PMTA Process • Flavor Bans & Restrictions • Legal Age of Purchase • PACT Act Expansion • Industry Responsibility
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.
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
Increase in Legal Age of Purchase of Tobacco to 21
BACKGROUND: At the end of 2019, Congress passed year-end spending bills that included a provision raising the legal age of purchase of tobacco to 21. While the statutory language outlines a rulemaking process, which would have concluded in fall of 2020, the Food and Drug Administration (FDA) posted a short notice on the website of the Center for Tobacco Policy that indicated the change in legal age of purchase was in effect as of December 20, 2019.
On January 15, 2020, the FDA issued a statement reiterating that the law is in effect.
Regarding retail clerks selling tobacco products, there is no federal minimum age requirement for clerks in retail stores that sell tobacco. However, some states do have minimum age requirements for cashiers selling tobacco products.
STATUS: The Legal Age of Purchase for Tobacco has been raised to 21 and is in effect.
PACT ACT Expansion
BACKGROUND: In June 2010 the original "Prevent All Cigarette Trafficking (PACT) Act" law went into effect. The PACT Act’s major components were: to regulate the mailing of cigarettes and smokeless tobacco products to consumers through the U.S. Postal Service; new requirements for registration, reporting, delivery and record keeping, including a List of Unregistered or Non-Compliant Delivery Sellers; increased penalties to a felony up to three years imprisonment; new inspection authority for the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) to examine any records required to be maintained and any cigarettes or smokeless tobacco kept on the premises.
The bill was passed before the introduction of electronic nicotine delivery systems (ENDS), and thus updates to expand the PACT Act to apply to e-cigarettes were needed.
STATUS: A bill called “Preventing Online Sales of E-Cigarettes to Children,” S. 1253, was introduced by Senators Dianne Feinstein (D-CA), John Cornyn (R-TX) and Chris Van Hollen (D-MD) in April 2019 on December 21, 2020, as part of the omnibus 2021 Consolidated Appropriations Act, Congress passed legislation extending the applicability of the Prevent All Cigarette Trafficking (“PACT”) Act to electronic nicotine delivery systems or “ENDS.”
The provision requires e-cigarette online retailers to:
- Verify the age of customers for all purchases.
- Require an adult with ID to be present for delivery.
- Label shipping packages to show they contain tobacco products.
- Comply with all state and local tobacco tax requirements.
BACKGROUND: The We Card Program, Inc. is a national non-profit organization serving the nation's retailers of tobacco, alcohol, e-cigarettes, vapor products and other age-restricted products. Individual retail establishments, as well as large retail chains, utilize We Card's educational and training services for their compliance efforts with federal, state and local laws on preventing age-restricted product sales to minors.
National and state retail trade associations, government officials, community groups and others also support We Card's ongoing efforts to raise awareness of responsible retailing and age verification requirements and to educate and train retail employees to identify and prevent underage attempts to purchase age-restricted products.
FOR MORE INFORMATION: We Card Program, Inc.
Questions? Contact Kathee Facchiano (firstname.lastname@example.org; (202) 638-1950)
or Sarah Herbert (email@example.com; (202) 638-0326).