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Attention copywriters. The FDA has taken out a bright red pen and is poised to mark up your product statements. The green shades (an antiquated description of newspaper copyeditors)  signaled much closer review of health claims with a warning to General Mills about oat cereal. The agency has also revised a health claim for selenium, rendering it useless to marketers. The size and stature of the companies involved suggests that all businesses, not just those operating in the back alleys, are subject to more intense scrutiny.

The FDA notified General Mills on May 5 that “your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.” On June 19, the agency changed the language for the prostate cancer health claim for selenium to to read as follows:

“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.”

After the new language was released, the Center for Science in the Public Interest filed a complaint with the FDA. In a letter dated June 29, the organization said that Bayer’s claims for its One A Day Men’s Health Formula vitamin overstated the health benefits related to prostate cancer. That followed a complaint filed June 18 with the Federal Trade Commission about marketing claims for the same supplement.

Why should the FDA put a spotlight on the giant companies when a Google search for other products would turn up claims that deserve equal if not more attention? The FDA does not respond to such inquiries, but the question may contain the answer: When a teacher gets tough with the biggest kids in a classroom, the little ones take notice and get in line. And given that both General Mills and Bayer both have backed off their product statements, it would seem that the FDA is very much in control.

Will there continue to be companies that ignore or try to test regulations on product claims? Of course. But the vast majority of nutritional supplement companies that want to play within the rules may become more conservative. Or at least more wary of FDA watchdogs.


Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.