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This article was originally published in The Tan Sheet

Executive Summary

EVENING PRIMROSE OIL IMPORT ALERT REVOCATION SOUGHT by the New York law firm Bass & Ullman on behalf of two clients, Traco Labs and Oakmont Investment Co., in a March 22 letter to FDA Import Operations & Policy Director Thomas Gardine. The letter from attorney Robert Ullman cites two recent U.S. circuit court decisions involving the firm's clients and another nutritional ingredient, black currant oil, in which the courts upheld lower court rulings and rejected FDA's legal argument that single- ingredient BCO 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). "In view of the unequivocal and undivided decisions from two circuit and two district courts, it is clear that FDA cannot maintain a position that all evening primrose oil regardless of form or intended use is subject to automatic detention," the letter states. Bass & Ullman noted that the law firm's clients "as well as other companies" have had "numerous shipments" of evening primrose oil detained because of the FDA import alert. According to the law firm, "regional import specialists and supervisors . . . say their hands are tied by the import alert from which they will not vary without express individual direction from Washington" despite the court rulings. Bass & Ullman said that some shipments were "eventually released" by FDA but that other shipments "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 asked FDA to either "immediately" revoke Import Alert No. 66-04 or "at least" immediately modify the alert "by [the] elimination of the automatic detention instructions relating to a food additive charge." The letter asks for a change in FDA's import policy on the basis of the court decisions and without the 180-day wait that would be precipitated by a petition to FDA Commissioner Kessler. The law firm also alleged that "some regional employees of the agency have gone so far as to say that FDA is not bound by the court decisions on this issue." If the courts were to reverse the rulings, FDA could reinstate its current policy, the law firm suggested. "In the meantime," the letter states, "it is hoped that FDA would respect the rulings of the courts and not subject importers to unnecessary, unproductive and harassing proceedings to obtain release of EPO and similar oil imports."

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