Troutman Sanders tobacco team partner Bryan Haynes was quoted in a January 30th Convenience Store News (“CSN”) article titled “Deeming Regulations: ‘The 800-Pound Gorilla.’”
Bryan Haynes and Nancyellen Keane gave the keynote speech at TPC 2014 on FDA regulation of tobacco products, regarding both the regulations currently in place and those regulations that the industry is waiting on with bated breath – the deeming regulations on other tobacco products, such as e-cigarettes and cigars. As expected, the talk of the convention was the deeming regulations, and when they will be released. During his speech, Haynes joked that anyone who says they know the date of their publication “is a liar.”
Much is still unknown about the regulations. The only solid fact is that they have now been under review with the Office of Management and Budget (“OMB”). Once the review process with the OMB is complete, Haynes stated that the FDA will open a public comment period on the regulations, which could last somewhere between 60-90 days. Once the comment period has elapsed the FDA will review the collected comments – a process that could take several months on its own. Then, a final rule will be issued by the FDA, and it will undergo one more review process at the OMB before the rule is made final. All in all, Haynes says, one might expect the process to take over a year from the date that the regulations are initially made public.
To read the full article, click here.