A federal court in Colorado has dismissed as premature a medical provider’s challenge to Food and Drug Administration (FDA) regulations potentially applicable to its medical procedures because the agency had issued only a warning letter against it, and warning letters are not final. Regenerative Sciences, Inc. v. FDA, No. 09-411 (D. Colo., decided March 26, 2010). The court’s analysis of the non-final nature of FDA warning letters may have some relevance in those consumer fraud actions against food makers citing such letters to establish a fact or using them as definitive evidence of wrongdoing or a violation of the law. The agency itself acknowledged that its warning letters do not constitute a determination that a particular statute or regulation applies to the specific circumstances that led FDA to issue the letters, noting “this is a factual issue that cannot be resolved until FDA brings an action against” the letter recipient.

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For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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