June 18, 2009 -- A consumers group complained to regulators and threatened a lawsuit Thursday over what it calls a drug company’s misleading claims that two of its multivitamins reduce the risk of prostate cancer.
The Center for Science in the Public Interest is taking aim at One A Day Men’s 50+ Advantage and Men’s One A Day Men’s Health Formula multivitamins, both of which contain selenium. The group says widespread ads for the products claiming selenium helps reduce the risk of prostate cancer are false and not supported by major scientific studies.
Early studies suggested selenium, an antioxidant, could have some protective effect against cancer. But a major government-sponsored trial published in January, called SELECT (The Selenium and Vitamin E Cancer Prevention Trial), concluded that selenium “did not prevent prostate cancer” in a population of healthy men.
But the group complained that Bayer Healthcare LLC, which makes both products, continues to claim on packaging and in ads that they help reduce the risk of prostate cancer.
“A complete multivitamin plus selenium, which emerging research suggests may reduce the risk of prostate cancer,” Bayer’s ads state, according to the CSPI’s complaint to the Federal Trade Commission.
“We urge the Federal Trade Commission to take swift and strong action to get these deceptive Bayer ads off television, radio, and Internet and out of newspapers and magazines or wherever else they may be displayed,” states the CSPI’s complaint to the FTC.
The FTC in 2007 ordered Bayer to stop making unproven health claims for a One A Day weight loss product and told the company not to make any unsubstantiated claims for any vitamins in the One A Day product line.
In a statement, Bayer says “We are aware of CSPI's complaint and are in the process of reviewing their allegations.”
“In the meantime, we stand behind all claims made in support of our products, including One A Day multivitamins. The claims made in support of selenium are based on an FDA-approved qualified health claim,” reads the statement, provided to WebMD.
The CSPI also threatened to sue Bayer if the company does not change its advertising for the One A Day multivitamins.
"Bayer is thumbing its nose at the Food and Drug Administration, the FTC, and any number of state consumer protection laws," CSPI Litigation Director Steve Gardner says.
"FTC can sometimes take years. Because these ads are so bad we've threatened to sue Bayer within 30 days if they don't stop running them," David Schardt, CSPI senior nutritionist, tells WebMD.
The CSPI also notes that prostate cancer experts from across the U.S. have written to the FTC in support of the CSPI complaint against Bayer.