Cig Label Fight Shows Growing Pains in New FDA Oversight
Richmond partner Bryan Haynes was quoted in a June 3 Law360 article about the FDA in late May deciding to hold off on pursuing a new guidance it issued in March that would require tobacco companies to go through a premarket approval process before they could make any significant changes to product labels. The decision to ease up on enforcing the policy came after a lawsuit by tobacco giant Philip Morris and others, who criticized the agency for trying to push through the new policy in the form of “swift guidance” rather than taking the more “drawn-out notice-and-comment rule-making procedure.”
According to the article, experts are saying the agency’s move to advance the new requirement and big tobacco’s response is an example of the regulator and the regulated trying to gauge how far they can push each other in this early phase of federal oversight for the tobacco industry. The FDA’s tactic also can put regulated companies in doubt about whether to comply or launch legal challenges, corporate attorneys say.
“It can be a difficult situation to be in when advising clients on compliance,” Bryan said. “The guidance may or may not be enforced, and it puts companies in the position of complying with a law or the agency’s interpretation of the law that they don’t agree with, or not complying and risking enforcement action. Because in some cases they can be limited in their ability to challenge that guidance, because of ripeness issues.”