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FDA HAS "NOT EXHAUSTED" DIETARY SUPPLEMENT JUDICIAL OPTIONS

This article was originally published in The Tan Sheet

Executive Summary

FDA HAS "NOT EXHAUSTED" DIETARY SUPPLEMENT JUDICIAL OPTIONS related to the agency's import policy on evening primrose oil, FDA Division of Import Operations and Policy Director Thomas Gardine told the New York law firm Bass & Ullman in a May 20 letter. Responding to an March 22 letter from the law firm questioning an FDA import alert for evening primrose oil ("The Tan Sheet" March 29, p. 9), Gardine said the agency "does not agree" with two recent federal appellate court rulings or with the law firm's interpretation of the decisions. "In any event," Gardine added, "the agency has not exhausted its judicial remedies in these cases." Bass & Ullman, which represents Traco Labs and Oakmont Investment, had asked FDA to revoke an import alert for evening primrose oil (Alert No. 66-04) based on decisions in federal appeals courts in Chicago and Boston that rejected FDA's legal argument that single-ingredient black currant oil is a "food additive" and therefore must be shown by the processor to be safe ("The Tan Sheet" March 1, p. 7 and March 8, In Brief). FDA's requests for rehearings of the two cases were subsequently rejected by the courts. FDA Commissioner David Kessler recently commented at a press briefing that the agency was considering whether to seek a Supreme Court review of the Traco BCO case ("The Tan Sheet" April 19, p. 1). Gardine said that "FDA will, of course, re-evaluate" the import alert "should the decisions in the First and Seventh Circuits ultimately stand." The FDAer noted that the agency's "concerns . . . persist" regarding evening primrose oil. "Accordingly," he added, "the agency intends to exercise its statutory authority to ensure that any Oil of Evening Primrose that is imported to the U.S. fits within the parameters of the law. While it is never FDA's intention to harass or impose unnecessary economic hardships on importers," Gardine continued, "the agency's primary concern is protection of the American consumer from products that may be adulterated, misbranded or otherwise injurious to health." Bass & Ullman suggested in their March 22 correspondence with Gardine that some imported shipments of evening primrose oil "are being unduly delayed, first on the basis of the import alert and then for an alleged need to test the imported oil." The law firm had asked FDA to "at least" modify the alert by eliminating the automatic detention instructions "relating to a food additive charge." In a May 24 follow-up to Gardine's letter, Bass & Ullman said it understands the letter "to mean that not-withstanding FDA's disagreement" with the two federal appeals court rulings, "the agency will not act in defiance of such decisions, but that it intends to sample, at its discretion, any incoming shipment of EPO (not labeled as a drug), to confirm its single ingredient status." The law firm said it assumes "that this is the basis for the FDA release of the recently sampled and/or detained Traco Labs' EPO shipments in Boston and in Chicago."
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