The FDA recently took the high-profile route in flexing its long dormant regulatory muscles against companies making unsubstantiated health claims about the dietary supplements and processed foods they make and sell. Food manufacturer General Mills received a highly publicized warning letter last month from the agency, citing claims its Cheerios breakfast cereal is being promoted as a drug.

At issue are the company's very popular marketing campaigns on the Web and on boxes -- accentuating the fast-acting, cholesterol-lowering power of Cheerios -- that promote the nearly 70-year-old breakfast cereal as a drug "intended for use in the prevention, mitigation and treatment of disease," according to the FDA letter.

The very interesting problem, according to legal experts: The FDA slapped General Mills for including the product's Web site address on boxes of Cheerios where unauthorized claims -- reducing the risks of heart disease and cancer -- were made.

Some believe, however, the complaints against General Mills are debatable because the FDA's objections mirror data published by the agency linking the risk of coronary heart disease to cholesterol levels.

Natural Products Insider June 2, 2009