WASHINGTON -- Though the public comment period for the U.S. Food and Drug Administration’s (FDA) proposed “deeming” regulations ended some 16 months ago, manufacturers, retailers and anti-tobacco groups alike are actively weighing in.
According to The Hill, since the White House Office of Management and Budget (OMB) received the FDA’s final deeming regulations in October, 21 meetings have been held to discuss the matter, with at least another dozen scheduled for December.
The much-contested regulations, which would “deem” that the FDA has authority over previously unregulated tobacco segments such as cigars and electronic cigarettes, were originally intended to be finalized this summer. A formal rulemaking agenda from the FDA later pushed that deadline back to Nov. 30, 2015. With that date having coming and gone, The Hill reports it “appears unlikely” the regulations will be published this year.
E-vapor manufacturers and advocates, including the Smoke-Free Alternatives Trade Association (SFATA) and Bill Godshall of Smokefree Pennsylvania, have called meetings to discuss the potentially devastating effects the pre-market tobacco product application (PMTA) requirement will have on the tobacco industry. Under the proposed regulations, any product that wasn’t on the market by Feb. 15, 2007, would be required to submit a time-and-cost-consuming PMTA—which Godshall likened to an outright ban of most vapor products.
“The FDA has failed miserably on both sides of their cost/benefit analysis of deeming’s impact on vapor products,” Godshall posted to the E-Cigarette Forum. “FDA failed to quantify any benefit of banning the products, and FDA have either not quantified at all, or dramatically under counted on the cost side as well as their assessment of impacts on small businesses.”
Groups like the Campaign for Tobacco-Free Kids, however, argue that the OMB should be considering health, not economics.
“E-cigarette companies say it will put them out of business, but this law is about protecting kids and public health,” Vince Willmore vice president of communications for the Campaign for Tobacco-Free Kids, told The Hill. “It’s not about protecting the ability of manufacturers to sell candy flavored e-cigs and cigars.”
Though the OMB does not comment on pending reviews or meetings, individuals and groups who have met with the OMB expressed optimism about the process.
“It’s always a good thing to be able to go and speak your mind and be heard,” Schell Hammel, owner of the McKinney, Texas-based Vapor Bar Inc., told The Hill “I think they have been very interested in hearing everything.”