The FDA’s New Deeming Regulations — Get Your Comments In!

The FDA issued proposed regulations yesterday that would extend the FDA’s regulatory authority under the Tobacco Control Act to all tobacco products, including e-cigarettes, cigars and pipe tobacco. It is important to note that this is a proposal only, and the regulations could become more reasonable or more onerous after a public comment period.

The regulations specify a 75-day period for the public to submit comments on the proposed regulations. The comment period begins April 26, 2014 and ends July 9, 2014. There is the possibility that the comment period could be extended, and given the importance of the proposed regulations, some stakeholders have already begun urging an extension of the comment period.

We cannot overstate the importance of submitting comments if you believe the proposed regulations have the potential to impact your business. The FDA has the legal obligation to consider your comments in drafting the final regulations, and it is not uncommon for regulations to be changed based on public input.

The FDA is actively encouraging comments, noting that “this is not a spectator sport.” Given the FDA’s acknowledgment that it currently has “more questions than answers” about the newly-deemed products, affected stakeholders should make their positions known regarding the FDA’s proposal.

We have assisted many clients with submitting comments on proposed FDA regulations, so please call us if you are impacted by the FDA’s proposal.

For questions and/or comments, please contact Bryan Haynes, Troutman Sanders Tobacco practice partner, at 804.697.1420 or by email.