The Reagan-Udall Foundation report reviewing the Food and Drug Administration’s Center for Tobacco Products (CTP) has validated many criticisms those in the tobacco industry already had with the agency: The premarket tobacco product application (PMTA) process is flawed, the agency’s goals are unclear and enforcement of illegal vapor products is lacking, the report, released in December, said, among other conclusions.
“I think they’ve lost sight of their mission a little bit,” Stacy Ehrlich, partner at Washington, D.C.-based Kleinfeld, Kaplan and Becker, said of the CTP. Ehrlich has been extensively involved with the FDA’s regulation of tobacco and nicotine products since the early legislative process of the Family Smoking Prevention and Tobacco Control Act.
The product standards the FDA is considering—like the menthol cigarette ban and the reduction of nicotine levels in cigarettes—only work if the agency has authorized appealing and satisfying, lower-risk alternatives for smokers, she said, which they haven’t yet.
“That’s a huge concern of mine. If we really want this vision to work, this comprehensive plan where we move smokers down the continuum of harm, we can’t just ban stuff and remove products from the market without giving these people who are addicted to nicotine alternatives that are lower risk,” she said. “I think the agency is too focused on youth initiation, especially in light of how rates of use of combustible products by youth have really diminished substantially.”
Being transparent with PMTA reviews and processing them in a timely fashion, while at the same time enforcing against players who are blatantly ignoring FDA’s rules, should also be a priority, she said.
For Greg Conley, the director of legislative and external affairs for the American Vapor Manufacturers Association, is not hopeful.
“We don’t think more money and enforcement powers is going to solve anything when the agency is looking to ban 99.9% of vaping products on the market,” he said. “More enforcement money is not going to do anything to stop the illicit market that is already started to pop up in areas that have banned flavors.”
Based on the track records of FDA Commissioner Robert Califf and CTP Director Brian King, there’s no reason to believe they are going to make it easier to introduce a new nicotine or tobacco product, Conley said.
Califf said the agency will review the report’s recommendations and provide an update on next steps by early February. The FDA responded to the report on its website but declined further comment to CSP Daily News.
Azim Chowdhury, tobacco and e-vapor partner at Keller and Heckman, agreed with Conley, noting that while the FDA was given a tough task to review entirely new tobacco products form e-cigarettes to modern oral nicotine, its requirements for PMTAs were unrealistic. The randomized controlled trials or longitudinal studies the agency said it required for flavored tobacco products take millions of dollars and years to complete, and manufacturers weren’t given enough notice about them, he said.
“It doesn’t seem like FDA is moving away from its position that to demonstrate that a flavored product is appropriate for the protection of the public health, the company, the applicant, needs to include the highest type of data,” Chowdhury said.
Supplier Standpoint
Chris Howard, executive vice president of external affairs and new product compliance with Swisher, Jacksonville, Florida, said he was happy to see several recommendations related to increasing transparency with respect to submission and review of PMTAs. Swisher’s sister company E-Alternative Solutions has pending applications.
“Manufacturers have consistently requested clear articulation of standards utilized by CTP in determining whether tobacco products are appropriate for the protection of public health and CTP’s policies related to the same,” he said. “It goes without saying that the industry would also benefit from a better understanding of the review procedures and by having access to public summaries of the decision-making process with respect to both market granted orders and market denial orders.”
The Regan-Udall Foundation clearly understands the industry’s desire for additional enforcement by the CTP, Howard said.
“The proliferation of non-compliant flavored disposable vapor products in particular has been frustrating for companies that play by the rules and strive to meet CTP’s requirements,” he said. “The good news is that Director King has already made it clear that CTP is exploring alternative approaches to enforcement in line with the Foundation’s recommendations.”