The Pearson Decision: 18 Months Later And Still No Health Claims

Analyzing the aftermath of last year’s court decision.

By Todd Harrison

In January 1999, the U.S. Court of Appeals for the District of Columbia Circuit (“Circuit Court”) handed down the Pearson decision, which invalidated FDA’s decision to prohibit health claims regarding antioxidant vitamins and certain cancers, omega 3 fatty acids and coronary heart disease, fiber and colorectal cancer and the superiority of dietary supplements as a source of folic acid. At that time, some in the industry hailed Pearson to be a landmark First Amendment case that would significantly impact FDA’s ability to restrict the use of health claims on the label and labeling of dietary supplements. Indeed, some thought that the Pearson decision required FDA to permit any health claim as long as there was some scientific evidence to support the claim and the claim was not inherently misleading.

It is now 18 months later and it appears that the Pearson plaintiffs are no closer to being able to make the health claims than they were the day Pearson was decided. Indeed, rather than bowing to pressure to immediately permit the claims, FDA started the administrative process anew by requesting comments regarding the scientific validity of the Pearson health claims, issuing a guidance document that was intended to clarify the “significant scientific agreement” standard for health claims and holding a meeting to discuss the implementation of Pearson.

To many, it appears that FDA is moving at a snail’s pace to implement Pearson. Indeed, the Pearson plaintiffs tired of this process filed an application for a preliminary injunction with the U.S. District Court for the District of Columbia (“District Court”) requesting that the court issue a preliminary injunction requiring FDA to permit the use of the health claims with an appropriate disclaimer until such time that the agency has concluded its review of the claims. In their application, the Pearson plaintiffs argued that the Circuit Court’s decision required FDA to permit the use of the health claims immediately, although FDA could require reasonable disclaimers to appear in connection with the claims.

District Court Ruling

This past May, however, the District Court denied the Pearson plaintiffs’ request for a preliminary injunction. In so doing, the District Court held that the Circuit Court’s decision required FDA to reconsider its denial of the health claims by reconsidering the claims anew. The District Court further noted that the Circuit Court’s decision does not require FDA to permit the use of the health claims with appropriate disclaimers if the disclaimers would not adequately communicate to consumers the level of scientific evidence in support of the claim. Indeed, the Circuit Court’s decision rests on the premise that if there is adequate scientific evidence to support a health claim, FDA must consider whether the use of an appropriate disclaimer would communicate to consumers the level of scientific support for the claim. If the disclaimer would clarify the level of support and not serve to further confuse consumers, FDA would be required to allow the claim with the disclaimer. Thus, it appears that the District Court had a reasonable basis to deny the Pearson plaintiff’s application.

The recent District Court’s decision demonstrates the continuing difficulty dietary supplement companies face in attempting to have health claims approved by FDA. Indeed, the District Court’s decision amply demonstrates that FDA is still firmly in control of the health claims process for at least the near future, unless Representative Helen Chenoweth-Hage’s recently introduced bill (H.R. 4604) becomes the law of the land.

The Chenoweth-Hage Bill

On June 8, Representative Helen Chenoweth-Hage introduced H.R. 4604, which would require FDA to permit any health claim unless “no scientific evidence supports the claim and that the claim is inherently misleading.” It appears that the introduction of this bill is in direct response to the District Court’s decision to deny the Pearson plaintiffs’ request for a preliminary injunction. Because the bill was introduced at the time this article was going to press, Congressional support for the measure was unknown. However, at first blush, it would seem that Congressional support would be lukewarm because every health claim petition that had at least one scientific study in support of it would require FDA to approve it although FDA could require a disclaimer to appear in connection with the claim. Thus, the potential to mislead consumers regarding the health benefits of a particular product could be great if the bill becomes law. Indeed, the use of a disclaimer in many in­stances would only act to further confuse the consumer regarding the claim.

Moreover, this bill is not necessarily good for the industry because it feeds into the popular press’s unjustified characterization that the majority of dietary supplement products lack efficacy and the claims are based on questionable science. Indeed, this bill, if passed, may provide additional fodder for the press’s attempt to sway public opinion against dietary supplements and in favor of greater regulation. With that said, the proposed bill is a good starting point for improving the current approach to the health claim approval process and the use of disease treatment claims for dietary supplements. Indeed, where there is sufficient scientific evidence to support the use of a particular dietary supplement in the cure or treatment of a particular disease or health-related condition, a system should be put in place that allows these claims to appear on product labels sooner rather than later.

In another health claim development, FDA rejected the saw palmetto/reduction in symptoms of BPH health claim petition on the basis that the Nutrition Labeling and Education Act’s (NLEA) health claim provisions do not permit the use of disease treatment claims on the label and labeling of foods or dietary supplements. Because of time constraints, we are not fully able to discuss FDA’s decision in this issue. However, FDA’s denial in this instance, while possibly correct, reinforces the need for a system that allows dietary supplements with known medicinal benefits to make disease treatment claims. In the next issue of Nutraceuticals World, we will provide an analysis of the FDA decision to deny the saw palmetto petition and proposed bill regarding health claims as well as some suggested alternatives to the present system of regulating disease treatment claims for dietary supplements. In the meantime, please feel free to e-mail or give me a call regarding this subject.

NW

Todd A. Harrison is a senior associate with the law firm Keller & Heckman, Washington D.C. He advises food and drug companies on a variety of FDA and FTC matters, with an emphasis on food and dietary supplement adulteration, labeling and advertising issues. He can be reached at Keller & Heckman, 1001 G. St. NW, Suite 500 W, Washington D.C. 20001; 202-434-4244; Fax: 202-434-4646; E-mail: [email protected].