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


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.