PACT Act • Flavored Vape Restrictions • Deeming Regulations/PMTA Deadlines • Legal Age of Purchase • Industry Responsibility
H.R. 2339 - Reversing the Youth Tobacco Epidemic Act of 2019
BACKGROUND: In April 2019, the Chairman of the Energy and Commerce Committee introduced legislation that included a ban on all flavors and raised the legal age of purchases to 21. The bill was referred to the Energy and Commerce Committee and on Nov. 19, 2019 the bill was favorably reported out by the committee. CDA went on the record, communicating in writing directly to members of the Energy and Commerce Committee the association’s concern about the flavor bans in the bill.
10/30/2019 - CDA sent an alert to members of the Executive Committee and Government Affairs Committee updating them on the status of the bill.
11/11/2019 – CDA sent an email to all 55 members of the Energy and Commerce Committee urging them not to support the flavor ban in H.R. 2339. The email included CDA’s Economic Impact Fact Sheet as well as a letter from signed by Kimberly Bolin.
11/18/2019 - CDA issued a call to action asking all CDA members to contact their MOC’s directly to oppose H.R. 2339
STATUS: The bill was reported out of the full Energy and Commerce Committee favorably on Nov. 19, 2019 by a vote of 28-24 and was passed by the full House on Feb. 28, 2020. A related bill, S. 3174, was introduced in early 2020, but Senate action is unlikely in the remainder of this Congress.
PACT ACT Expansion
BACKGROUND: The original "Prevent All Cigarette Trafficking (PACT) Act" law went into effect on June 29, 2010. The PACT Act’s major components are as follows: it regulates the mailing of cigarettes and smokeless tobacco products to consumers through the U.S. Postal Service; adds new requirements for registration, reporting, delivery and record keeping, including a List of Unregistered or Non-Compliant Delivery Sellers; increases penalties to a felony up to three years imprisonment; and gives the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) inspection authority 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 CDA supports expansion of the PACT Act to apply to e-cigarettes. 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. The bill would prevent sales of e-cigarettes to minors by applying the same safeguards already in place for regular cigarettes and smokeless tobacco products. An identical bill, H.R. 3942, was introduced in the House by Representative Rep. Rosa DeLauro (D-CT) in July 2019.
Specifically, the bill would require 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.
STATUS: The House bill passed by voice vote in October 2019 and the Senate bill was passed on July 2, 2020. The bills were not identical, so the House will have to pass the Senate version or a negotiated compromise bill will have to be passed by both chambers before the President can sign the bill into law.
Flavored Vape Restrictions
BACKGROUND: In September 2019, the Trump Administration announced a ban on flavored vape products in a high-profile Oval Office meeting attended by Acting Food and Drug Administration (FDA) Commissioner Dr. Ned Sharpless, Health and Human Services (HHS) Secretary Alex Azar, the President and the First Lady. The President’s strong words, which seemed unequivocal, led to national headlines indicating that the Administration planned to ban flavored vaping products.
In early January 2020, Secretary Azar released industry guidance which outlines that the agency’s enforcement priorities will focus on flavored pod-based electronic nicotine delivery systems (ENDS), other than tobacco and menthol. While not an outright ban, it is a de facto ban on some types of vape products, as the agency will prioritize 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.
CDA sent alerts on this topic on Sept. 11, 2019 and an update in the Convenience Distribution News e-news on Jan. 2, 2020.
STATUS: The new enforcement standards for certain flavors of pod-based vape products is in effect.
Changes in Deeming Regulations and Moving Targets for PMTA Deadlines
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.
On April 24, 2014, the FDA released its proposed regulations, which would eliminate many products by requiring manufacturers to submit premarket tobacco applications (PMTAs) for all existing products within two years after the final rule was issued.
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 2017, newly confirmed FDA Commissioner Dr. Scott Gottlieb signaled that there is a positive role for e-cigarettes, saying, “We need to redouble efforts to help more smokers become tobacco-free. And, we need to have the science base to explore the potential to move current smokers – unable or unwilling to quit – to less harmful products, if they can’t quit altogether.”
Gottlieb also lead efforts at the FDA to lower nicotine levels and began a rulemaking to reduce nicotine in cigarettes to below addictive levels. Gottlieb said that e-cigarettes were an important part of his “comprehensive plan,” and that the FDA would postpone the 2018 PMTA submission deadline for four years, until Aug. 8, 2022, to allow time for the agency to create workable premarket review standards. He also said that while applications were being reviewed, products could remain on the market indefinitely (prior guidance allowed them to be sold for only one year, even if the FDA had not determined their eligibility).
In mid-2017, stories of widespread use of JUUL products by teenagers began to hit the media, with flavors being cited as a major driver of youth usage. In March 2018, the FDA issued its advanced notice of proposed rulemaking for flavors. On Nov. 15, 2018, Commissioner Gottlieb gave a speech announcing a ban on flavors, (other than tobacco, menthol and mint) except for sales in adult-only stores, like vape or tobacco shops. This was particularly alarming to CDA members, and the association submitted a strongly worded letter to the Commissioner pushing back against the proposal, which puts the convenience channel at a disadvantage and violates the Tobacco Control Act. He also promised new guidelines for online sales that would require “heightened” age verification standards.
Under pressure, Commissioner Gottlieb began shifting his focus to teen nicotine use. By summer, he was using the word “epidemic,” and in September 2019, the FDA chief threatened to ban flavors and possibly remove products from the market, based on unpublished preliminary data from a 2018 Centers for Disease Control and Prevention (CDC) survey. The agency announced a $60 million ad campaign featuring a video titled “Epidemic,” which shows teenagers infested with bugs crawling under their skin while they vaped.
As Congress and two 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.
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 now have until May 12, 2020 to submit applications for market approval in order to continue selling their products.
STATUS: As the COVID-19 pandemic took hold, the FDA petitioned the U.S. District Court to extend the deadline for applications. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.
CDA has shared materials that CDA members can us to request information on the PMTA and SE process from their manufacturer partners.
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 Dec. 20, 2019.
On January 15, 2020, the FDA issued a statement reiterating that the bill is in effect. The statement goes on to say that during a “transition period” in which the FDA “and some retailers will need to update current practices to implement this new law as FDA will need time to do outreach and education to retailers and update the Agency’s programmatic work to reflect this change,” the agency will “only use minors under the age of 18 in its compliance check program.” There is no timeline for the transition and CDA and others will be pressing the FDA for additional information on what that timeline is.
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.
CDA sent three Government Alerts on this topic on Dec. 20, 2019, Dec. 30, 2019 and Jan. 16, 2020.
STATUS: The Legal Age of Purchase for Tobacco has been raised to 21 and is in effect.
The We Card program 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. More information.