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Traco evening primrose oil

This article was originally published in The Tan Sheet

Executive Summary

FDA warning letter sent March 23 chastises the company for distributing the imported product prior to receiving a "May Proceed or Release Notice" from FDA. The agency sent the warning letter to Traco after the imported product was "returned intact" to FDA's field office in Boston, the port of entry for the product. In an April 6 letter, Traco asserted that because the product was returned "intact, . . . the alleged violation did not occur" and the warning letter "should not have been issued." Sampling was completed to FDA's satisfaction and a "May Proceed" notice is expected soon, Traco said. Reportedly, Traco agreed to market EPO only as a single ingredient at FDA's request.
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