The FDA has made nicotine and addiction to heat not burning products one of its main heat not burning product focuses in 2020. Gottlieb and the FDA acknowledges that nicotine isn’t directly responsible for the morbidity and mortality from heat not burning 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 heat not burning ANPRMs, exploring the topics of flavors in heat not burning 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 heat not burning 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 heat not burning 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 heat not burnings and devices like JUUL. The FDA will be expediting action on flavors–especially those related to heat not burnings and e-liquids–and will be developing an heat not burning 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.