Representatives John Dingell and Bart Stupak are investigating advertising claims made for Wyeth Pharmaceuticals’ Centrum Cardio multi-vitamin. The inquiry stems from a review of direct-to-consumer advertising for pharmaceutical products by the Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations. In a September 12, 2008 letter to Wyeth, the Congressmen requested documentation for advertising claims that Centrum Cardio can reduce cholesterol within four weeks, reduce the risk of heart disease, block cholesterol absorption, and significantly lower LDL cholesterol. Some of the claims appear in TV advertisements, and others appear on the Company’s web site. Both the Food and Drug Administration ("FDA") and the Federal Trade Commission ("FTC") can assert jurisdiction over web site content: the FDA, as labeling, the FTC, as advertising.
Wyeth appears to be basing many of these advertising claims on FDA’s health claim regulation and enforcement discretion letter for products containing plant sterol/stanol esters. Qualifying products can bear the health claim as well as other information described in the regulation related to plant sterol/stanol esters and coronary heart disease – specifically, that plant sterol/stanol esters may reduce the risk of coronary heart disease and lower blood total and LDL cholesterol levels.
The claims Wyeth makes for Centrum Cardio appear to substantially comply with FDA’s plant sterol/stanol health claim regulation and enforcement discretion letter. Although some of the claims may be more aggressive than the wording in FDA’s regulation (e.g., lowers cholesterol within a month), the claims generally follow the spirit of the health claim regulation.
Moreover, for the claims appearing in pure advertising – for example, radio or TV advertisements – Wyeth technically need only be sure that its claims are truthful, not misleading, and adequately substantiated, which is the standard employed by the FTC. Therefore, Wyeth should be able to make claims for Cardio Centrum in advertising that go beyond those provided in FDA’s plant sterol/stanol esters health claim regulation as long as the Company has adequate substantiation to support the claims.
For claims related to health, the FTC typically consults with scientific experts – that is, experts in the field that relates to the claim – to see whether they agree that there is sufficient substantiation, based on “competent and reliable scientific evidence,” to support the claim. How Congress expects to make the determination as to whether the claims are substantiated, however, is unclear.