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July 25, 2012 / Admin

Three States Settle With Bayer Over Misleading Vitamin Claims

On October 26, 2010, Reuters reported that Attorneys General in Illinois, Oregon and California agreed to a $3.3 million settlement over misleading claims that Bayer vitamins reduce the risk of prostate cancer. Bayer had made claims in its packaging and promotional materials that selenium in its men’s vitamins reduced the risk of certain cancers. In June 2010, the FDA concluded that there was very limited credible evidence for qualified health claims for selenium dietary supplements and prostate cancer. In addition to the monetary payments, Bayer was revising its packaging and promotional materials.

Significantly, the FDA made findings about selenium dietary supplements as it relates to other site-specific cancers. The FDA concluded that there is no credible evidence to support qualified health claims for selenium dietary supplements and a reduced risk of urinary tract cancers other than bladder cancer, lung and other respiratory tract cancers, colon and other digestive tract cancers, brain cancer, liver cancer, or breast cancer. However, FDA concluded that there is very limited credible evidence for qualified health claims for selenium dietary supplements and bladder cancer,  prostate cancer, and thyroid cancer, provided that the qualified claims are appropriately worded so as not to mislead consumers.

This settlement and the FDA findings should remind all dietary product manufacturers to use caution when making health benefit claims about their products and to appropriately limit claims so as not to mislead consumers.

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