Session 1: Enforcement of existing U.S. tobacco and nicotine regulations

While the title is a bit deceiving, the session wasn’t. Moderator Patricia Kovacevic, general counsel and chief compliance officer for Nicopure Labs, said the purpose of the gathering was to give attendees an overview of regulations in the U.S. today, where those regulations are going and what will be the focus of regulation will in the future.

The crowd was reminded that the U.S. Food and Drug Administration (FDA) is just one of many actors involved in tobacco regulation. The industry is also governed by state and local governments. The session opened with an overview of FDA Commissioner Scott Gottlieb’s announcement, on July 28, that he said would help reframe the debate surrounding tobacco and vapor products in a more productive way. Gottlieb announced an extension of the premarket tobacco product application (PMTA) deadlines for newly deemed tobacco products.

In his announcement, Gottlieb envisioned “a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources.” The FDA’s new approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts.

According to the FDA, a key piece of its approach is demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.

This is a huge change of direction for the FDA, noted one speaker, despite the fact that Mitch Zeller, director of the FDA Center for Tobacco Products, had been giving essentially the same speech for the past four years.

The agency has been touting harm reduction and relative risk for some time now. However, the industry has never seen any action from the FDA that would be reflective of those views. That’s why the industry should be weary until it sees how the agency intends to move forward, according to the panelist, who added that this isn’t going to be a quick process because rule-making takes a long time.

Another speaker speculated that the FDA could move quickly on tobacco regulations because it realizes there might only be a limited amount of time—if President Donald Trump isn’t re-elected in 2020—to act on the new regulations.

Innovation is dead under current regulations, noted one panelist. The FDA is not allowing any new products on the market that were not on the market as of Aug. 8, 2016. This is a detriment to public health and should be a focal point for the industry moving forward. Allowing innovation will help convert more smokers to less-harmful products.

It was also said that, even if the FDA wants to base its rules on science, members of Congress might act differently. Politicians will often move in the direction they see as the way their constituents want them to move, and that may not be based on science. Perception is everything, the speaker said. If vapor is perceived to be just as bad as smoking, the industry will have to fight every step of the way. That public perception needs to be changed. Current regulations prevent any company with potentially less harmful products, such as vapor or snus, from claiming that these products are safer than combustible cigarettes.

Meanwhile, there are numerous battles being fought in many U.S. states. More than 300 vapor-related bills had already been filed in 2017, including more than 50 vapor tax proposals in 25 states. There are also more than 30 indoor clean air ban expansion bills and more than 50 proposals increasing the legal age to vape.

Many vapor and tobacco battles have been won. For example, Indiana had its unconstitutional vapor law revoked, a 60 percent wholesale tax on vapor was defeated in Ohio, and a proposed 86 percent vapor wholesale tax was rejected in Utah.

Nonetheless, these battles must continue to be fought on every front to help the industry grow and succeed in helping smokers quit.