FDA Commissioner Gottlieb says low-risk nicotine products are the future — but are they our products?
The FDA is planning to take most of the nicotine out of cigarettes, to try and move smokers to safer forms of nicotine. How does that affect vaping?
FDA Commissioner Scott Gottlieb announced last July a comprehensive approach to nicotine and tobacco regulation that would reduce nicotine in cigarettes, while encouraging smokers to migrate to low-risk nicotine products. At that time the agency extended the deadline for deemed tobacco products like vapes to submit applications for marketing approval to 2022.
Since then the tobacco regulators have begun working toward the goal of remaking the nicotine landscape. Thursday the FDA launched its plan in earnest, publishing an Advanced Notice of Proposed Rulemaking (ANPRM) — a call for public comment on its intention to reduce the nicotine in cigarettes below addictive levels. The comment period is 90 days.
While the 2009 legislation that underpins all regulation from the FDA’s Center for Tobacco Products (CTP) — the Family Smoking Prevention and Tobacco Control Act (TCA) — prevents the FDA from eliminating all nicotine in cigarettes, it does allow the agency to reduce the levels of the drug. The idea of lowering nicotine content in cigarettes has been around since at least 1994. Now it finally has a powerful advocate in Gottlieb, and backing from the Trump Administration.
Without the protection a Cole-Bishop fix to the deeming predicate date provides, vaping will likely twist in the wind, and the independent industry will probably wither and die.
The next ANPRM the agency publishes will be a call for comments on the regulation of e-liquid flavors, which the FDA is framing as a choice between “kid-appealing” flavors and products that are made to help smokers switch. Meanwhile, Gottlieb said in his statement Thursday that the FDA will “take vigorous enforcement steps to make sure that tobacco products aren’t being marketed to kids, including e-cigarettes.”
The other major FDA nicotine initiative will be to “re-evaluate and modernize our approach to the development and regulation of safe and effective medicinal nicotine replacement products such as nicotine gums, patches and lozenges that help smokers quit.”
The process of improving pharmaceutical cessation products could mean that future vaping products will be made by names like Pfizer and Johnson & Johnson, and sold in pharmacies instead of vape shops. Nicotine replacement therapy products haven’t proven to be very successful, in large part because they don’t replace the act of smoking.
Read more at http://vaping360.com