The White House ‘Deeming’ Review: What’s Next?
How convenience-store retailers, tobacco manufacturers can get involved
WASHINGTON -- More than a year after the public comment period ended, the U.S. Food and Drug Administration (FDA) has finally filed its updated the “deeming” regulations determining whether electronic cigarettes, cigars and other previously undeemed tobacco products fall under the FDA’s control.
“The White House Office of Information and Regulatory Affairs (OIRA) accepted FDA's draft final deeming rule for review on Oct. 19, 2015,” Andrew Perraut, a former OIRA policy analyst who now works as an industry consultant, told Tobacco E-News. “OIRA will coordinate the rule's review at the White House and throughout the federal government, and ensure that it complies with the president's priorities and principles of cost-benefit analysis.”
This represents the eighth step in the nine-step rulemaking process. Following the OIRA/White House Office of Management and Budget (OMB) review, the ninth and final step is for the FDA to issue its finalized regulations to the public.
As Perraut pointed out, unlike the FDA, which considers public health, the White House review seeks to ensure the regulations align with the president’s agenda and looks at the costs and benefits of the proposed regulations. As such, proposed regulations can be significantly changed during the White House review.
Perraut, who worked on the 2014 redrafting of the original proposed deeming regs, said the proposed rule was “fundamentally different” after the White House sent it back to the FDA.
Many within the tobacco and vapor industry are hoping for similar results this time around.
“If the FDA's position on the grandfather date has not radically shifted in the past year, the deeming regulation will unquestionably harm public health and close down thousands of small businesses,” said Gregory Conley, president of the American Vaping Association. “We are hopeful that the OMB will take a serious look at the negative health and financial impacts that will result from deeming these smoke-free and tobacco-free products to be ‘tobacco’.”
Though the FDA’s public comment period ended in August 2014, there is an opportunity for interested parties to participate in the White House review process. According to Perraut, retailers and manufacturers can request a meeting to present their case to OIRA during the review period.
“It’s as important, if not more important, to be engaged during the period of White House review than it is to give comments” to the FDA, he said.
There is no official deadline for the White House to complete its review, but the process typically takes a maximum of 90 days. “Although in some cases the review period may be longer or shorter than that,” Perraut added.
He means that the time to get involved is now—especially since The Cigar Authority reported “the FDA is pushing for an expedited process.”