FDA warning letter
This article was originally published in The Tan Sheet
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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FDA threatens enforcement action against two firms selling red yeast rice supplements adulterated with lovastatin - the active ingredient in Merck's Rx cholesterol-lowering drug Mevacor. Consumers should not purchase or consume Swanson Healthcare Products' Red Yeast Rice and Red Yeast Rice/Policosonal Complex or Sunburst Biorganics' Cholestrix since FDA testing revealed the presence of the statin, which can cause harmful side-effects such as muscle weakness and kidney issues and may interact with other medications, FDA announces Aug. 9. The agency determined the adulterated supplements are unapproved new drugs, sent warning letters to the companies marketing the products and threatens to employ enforcement actions, such as seizure of illegal products and criminal prosecution if the companies fail to resolve the violations immediately, according to the warning letters. In January 2005, Source Naturals received a courtesy letter from FDA for the same problem (1"The Tan Sheet" Jan. 24, 2005, In Brief)...
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
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