Consumer advocacy Center for Science in the Public Interest (CSPI) today notified Bayer that it will sue the company unless it ceases the ad claims.
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 also filed a complaint today with the Federal Trade Commission (FTC) today, urging them 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”.
Permitted Claims
Selenium is the only mineral that can carry an FDA-approved qualified health claim for general cancer reduction incidence.
The claim 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 qualified health claim guidance for selenium, click here.
Where’s the science?
Bayer’s ads include statements such as: “Did you know that there are more new cases of prostate cancer each year than any other cancer? Now there is something you can do.”
However, this goes against the body of scientific evidence on selenium and prostate cancer, says CSPI.
Specifically, a seven-year, $118m study funded by the National Institutes of Health found last year that selenium does not prevent prostate cancer in healthy men, said CSPI.
“The Selenium and Vitamin E Cancer Prevention Trial (SELECT) involving 35,000 US and Canadian men was halted in October when researchers determined that selenium was not protecting the men from prostate cancer and may have been causing diabetes in some of them,” it wrote.
Another study conducted in 1996 – the Nutritional Prevention of Cancer (NPC) trial – found that selenium supplementation could prevent prostate cancer in men with a history of skin cancer, pointed out CSPI. However, later analyses of the results found that the benefits only affected a small minority of men and that selenium supplementation also increased the risk of developing diabetes.
Thumbing noses
“With these indefensible claims, Bayer is thumbing its nose at the Food and Drug Administration, the FTC, and any number of state consumer protection laws,” said CSPI litigation director Steve Gardner.
Marc Ullman, food and supplement lawyer from Ullman Shapiro & Ullman told NutraIngredietns-USA.com this morning that he was “not surprised” by CSPI’s announcement.
“Whenever I’ve seen the One A Day advertisements with the line about prostate cancer, I’ve asked myself: ‘What would FDA do if this was a mainstream dietary supplement manufacturer instead of Bayer?’,” he said.
Referring to the permitted FDA health claim on selenium, Ullman said: “Obviously this isn’t the greatest marketing message so Bayer chose to ignore what FDA had to say on the matter.”
Industry diligence
Daniel Fabricant PhD, vice president of scientific and regulatory affairs at the supplement trade group Natural Products Association (NPA) said today’s action “puts folks on notice”.
“No matter the size or type of the firm, the nature of their business, […] someone is always watching, whether it’s FDA, FTC or a NGO like CSPI,” he wrote in an e-mail.
“While [companies] may have their own interpretation of the rules and regulations as to how dietary supplement products are marketed, we need to remain diligent and ensure that all the industry, in marketing products, are taking positions that are defensible and consistent with the state of the science.”
Bayer Healthcare did not respond to calls for comment in time for publication.