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FDA warns Mountain Meadow Herbs

This article was originally published in The Tan Sheet

Executive Summary

FDA makes good on its promise to follow up on enforcement actions by sending a warning letter to Mountain Meadow Herbs after the firm inadequately corrected problems identified during an inspection. In a Sept. 21 letter, the agency warns the Kalispell, Mont., supplement firm to revise claims that make its supplements Natural Attention-Aid, Winter-Immune Booster, Herbal Respiratory and othersunapproved new drugs. The letter follows several notices the agency sent the firm after it inspected its manufacturing facility and notified it of similar concerns. Mountain Meadow Herbs revised its claims in response to the first notice, but the changes did not satisfy FDA. Commissioner Margaret Hamburg said Aug. 6 the agency will follow up on warning letters and other enforcement actions. FDA also set a firm 15-day post-inspection deadline for firms to respond to inspections (1"The Tan Sheet" Aug. 10, 2009)

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