On Dec. 2, 2021, the Food and Drug Administration (FDA) Center for Tobacco Products Director Mitch Zeller presented a live webinar on FDA tobacco regulations. The presentation focused on premarket tobacco applications (PMTA), the new graphic cigarette health warnings and synthetic nicotine products, and gave insights into what might await the category in the new year.
Premarket Tobacco Applications
FDA regulations required that manufacturers of cigars (excluding premium cigars), pipe tobacco, electronic cigarette products, hookah tobacco and oral nicotine products, which were introduced in the market after Feb. 15, 2007, and on the market as of Aug. 8, 2016, file a PMTA with the agency by Sept. 9, 2020. A PMTA filing allowed the product to continue to be sold while the FDA reviewed the PMTA to determine if the product should remain on the market.
More than 15,000 PMTAs covering nearly 6.7 million tobacco products were filed with the FDA by Sept. 9, 2020. The vast majority of these PMTAs were for electronic nicotine delivery systems (ENDS).
According to Zeller, manufacturers must provide robust, reliable evidence that the product’s potential benefit for adult smokers outweighs the risk to youth. Then, the FDA must review each PMTA and assess the scientific evidence an applicant submits to determine whether the product is “appropriate for the protection of the public health,” based on risks and benefits to users and nonusers, i.e., whether current tobacco users would stop or reduce their usage, or current nonusers start using tobacco products.
As of early December, the FDA had reviewed about 99% of the 15,000-plus PMTA applications. The agency continues working on PMTAs that cover some 55,000 ENDS.
Zeller indicated that the FDA has issued Refuse to Accept (RTA) letters and Refuse to File (RTF) letters to manufacturers for over 5 million ENDS products because the PMTAs had deficiencies in or information missing from them. These letters mean that a manufacturer needs to remove the products coverd by a PMTA from the marketplace. In addition, the FDA has issued Marketing Denial Orders (MDO) denying PMTAs for more than 1 million flavored ENDS.
Manufacturers have filed 46 lawsuits challenging individual MDOs issued by the agency, and 45 of the legal challenges are still pending. In addition, manufacturers have requested dozens of agency reviews of MDOs issued on PMTAs.
Ten new tobacco products have received Marketing Granted Orders (MGO), which means a PMTA was authorized and the product can remain on the market. The MGOs include R.J. Reynolds Vapor Co.’s Vuse Solo tobacco-flavored ENDS and several U.S. Smokeless Tobacco Co.’s Verve oral nicotine products.
Graphic Health Warnings
The FDA’s new health warning rule requires graphic health warnings on cigarette packages and advertisements beginning Jan. 9, 2023. However, there are two pending lawsuits filed by manufacturers seeking to overturn the new graphic cigarette health warnings.
Menthol Cigarette & Flavored Cigar Ban
By April of this year, the FDA plans to issue two new regulations that would prohibit menthol in cigarettes and ban characterizing flavors in all cigars. FDA believes that the new regulations will reduce youth initiation, increase chances of smoking cessation and address health disparities among certain population segments.
Under current federal law, nicotine made or derived from tobacco is considered to be a tobacco product and regulated by the FDA. However, Zeller indicated that when nicotine is not derived from tobacco, FDA’s regulatory authority is less clear.
Previously, chemistry readily differentiated tobacco-based nicotine from synthetic nicotine, but changes in synthetic nicotine make that differentiation more difficult. The FDA is concerned, from the standpoint of public health and fairness to manufacturers that filed PMTAs for products containing nicotine derived from tobacco, about those manufacturers using synthetic nicotine to evade federal regulation. The agency is exploring how to address synthetic nicotine and has made Congress aware of the synthetic nicotine issue.
Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATO’s mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco segment in a responsible manner.