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FDA complaint filed for Bayer selenium cancer claims

By Lorraine Heller , 30-Jun-2009

In the next episode of the recent selenium saga, a formal complaint was yesterday filed with the US Food and Drug Administration (FDA) requesting that the agency seize stocks of Bayer vitamins for making misleading prostate cancer health claims.

According to the complaint, filed by consumer advocacy Center for Science in the Public Interest (CSPI), the claims made on Bayer HealthCare’s One A Day Men’s Health Formula multivitamins are false and classify the product as an unapproved drug.

Earlier this month, CSPI had filed a complaint with the Federal Trade Commission (FTC) urging it to put a stop to the claims and to require Bayer to run a corrective advertising campaign since its ads have “for so long reinforced the false notion that selenium prevents prostate cancer”.

Advertisements and labels for Bayer’s One A Day Men’s 50+ Advantage and One A Day Men’s Health Formula multivitamins claim that “emerging research” suggests selenium may reduce the risk of prostate cancer.

However, according to CSPI, such claims are deceptive and are not backed by sufficient science. The group yesterday urged FDA to work together with FTC to stop the use of these claims, which, it said, “are an important part of a large-scale campaign to deceive consumers”.

New selenium - prostate claim approval

On June 19, FDA approved the use of a prostate cancer qualified health claim to be used on products containing over 14 micrograms of selenium.

However, the highly qualified nature of the claim renders it almost unusable to industry. It reads:

“Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.”

To read more on that and other new selenium claim approvals, click here .

Another FDA approved claim for selenium and non site-specific cancer risk reduction is more user-friendly, and classifies selenium as the only mineral to carry such a claim. It reads:

“Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”

To access FDA’s guidance for that claim, click here .

Product withdrawals

CSPI’s complaint to FDA, available here , requests that Bayer’s One A Day Men’s Health Formula products are removed from store shelves as they “are dangerous to the health of men suffering from prostate cancer and may increase the risk of diabetes and hypertension”.

Bayer was unable to respond to a call for comments prior to publication this morning. However, press reports suggest that the company may be halting claims that its products could help reduce the risk of prostate cancer.

FDA criticism

FDA’s recent approval of three highly qualified health claims for selenium generated heated criticism from some industry members for being more damaging than useful.

According to attorney Jonathan Emord, whose petition filed last year prompted the health claim approvals, FDA’s decisions violate First Amendment standards.

He recently told The Tan Sheet that the decisions “reveal a profound and unscientific bias against communication of accurate information concerning the relationship between these nutrients and these disease risks.”

However, another interpretation of the decisions suggests that FDA is sending signals to industry that it needs to meet more stringent scientific requirements.

According to Daniel Fabricant Ph.D, vice president of scientific and regulatory affairs at the supplements trade group Natural Products Association (NPA), “FDA has made it clear that we’ve got some additional work to do in terms of supporting evidence for health claims.”

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