Regulation: The US

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April 2024: Vermont

Vermont Governor vetoed the Bill S.18 that would ban flavored tobacco products and e-liquids. The Bill had passed the Senate and the House in a 18-11 and 83-53 vote, respectively – which is not a large enough majority to override the veto.

States in which flavored tobacco is banned: California (Dec 2022), Massachusetts (June 2020)

March 2024: Vermont & Michigan

In Vermont, the Legislature recently passed the Bill (S.18) that would – effective January 1, 2026 – ban the sale of any flavored tobacco substitute and e-liquid as well as menthol flavored tobacco products, including cigarettes, cigars, snuff, and snus. For Other Tobacco Products, non-menthol flavors such as mint and cherry would be permitted. The Governor is weighing whether to sign the Bill due to its potential impact state revenues.

A survey from the Vermont Department of Health found that the rate of e-cigarette use in the state doubled from 3% to 6% between 2016 and 2022 while the smoking decreased from 17% to 13%. Around half of smokers and nearly 90% of the vapers use flavored products in Vermont1. Of adults who took the survey, 53% said they supported outlawing the sale of products with flavored tobacco in Vermont. However, there is less support among people who currently use tobacco – 24% of that group said they supported a flavored tobacco ban.

Meanwhile, two Senate Bills are pending in Michigan. Senate Bill 648 bans the sale of all flavored tobacco products, including menthol cigarettes. Senate Bill 649 foresees $1.5 per pack cigarette tax increase, 15% (of the wholesale price) snuff tax increase and imposition of 57% (of the wholesale price) tax for vapes and nicotine pouches. Menthol products make up 41% of the cigarette volume in Michigan.

January 2024

The US Supreme Court declined to hear British American Tobacco’s challenge to a voter-approved measure in California that banned flavored tobacco products2.

Background: A ban on all flavored tobacco products went into effect in December 2022 in California following the approval of the measure on a ballot by nearly two-thirds of the voters. RJ Reynolds (a subsidiary of BAT) and other plaintiffs filed a lawsuit arguing that the federal Tobacco Control Act preempts state and local laws from banning flavored tobacco products. However, both a Federal Court and a Court of Appeals concluded that the California’s law did not conflict with the federal statute regulating tobacco products. RJ Reynolds appealed the decision to the US Supreme Court.

In December 2022, the US Supreme Court also rejected BAT’s request to prevent the California law from taking effect.

December 2023

The US FDA plans to announce the tobacco product standard3 that would establish a maximum nicotine level in cigarettes and certain other finished tobacco products in April 2024. By limiting the nicotine levels, FDA aims to reduce addictiveness of cigarettes, thus giving smokers a greater ability to quit and preventing experimenters (mainly youth) from initiating regular use.

December 2023

The US FDA’s Center for Tobacco Products (CTP) released a 5-year Strategic Plan4 that defines five goals and the desired outcomes for each goal.

1. Develop, Advance and Communicate Comprehensive and Impactful Tobacco Regulations and Guidance: The evolving marketplace is comprehensively regulated while the public and stakeholders are aware of and contribute to regulations and guidance

2. Ensure Timely, Clear and Consistent Product Application Review: Tobacco product applications are reviewed using an efficient, transparent and consistent process while the marketing decisions are supported by the best available science

3. Strengthen Compliance of Regulated Industry Utilizing All Available Tools, Including Robust Enforcement Actions: Violative tobacco products, particularly the youth-appealing ones, are not in the marketplace while the regulated industry is educated on how to be compliant with the law

4. Enhance Knowledge and Understanding of the Risks Associated With Tobacco Product Use: The public receives timely, clear and evidence-based health communication and education

5. Advance Operational Excellence: A talented, diverse and engaged workforce is attracted and retained while the business operations are efficient and effective in supporting program goals.

These goals are reinforced by four overarching themes:   

Science: Maintaining the commitment to use data and evidence-driven approaches to inform CTP decision-making

Health Equity: Pursuing the highest level of health for all people by integrating health equity into all CTP activities

Stakeholder Engagement: Continuously striving to optimize engagements with interested parties both external and internal to FDA, including other federal agencies

Transparency: Promoting understanding of tobacco regulation through clear, consistent and comprehensive communication

December 2023

The US federal government published the Unified Agenda of Regulatory/Deregulatory Actions (i.e. regulatory to-do list)5 which confirms that the final menthol rule (that would ban menthol flavored cigarettes) is now expected in March 2024. The delay angered health advocates who claim that the Administration postponed the ban to avoid alienating African American voters, who mostly smoke menthol-flavored tobacco products.

The Administration had originally planned to have the rule finalized by August 2023 and, later, signaled that the rule would come before the end of 2023. Now, the rules are not expected until March 2024, at the earliest. 

December 2023

The US FDA issued complaints for civil money penalties (CMPs) against 25 brick&mortar and online retailers for the illegal sale of unauthorized Elf Bar, EB Design and other e-cigarettes. The complaints include cases against online retailers for the first time and seek the maximum CMP of $19,192 for a single violation from each retailer.

In order to remove unauthorized e-cigarettes from the marketplace, as of December 5, FDA has

– issued more than 400 warning letters to retailers and filed CMPs against 67 retailers

– issued more than 630 warning letters to manufacturers/distrubutors and filed CMPs against 36 manufacturers

– (in coordination with the US Department of Justice) sought injunctions against 7 manufacturers.

December 2023

It is speculated that the long-awaited ban on menthol cigarettes in the US may not be announced by the end of the year6 and the delay could be announced as early as next week. It is also a possibility that the ban could be delayed well into 2024 – even to after the November presidential election.

This is in line with our expectations that there is more than fair chance of US menthol ban not being finalized by the end of this year. It is always challenging for an administration to take such a highly-politicized & wide-ranging decision when less than a year is left before the elections.

October 2023

The US FDA sent the rule banning menthol cigarettes and flavored cigars to the White House Office of Management and Budget for final review7 (the last regulatory step before the rule becomes final). The FDA has been considering menthol regulations for more than a decade. In June 2020, Massachusetts became the first to ban all flavored tobacco products, including menthol. In December 2022, California’s menthol ban went into effect. In an effort to work around the state bans and to lay the groundwork for a potential federal ban, tobacco companies have introduced cigarettes with a menthol-like synthetic cooling agent. It is not clear whether the final rules would address the workarounds. Once the federal government makes its final rules, tobacco companies are expected to sue.

September 2023

The US FDA issued complaints for civil money penalties (CMPs) against 22 retailers for the sale of Elf Bar/EB Design8 (referred as “a popular, illegal youth-appealing e-cigarette brand” by the FDA). CMP action is a result of the retailers not correcting the violations (i.e. selling an unauthorized tobacco product) despite being warned. The complaints seek the maximum penalty of $19,192 for a single violation from each retailer. While the FDA has issued CMPs to retailers for selling unauthorized tobacco products in the past, this is the first time the Agency is seeking CMPs for the maximum amount for this type of violation.

September 2023

The US FDA missed the self-imposed deadline (August 2023) to publish the final regulation that would prohibit the sale of menthol cigarettes and flavored cigars9. The Agency will instead complete the work “in the coming months” (presumably, still in 2023).

August 2023

FDA provided an update on its efforts to curb the marketing of unauthorized nicotine products across the tobacco product supply chain10:

– Issued a warning letter to Amarillo Snuff for manufacturing & selling unauthorized smokeless (non-tobacco) nicotine products, including products that are made with corn husks instead of tobacco leaves

– Issued ~600 warning letters to manufacturers of unauthorized tobacco products (including 100+ warning letters for unauthorized non-tobacco nicotine products)

– Issued 2,800+ warning letters and 825 civil money penalties to e-cigarette retailers selling products to underage purchasers (including 1,000+ warning letters and 140+ civil money penalties for violations in relation to sale of non-tobacco nicotine products to underage purchasers).

Meanwhile, a federal judge struck down the FDA’s authority to regulate premium, hand-rolled cigars in the US11. The judge’s order applies to cigars that are hand-rolled and tend to be sold in humidors in specialty stores, rather than the mass-produced cigars typically sold in c-stores. The cigar industry has been fighting the FDA’s efforts at regulation in court since 2016.

June 2023

The US FDA provided updates on pending tobacco regulations as part of the Spring 2023 Regulatory Agenda12.

Flavor (Menthol) ban: In May 2022, the FDA proposed prohibition of the use of menthol in cigarettes, RYO and heated tobacco products and prohibition of all characterizing flavors (other than tobacco) in cigars. The public comment period ended on July 5, 2022. The FDA received ~247k comments on these two proposals, mostly opposing the bans. The FDA reiterates its intent to publish final regulations in Aug 2023 – with menthol regulation becoming effective 1-2 years after the date of publication.

Legal Age: The 2020 Consolidated Appropriations Act raised the federal minimum age for tobacco purchase from 18 to 21 years. The FDA plans to update the federal legal requirement to 21 in April 2024.

Nicotine level in combustible tobacco products: In June 2022, the FDA announced the plan to place a cap on the max amount of nicotine allowed in combustible tobacco products. The FDA previously stated that the regulation would be published by Oct 2023; now it is moved to Dec 2023.

Nicotine toxicity warnings: The FDA is planning to establish acute nicotine toxicity warning requirements for nicotine-containing liquids – in order to increase consumer awareness & knowledge of acute toxicity risks as a result of accidental nicotine exposure. The FDA expects to publish this regulation in Oct 2024.

E-cigarette safety standards: The FDA plans to set safety standards for toxicants and impurities in nicotine and PG/VG used in e-cigarettes – including setting of limits on the level of toxicants. The FDA expects to publish this regulation in Dec 2024.

Feb 2023

US Supreme Court declined to hear Reynolds’ appeal of flavored-tobacco ban in Los Angeles County13. The ban went into effect in June and now stays in force with the Supreme Court decision – which was made without comment.

FDA’s tobacco unit (CTP)  pledged reset after criticism14. CTP will deliver a 5-year strategic plan by year’s end outlining priorities, including efforts to clean up a sprawling market of largely unauthorized e-cigarettes.

FDA fined e-cigarette makers for selling products illegally in a “wake-up call”15. This is the first time that FDA filed (what it calls) a civil money penalty (CMP) against e-cigarette makers who haven’t complied with the federal process.

FDA appealed the court’s order that found the graphic cigarette health warning rule unconstitutional16. The court decision was issued in Dec 2022 on the basis of violating free speech protections under the First Amendment.

CDC survey revealed that most US adults support banning sales of all tobacco products17; nearly two-thirds support banning menthol cigarettes. More than a third of current smokers support menthol ban. More than a quarter support complete tobacco ban.

Jan 2023

US FDA committed to complete the PMTA review of the most popular e-cigarettes by Dec 31, 202318. This is six months later than previously anticipated/communicated.

FDA updated the regulatory plan, moving forward the timeline for a federal ban on menthol cigarettes19. FDA intends to publish a final menthol rule by Aug 2023. US menthol cigs account for 25% of BAT’s and 15% of Imperial’s total profits.

Reynolds (BAT) pivoted to new cigarette pitches as the flavor ban takes effect in California. Reynolds launched a new, non-menthol Newport cigarette which offers “a taste that satisfies the senses” and “a new fresh twist”. Reynolds claim that the products introduced in California “meet and comply with all applicable regulatory requirements” and “are not subject to the recently enacted ban because they do not have a distinguishable taste or aroma other than tobacco”.

Dec 2022

[US FDA] Independent review panel identified that20

– lack of clarity hinders tobacco regulation

– CTP needs better enforcement and a streamlined review process

– CTP is more reactive than proactive and plagued by litigation from frustrated parties.

FDA scored a win in battle against flavored e-Cigarettes21. Avail Vapor lost its challenge to the FDA’s denial of its PMTA for new flavored electronic cigarettes. The court ruled that FDA’s decision was based on scientific evidence. Avail failed to disprove the FDA’s conclusion that its products pose a serious risk to youth without enough offsetting benefits to adults, according to the US Court of Appeals for the Fourth Circuit.

Meanwhile, the US FDA rule mandating graphic warnings on cigarettes was blocked by judge22

– Judge finds rule would violate tobacco companies’ First Amendment rights

– Requirement was set to take effect October 2023.

Oct 2022

US Deptartment of Justice, on behalf of the FDA, sued six companies that reportedly continue to sell e-cigarettes without submitting PMTA23. These cases represent the first time injunction proceedings are initiated to enforce PMTA requirements.

Aug 2022

“The US FDA must reconsider its denial of six companies’ applications to sell flavored e-cigarette products”, a federal appeals court ruled24.

July 2022

US FDA sent its first two warning letters to manufacturers for unlawfully marketing synthetic nicotine products without authorization25. The FDA is processing 1 million applications for synthetic nicotine products submitted by more than 200 companies.

The US FDA’s decision to regulate premium cigars under the same federal law as other tobacco products like cigarettes was “arbitrary and capricious”, a federal judge ruled26. Cigar groups and FDA will submit briefs on remedy.

June 2022

US FDA committed to slash the nicotine levels in cigarettes. A proposed rule would be issued in May 2023 seeking public comment on establishing a max nicotine level in cigarettes. Only one other nation, New Zealand, has advanced such a plan.

May 2022

The US FDA Commissioner, Califf hired Brian King – a top official at the CDC’s Office on Smoking and Health – to lead the FDA Center for Tobacco Products27. Anti-tobacco groups praised the choice, the Industry pushed back.

“Agency needs more resources to speed up its review of e-cigarettes and is avoiding making hasty decisions that could incite lawsuits from the industry”, said the US FDA Commissioner Califf28.

References:

  1. E-cigarette usage doubles in Vermont as bill seeks to ban flavored tobacco | Vermont Public ↩︎
  2. https://www.reuters.com/legal/us-supreme-court-rejects-challenge-california-flavored-tobacco-ban-2024-01-08/ ↩︎
  3. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI76 ↩︎
  4. CTP Strategic Plan | FDA ↩︎
  5. Critics charge political concerns have led Biden administration to delay long-awaited ban on menthol cigarettes | CNN ↩︎
  6. https://www.nbcnews.com/health/health-news/long-awaited-ban-menthol-cigarettes-delayed-2024-public-health-groups-rcna127608 ↩︎
  7. https://edition.cnn.com/2023/10/16/health/fda-menthol-cigarettes-rules ↩︎
  8. https://www.fda.gov/news-events/press-announcements/fda-seeks-fines-against-22-retailers-selling-illegal-youth-appealing-e-cigarettes ↩︎
  9. https://edition.cnn.com/2023/09/01/health/fda-menthol-regulation/index.html ↩︎
  10. https://www.fda.gov/tobacco-products/ctp-newsroom/fda-warns-firm-responsible-illegal-smokeless-products-made-non-tobacco-nicotine ↩︎
  11. https://www.nytimes.com/2023/08/10/health/fda-cigar-exemption.html ↩︎
  12. https://www.reginfo.gov/public/do/eAgendaHistory?operation=OPERATION_GET_PUBLICATION&showStage=longterm&currentPubId=202304 ↩︎
  13. https://journalnow.com/business/local/us-supreme-court-declines-to-hear-reynolds-appeal-of-flavored-tobacco-ban-in-los-angeles/article_48a3aa36-b6b0-11ed-9293-c30f020d534c.html ↩︎
  14. https://apnews.com/article/politics-us-food-and-drug-administration-business-health-vaping-fc7a384693fb91861a6bb17e5b5bb6d9 ↩︎
  15. https://edition.cnn.com/2023/02/22/business/fda-fines-ecigs/index.html ↩︎
  16. https://cspdailynews.com/tobacco/fda-appeals-courts-graphic-cigarette-health-warnings-decision ↩︎
  17. https://edition.cnn.com/2023/02/02/health/tobacco-ban-support/index.html ↩︎
  18. https://durbin.senate.gov/newsroom/press-releases/durbin-to-fda-follow-the-law-pull-unauthorized-e-cigarettes-from-the-market-immediately-to-protect-americas-children ↩︎
  19. https://journalnow.com/business/local/fda-updates-potential-tobacco-regulatory-timelines/article_7fe11418-8e09-11ed-846d-93735f2ea83d.html ↩︎
  20. https://politico.com/newsletters/prescription-pulse/2022/12/20/fda-tobacco-center-needs-clarity-says-expert-panel-00074698 ↩︎
  21. https://news.bloomberglaw.com/us-law-week/fda-scores-another-win-in-battle-against-flavored-e-cigarettes ↩︎
  22. https://reuters.com/legal/litigation/fda-rule-mandating-graphic-warnings-cigarettes-blocked-by-judge-2022-12-08 ↩︎
  23. https://fda.gov/news-events/press-announcements/fda-doj-seek-permanent-injunctions-against-six-e-cigarette-manufacturers ↩︎
  24. https://reuters.com/legal/litigation/fda-must-reconsider-rejection-flavored-vapes-11th-circuit-2022-08-24 ↩︎
  25. https://edition.cnn.com/2022/07/14/health/fda-synthetic-nicotine/index.html ↩︎
  26. https://reuters.com/legal/government/fda-regulation-premium-cigars-arbitrary-capricious-judge-finds-2022-07-05 ↩︎
  27. https://news.bloomberglaw.com/health-law-and-business/califf-taps-cdc-official-to-lead-fda-center-for-tobacco-products ↩︎
  28. https://news.bloomberglaw.com/health-law-and-business/fda-must-be-judicious-in-vaping-enforcement-califf-says ↩︎

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