative statement must be submitted to the FDA for authorization before marketing.     

Health claims differ from the so-called structure/function claims permitted by federal law for foods since 1938 and expressly for dietary supplements since enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Structure-function claims describe the usefulness of a food or supplement ingredient in maintaining the normal, healthy structure and function of the body and may not mention disease or symptoms of disease.  Such claims must be truthful and not misleading, and supported by reliable scientific evidence, but are not required to be pre-approved by the FDA. Nutrient content claims are claims that describe the level of nutrients in foods and dietary supplements and must comply with FDA regulations, but do not require pre-market approval by the FDA. 

^†In Nutraceutical Corp. v. Crawford (2005), Emord & Associates filed suit on behalf of Nutraceutical Corp. and its division Solaray, Inc., challenging the FDA’s choice to ban all ephedrine alkaloid-containing dietary supplements. The court held that the analysis used by the FDA to determine ephedrine’s risk was inappropriate because it placed the burden on the producers of supplements containing the herb ephedra (Ephedra sinica) to demonstrate a benefit as a precondition to sale. The court further stated that the FDA failed to show that “a dosage of 10 mg or less of ephedrine alkaloids presents a significant or unreasonable risk of illness or injury.” This case reaffirmed that FDA bears the burden of proving the adulteration of dietary supplements, but the decision was reversed in an appeal. [Source: Nutraceutical Corp. v. Crawford, 364 F. Supp. 2d 1310 (D. Utah 2005).]

^‡This testimony by David Graham was given before the Senate Finance Committee on November 18, 2004, in regards to the Vioxx scandal.

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