DSHEA
We believe that the Dietary Supplement Health and Education Act of 1994 to be one the single most important events to happen for health freedom.  That is why we believe in protecting and defending this bill.

Below are just a few of the initiatives that we have undertaken in support of DSHEA.

Pearson v. Shalala

This was a landmark case in which AAHF, 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, AAHF 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

AAHF filed several emergency petitions addressing the U.S. Food and Drug Administration's regulations on health claims for dietary supplements. We have also filed several 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 U.S. Food and Drug Administration to implement the Pearson decision, AAHF joined in filing health claims for saw palmetto, folic acid, Omega 3 fatty acids, fiber, Vitamin E and Vitamin B. The agency initially denied four of the claims, and refused to allow the use of disclaimers in every instance, so we pursued them as outlined below. It is important to keep in mind that, in spite of the Appeals Court decision, the agency has not yet defined the "significant scientific agreement" standard which was ruled unconstitutional and which was nevertheless used to review these claims. Our win/loss record to date is as follows:

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 agency 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 mislead 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 agency insisted that there is no significant scientific agreement, and that until a rulemaking to reconsider the general health claims regulations for supplements is complete, FDA intends to deny, without prejudice any claims that fail to meet that 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 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."

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