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Capitol Comment

    Capitol Comment 186 - The FDA Should Come Clean: Consumers Have a Right to Know How Long the FDA Hid Psyllium’s Ability to Fight

    05/13/1998

    Coronary heart disease (CHD) is America’s number one killer, causing or contributing to more than 750,000 deaths each year. Over half of American adults have borderline or high cholesterol levels, which contribute to CHD. Studies have shown that certain types of fiber (as part of a low-fat, low-cholesterol diet) can help lower one’s cholesterol levels and therefore reduce one’s risk of heart disease.

    Psyllium (silly-um). On February 18, 1998, the FDA announced it will allow foods containing soluble fiber from the husk of psyllium seeds, such as breakfast cereals and dietary supplements, to advertise their ability to lower the risk of CHD. This information will provide an important tool to consumers who seek to lower their risk of heart disease.

    However, this information is not new. Psyllium’s ability to lower cholesterol levels has been reported in medical journals for at least nine years. Yet consumers had a hard time learning of this tool for fighting heart disease until this year, because the FDA suppressed this consumer information for the better part of a decade through censorship and unlawful bureaucratic delays.

    FDA censorship. The FDA’s announcement confirmed that fiber from the husk of psyllium seeds (a type of harvestable grain) "may reduce the risk of CHD by lowering blood cholesterol levels."1 This ruling validated studies dating back to 1989. However, for the past nine years, the only way consumers could learn about psyllium’s benefits was if they happened to pick up a 1989 copy of the Journal of the American Medical Association (JAMA) or read about it elsewhere.2

    Congress gives the FDA authority to regulate what health claims may appear on food labels. As a result, many consumers do not learn that highly respected medical journals have found a food fights disease until its manufacturer clears the claim with the FDA. Yet, getting the FDA’s permission to repeat something published in JAMA is no easy chore.

    Unlawful delays. Hiding healthful information is every bit as dangerous as allowing misinformation, which is why Congress enacted statutory deadlines for the FDA’s approval of food health claims. 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 — nearly three times the allowed timeframe — and another 272 days to publish the final rule.

    The FDA’s announcement made no mention of this. The only way consumers would learn that the FDA failed to meet the statutory deadline is if they happened to pick up the May 22, 1997, issue of the Federal Register, count the dates, and compare them to the deadlines in section 403(r)(4) of the Food, Drug, and Cosmetic Act — if they happened to have a copy lying around.

    Consumers and taxpayers have a right to know if the FDA is not doing its job. When approving a health claim, the FDA should disclose how long it suppressed that information (starting the clock at the publication of the first valid study) and what impact that suppression has had on the public health. Similarly, the FDA should report on its compliance with the statutory deadlines laid out in the Food, Drug, and Cosmetic Act for each health claim petition.

    Consumers should be glad the good news about psyllium is now available. However, they and Congress should hold the FDA accountable for the censorship and bureaucratic delays that suppressed this healthful information for nine years.

    1"Food Labeling: Health Claims; Soluble Fiber From Certain Foods and Coronary Heart Disease," Federal Register (21 CFR Part 101), Vol. 63, No. 32, February 18, 1998, p. 8103.

    2 Bell, et al., "Cholesterol-lowering Effects of Psyllium Hydrophilic Mucilloid — Adjunct Therapy to a Prudent Diet for Patients With Mild to Moderate Hypocholesterolemia," Journal of the American Medical Association, 261:3419-23, 1989.