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FDA Urged to Improve Regulation of Functional Foods
WASHINGTON, D.C. - The Center for Science in the Public Interest (CSPI) today urged the Food and Drug Administration (FDA) to tighten controls over the marketing of so-called functional foods made with herbal medicines, amino acids, plant extracts, and other unconventional ingredients. CSPI urged the agency to ensure that all such ingredients are safe and that label claims are valid.
Functional foods typically tout the health benefits of ingredients that have drug-like effects on the body. While current FDA regulations generally prohibit the use of untested ingredients and unapproved health claims, companies get around those rules by taking advantage of a variety of regulatory loopholes.
In a letter to FDA Commissioner Jane Henney, CSPI charged that functional foods hold much promise, but, without effective regulation, may merely become the snake oil of the next century. The letter was accompanied by a report entitled Functional Foods Public Health Boon or 21st Century Quackery.
The report details how companies are using regulatory loopholes such as selling foods as dietary supplements or medical products to market functional foods in the U.S., the United Kingdom, and Japan. A report on functional foods is also the cover story of CSPIs April issue of Nutrition Action Healthletter (NAH), which reaches over one million subscribers.
The FDA is failing to protect the public from numerous questionable ingredients and misleading claims in the estimated $15-billion-a-year functional-foods market, stated Bruce Silverglade, CSPI director of legal affairs. All too often, companies are merely trying to cash in on the burgeoning demand for alternative health remedies, he said. Product examples include:
Some functional foods may contain insignificant amounts of the promoted ingredient, while others contain too much fat or sugar. For example:
In other situations, conventional foods are misleadingly marketed as functional foods on the basis of the purported effect of a naturally occurring ingredient. For example:
The FDA recently stopped McNeil Consumer Products from marketing Benacol margarine as a dietary supplement rather than as a food. The product contains plant stanol esters that reduce blood cholesterol. The FDAs action prohibited the company from selling the product until it could demonstrate that the functional ingredient in the margarine was safe for use in foods (the agency has not yet determined what claims, if any, could be made on the label). Although the FDA acted in that case, CSPIs report reveals that the agency has generally failed to require proof of safety for ingredients in other functional foods and has failed to stop many dubious label claims.
The FDA must beef up its enforcement actions, close the loopholes, and require that all functional ingredients are safe and that claims are valid, stated Ilene Ringel Heller, a senior CSPI staff attorney who co-authored the report.
In contrast, the food industry is calling on the FDA to revamp its application review process for ingredients and claims and eliminate unnecessary regulatory roadblocks. In its report, however, CSPI detailed how companies take advantage of the already lax regulatory environment to flood the market with products of dubious benefit.
In its letter and report, CSPI urged the FDA to: