Bayer to Face Lawsuit Over 'One A Day' Disease Claims

Bayer makes unsubstantiated and illegal claims that One A Day multivitamins can prevent various diseases, according to the Center for Science in the Public Interest. The nonprofit group today notified the drug company that it will be sued for violations of state consumer protection laws unless the company drops the claims that the supplements "support" breast, heart, eye, and joint health, as well as physical energy, immunity, healthy blood pressure, bone strength, and metabolism. Such a notification is required in advance of a lawsuit in several of the states in which the suit might be filed.

"Every three minutes a woman in the United States is diagnosed with breast cancer, and according to the American Cancer Society, the chance of a woman having invasive breast cancer at some point during her life is about 1 in 8," warns a One A Day web site. That page offers tips for avoiding the deadly disease, such as conducting self-examinations, getting annual mammograms, and eating a healthy diet. Bayer's final tip? "Take One A Day Women's multivitamins formulated with a high level of vitamin D to support breast health." The evidence that vitamin D plays a role in preventing breast cancer is inconclusive, according to studies cited by CSPI, but supplement manufacturers are prohibited from making disease-prevention claims altogether.

"Bayer is literally putting One A Day multivitamins on a par with mammograms," said CSPI litigation director Steve Gardner. "Bayer is saying: 'Take these pills and you'll reduce your risk of breast cancer.' And elsewhere, when the company says it 'supports breast health,' it knows full well that cancer is far and away the top breast health issue for women."

Labels and marketing copy for several One A Day multivitamins also claim that the product is formulated to "support heart health" or "support healthy blood pressure," basing such claims on the presence of vitamins B, C, and E. But in the same way consumers interpret "supports breast health" as "prevents breast cancer," consumers interpret these claims to mean that the pills prevent heart disease or lower blood pressure, according to CSPI. There is inconclusive evidence that those particular nutrients do either.

Bayer might have realized it had gone too far with claims for One A Day Cholesterol Plus, which it marketed thusly: "Keeping cholesterol and blood pressure levels within a normal range helps control two of the key risk factors for heart disease. That's why One A Day developed Cholesterol Plus." That product was discontinued in 2011.

Bayer uses similar tactics when it claims its pills variously support bone strength, joint health, or eye health: It knows that some consumers will interpret those words to mean that the supplements will help prevent osteoporosis, arthritis, or eye diseases such as glaucoma or macular degeneration, CSPI says. When One A Day Women's Active Metabolism multivitamins are described as "specially formulated to help support your metabolism," Bayer is implying that the pills will aid weight loss. Labels and web copy cite its B vitamins, chromium, and caffeine as the foundation for its "supports metabolism" claims, but CSPI says there is no evidence that B vitamins aid weight loss and mixed and debatable evidence that chromium does. Caffeine may speed up metabolism slightly for a brief period of time but there is little evidence that it helps people lose weight.

This is not the first time Bayer has faced legal action over One A Day multivitamin marketing. In October 2009, CSPI filed suit against Bayer over its claims that One A Day Men's multivitamins with selenium might reduce the risk of prostate cancer. In fact, the largest prostate cancer prevention trial ever conducted was abandoned once it became clear that selenium was no more effective at reducing prostate cancer risk than a placebo. In October 2010, Bayer settled with a group of state attorneys general who accused Bayer of deceptively leveraging fear of prostate cancer in order to market One A Day to men. That settlement agreement prohibited the German pharmaceutical giant from claiming that One A Day multivitamins may cure, treat, or prevent any disease, including cancer, unless the company can back up its claims with reliable scientific evidence.

Even earlier, in 2007, Bayer paid a $3.2 million civil fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice over weight-loss claims on One A Day.

Bayer's legal problems have not been limited to its supplement business. In the past decade, Bayer has also pleaded guilty to two separate criminal charges, one related to a scheme to overcharge Medicaid for the antibiotic Cipro, and another related to a price-fixing conspiracy involving a chemical used to make rubber products. In 2009, Bayer paid $8 million to settle allegations by state attorneys general that the company failed to warn physicians and consumers about safety issues surrounding its now-withdrawn cholesterol-lowering drug Baycol. And in 2009, it was required to run a corrective advertising campaign about its birth control pill Yaz as part of another legal settlement secured by state attorneys general and the Food and Drug Administration.

"By positioning One A Day as a preventive for breast cancer, heart disease, and other conditions, Bayer is thumbing its nose at the Food and Drug Administration, the Federal Trade Commission, and a dozen or so state attorneys general—continuing a decade-long spree of irresponsible and sometimes felonious behavior," Gardner said. "There's nothing wrong with selling—or taking—a daily multivitamin. But you can't sell something you can't deliver."