The Federal Trade Commission either should issue advisory opinions concerning dietary supplement structure/function claim advertising or define the criteria it uses in deciding whether such ads satisfy the "competent and reliable scientific evidence" standard, four supplement marketers say in a petition for rulemaking filed with FTC Dec. 21.

The petitioners assert they have refrained from disseminating print ads containing certain structure/function claims "in light of uncertainty as to whether the science supporting the claims will be regarded by FTC as competent and reliable."

The petitioners are Julian Whitaker, MD, Pure Encapsulations, Imagenetix and XCEL Medical Pharmacy. The action was filed by Washington, D.C.-based Emord & Associates, the plaintiffs' counsel in Pearson v. Shalala.

Whitaker and Pure Encapsulations are among five plaintiffs who sued FDA Dec. 7 over the agency's denial of a health claim relating to saw palmetto and benign prostatic hyperplasia ("The Tan Sheet" Dec. 13, 1999, p. 4). That case also was filed by Emord.

Saw palmetto structure/function claims for prostate health, urinary function and flow are among the advertising claims petitioners cite in the FTC action. Others include omega-3 fatty acids and cardiovascular health; folic acid, B vitamins and vascular health; vitamin E and cardiovascular health; and antioxidant vitamins and cellular structure integrity.

FTC deems a structure/function claim ad deceptive unless supported by "competent and reliable scientific evidence," the petitioners note. In its case law, FTC has indicated two well-designed, double-blind, placebo-controlled clinical trials are the minimum acceptable corroboration for health claim advertising for drugs.

"The lack of a comparable, clear definition for 'competent and reliable scientific evidence' as it applies to dietary supplement structure/function claim advertising makes it impossible for the joint petitioners to discern" the scientific corroboration the commission deems necessary, the petition states.

FTC's "Dietary Supplements: An Advertising Guide For Industry" is helpful but "does not provide necessarily specific guidance on the level, degree, quality, quantity and kind of scientific evidence FTC expects," the petition says.

The document, published in 1998, says a "guiding principle" in the commission's determination of the amount and type of evidence needed to substantiate supplement ad claims is based upon "what experts in the relevant area of study would generally consider to be adequate" ("The Tan Sheet" Nov. 23, 1998, p. 4).

Since the guide's release, industry representatives have criticized FTC's reluctance to make available to marketers the experts it consults regarding adequacy of substantiation, a complaint echoed by the petitioners.

"The FTC has never revealed precisely what objective criteria it uses to evaluate scientific evidence submitted to it in response to access letters and civil investigative demands that call into question scientific corroboration for dietary supplement structure/function claim advertising," the petition asserts.

"In its...decisions and in its consent agreements concerning those claims, the FTC does not explain the content of the staff's scientific evaluations and never reveals the content of the scientific evaluations supplied to it by independent reviewers," the marketers say, asserting FTC's criteria and the weight it gives such factors are "hidden from advertisers."

The supplement marketers also assert FTC's failure to define criteria it uses to evaluate structure/function claim advertising, either case by case, through a separate rule or by advisory opinions, violates the Administrative Procedures Act's prohibition of arbitrary and capricious agency action.

Additionally, the commission's practice is unconstitutionally vague under the Fifth Amendment and violates the First Amendment's commercial speech standard, the marketers say.

FTC "must explain with particularity the criteria it uses in evaluating dietary supplement structure/function claims or, in the alternative, authorize the issuance of advisory opinions to guide the joint petitioners and all regulatees on a case-by-case basis," the petitioners urge. "The agency's criteria must distinguish potentially from inherently misleading claims and must permit use of disclaimers in association with potentially misleading claims as an alternative to outright suppression."

The petitioners say such clarification could lead to fewer FTC prosecutions "because the regulated class will perceive the principles that guide agency action."

FTC Criteria For Structure/Function Claim Ad Evaluation Sought By Marketers

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