Jonathan Emord Comments on Alliance for Natural Health v. Sebelius Victory Over FDA

On May 27, 2010, the Honorable Judge Ellen S. Huvelle of the United States District Court for the District of Columbia reaffirmed the supremacy of the First Amendment over the FDA’s exercise of censorship.  See her Decision.  She held FDA’s censorship of the following, science-backed selenium-cancer risk reduction claims unconstitutional under the First Amendment:

1. Selenium may reduce the risk of certain cancers
2. Selenium may produce anticarcinogenic effects in the body.
3. Selenium may reduce the risk of lung and respiratory tract cancers.
4. Selenium may reduce the risk of colon and digestive tract cancers.
5. Selenium may reduce the risk of brain cancer.
6. Selenium may reduce the risk of liver cancer.
7. Selenium may reduce the risk of breast cancer.

She remanded these first seven claims to FDA with instructions that it proceed with “reasonable speed” in crafting succinct and accurate disclaimers to accompany them.

She also held FDA’s disclaimers (italicized below) for the following three selenium-cancer risk reduction claims unconstitutional.  She found them false and verbose:

8.   Selenium may reduce the risk of prostate cancer. 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.

9.   Selenium may reduce the risk of bladder and urinary tract cancers.  One study suggests that selenium intake may reduce the risk of bladder cancer in women.  However, one smaller study showed no reduction in risk.  Based on these studies, FDA concludes that it is highly uncertain that selenium supplements reduce the risk of bladder cancer in women.

10.   Selenium may reduce the risk of thyroid cancer.  One weak, small study suggests that selenium intake may reduce the risk of thyroid cancer.  Based on this study, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of thyroid cancer.

Judge Huvelle rejected FDA’s demand that the Court reverse the legal standard of the landmark Pearson v. Shalala I decision.  She instead held that the FDA could not escape the strictures of the First Amendment when it evaluated claims and claim qualifications and would be subject to a de novo review by the courts every time it engaged in suppression of claims.  The Court reaffirmedPearson v. Shalala.

Judge Huvelle rejected FDA’s demand that the Court reverse its earlier decision in Whitaker v. Thompson I.  She instead applied the requirement from that decision, which in turn is based on Supreme Court commercial speech precedent, that FDA rely on “succinct and accurate” claim qualification.

Judge Huvelle found that FDA misinterpreted the scientific evidence, conveying the false impression that certain science supportive of the claims did not exist or was not supportive.  She reasoned, “the Agency’s stated reason for its disregard of the [SU.VI.MAX] study is unsupported by the record.  And the FDA provided no response to the plaintiffs’ argument regarding the results of the study . . .”  She further reasoned,

Upon review of the [Peters’] 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.” 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.”  The authors later stated that “[f]indings from our study [and another study] particularly support inverse association [between selenium and] advanced adenoma.”  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.  [Emphasis added.]

She further reasoned,  “[t]he Court concludes that the FDA’s exclusion of the [Ghadrian study on colon cancer risk reduction] from [FDA’s] evaluation . . . was unreasonable, given the clear representations in the study as to the nature of the selenium intake observed.”  She went on to fault FDA, finding it “difficult to discern the logic in the FDA’s decision to exclude from its evaluation of plaintiffs’ digestive tract claim studies the Agency relied on for scientific conclusions concerning other of plaintiffs’ claims,” concluding “[t]he Court therefore finds that the FDA erred when it excluded these studies.”

Concerning FDA’s false and verbose disclaimers, Judge Huvelle held that the qualifications unconstitutionally “contradict . . . the claim and defeats the purpose of making [it] in the first place.”  She found the qualifications to “completely eviscerate[] plaintiffs’ claim, with no explanation as to why a less restrictive approach would not be effective.”  She found the agency’s disclaimer “inaccurate,” explaining:

[T]he 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.”  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.”  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.”  . . . . [T]he Court concludes that the Agency erred in finding that the study “show[s] no reduction in [prostate cancer] risk.”

Judge Huvelle rejected the Agency’s repeated resort to verbose and falsely condemnatory qualifications that contradicted the claims, writing: “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 . . . . [T]he Agency’s replacement [qualification] mischaracterizes at least one study (Li et al.), suggesting that the FDA’s proposed [qualification] is inaccurate.”

Alliance for Natural Health v. Sebelius stands as another bulwark in favor of the right to communicate emerging science concerning dietary ingredients to consumers.  It upholds the landmark Pearson I decision against a direct frontal assault by the FDA.  It demands that FDA speech police defer to a health claimant’s speech unless the agency can prove with empirical evidence that the speech is false and hopelessly beguiling to consumers even if reasonably qualified.  It forces FDA to avoid claim contradiction in its qualifications and to tailor them, narrowly, to be succinct and accurate.

By refusing to implement the final and binding order of our Court of Appeals in Pearson I since it was issued in 1999, the FDA has taken the position that it is above the law, not limited by the constitutional strictures imposed upon it by the courts in over a half dozen decisions following that landmark case.  That refusal to follow the law begs the ultimate question of whether the FDA Commissioner and the Director of the Center for Food Safety and Applied Nutrition will have to be held in contempt of court and be personally subject to civil fines before they will come to appreciate that no government official may abuse his office to violate the Constitution of the United States.