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FDA Warnings to Food Companies Based on Misinterpretation
of Food Additive Law

June 7, 2001: Recent FDA warnings to manufacturers of food products containing herbs are founded on misinterpretation and misuse of food additive regulations passed in 1958, according to Rob McCaleb, president of the Herb Research Foundation in Boulder, CO.

Citing concerns about "the integrity of the conventional food supply," the FDA sent warning letters yesterday to three food manufacturers, cautioning them that their products contain "novel ingredients" that are not generally recognized as safe (GRAS) by the agency. More warning letters will follow during the coming week, FDA claims.

McCaleb asserts that the ingredients singled out by the FDA are neither food additives nor "novel food ingredients," but rather whole foods that have been safely consumed as herbal teas, dietary supplements, and traditional foods for decades. "The FDA is again abusing food additive law in much the same way it did with herbs before the passage of DSHEA [the Dietary Supplement Health and Education Act]," said McCaleb. "Congressman Delaney introduced food additive regulations in 1958 because he was concerned about the increasing levels of chemicals in our food supply. Delaney specified that the law would cover 'food chemicals only,' not whole food ingredients like herbs."

Based on the long history of safe use of the herbs most commonly added to functional beverages, safety should not be an issue with the FDA, said McCaleb. This is particularly true in light of the fact that very small amounts of herbs are typically added to foods and beverages. "It's ironic that the FDA has singled out two herbs, echinacea and Siberian ginseng, that are renowned for their exemplary safety," he remarked. "There are no reports in the literature of harm resulting from consumption of either of these herbs, in dietary supplements or in foods. In addition, their long history of use indicates that they are 'grandfathered' under the food additive law, because they were both in widespread use before 1958."

Sales of "functional" foods and drinks containing herbs totaled $700 million last year. Drinks containing herbs constitute the fastest-growing segment of the beverage market, according to the market research firm Frost & Sullivan


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