Supplement lawyer Jonathan Emord has filed three important suits this summer challenging FDA administrative action on first amendment grounds. The suits were all filed on behalf of long-time Emord clients Durk Pearson, Sandy Shaw, the Alliance for Natural Health, and the Coalition to End FDA and FTC Censorship.
The complaints in all three cases were filed in federal district court for the District of Columbia and are captioned identically. The first suit challenges the FDA’s rejection of qualified health claims for supplements containing the powerful antioxidant and anti-carcinogenic selenium (the “Selenium Challenge”). ((Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01470-ESH, Aug. 4, 2009, Huvelle, J.)) A second suit challenges the FDA’s rejection of qualified health claims for antioxidant vitamins C and E (the “C and E Challenge”). ((Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01546-RJL, Aug. 14, 2009, Leon, J.)) The third suit challenges the FDA’s dietary supplement current Good Manufacturing Practice regulations (the “cGMP Challenge”). ((Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship v. Kathleen Sebelius, US Dept. of Health and Human Srvcs., Margaret M. Hamburg, M.D., FDA and USA, 1:09-cv-01523-CKK, Aug. 12, 2009, Kollar-Kotelly, J.))
These plaintiffs and their lawyer are well known for making law in the Pearson/Whitaker Cases that has benefitted the supplement industry significantly over the past ten years. ((See, e.g., Pearson v. Shalala, 98-5043 (D.C. Cir. Jan. 15, 1999) and Whitaker v. Thompson, 03-5020 (D.C. Cir. Jan. 9, 2004))). Since the court decisions that may emerge from the new Selenium Challenge, C and E Challenge, and cGMP Challenge cases could have a significant impact on the law regulating supplement formulators, manufacturers, and marketers, and the FDA’s interpretations of that law, we are providing more expanded coverage here of these potentially important cases. Part I will address the Selenium Challenge and the Vitamins C and E Challenge, and Part II will follow in a separate blog post to address the cGMP Challenge.
The Selenium Challenge and the Vitamin C and E Challenge – Does the FDA disregard the law and Supreme Court precedent by suppressing commercial speech about supplements?
For anyone not acquainted with the herculean legal struggle undertaken by Emord and his clients in the Pearson/Whitaker series of cases, the Complaint in the Selenium Challenge is a worthwhile read and I commend you to it. The point of all the billable hours invested in this struggle may seem elusive but is actually quite simple: force the government to limit its censorship of claims about supplements to the “least restrictive means” test articulated again and again by the US Supreme Court in commercial speech cases. ((See, Central Hudson Gas & Elec. v. Public Svc. Comm’n, 447 U.S. 557 (1980)))
What does this mean from a practical standpoint for supplement companies? It means that if you have a claim to make about your ingredient or formulation, and that claim is supported by competent and substantial scientific evidence, you should be allowed to make that claim as long as the claim is not deceptive or misleading. Sounds simple, right? Sounds like the good practice you are already following for structure-function claims, right?
Well, what if that claim is a disease claim, like a claim that says “take this supplement and you may be able to prevent yourself from cancer.” That’s not a DSHEA structure-function claim. On the contrary, that’s the holy grail of supplement marketing, a claim that the FDA would say makes your product an unapproved drug and subjects you to prosecution for violation of the Food, Drug and Cosmetics Act.
Emord’s victories in the Pearson/Whitaker Cases paved the way for such claims, and required the FDA to create a new category of claims called “Qualified Health Claims.” Qualified Health Claims are claims with disclaimers that provide a balanced view of the scientific evidence available to support a particular supplement’s impact on a specific disease state by incorporating a disclaimer that makes it clear to the consumer that the “jury is still out” on the ultimate conclusion suggested by the claim, but at the same time gives the consumer solid information to make critical purchase decisions. ((See Guidance for Industry: FDA’s Implementation of “Qualified Health Claims”: Questions and Answers; Final Guidance (29 August 2009)))
Fast forward several years to the emerging body of evidence developing around the powerful anti-carcinogenic effects of selenium.
This body of evidence shows significant correlation between selenium intake and the reduction in risk for certain cancers including cancers of the prostate, lung, respiratory tract, colon, and digestive tract. Is the evidence conclusive? No. But is it powerful and supported by valid studies using recognized methods and conducted by reputable scientists? Yes.
In reliance upon the body of evidence developed, Pearson and Shaw petitioned the FDA for approval of five qualified claims for selenium. ((Selenium and a Reduced Risk of Site-specific Cancers, FDA-2008-Q-0323)) Four out of the five claims were rejected outright. A fifth claim, for prevention of prostate cancer, was saddled with disclaimers that were so onerous it was almost not worth making since the disclaimer was so long you could barely even fit it on the box or bottle with the supplement.
Some perspective is valuable here: FDA reviewed 233 studies in the course of its review of the challenged claims. Pearson and Shaw submitted 77 studies as supportive of their claims. According to the Selenium Challenge complaint, almost all the evidence submitted was ignored by FDA. To their credit, Pearson and Shaw acknowledge that the evidence is not conclusive, but they do seem to have the weight of the credible scientific evidence on their side, much of which is detailed in the Selenium Challenge complaint complete with citations to the literature.
Pearson and Shaw also petitioned the FDA for approval of qualified claims for the antioxidant effects of Vitamins C and E. ((Petition for Qualified Health Claims: Antioxidant Vitamins C and E and Reduction in the Risk of Site-Specific Cancers, FDA-2008-Q-0299)) The claims consisted of ten Vitamin C qualified health claims and 7 Vitamin E qualified health claims involving the relationship between Vitamins C and E and the reduction in the risk for cancer. In support Pearson and Shaw submitted over 200 scientific publications demonstrating a nutrient-disease relationship between vitamins C and E and site-specific cancers.
Pearson and Shaw had hope that at least some of their claims might be approved. However, in the interim, the FDA issued its guidance document, “Evidence-Based Review System for the Scientific Evaluation of Health Claims.” In this guidance document, according to the C and E Challenge, the FDA mucked up the analysis required for qualified claims by conflating it with the higher standard set for FDA Approved Claims. Once again, FDA rejected most of the proposed qualified claims, and for the ones that it accepted it rewrote them and included so much negatively laden verbiage as to make the claims unusable.
Both these challenges seek to reorient FDA thinking (to put it mildly) as it pertains to the qualified claims review system. Emord clearly hopes that the D.C. Circuit will take FDA to task for its failure to comply with past decisions requiring it to lift excessive burdens on the free speech rights of supplement marketers so that consumers can be fully informed about developing science behind powerful dietary therapies available to treat and prevent disease. We will see in Part II of this post how the new cGMP system also places burdens on the commercial speech rights of supplement makers, so stay tuned…