ANH-USA Initiatives in Support of DSHEA
Pearson v. Shalala
This was a landmark case in which ANH-USA, joined by four other plaintiffs, sued the U.S. Food and Drug Administration and won. Along with Durk Pearson, Sandy Shaw, Citizens For Health and the National Health Federation, ANH-USA sued the agency for violating the First Amendment as well as the Administrative Procedure Act by not allowing the dissemination of truthful, scientific information on dietary supplement labels, and by holding manufacturers to an undefined standard called “significant scientific agreement.” On January 15, 1999, the U.S. Court of Appeals for the District of Columbia agreed, directing the agency not only to devise a definable standard, but also to permit the use of disclaimers on labels.
Dietary Supplement Health Claims
ANH-USA has filed several emergency petitions addressing the FDA’s regulations on health claims for dietary supplements. We have also filed numerous citizens’ petitions and continue to file comments on proposed agency regulations affecting the free flow of information to consumers.
The battle continues. In an effort to press the FDA to implement the Pearson decision, ANH-USA joined in filing health claims for saw palmetto, folic acid, Omega 3 fatty acids, fiber, vitamin E and vitamin B. The agency denied four of the claims and refused to allow the use of disclaimers in every instance, so we pursued them as outlined below. In 2009 we also filed two additional lawsuits, for selenium and antioxidants C and E. It is important to keep in mind that, despite the Appeals Court decision, the agency has still not defined the “significant scientific agreement” standard that was ruled unconstitutional but was, nevertheless, used to review these claims. Our win/loss record to date is as follows:
WON: On May 27, 2010 a federal judge in the U.S. District Court for the District of Columbia ruled unconstitutional the FDA’s censorship of selenium dietary supplement health claims. The Alliance for Natural Health USA, along with dietary supplement formulators Durk Pearson and Sandy Shaw, and the Coalition to End FDA and FTC Censorship, represented by Jonathan Emord of Emord & Associates, were successful in protecting the First Amendment right of dietary supplement manufacturers to provide “qualified health claims” which accurately communicate the state of science in relation to the dietary supplement. All principal parts of the decision were clear victories for the ANH-USA and its fellow plaintiffs. The case was originally filed on July, 31 2009.
WON: Folic acid supplementation (.8mg) is more effective than a lesser amount, and more effective than from foods in common form, in preventing neural tube defects. While the FDA would not approve a claim or a disclaimer for .8 mg, it did write four claims of its own for .4 mg of folic acid. We felt the agency ignored valid scientific evidence and misled women with its claims, so we again filed suit against the agency, along with Durk Pearson, Sandy Shaw, Dr. Julian Whitaker, Pure Encapsulations Inc., and XCEL Medical Pharmacy Ltd. We also filed an injunction preventing the agency from prohibiting use of our claim until a decision was reached on the merits of the lawsuit.
On February 1, 2001, U.S. District Court Judge Gladys Kessler partially granted the motion for a preliminary injunction and ordered the agency to consider one or more disclaimers, saying, “It is clear that the FDA simply failed to comply with the constitutional guidelines outlined in Pearson. Indeed the agency appears to have at best misunderstood, and at worst, deliberately ignored, highly relevant portions of the Court of Appeals opinion. Even a cursory examination of the scientific literature on which the FDA relied…demonstrates that the FDA’s conclusion that the ‘weight’ of the evidence was against plaintiffs’ folic acid claim was arbitrary, capricious and an abuse of discretion.” On April 3, 2001, the agency conceded defeat and authorized a health claim with a disclaimer for .8 mg of folic acid.
LOST: Vitamin E supplements and heart disease. The FDA insisted there is no significant scientific agreement, and that until a rulemaking to reconsider the general health-claims regulations for supplements is complete, the agency intends to deny, without prejudice, any claims that fail to meet this undefined standard; nor is it authorizing the use of disclaimers until that time.
LOST: Fiber and colorectal cancer. The agency denied the claim, citing lack of significant, scientific agreement, and denied the proposed disclaimer, saying, “The weight of the evidence for a health claim about dietary fiber and colorectal cancer is outweighed by the evidence against such a claim. Therefore, FDA has determined that health claims relating dietary fiber and reduced risk of colorectal cancer are inherently misleading and cannot be made non-misleading with a disclaimer or other qualifying language.”
WON: B Vitamins and vascular disease. After the agency rejected our initial claim, we joined Dr. Julian Whitaker, Durk Pearson, Sandy Shaw and Pure Encapsulations Inc. in yet another lawsuit against the FDA. We also filed an application for preliminary injunction and were prepared to file two motions for summary judgment against the FDA commissioner and the director of the Center for Food Safety and Applied Nutrition, compelling them to comply immediately with the disclaimer requirement set forth in Pearson v. Shalala. On March 27, 2001, shortly before the agency had to respond to the preliminary injunction, it announced that it had changed its position and would permit use of the health claim we had originally filed, with the disclaimers we said we would accept. Effective immediately, the government agreed to allow the use of our health claim on all products that contain the combination of vitamin B6, B12 and folic acid, stating that, as part of a well-balanced diet low in saturated fat and cholesterol, the supplements may reduce the risk of vascular disease.
WON: Omega-3 fatty acid. While the agency did not approve our health claim, it did approve a lengthy one of its own crafting, making the connection between Omega-3 fatty acid and the reduction of coronary heart disease. While we believe that the agency’s version is unnecessarily wordy and negative, we decided not to challenge it. The FDA decision is available on line at www.fda.gov
UNDECIDED: The claim regarding saw palmetto and BPH is still under review by the agency, but initial responses seem to suggest that the claim will be considered a drug claim, not a health claim, and therefore be denied. To date, the agency has been unable to complete its review of the antioxidant claim, saying that its work is complicated by the large number of new human studies that were conducted since FDA’s original 1991-1993 review. “Further,” the agency wrote, “the review has been complicated by the fact that the proposed claim addresses relationships between antioxidant vitamins and a number of different types of cancers. Each of these multiple relationships needs to be evaluated individually.”
UNDECIDED: On August 14, 2009, ANH-USA, along with Durk Pearson, Sandy Shaw, and the Coalition to End FDA and FTC Censorship, sued the FDA after the agency denied scientifically supported, qualified health claims and reversed previously approved qualified health claims about antioxidants C and E. The suit seeks declaratory and injunctive relief on the grounds that FDA’s decision to suppress claims that antioxidants reduce the risk of cancer infringes on AHN-US’ right to speak freely about truthful health information.
ANH-USA Initiatives in Support of DSHEA