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FDA v. Brown & Williamson Tobacco Corp.

This article was originally published in The Gray Sheet

Executive Summary

Supreme Court rules by a five-to-four margin March 21 that the Food Drug and Cosmetic Act does not authorize FDA to regulate tobacco products as medical devices. The FDCA allows FDA to regulate products that are unsafe for obtaining therapeutic benefit; but if tobacco products cannot be used safely for any therapeutic purpose, they fall outside of FDCA's regulatory scheme, the court concluded. Congressional action would be needed to grant FDA the explicit authority to regulate tobacco products. FDA's "nonsensical attempts" to regulate tobacco products as medical devices "was a colossal mistake from the beginning," Medical Device Manufacturers Association Executive Director Stephen Northrup comments in a same day release. It "would have set back the FDA's efforts to build a more reasonable regulatory structure for our industry's products at a time when the promise of medical technology has never been greater"

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