Advertisements and labels for Bayer’s One A Day Men’s 50+ Advantage and One A Day Men’s Health Formula multivitamins had claimed that “emerging research” suggests selenium may reduce the risk of prostate cancer.
The CSPI, a consumer advocacy group, threatened to sue Bayer in June unless it stopped claiming that its vitamins for men could reduce prostate cancer due to their selenium content; it also asked the FDA to seize stocks of Bayer’s products and filed a complaint with the Federal Trade Commission.
The threat followed the FDA issue of a qualified health claim on selenium and prostate cancer on June 19, stating: “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.”
This claim applies to products containing over 14 micrograms of selenium, but its wording is such that it is almost unusable by industry.
In July Bayer told NutraIngredients-USA.com that it was “in the process of revising the packaging and promotional materials for its One-A-Day Men's and One-A-Day Men's 50+ to exclude reference to the qualified health claim regarding the relationship between selenium intake to the reduced risk of certain cancers.”
It said its product formulation would remain unchanged.
Now, however, the CSPI has filed a law suit against Bayer because it did not recall existing packages bearing the original claims, and it also alleges that some of the offending claims were not removed.
Finally, CSPI complains that Bayer “failed to put in writing that it will not make those claims in the future”.
The lawsuit has been filed in the Superior Court of California in San Francisco, according to the CSPI.
However a spokesperson for Bayer told NutraIngredients-USA.com: “We have been made aware through a press release posted by the CSPI of a lawsuit but have not yet been served or reviewed the suit.
“Bayer based a portion of the promotion for One A Day Men's Formula on the U.S. Food & Drug Association's permitted qualified health claim that “Selenium may reduce the risk of certain cancers”.
Bayer says the main support for FDA's permitted use of this claim, relating to non site-specific cancers, was data relating to prostate cancer.
“As part of our routine and regular processes, Bayer monitors developments in available science, as well as regulatory pronouncements relevant to the company's products and promotional claims.”