CSE Analysis: Another Case of FDA Delay And Censorship

Regulation Policy

CSE Analysis: Another Case of FDA Delay And Censorship

A recent case shows Food and Drug Administration censorship still denies consumers potentially lifesaving information, and the FDA illegally delays action, claim critics. In this instance, consumers were denied information about a food supplement that can lower their cholesterol levels, and thus the risk of heart disease, for nine years.

On February 18, 1998, the FDA announced it will allow foods containing soluble fiber from the husk of psyllium (silly-um) seeds, such as breakfast cereals and dietary supplements, to advertise their ability to lower the risk of coronary heart disease (CHD). CHD is America's number one killer, causing or contributing to more than 750,000 deaths each year. And more than half of American adults have borderline or high cholesterol levels which contribute to CHD.

Beginning with a 1989 report in Journal of the American Medical Association (JAMA) studies have found psyllium may reduce the risk of CHD by lowering blood cholesterol levels. However, food producers cannot give consumers information about health claims until the FDA approves.

Congress gives the FDA authority to regulate what health claims may appear on food labels.

The FDA is required to file a health claim petition within 100 days of receipt and propose a final ruling after another 90 days.

The FDA filed the psyllium claim within 100 days --98 to be exact -- however, the agency took 246 days to propose a final rule, which is nearly three times the allowed time frame, and another 272 days to publish the final rule.

Consumers and taxpayers have a right to know if the FDA is not doing its job, say critics. And when it approves a health claim, the FDA should disclose how long it suppressed that information.

Source: Michael F. Cannon, "The FDA Should Come Clean: Consumers Have a Right to Know How Long the FDA Hid Psyllium's Ability to Fight Heart Disease," Capitol Comment No. 186, May 13, 1998, Citizens for a Sound Economy Foundation, 1250 H Street, N.W., Suite 700, Washington, D.C. 20005, (202) 783-3870.

For text http://www.cse.org/cc186-csef-health.htm

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