FDA Announces New Initiatives and Policy Changes for Premarket Applications and E-Cigarettes

On the ninth anniversary of the Family Smoking Prevention and Tobacco Control Act (TCA) being signed into law, Scott Gottlieb, M.D., the commissioner of the U.S. Food and Drug Administration (FDA) penned a new blog post revealing his agency’s plan for reviewing submissions to the three tobacco-related Advanced Notice of Proposed Rulemaking (ANPRM) issued earlier this year.

The FDA has made nicotine and addiction to tobacco products one of its main tobacco product focuses in 2018. Gottlieb and the FDA acknowledges that nicotine isn’t directly responsible for the morbidity and mortality from tobacco but that it’s part of what makes cigarettes addictive. That’s why the FDA has been making moves to minimize addiction to what it views as the most harmful products while doing its part to also encourage innovation and ways for smokers to have access to nicotine without the harmful effects of combustion and cigarettes. That initiative is part of why the FDA issued the three tobacco-related ANPRMs, exploring the topics of flavors in tobacco products, nicotine levels, and premium cigar regulation. The commenting period was extended into July and has since ended, with the FDA now reviewing all the comments and submissions made.

Gottlieb also revealed the FDA is pursuing new policies to improve the efficiency and effectiveness of the agency’s tobacco regulatory programs. The FDA is currently working on improving the process behind developing nicotine replacement therapy (NRT) products.

“The agency’s efforts to re-evaluate and modernize its approach to the development and regulation of NRT products is aimed at opening up new pathways for the development of improved products, regulated as new drugs, that demonstrate that they are safe and effective for the purpose of helping smokers quit,” wrote Gottlieb.

He also acknowledges that the process for filing product applications needs to improve, another new aim for the FDA. New efforts are underway to improve transparency and efficiency of the premarket review process, something many manufacturers have had issue with and complained about as regulations have increased. With this, the FDA hopes to advance the premarket review of tobacco products. To accomplish this, the FDA will be publishing fundamental rules regarding premarket applications, holding a public meeting on premarket review, and will look into ways to modernize and improve the premarket review process.

Gottlieb reaffirmed the FDA’s crackdown on underage use of e-cigarettes and devices like JUUL. The FDA will be expediting action on flavors–especially those related to e-cigarettes and e-liquids–and will be developing an e-cigarette product standard. The FDA is also looking to improve its handling of violations and the speed in which it enforces the law when a business or company is seen in violation of policy. This includes strengthening its relationship with other agencies including the Federal Trade Commission.

To read the full blog post from the FDA and all the new policy initiatives announced, click here.