New FDA Tobacco Plan Is A Mixed Bag

By Ruth Kava — Jul 31, 2017
The FDA announced new regulations on tobacco products — some good, some not so great. We'd like to see the data supporting the idea that lowering the nicotine level in cigarettes would be less addictive. But we applaud the move to give tobacco manufacturers more guidance and time to apply for approval of their products.

Under the new director, Dr. Scott Gottlieb, the Food and Drug Administration just announced a new "comprehensive regulatory plan" to decrease the plague of tobacco-related deaths. While we're pleased to see the FDA continue to pay attention to this totally preventable cause of death, we're not sure that the steps they've outlined will all be effective in doing so.

One of the more questionable aspects of the new plan is the possible encouragement of producing cigarettes with lower nicotine levels as a way to make them less addictive. While we certainly agree that nicotine is highly addictive, we must ask what data suggest that lowering nicotine levels will make it more likely for smokers to be able to quit — in fact the data suggest that's not necessarily true — which we wrote about a couple of years ago. Would it mean that people (especially youngsters) who are beginning to smoke would become less addicted if the level of nicotine were lower? Are there data that support that idea? And would all cigarettes have to have lower nicotine levels? If not, what would encourage new smokers to choose the lower nicotine versions? Obviously, the suggestion will have to be carefully evaluated, which is perhaps why the FDA will open a public comment line on this topic.

We can, however, applaud the FDA's move to extend the timelines for submission of tobacco product review applications for newly regulated tobacco products (those that have been sold since August, 2016). The point of this extension is to encourage "innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes." It will also allow manufacturers more time to improve their products. Manufacturers of combustible products such as cigars, pipe tobacco and hookah tobacco will have until 2021 to submit applications, while non-combustible product manufacturers (e.g. e-cigarettes) will have until 2022 to do so. In addition, the agency's notice states that it will provide regulations "outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE)."

This latter move will help streamline the application process, while the extended deadlines should provide manufacturers a reasonable timeframe in which to respond. Hopefully the FDA will provide its information in a timely manner so that they can do so.