Wyeth says both science and FDA support the claims for Centrum Cardio that the House Energy and Commerce Committee is questioning.

The committee asks for substantiation that the multivitamin can lower cholesterol within a month with "a natural ingredient derived from soybeans that blocks cholesterol absorption and significantly lowers bad [low-density lipoprotein] cholesterol."

Wyeth spokesman Doug Petkus said the product is "based on sound science" and the claims are made according to an interim final rule FDA published in September 2000 for labeling food products containing plant sterol/stanol esters.

FDA updated the IFR in April 2008 but has yet to adopt a final rule for the regulation.

The phytosterols used in Wyeth's product are naturally derived from soybeans and can lower cholesterol, Petkus said in an e-mail.

According to the IFR, "Scientific evidence demonstrates that diets that include plant sterol/stanol esters may reduce the risk" of coronary heart disease. Additionally, FDA says products containing plant sterol/stanol esters may be labeled with that claim.

Moreover, FDA says the claims may state there is an "intermediate link" between cholesterol and CHD risk. The IFR says there is scientific evidence that including plant sterol/stanol esters in the diet helps lower blood-total and LDL cholesterol levels.

The agency says populations with low incidences of CHD "tend to have relatively low blood-total cholesterol and LDL cholesterol levels."

Enforcement Discretion Stated

According to Washington-based Hyman, Phelps and McNamara's FDA Law Blog post on Sept. 18, food products can bear health claims using the information described in the regulation, mainly that plant sterol/stanol esters may reduce the risk of CHD and lower blood-total and LDL cholesterol levels.

In the blog, the firm's Cassandra A. Soltis writes that Wyeth's claims for Centrum Cardio appear to "substantially comply" with FDA's health claim regulation, as well as an enforcement discretion letter FDA wrote in 2003 to Cargill Health and Food Technologies.

FDA contacted Cargill in response to the firm's request that the agency use "enforcement discretion with respect to the expanded use" of the interim health claim rule. FDA said it would develop a final rule on the health claim and, based on scientific evidence, it would consider "the exercise of enforcement discretion" in the meantime with respect to the health claim (¹ Also see "Phytosterol CHD Health Claim Expanded Interim Use Permitted By FDA" - Pink Sheet, 24 February, 2003., p. 4).

Soltis points out some of Wyeth's claims may be "more aggressive than the wording in FDA's regulation," citing the claim that the product lowers cholesterol in one month.

However, she says under the Federal Trade Commission's advertising laws, Wyeth need only be sure its claims in its TV and radio advertisements are truthful, substantiated and not misleading.

"Therefore, Wyeth should be able to make claims for Centrum Cardio 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," Soltis writes.

Trade Group Support

The Council for Responsible Nutrition says the phytosterol ingredient in Wyeth's multivitamin has been proven to help lower cholesterol by blocking the absorption of cholesterol by the body.

CRN President and CEO Steve Mister said under FDA's rule, the Centrum Cardio claims are "legal and legitimate." Mister said CRN trusts the committee will "quickly realize" there is a "great deal of scientific substantiation."

Natural Products Association VP of Scientific and Regulatory Affairs Daniel Fabricant said there is a possibility of oversight of the health claim on the committee's part.

Energy and Commerce Committee Chairman John Dingell and Oversight and Investigations Chairman Bart Stupak on Sept. 12 asked Wyeth to substantiate claims for the product it launched in November 2007 (² Also see "Lawmakers Ask Wyeth To Substantiate Centrum Cardio Cholesterol Claims" - Pink Sheet, 15 September, 2008., p. 12).

The Michigan Democrats say the inquiry is part of the committee's ongoing investigation into direct-to-consumer advertising for pharmaceutical products.

In their letter to Wyeth President and CEO Bernard Poussot, the lawmakers say their concern stems from statements that may be misleading to consumers. "Patients with high cholesterol may erroneously substitute Centrum Cardio for a treatment plan prescribed by their physicians," they say.

Committee Communications Director Jodi Seth said the letter was drafted after a committee investigator took note of the Centrum Cardio claims when an ad was broadcast during the Olympics.

Will Similar Claims Be Targeted?

So far, no other nonprescription products - supplements or OTC drugs - are on the radar for the committee's investigation of pharmaceutical ads, Seth said.

However, food and drug attorney Marc Ullman said he expects advertising for other vitamin and supplement products to be targeted.

The inquiry is "definitely targeted at supplements as a whole," said Ullman, of New York-based Ullman, Shapiro & Ullman.

In an e-mail, he added it is "interesting" the committee took aim at Wyeth's multivitamin in the pharmaceutical advertising investigation. "You'd think that they'd have enough to deal with on that subject."

Ullman noted products making blood pressure claims would be likely candidates for questions from the committee. "There would seem to be any number of supplements making more aggressive claims [than Centrum Cardio] to prescription drug users," he said.

The legislators ask that Wyeth provide the information within two weeks of receiving the letter.

Petkus said Wyeth plans to provide the appropriate information.

- Katie Stevenson (k.stevenson@elsevier.com)

Science, FDA Rule Support Centrum Cardio Claims, Wyeth Will Tell Congress

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