Tobacco Issues
PMTA Process • Flavor Bans & Restrictions
Nicotine
The Biden administration has announced a plan to publish a proposed rule to limit nicotine in cigarettes. CDA will provide opportunities to engage on this issue when the proposed rule is published.
PMTA Process
BACKGROUND: The 2009 Tobacco Control Act gave the Food and Drug Administration (FDA) the authority to “deem” new products containing “nicotine made or derived from tobacco” to be a tobacco product, putting e-cigarettes squarely under the jurisdiction of the FDA.
As Congress and now three Administrations have grappled with regulation of e-cigarettes and the changing landscape related to reduced harm products and youth usage, there have been numerous changes to the Deeming Regulations and PMTA deadlines for ENDS. The FDA’s website notes that Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule has been revised seven times, creating a sense of confusion and uncertainty for the market.
On May 5, 2016, the FDA announced the finalized Deeming Rule, which deemed certain products to be subject to the Tobacco Control Act. The agency also issued guidance for industry to instruct manufacturers in the PMTA process. The deeming regulations were to take effect on Aug. 8, 2016. The deadline for submission of PMTAs for existing products would be Aug. 8, 2018.
In the summer of 2019, a Federal judge for the U.S. District Court for Maryland ruled that manufacturers and importers of products such as e-cigarettes and ENDS have 10 months to submit applications for marketing to the FDA. The deadline is applicable to new tobacco products on the market as of the Aug. 8, 2016 deeming rule that extended the FDA’s regulatory jurisdiction to include all tobacco products. Thus, manufacturers of e-cigarettes were given until May 12, 2020 to submit applications for market approval in order to continue selling their products, a deadline which was extended again at the request of FDA until September 9, 2020. CDA urged the FDA to provide data on which products manufacturers have filed applications for, as a way to assist members in their efforts to comply with the regulations
On March 15, 2022, President Biden signed the “Consolidated Appropriations Act of 2022” into law. The new law amends the definition of the term “tobacco product” under the Family Smoking Prevention and Tobacco Control Act to define a tobacco product as “any product made or derived from tobacco or containing nicotine from any source, that is intended for human consumption." Electronic vapor products that contain synthetic nicotine are now subject to FDA regulation.
The law became effective on April 14, 2022, and manufacturers will have until May 14, 2022 to either submit a premarket tobacco product application (PMTA) to the FDA for each of their electronic vapor products that contain synthetic nicotine or stop marketing those products in the marketplace. Manufacturers that do submit a PMTA to the FDA by the May 14, 2022 deadline can continue marketing their products until July 13, 2022, after which time the products must be removed from retail stores unless the FDA has issued a PMTA marketing authorization order by the July 13, 2022 deadline date.
The FDA has begun to issue warning letters to manufacturers who have not submitted PMTAs and have indicated they will soon enforce against those companies whose marketing orders have been denied.
STATUS: Products for which PMTA Applications have been filed can be viewed here.
FOR MORE INFORMATION: FDA website
Flavor Bans & Restrictions
BACKGROUND: In September 2019, the Trump Administration announced a ban on flavored vape products. In early January 2020, then-Secretary Azar released industry guidance which outlines the agency’s enforcement priorities to focus on flavored pod-based electronic nicotine delivery systems (ENDS), other than tobacco and menthol. While not an outright ban, it was a de facto ban on some types of vape products, as the agency prioritized enforcement against pod-based flavored ENDS products that have not been through premarket authorization. The policy does not apply to “open tank” type vaping systems or disposables.
STATUS: The new enforcement standards for certain flavors of pod-based vape products are in effect. Many states and localities have enacted bans on flavored tobacco products, including ENDS.
In April 2021, the FDA announced its plans to propose tobacco product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars. On May 4, 2022, FDA published two new standards for tobacco products in the Federal Register:
The comment period opened on May 4, 2022 and ended on Aug. 2, 2022.
CDA submitted comments on behalf of the industry.
FOR MORE INFORMATION: the Congressional Research Service Report can be found at
Regulation of Electronic Nicotine Delivery Systems (ENDS): Background and Select Policy Issues in the 117th Congress
Questions? Contact Tom Briant (tomb@cdaweb.net; (703) 208-1641),
Kathee Facchiano (kfacchiano@capitoldecisions.com; (202) 638-1950)
or Sarah Herbert (sherbert@capitoldecisions.com; (202) 638-0326).