The Center for Science in the Public Interest says FDA should "flex its muscles" and make an example of Bayer's selenium claims for One A Day Men's multivitamins, just as it did with General Mills' heart health claims for Cheerios .

In a June 29 ¹ letter, CSPI asks FDA's Center for Food Safety and Applied Nutrition to seize existing stockpiles of Bayer's products that claim a link between selenium and prevention of prostate cancer -- One A Day Men's Health Formula and Men's 50+ Advantage vitamin supplements.

The advocacy group says the products pose a health risk to consumers because results from studies associate selenium intake with increased risk of developing diabetes and with increased risk of aggressive prostate cancer.

CSPI hopes "FDA takes this opportunity to follow up the tough stance it took in the Cheerios warning letter, to follow up that tough stance with the dietary supplement industry," said Bruce Silverglade, legal affairs director.

FDA May 5 told General Mills that label claims touting the clinically proven ability of the toasted whole grain oat cereal to lower one's cholesterol make Cheerios an unapproved new drug for treatment of hypercholesterolemia (² Also see "FDA Cheerios Warning Signals Tougher Stance On Health Claims Enforcement" - Pink Sheet, 18 May, 2009.).

Confronting an industry leader such as Bayer "is an excellent opportunity for the FDA to flex its muscles and show the industry that it's serious," Silverglade said.

Even without a record of adverse event reports stemming from One A Day vitamins, "there's certainly a precedent for FDA seizing products where there's health risks involved," he added.

By burying an FDA-approved qualified health claim regarding selenium and certain forms of cancer beneath other label language that says selenium may reduce the risk of prostate cancer, the Men's Health Formula is an unapproved drug and is misbranded, CSPI argues.

Bayer said it intends to stop using the QHC for selenium and prostate cancer on labeling and packaging, in light of new science and in the wake of FDA's recent acceptance of an extremely qualified prostate cancer-specific health claim (³ Also see "FDA Looms Large As Bayer Surrenders One A Day Selenium Prostate Claims" - Pink Sheet, 29 June, 2009.).

However, the firm declined to say whether it will discontinue the claim that selenium "supports prostate health."

Silverglade said this structure/function claim is still false and misleading, and is functionally a "surrogate for the qualified health claim."

CSPI also maintains that FDA's approved QHC is intended for the selenomethionine form of selenium, meaning the sodium selenate in One A Day Men's is ineligible for a cancer claim in the first place.

Additionally, language on One A Day's Web site that associates the product with support of the Prostate Cancer Foundation and the Major League Baseball Strikeout Prostate Cancer Challenge should be considered labeling, and thus within FDA's purview, CSPI says.

PCF President and CEO Jonathan Simons said in an e-mail the foundation hopes Bayer will adjust its advertising claims to conform to the existing science on selenium and "continue to support awareness for prostate cancer."

The Waiting Game

CSPI on June 18 filed a complaint with the Federal Trade Commission about Bayer's claims for the One A Day Men's products. The center also notified Bayer with a threat of a lawsuit if the firm did not revise its labeling and advertising within 30 days.

Stephen Gardner, CSPI's director of litigation, said in an e-mail that he is not surprised Bayer has not replied to the center's letter.

Despite the ultimatum, "we don't anticipate suing immediately on the 31st day," he said, adding that CSPI "would much prefer to resolve the issue without a lawsuit."

State attorneys general also may be conducting investigations of One A Day products under consumer protection laws.

A spokesman for the Oregon Department of Justice said in a June 23 e-mail his office was "already looking into Bayer's marketing of One A Day vitamins" prior to CSPI's actions.

- Dan Schiff (d.schiff@elsevier.com)

CSPI Calls On FDA To Make Example Of Bayer One A Day Selenium Claims

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