On July 28, 2017, when FDA commissioner Scott Gottlieb announced a four-year delay for the final deadline to submit premarket tobacco applications (PMTA’s) for vapor products (and other newly deemed “tobacco” products), it created some confusion among vapers and vape vendors. We created this timeline to offer an easy-to-understand timeline of deadlines that remain in the deeming process. It is up to date as of July 31, 2018 — and we’ll keep it that way if additional changes happen.
No. The delay for PMTA submission allows products that were already available before August 8, 2016 to remain on the market until August 8, 2022. Any products introduced after August 8, 2016 must have a marketing order from the FDA before sale. That means all new products require a PMTA to be filed and approved.
Nothing has changed yet. But the Gottlieb announcement included the promise that the agency would make some big changes.According to the agency’s July 28 press release, “the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission.“Among other things, the FDA intends to issue 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). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS.”
Not immediately, but the agency has begun the process of regulating flavors, and the wording in the advanced notice for proposed rulemaking is not encouraging. The entire endeavor is predicated on how flavors will affect youth vaping uptake. Remember, the FDA has the authority to ban or restrict the availability of flavors in all deemed products. In fact, the agency originally planned to ban flavors, but were prevented after review by the White House Office of Management and Budget (OMB).
The FDA says no. The most-discussed part of Gottlieb’s announcement — for everyone but vapers, that is — was his suggestion that the FDA would reduce the nicotine in cigarettes to eliminate their “addictive potential.”“Armed with the recognition of the risk continuum, and the reality that all roads lead back to cigarettes as the primary cause of the current problem, we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels,” said Commissioner Gottlieb. “And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.”That seems to indicate that vapor products with “satisfying levels” of nicotine will still be around. BUT…who knows what the FDA will decide to do if and when they are able to reduce the nicotine in cigarettes? Having fulfilled the fantasy of many tobacco control zealots, who can say they won’t continue and try to create a nicotine-free world?However, the process of showing that “Very Low Nicotine Cigarettes” (VLNC’s) can be effective in reducing smoking, and that they won’t simply create the biggest black market for any product ever, will be a long and tedious one for the agency. So if the FDA ever gets around to trying to reduce or eliminate nicotine in vapes, it will be many years down the road.