‘Intended Use’ Rule: Industry Urges US FDA To Revoke ‘Totality Of Evidence’ Standard

Trade groups say final rule would allow any activity to be considered evidence of a manufacturer’s intended use of a product and increase exposure to potential liability.

A final rule FDA issued in January has shaken industry groups who say it creates a new legal standard for assessing a manufacturer’s “intended use” of a product that will allow any evidence to be used to bring a criminal misbranding action – thus exposing companies to potential liability for normal business activity.

Revisions to the “intended uses” regulations were included in a final rule on tobacco-derived products. “If the totality of evidence...