FDA has retracted a warning letter previously issued to Glanbia Performance Nutrition, Inc. that alleged that the company was selling adulterated dietary supplements. The warning letter had been issued as part of a set of 11 such letters, which were also reported in an earlier AHPA Legal Alert.
FDA had erroneously asserted that the company was selling products Uplift Max and Shred Her Max from a sales website which inaccurately claimed to be the property of one of Glanbia Inc.’s subsidiaries, Optimum Nutrition. Glanbia Inc. discovered this error and immediately notified the FDA. Following the retraction, the agency is now investigating the website’s ownership to reissue the warning letter. The agency has updated its previous announcement to reflect the retraction and stated its regret for the confusion caused by the error.
The revised warning letter announcement is available here.