A preliminary injunction against FDA requested by the Pearson v. Shalala plaintiffs was denied May 24 by D.C. federal court judge Gladys Kessler. An appeal was filed May 26 by Emord & Associates (Washington, D.C.).

The plaintiffs - Durk Pearson, Sandy Shaw and the American Preventive Medical Association - had asked that FDA be enjoined from upholding its ban on the use of the four Pearson health claims "and allow the immediate use of the claims with appropriate disclaimers."

The four health claims concern dietary fiber and cancer, antioxidants and cancer, omega-3 fatty acids and coronary heart disease, and folic acid and neural tube defects. The claims have been the subject of litigation with FDA since 1995.

In her opinion, Kessler notes the plaintiffs were required to demonstrate a "likelihood of success on the merits"; "irreparable harm absent the injunction"; "the balance of hardships tips in their favor"; and "the public interest lies in granting an injunction."

Considering the first point, Kessler states the plaintiffs argue FDA's refusal to allow them to use the health claims on their labels with disclaimers "violates not only the Court of Appeals' mandate, but also the First Amendment to the Constitution."

However, Kessler maintains the plaintiffs do not "contest the validity of the pre-clearance process" for health claims, but they argue the Pearson decision "allows them to by-pass these procedures" because the agency's prohibitions were "invalidated" in the case.

"The problem with the Plaintiffs' argument is that the Court of Appeals' mandate does no such thing," Kessler states. She says the plaintiffs incorrectly assume "invalidation of the [FDA] regulations allows them to make their health claims with disclaimers, without any further pre-clearance....It does not."

Rather, the decision establishes a "new administrative record" for the claims, Kessler opines, adding the Pearson decision did not give the plaintiffs "license to make their health claims immediately," but instead "require[d] the FDA to reconsider plaintiffs' claims...to determine whether significant scientific agreement supports those claims."

Kessler adds that a complete review of all the scientific literature is merited, given that much of the data supporting the claims is new since they were first reviewed by FDA. Therefore, an injunction against the agency would handcuff its mission, making it not in the public's interest and tipping "the balance of hardships...in favor of FDA," she states.

Kessler also finds irreparable harm has not been done because the agency's actions were appropriate, which means the plaintiffs "have not suffered any First Amendment injury which this court can redress."

In response to another health claim, FDA reaffirmed its decision May 26 to deny a claim concerning saw palmetto and the symptoms of benign prostatic hypertrophy. The agency agreed in February to reconsider its original denial of the saw palmetto claim, which it had disallowed since it "goes beyond risk reduction to claim an effect on an existing disease" (¹ Also see "Three USP Botanicals Monographs Expected By March 2000" - Pink Sheet, 22 November, 1999.).

The agency's original denial of the saw palmetto claim prompted Emord & Associates to file suit on behalf of Julian Whitaker, MD, and other supplement marketers.

However, after reviewing the claim a second time, Center for Food Safety & Applied Nutrition Director Joseph Levitt again voiced concern that the claim, "Consumption of 320 mg daily of saw palmetto extract may improve urine flow, reduce nocturia and reduce voiding urgency associated with mild benign prostatic hyperplasia (BPH)," is, in fact, a disease claim.

"Claims about effects on existing diseases do not fall within the scope of the health claim provisions" in the Nutrition Labeling & Education Act, and therefore "may not be the subject of an authorized health claim," the letter says.

FDA also notes saw palmetto's use in treating BPH was considered in 1990 during the drafting of the final rule on OTC Miscellaneous Internal Drug Products, but clinical trials did not provide enough supporting evidence and that health risks were associated with its use.

Following FDA's decision, Judge Kessler released a new procedural schedule in the Whitaker case. Plaintiffs plan to file a motion for summary judgment on June 13.

Pearson Injunction Against FDA Denied By Federal Judge

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