FDA should take action to ensure "functional food" products are safe and bear truthful labeling claims, the Center for Science in the Public Interest asserts in a March 25 letter to FDA Commissioner Jane Henney, MD, and in an accompanying report entitled "Functional Foods - Public Health Boon or 21st Century Quackery."

"Functional foods hold much promise," the letter states, "but, without effective regulation, may merely become the snake oil of the next century."

"We urge you to direct the FDA's Center for Food Safety & Applied Nutrition to ensure that ingredients in so-called functional foods are safe and that label claims for such products are valid," CSPI says.

Functional foods "typically contain unconventional ingredients such as herbal medicines, amino acids and plant extracts," the group notes, adding "labels often tout purported health benefits of such ingredients."

While current FDA regulations generally prohibiting the use of untested ingredients and unapproved health claims, "companies are taking advantage of a variety of regulatory loopholes and marketing 'functional foods' as dietary supplements or medical foods," the letter states.

"Importantly, the FDA already has blocked the marketing of one such product, Benecol margarine, until the manufacturer demonstrates that the 'functional' ingredient in the product is safe for use in food," the group continues. "We support the FDA's action in the case. However, dozens of other products that raise similar concerns remain on the market." Benecol is being developed by McNeil.

CSPI notes it discussed the issue with CFSAN representatives Feb. 4 but "unfortunately, it appeared that the agency had no strategy to address this issue." "Frankly, FDA staff seem befuddled and are failing to enforce the law," the group says. "Not surprisingly, many companies are taking advantage of the regulatory vacuum and seeing what they can get away with."

CSPI urges FDA: "require all companies to prove that 'functional' ingredients are safe prior to marketing"; "require all express and implied health claims to be authorized by the agency"; and "require structure/ function claims to be based on universally recognized factual statements about known and substantively significant relationships regarding the effect a substance on the normal structure or functioning of the body (e.g., calcium and bone development)."

At a March 16 Public Voice for Food & Health Policy meeting, CSPI Senior Staff Attorney Ilene Heller recommended FDA research consumer understanding of claims, maintaining that most consumers do not grasp the difference between structure/function and drug claims ("The Tan Sheet" March 22, p. 4).

Labeling should be required to declare the amount of the "functional" ingredient present and include appropriate warnings, CSPI urges as well.

The agency also should "prevent companies from selling 'functional foods' as dietary supplements or 'medical foods' in order to escape FDA regulation," and work with the Federal Trade Commission to create a consistent policy for advertising and labeling claims, CSPI recommends. The group has made similar requests of the Japanese Ministry of Health & Welfare and the U.K. government.

"There is no question that certain substances that occur naturally, or that are added to foods, may offer particular health benefits," the executive summary of the report says. "However, research in this area is still in its infancy, and scientifically valid health claims cannot yet be made with regard to many ingredients."

Some "functional foods" are being sold as dietary supplements to "avoid FDA rules governing foods," CSPI asserts. For example, the group notes, Hain's Chicken Broth and Noodles with Echinacea claims to help "Support the immune system," and Brain Gum with phosphatidyl serine is said to "Improve concentration."

The group also cites Cooke Pharma's HeartBar with L-arginine. HeartBar is launching in May with a $15 mil. national ad campaign ("The Tan Sheet" Dec. 14, 1998, p. 15). Promoted "for the dietary management of vascular disease," HeartBar is "labeled as a medical food for 'use under the supervision of a physician' in an attempt - so far successful - to evade FDA rules that require pre-market of health claims for conventional food products," CSPI says.

FDA Strategy For Functional Food Safety And Claims Needed, CSPI Urges

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