FDA warning letter
This article was originally published in The Tan Sheet
Executive Summary
Nature's Way Products should take prompt action to correct a number of violations identified during an FDA inspection of the company's Springville, Utah, facility in September, the agency says in a recent letter to the firm. The company was required to notify the agency in writing of specific steps it would take to correct the violations, including the fact its red yeast rice product promoted as a dietary supplement was found to contain lovastatin, an ingredient in FDA-approved drugs used to treat patients with primary hypercholesterolemia, FDA maintains. The product's labeling confirms its use as a drug, since it claims to "prevent, treat, or cure disease conditions or to affect the structure or function of the body," FDA adds. Additionally, the product is misbranded since it fails to bear adequate direction for its intended uses. "Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction," FDA adds. The agency issued similar warnings to other firms and announced a crackdown on adulterated red yeast rice products in August (1"The Tan Sheet" August 13, 2007, In Brief)...
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Nature's Way Products should take prompt action to correct a number of violations identified during an FDA inspection of the company's Springville, Utah, facility in September, the agency says in a recent letter to the firm. The company was required to notify the agency in writing of specific steps it would take to correct the violations, including the fact its red yeast rice product promoted as a dietary supplement was found to contain lovastatin, an ingredient in FDA-approved drugs used to treat patients with primary hypercholesterolemia, FDA maintains. The product's labeling confirms its use as a drug, since it claims to "prevent, treat, or cure disease conditions or to affect the structure or function of the body," FDA adds. Additionally, the product is misbranded since it fails to bear adequate direction for its intended uses. "Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction," FDA adds. The agency issued similar warnings to other firms and announced a crackdown on adulterated red yeast rice products in August (1 'The Tan Sheet' August 13, 2007, In Brief).... |