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For Immediate
March 25, 1999

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International Release March 26, 1999
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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 CSPI’s 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:

  • Hain’s Chicken Broth and Noodles with Echinacea. The label claims that Echinacea helps “support the immune system.” The soup is labeled as a “supplement” in an attempt to evade FDA requirements for food additives and label claims.

  • Brain Gum, a chewing gum with phosphatidyl serine (PS). PS is a fat-like substance extracted from soybeans that is also found naturally in brain cells. The product claims to “improve concentration” and is sold as a dietary supplement presumably to avoid FDA rules governing foods.

  • HeartBar, a snack bar with L-arginine. Arginine is an amino acid required to produce nitric oxide, a potent dilator of blood vessels. The product claims that it is “for the dietary management of vascular disease.” It is labeled as a medical food for “use under the supervision of a physician” in an attempt to evade FDA rules that require pre-market approval of health claims for conventional food products.

Some “functional foods” may contain insignificant amounts of the promoted ingredient, while others contain too much fat or sugar. For example:

  • Snapple Ginseng Tea labels do not list ginseng content and the company refuses to disclose the information.

  • Kellogg’s Ensemble Carrot Cake labels state that the product contains psyllium, “a natural soluble fiber that actively works to promote heart health.” Psyllium can help reduce cholesterol. The cake, however, contains too much fat to qualify for an FDA-approved heart-disease-prevention claim so the company merely claims it can “promote heart health.”

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:

  • Heinz advertises that lycopene in catsup “may help reduce the risk of prostate and cervical cancer.” The company only makes the claim in ads and not on labels because the Federal Trade Commission (FTC), which regulates advertising, does not require pre-market approval of such claims and employs weaker substantiation standards than the FDA.

  • Campbell’s V8 Juice labels and ads state that antioxidants in the product “may play an important role in slowing changes that occur with normal aging.” The claim is based on preliminary scientific evidence. In any case, the juice is high in sodium, which promotes high blood pressure, a condition that becomes more prevalent with aging. The sodium content disqualifies the juice from making any FDA-approved health claim on labels. Neither the FTC nor the FDA have taken any public action to stop the claim.

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 FDA’s 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, CSPI’s 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:

  • Require that functional ingredients be proven safe prior to marketing.
  • Require claims to be approved by the agency or be based on scientific consensus.
  • Issue rules that require labels to disclose how much of a “functional” ingredient a serving of the food contains, how much people should consume, and, if appropriate, warning information.
  • Prevent companies from selling “functional foods” as dietary supplements or “medical foods” in order to escape FDA regulation.
  • Work with the FTC to develop a consistent policy for claims in advertising and labeling.