Deeming Regulations: ‘The 800-Pound Gorilla’

LAS VEGAS -- Among the attendees and exhibitors at this week’s 2014 Tobacco Plus Convenience Expo, there was one issue looming large, even if it was unseen: deeming regulations.

Calling deeming regulations the "800-pound gorilla in the room," Bryan Haynes, partner in the tobacco practice at Troutman Sanders, said people ask him every day when the Food and Drug Administration (FDA) is going to publish its deeming regulations for tobacco products. His answer, jokingly, is that anyone who tells you they know "is a liar."

Deeming regulations stem from a provision of the 2009 Tobacco Control Act (TCA) that states that other tobacco products not specified in the TCA fall under the FDA’s authority. Those other tobacco products mainly include electronic cigarettes and cigars.

It is widely known that the FDA has prepared deeming regulations and submitted them to the federal Office of Management and Budget (OMB) for review in October. That step, according to Haynes, is an important check on the agency's authority and prevents over-regulation. However, it can also be a source of additional delay -- as is the case currently. The OMB had up to 90 days to release the deeming regulations, but has missed that deadline.

Once the OMB finishes its review, the deeming regulations will be published and a 60- to 90-day public comment period will be opened, Haynes explained.

Just when that will happen is anyone's guess. And even if the deeming regulations are published tomorrow, final implementation will take some time. The FDA could take up to six months to review the public comments before preparing a final rule, which then must be submitted to the OMB for a final analysis, Haynes said.

As for timing, he predicts it will take approximately one year from when the deeming regulations become public to when the final rule takes effect.