Dear Mr. Sawan:

I write on behalf of the Vapor Technology Association (VTA), the U.S. trade association representing the interests of manufacturers, distributors, wholesalers, retailers and consumers of nicotine vaping products – regarding Shell’s recent decision to remove from its associated retail locations electronic nicotine delivery systems (ENDS), also known as e-cigarettes or vapes. Shell’s Business Risk Assessment and Mitigation violation notification (attached) was sent out widely in June in response to a policy change by Mastercard. While I am sure you are aware of this action, I write to ensure you are also aware that Shell’s June BRAM notification direct conflicts with the FDA’s recently articulated enforcement guidance and, therefore, undermines the Trump Administration’s efforts to comprehensively address vaping regulations.

Brief Background on Vaping Regulation Your action was premised on the claim that all tobacco products are illegal under the 2009 Tobacco Control Act (TCA) unless first authorized by the FDA. At first blush, this simple, accurate statement is compelling. But nothing is ever simple, particularly in the world of tobacco regulation. Because vaping products were already on the market for many years before they were first regulated as tobacco products and subject to the premarket requirements of the TCA, the regulations which made them subject to those requirements necessarily permitted products to remain on the market as the regulatory process unfolded, always subject to FDA’s exclusive enforcement discretion. Hence, during the entire time that vaping products have been on the market, Shell retailers have been selling tobacco products without premarket authorization due to their being unregulated, or by design of subsequent federal regulation, or by court orders, and/or pursuant to FDA’s exclusive enforcement discretion. This begs the question of why such dramatic action is being taken now when the same position could have been taken at any time in the past eight years?

It is true that the FDA has authorized a small number of ENDS products on the list cited in your BRAM notice. However, the true number of commercially available products on that list is dramatically smaller (about 10-14 unique devices, of which even fewer are available in your stores).¹ The paucity of FDA authorizations is the direct result of ideological opposition to ecigarettes by the prior Administration and the overburdensome, opaque requirements and lack of a clear standard of review. As a result, vape companies have had to contend with changing requirements, shifting goal posts, unlawful denials, histrionic narratives, and FDA’s inability or refusal to authorize products, with all the prior Administration’s efforts directed toward eliminating flavored vaping products.²

For this reason, President Trump made his campaign promise in 2024 to save flavored vaping, just as he did in 2019.³

In its second term, the Trump Administration has been working to fix the broken regulatory system it inherited, save vaping, protect consumers, protect youth, and protect an industry which generates more than $33.0 billion in total economic impact in the U.S.

Shell’s Action Undermines and Conflicts with the Administration’s Goals and Regulation

Shell’s BRAM notification states, “These notices are part of broader enforcement efforts across the industry to ensure alignment with FDA regulations” and directs stores to ensure that “any unauthorized e-cigarette or ENDS products are removed from store shelves,” and that “only FDAauthorized products, based on the FDA’s latest approved list, are offered going forward.” However, Shell’s action is complete misalignment with FDA regulations.

In early May, President Trump made clear that FDA needed to move faster to save flavored vaping products.⁴ As a result, on May 8, 2026, FDA announced a major regulatory enforcement directive in a final guidance entitled Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.⁵ Contrary to position taken in Shell’s BRAM notice, FDA does not and will not treat the list of authorized products as the sole determiner for whether products should remain on the market pending review of the products’ applications by FDA.

To wit, FDA stated it will not prioritize enforcement of the premarket authorization requirement for certain ENDS products that are part of FDA’s compliance review process and clearly articulated FDA’s parameters. Also, to provide clarity to the marketplace, FDA announced that it “will create and maintain a public-facing webpage identifying manufacturers and associated products that FDA generally does not intend to prioritize enforcement against.” Further, FDA stated it would target its efforts and prioritize enforcement to protect youth by focusing on products with “presumptively underage-appealing elements such as depicting a cartoon-like fictional character, disguising its nature as a vaping product, or resembling a children’s toy, phone or gaming platform.”⁶ Thus, based on the FDA’s May announcement, it is now certain that Shell’s extreme restriction on the availability of ENDS products will be completely out of step with the FDA’s enforcement discretion list when published.

Yet, all Shell stores and associated retailers are being instructed to indiscriminately remove virtually all vaping products, including those sold by American companies that are actively engaged in FDA’s compliance process, which the FDA itself has said are deserving of enforcement discretion and products which raise none of the youth or safety issues being targeted by the Administration. Shell’s sweeping removal of vape products not only conflicts with the FDA’s declared policy and regulations, but it will undermine Administration efforts to save vaping.

You should be aware that, in addition to the commercial disruption this is causing long-standing business relationships, Shell has been drawn into a contentious political debate over consumer choice. There are 25 million adult vape consumers in the U.S. Market data shows that more than 90% of them are purchasing flavored ENDS products that are not on the FDA authorized list. Vaping consumers are very protective of their right to choose because quitting smoking is extremely difficult and individualized – they want what works for them. Similarly, vaping voters are highly engaged in defending their rights and strongly disfavor vaping bans or being told what they can and cannot use.

This is important because, given the paucity of e-cigarette options on the “FDA-approved list,” your BRAM actions amount to a ban on flavored e-cigarettes which tens of millions of adult consumers are using as their preferred alternatives to smoking. Not only has the science concluded that vapes are dramatically safer than cigarettes, but it has also concluded that they are the most effective tool on the market to help Americans quit smoking. And yet, based on your recent action, low margin cigarettes – which kill half a million Americans every year, making them the number one cause of death and disease in the U.S. – remain ubiquitously available in your stores.

In light of the foregoing, we strongly encourage Shell to immediately bring its policy in alignment with the Administration’s regulation and to address the damage currently unfolding by:

1. Immediately announcing a reversal of Shell’s recent BRAM notifications; and

2. Waiting for the Trump Administration to complete its work and then act based on the FDA’s published list of products receiving FDA enforcement discretion.

Of course, if you believe some form of current action is necessary, we suggest a targeted BRAM notification addressing tobacco products “with presumptively underage-appealing elements such as depicting a cartoon-like fictional character, disguising its nature as a vaping product, or resembling a children’s toy, phone or gaming platform,” as specified by the FDA.

This approach will allow Shell to accurately target product removals based on the Administration’s priorities and forthcoming list. As importantly, this approach will eliminate the serious commercial chaos your stores are presently dealing with, will protect the business relationships that are being unnecessarily disrupted, and will protect millions of your adult customers’ access to the less harmful vaping products they both want and need.

Thank you for your time in considering this matter. We would welcome the opportunity to provide additional information and work constructively with you in addressing this important, complex and evolving regulatory environment.

Sincerely,

Tony Abboud Executive Director

Enclosure

¹Most of the authorized products are antiquated (8-15 years old) and, therefore, widely unavailable on or already removed from the market, or barred from the market due to patent litigation. And given the list is devoid of flavored vaping products, the list is largely irrelevant to 90% of American vaping consumers frequenting your stores.

²Your stores know the critical importance of flavored vaping products, especially those not on the FDA approved list, to their bottom line, given that the margins for flavored vapes far exceed the margins for cigarettes (inventories of which they are forced to carry despite fewer and fewer Americans purchasing cigarettes).

³In 2019, President Trump executed a targeted action directed at the flavored products that all the kids were using and he exempted from that partial flavor ban the very products you are now removing from your store shelves today.

⁴Choi, Joseph and Weixel, Nathaniel, FDA drops guardrails on vaping industry in major Trump pivot, The Hill, May 18, 2026, at https://thehill.com/policy/healthcare/5880802-flavored-vapes-fda-guidance/.

⁵FDA Issues Guidance on Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products, May 8, 2026, available at https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-guidance-enforcement-prioritiesunauthorized-ends-and-nicotine-pouch-products.

⁶One year ago, VTA loudly called on the Administration to take this action. VTA Press Release: One-MillionDollar Ad Campaign Launched by VTA Urging Immediate Action to Remove Youth Targeted Vapes, July 14, 2025.

THIS DOCUMENT IS NOT INTENDED NOR SHOULD BE RELIED ON AS LEGAL ADVICE. PLEASE CONSULT LEGAL COUNSEL ABOUT YOUR SPECIFIC PRODUCTS. 

TO: VTA Members

DATE: July 28, 2026

RE: Regulatory Alert: HHS Unified Agenda Published

Each year the Administration publishes its Unified Agenda as the public reporting mechanism for regulatory and deregulatory actions under development across the federal government. (RegInfo.gov). The 2026 HHS Unified Agenda was quietly published yesterday. Regarding regulations pertaining to our industry and PMTAs, specifically, the HHS/FDA agenda signals a FDA tobacco regulatory pivot toward enforceable standards, import controls, and supply-chain enforcement, especially for ENDS. We address nine relevant rules included in the agenda.

What is striking is that FDA appears to be adopting the approach for PMTAs for which we have been clearly advocating

Tobacco Rules on Unified Agenda

Proposed Rules with PMTA Implications. The first three proposed rules below impact PMTA requirements and review and could provide a basis for clarifying and streamlining the requirements.

1. FDA Answers VTA’s Call for ENDS Tobacco Product Standards.

For years (for-ever), FDA has refused to consider implementing tobacco product standards for ENDS products even though it is one of the key requirements in the PMTA statute. Now, for the first time, HHS/FDA announced that they will be proposing a new “Product Standards for Electronic Nicotine Delivery Systems” rule, scheduled for July 2026, which FDA describes as creating ENDS product standards under FDCA §907 to “establish product standards for ENDS products to provide greater clarity and predictability for industry and stakeholders by describing standards applicants must meet as part of premarket review.” As you know, this is one of the two things that VTA has said was essential and it is being proposed for the same reason we have articulated: “clarity and predictability.” (Tobacco Product Standards)

The notice provides no specifics but it is a very encouraging sign for the reasons stated above and it is a major departure from all prior FDA positioning.

2. FDA Answers VTA’s Call for Standards on ENDS toxicants/impurities.

The ENDS Safety Standards rule, RIN 0910-AI06, would establish standards for ENDS, including purity standards for nicotine, propylene glycol, and vegetable glycerin in e-liquid. FDA states that toxicants and impurities in those ingredients can cause death or other adverse health effects and that the rule would set limits appropriate for public health protection. (ENDS Safety Standards Rule) A similar rule was first proposed during Trump’s first Administration but once the youth vaping epidemic took center stage, the focus shifted, as you all know, to talk of a flavor ban.

Once again, a key element of our messaging for our science-based guidance has been to address these issues to ensure the “safety” of ENDS products. This message was recently reiterated during our meeting with Secretary Kennedy. Again, the notice provides no specifics so we will have to review the proposed rule when it comes out. But, this is potentially another positive development if the standards are objective, track what we have proposed, and commercially feasible. They could create a clear compliance baseline for ingredient suppliers and e-liquid manufacturers. They also could support a more rational PMTA review process.

3. Environmental Assessment requirements may be limited/withdrawn.

The Environmental Impact Considerations rule would update FDA’s NEPA regulations. FDA says the updates include removing reliance on CEQ regulations, removing FDA’s rule on environmental effects abroad of major agency actions, incorporating statutory deadlines/page limits, and creating new or updated categorical exclusions. FDA identifies the rule as deregulatory. (Environmental Assessment Rule)

For tobacco, this could matter because PMTAs require environmental assessments or categoricalexclusion analyses. While the proposed rule is not tobacco-specific, it could reduce PMTA submission burdens if FDA broadens categorical exclusions or streamlines environmental documentation.

Proposed Rules with Enforcement Implications. The following four rules would enhance FDA’s enforcement capabilities. The four rules should be read together as defining a clear policy architecture emphasizing enforcement: identify the source, identify the product, screen the import, identify PMTA status, detain the noncompliant product.

4. The ACE import rule being finalized.

The previously published ACE import-data final rule is expected to be published as a final rule in September 2026. It would amend 21 CFR 1.79 to require import filers to submit the FDA premarket application number at entry for ENDS products. FDA says this will allow it to determine the marketingauthorization status of ENDS imports more effectively and enforce Chapter IX premarket requirements. (ACE import-data rule)

5. Administrative Detention Rule moving forward.

The Administrative Detention of Tobacco Products would allow detention of products believed to be adulterated or misbranded when encountered during inspections of manufacturers, vape shops, or other establishments that manufacture, process, pack, or hold tobacco products. FDA specifically identifies unauthorized e-cigarettes and illegal overseas shipments as targets. (Administrative Detention of Tobacco Products) The legal and practical effect is that FDA would gain a much faster tool to stop movement of products before a full seizure action. FDA explains that detention would give the agency time to consider further action, including DOJ involvement and seizure, and says the authority would help prevent firms from moving products to evade seizure. (Administrative Detention Rule) For retailers, distributors, and importers, this materially increases operational risk: products may be frozen in place before the company has a full adjudication on the merits.

6. Establishment Registration and Product Listing.

We previously reported to you the Establishment Registration and Product Listing rule that was recently published. Again, FDA says current law requires only domestic manufacturers to register and list, creating “significant gaps” in FDA’s information, and that the rule would extend registration/listing and FDA inspections to foreign establishments and new domestic categories. (Establishment Registration and Product Listing)

7. Civil Monetary Penalties.

FDA announced that it will implement an Interim Final Rule called CY 2026 Civil Monetary Penalties Inflation Adjustment, RIN 0991-AC42 to adjust for inflation the administrative penalties it can impose for violations. The rule is expected to be finalized in January 2027. While this will increase penalties, a recent court case has found that FDA can no longer impose these penalties through its own administrative law process. As such, for FDA to pursue these penalties (often imposed on small businesses), it will have to do so through the courts which could dramatically impact its willingness to pursue them. Other Related Rules. There are two additional rules of note that could impact the tobacco segment.

8. Tobacco Product Manufacturing Practice rule still active, but not immediate.

The previously announced Tobacco Product Manufacturing Practice rule remains in long-term actions, with a final rule projected for July 2027. FDA says it would establish manufacturing-practice requirements for finished and bulk tobacco products, including manufacture, pre-production design validation, packing, and storage, to prevent contaminated or nonconforming products. (TPMP Rule)

9. HHS Petition Process Rule may create a useful deregulatory pathway.

The Petition Process for Rulemaking and Regulatory Review rule is listed as a first-time HHS Office of the Secretary rule at the final-rule stage, with an interim final rule expected in July 2026. It would establish procedures for petitions to amend or repeal rules under 5 U.S.C. § 553(e) and for regulatory review under 5 U.S.C. § 610(b). HHS characterizes it as deregulatory and says the rule is intended to reduce burdens, standardize petitions, and improve transparency. (HHS Petition Process Rule)

For the tobacco sector, this could become a formal pathway to seek amendment or repeal of outdated or unworkable rules. It may also be relevant to small-business advocacy because § 610 review focuses on rules that have significant economic impact on a substantial number of small entities.

What this means strategically

This Unified Agenda is best understood as a standards-and-enforcement package. FDA appears to be moving toward a system in which ENDS products are governed by clearer standards, but those standards are paired with better enforcement tools. Both of these are concepts that VTA has vigorously advocated for pursuant to the strategic plan that you have endorsed.

For responsible manufacturers, especially companies already in the compliance process, the opportunity is that FDA may finally articulate objective standards that can be met.

For retailers and distributors, the most immediate risk is enforcement disruption. Administrative detention and ACE import screening could affect inventory movement well before broader product-standard litigation or PMTA disputes are resolved. This is why we are pushing for a comprehensive solution to the current PMTA review/enforcement scheme.

For foreign manufacturers, the direction is unmistakable: FDA wants visibility, traceability, and inspection/enforcement leverage over foreign-made tobacco products entering the U.S. market.

Below is a table summarizing the rules discussed herein that are on the Unified Agenda.

Table of Tobacco / PMTA Related Rules on Unified Agenda

THIS DOCUMENT IS NOT INTENDED NOR SHOULD BE RELIED ON AS LEGAL ADVICE. PLEASE CONSULT LEGAL COUNSEL ABOUT YOUR SPECIFIC PRODUCTS. 

Dear Mr. McInerney, Mr. Miebach, Mr. Squeri, and Mr. Fairbank:

I write on behalf of the Vapor Technology Association (VTA), the U.S. trade association representing the interests of manufacturers, distributors, wholesalers, retailers and consumers of nicotine vaping products – regarding action which your companies have been asked to take to bar payment processing services to businesses selling electronic nicotine delivery systems (ENDS), also known as e-cigarettes or vapes. The request for action made in an April 14, 2026 letter your General Counsel from a group of State Attorneys General (the “State AG Letter”) directly conflicts with the recently announced FDA policy and strategic objectives.

The State AG Letter advised your counsel that there are only 45 ENDS products which have been authorized by FDA, and can be legally sold, and tasked your companies with helping them end the sale of all other products not on the FDA’s authorized list. In actuality, the list of authorized ENDS commercially available is significantly smaller.¹ Given the paucity of the list and that it does not represent what 90% of American vaping consumers are using, the actions requested of you are tantamount to a category ban drawing your company into a politically charged debate.

Brief Background on Vaping Regulation

The State AG Letter argues that all tobacco products are illegal under the 2009 Tobacco Control Act (TCA) unless first authorized by the FDA. At first blush, this simple, accurate statement is compelling. But nothing is ever simple, particularly in the world of tobacco regulation. Vaping products were not covered by the TCA when it was passed. Because they were widely available on the market, for many years before they first became regulated as tobacco products and subject to the premarket requirements of the TCA, the regulation which made vaping products subject to those requirements necessarily permitted products to remain on the market as the regulatory process unfolded. Hence, during the entire time that vaping products have been on the market, companies using your services have been selling these products without premarket authorization due to their being unregulated, or by design of subsequent federal regulation, or by court orders, and/or pursuant to FDA’s exclusive enforcement discretion. This begs the question of why such dramatic action is asked of you now when the same request could have been made at any time in the past eight years?

The State AG Letter suggests “youth exploitation” should justify your action because products are “colorful” and “flavored.”² Yet, despite this, the youth vaping rate plummeted 74% to “historic lows” after President Trump raised the age to purchase all tobacco products to 21 back in 2019 (a commonsense law championed by VTA), and youth vaping is essentially disappearing according to the FDA’s most recent data.³ Further, the State AG Letter raises the specter of “criminal enterprises” to justify your action. Yet, there is one guaranteed result of eliminating the most popular flavored vaping products used by 25 million Americans: a black market run by Mexican cartels which are already filling the void created by Mexico’s vape ban.⁴ Also, the State AG Letter raised questions about product safety. Yet, the scientific debate is over: vaping products are dramatically safer than cigarettes and the most effective tool available to help Americans quit smoking.⁵

VTA recognizes and shares the core concerns reflected in the State AG Letter: youth access must be prevented, deceptive or youth-oriented marketing should not be tolerated, and bad actors should be the focus of serious enforcement. Responsible companies have a strong interest in a lawful, transparent, and well-regulated marketplace. Yet, due to a series of ideological actions by the prior Administration, the ENDS marketplace has not been well-regulated, and companies have had to contend with changing rules, changing requirements, unlawful denials, and histrionic narratives that paint a dramatically inaccurate picture of the product category and industry.

Thus, President Trump made a campaign promise to save flavored vaping, just as he did in 2019.⁶

In its second term, the Trump Administration has been working to fix the broken regulatory system it inherited, save vaping, protect consumers, protect youth, and protect an industry which generates more than $33.0 billion in total economic impact in the U.S.

Action Based on the AG Letter Conflicts with the Administration’s Goals and FDA Regulation

In early May, President Trump made clear that FDA needed to move faster to save flavored vaping products.⁷ As a result, on May 8, 2026, FDA announced a major enforcement policy declaration in a final guidance entitled Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.⁸ The new regulatory guidance makes clear that FDA does not and will not treat the list of authorized products as the sole determiner for whether products should remain on the market pending review of the products’ applications by FDA. Instead, the guidance identifies a clear federal strategy making the request of the State AG Letter both unnecessary and in direct conflict with the Administration’s and FDA’s actions and goals.

First, FDA stated it will not prioritize enforcement of the premarket authorization requirement for certain ENDS products and described those specifically. FDA announced that “to promote transparency to consumers, retailers and other industry stakeholders…, FDA will create and maintain a public-facing webpage identifying manufacturers and associated products that FDA generally does not intend to prioritize enforcement against.” When published, FDA’s new list will be dramatically different than the impoverished list on which the State AG Letter directs you to rely.

Second, FDA stated it would prioritize enforcement to protect youth and ensure safety, both concerns raised in the State AG Letter to spur action by your companies. Regarding youth, FDA will focus on products with “presumptively underage-appealing elements such as depicting a cartoon-like fictional character, disguising its nature as a vaping product, or resembling a children’s toy, phone or gaming platform.”⁹ Regarding safety, FDA will focus on products which present “significant public health or safety concern than generally presented by ENDS” and provided various examples.

As such, the blunt action requested of you in the State AG Letter bears no resemblance to the strategic and surgical approach being taken by the Administration and the FDA. Very simply, the broad sweeping action requested not only conflicts with the FDA’s declared policy and strategy, but it will undermine Administration efforts to save vaping. To be sure, the action taken by Mastercard already has caused major retailers such as Shell, BP/Amoco and others, to precipitate a frenzy to remove of all vaping products from retailer shelves (save the handful of devices on FDA’s authorized list). (See, e.g., attached Shell BRAM Notice.) These actions are removing not just problematic products but indiscriminately removing all products including those sold by companies that are actively engaged in FDA’s compliance process and products which the FDA itself has said are deserving of enforcement discretion during the compliance process.

Also, you should be aware that your companies are being unwittingly drawn into a contentious political debate over consumer choice. There are 25 million adult consumers who are purchasing vaping products. Market data shows that more than 90% of adult consumers are purchasing flavored ENDS products that are not on the FDA authorized list. Vaping consumers are very protective of their right to choose because quitting smoking is extremely difficult and individualized – they want what works for them. Similarly, vaping voters are highly engaged in defending their rights and strongly disfavor vaping bans or being told what they can and cannot use. In this regard, given the paucity of e-cigarette products on the “FDA-approved list,” your restricting businesses to this list is tantamount to a ban on the flavored e-cigarettes which tens of millions of adult customers are using as their preferred alternatives to smoking deadly cigarettes.

Moreover, the downstream implications of effectively supplanting the FDA’s enforcement decisions with your own will have a dramatic adverse impact on the small businesses that President Trump committed to saving, not to mention steep adverse economic consequences when small businesses are fined out of business or brand owners have so much inventory removed they must cease operating.

For those companies which have not yet acted, we encourage you to exercise caution and wait for FDA to complete its work and publish its enforcement discretion list. This will allow your company to know precisely which products present genuine compliance risk, align your company with current federal regulatory policy on enforcement, and preserve your ability to take targeted action. At the same time, it will avoid unnecessary disruption to your licensed, taxpaying American small business customers and your millions of adult consumer customers, and will ensure that the products FDA itself has determined should receive enforcement discretion remain available.

For those companies which have already acted, we strongly urge you to immediately reverse your announced policy, until the FDA completes its work and publishes its enforcement discretion list. This will realign your company with the current federal regulatory enforcement scheme, protect your millions of consumers, and attenuate the serious marketplace disruption you have caused.

This is a national issue governed by federal regulations. States have myriad options to change their laws and restrict markets. But, your companies should not be the tool used to effectuate non-legislated bans, particularly those that conflict with federal regulations and state laws, and when there is no urgency that is not already being addressed by the Trump Administration and the FDA.

Thank you for your time in considering this matter. We would welcome the opportunity to provide additional information and work constructively with you in addressing this important, complex and evolving regulatory environment.

Sincerely,

Tony Abboud Executive Director

Enclosure

¹Most of the authorized products are antiquated (8-15 years old), are widely unavailable on or already removed from the market, or barred from the market due to patent litigation. And since virtually none are flavored e-cigarettes, the list is largely irrelevant to the consuming public.

²This same argument could easily apply to the myriad colorful and flavored alcoholic beverages that have flooded the market, which are used by youth at dramatically higher rates than vapes, and for which your services remain available.

³FDA, FDA Publishes Peer-Reviewed Journal Article, Releases 2025 Youth Tobacco Findings, June 23, 2026. 4Verza, Maria, After Mexico bans vapes, cartels tighten grip on booming market | AP News, January 30, 2026,

⁵It is worth noting that your services remain readily available for businesses to sell and consumers to buy cigarettes, a legal product which when used as intended kills half a million Americans every year, making it the number one cause of death and disease in the U.S. 6In 2019, President Trump executed a targeted action directed at the flavored products that all the kids were using and he exempted from that partial flavor ban the very products you are now removing from your store shelves today.

⁶In 2019, President Trump executed a targeted action directed at the flavored products that all the kids were using and he exempted from that partial flavor ban the very products you are now removing from your store shelves today.

⁷Choi, Joseph and Weixel, Nathaniel, FDA drops guardrails on vaping industry in major Trump pivot, The Hill, May 18, 2026, available at https://thehill.com/policy/healthcare/5880802-flavored-vapes-fda-guidance/.

⁸FDA, FDA Issues Guidance on Enforcement Priorities for Unauthorized ENDS and Nicotine Pouch Products, May 8, 2026, available at https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-guidance-enforcement-prioritiesunauthorized-ends-and-nicotine-pouch-products.

⁹One year ago, VTA loudly called on the Administration to take this action. VTA Press Release: One-Million-Dollar Ad Campaign Launched by VTA Urging Immediate Action to Remove Youth Targeted Vapes, July 14, 2025.

THIS DOCUMENT IS NOT INTENDED NOR SHOULD BE RELIED ON AS LEGAL ADVICE. PLEASE CONSULT LEGAL COUNSEL ABOUT YOUR SPECIFIC PRODUCTS. 

Overview

Pennsylvania law establishes a state-managed directory for electronic nicotine delivery
systems (ENDS) products. Only products that comply with certification requirements and
are listed on the Pennsylvania directory may be legally sold in the Commonwealth following
enforcement.

Important Dates

• April 21, 2026: An ENDS manufacturer seeking to have its product included on the ENDS directory must submit a certification to the Attorney General.
• June 20, 2026: The ENDS directory will be published.
• October 19, 2026: ENDS products not appearing on the directory shall be subject to seizure by the Commonwealth.
• Annual: Submission of a certification to the Attorney General by April 21 of each year after 2026 to remain on the directory.

What You CLEARLY CAN Sell

• Products that have submitted required certifications and are listed on the Pennsylvania ENDS Directory may be sold.
• The directory is maintained by the Pennsylvania Office of Attorney General and can be accessed here: https://www.attorneygeneral.gov/ends/
• Manufacturers must certify that each product complies with federal FDA requirements, including PMTA status (submitted, under review, or authorized).

“Electronic Cigarette that Contains Nicotine” means an electronic cigarette labeled,
advertised, or marketed as containing nicotine or an electronic cigarette determined by
the department or the Attorney General to contain nicotine. The term includes an
electronic cigarette that bears the same brand name as an electronic cigarette determined
to contain nicotine by the department or the Attorney General.

“Timely filed premarket tobacco product application.” An application under 21 U.S.C. § 387j
(relating to application for review of certain tobacco products) for an electronic cigarette
that contains nicotine derived from tobacco marketed in the United States as of August 8,
2016, that was submitted to the FDA on or before September 9, 2020, and was accepted for
filing by the FDA.

What You CLEARLY CANNOT Sell

• Any ENDS product not listed on the Pennsylvania directory.

What Products Should You Consult Legal Counsel Before Selling

• Any Hardware or Open System Devices that Do Not Contain Nicotine. 
• Any component parts such as coils or batteries
• Zero MG products or products that do not contain nicotine

Responsibilities by Entity

Manufacturers

• Submit certification forms to the Pennsylvania Attorney General
• For electronic cigarettes containing nicotine manufactured outside of the United  States, the manufacturer must provide a complete list of importers into the United States who sell the  products in the Commonwealth and the brand families sold by the importers 
• Pay required registration fees
• Provide documentation demonstrating compliance with federal FDA requirements
• If a non-resident manufacturer, you must have an agent for service of process registered in Pennsylvania
• Must submit a surety bond as required of at least $50,000. This amount may be required to be higher by the Attorney General

Distributors / Wholesalers

• Verify products are listed before selling or shipping into Pennsylvania 

Retailers / Sellers

• Sell ONLY products listed on the Pennsylvania Directory 
• Stop selling non-listed products after the compliance deadline 
  • Note: 120-day sell-through provision after the Attorney General first makes the registry available 
• Monitor directory updates regularly

Penalties for Non-Compliance

• Civil penalties can include: 
  • Up to $1,500 per product per day for retailers, wholesalers, or importers (standard violations)  
  • Up to $1,000 per violation per product until the offending product is removed by manufacturers.  
• Each non-compliant product offered for sale may be treated as a separate  violation, which can significantly increase total liability 
• The Attorney General may also pursue other enforcement actions: 
  • Injunctive relief (court orders to stop sales) 
  • Product removal from the market  
  • Seizure of non-compliant products  

Ongoing violations can result in cumulative penalties and escalated enforcement actions. 

Important Note 

Federal FDA requirements still apply. Pennsylvania’s law adds an additional state-level restriction.

THIS DOCUMENT IS NOT INTENDED NOR SHOULD BE RELIED ON AS LEGAL ADVICE. PLEASE CONSULT LEGAL COUNSEL ABOUT YOUR SPECIFIC PRODUCTS. 

State of New Mexico, ex rel, Raul Torrez, Attorney General v. Circle K Stores, Inc., et al. County of Santa Fe, First Judicial District, Case No. D101-CV-2026-00900

Implications for Vapor Industry
VTA is monitoring a newly filed lawsuit brought by the State of New Mexico against several retailers and distributors involved in the sale of flavored disposable vapor products. We recognize that actions of this nature can raise concerns across the industry, and wanted to provide some perspective. The State’s claims rely heavily on generalized public health concerns regarding youth nicotine use and the characteristics of flavored products, rather than identifying specific misrepresentations or unlawful conduct by individual businesses. The State’s theory attempts to treat common product characteristics — such as flavor descriptions, packaging presentation, or consumer demand — as evidence of unfair or deceptive practices.

Key Takeaways for Industry Members

1. The Complaint advances untested legal theories directed at the supply chain
While the Complaint is framed as a public health enforcement action, it relies on expansive and lnovel theories of liability that seek to extend responsibility beyond manufacturers to include participants throughout the lawful supply chain, including retailers and distributor entities whose role is limited to the sale of finished products. The State alleges that participation in ordinary commercial relationships may constitute actionable conduct where products are later alleged to appeal to youth.  Novel and/or expansive theories often face serious scrutiny from courts.  We expect that to be the case here as the State attempts to advance the case.

2. Claims rely heavily on generalized policy concerns rather than individualized misconduct
The Complaint includes wholly incomplete facts and makes misrepresentations regarding youth nicotine use trends and potential health effects of e-cigarettes to support its case. But, the Complaint does not clearly identify specific misrepresentations directed to consumers by the named defendants. This approach reflects an effort to use consumer protection statutes to regulate product characteristics that remain the subject of ongoing federal regulatory review.  This too will invite serious scrutiny from the court.

3. The case seeks to expand traditional interpretations of “unfair practices” law
The State alleges that the marketing and distribution of flavored products may constitute unfair or deceptive conduct even where such products remain widely sold in regulated retail environments subject to age restrictions. Courts have historically required clear statutory authority before extending liability theories that could affect lawful commercial activity.  In Ohio, multiple cases filed by the Attorney General seeking to impose liability under that state’s consumer fraud and/or deceptive practices statute were dismissed based on federal preemption grounds.

4.  Example of Overreach:  Failure to warn claims ring hollow.
The State asserts numerous claims against the distributors and retailers asserting their failure to warn consumers (specifically youth and their parents) about the addictiveness of nicotine.  Of course, every product sold bear the specific federally mandated warning in the specific federally mandated formatting which expressly states that the product contains nicotine and that nicotine is an addictive chemical.  Thus, efforts by the State to impose some higher standard likely will be viewed skeptically.

VTA Perspective

VTA believes it is important for members and industry to understand that:

• The Complaint does not alter existing federal regulatory requirements governing vapor products.
• The parties to this case have numerous defenses to challenge the State’s novel and expansive legal theories.
• The court will closely scrutinize State’s attempts to expand liability theories beyond established precedent, particularly when the alleged facts require serious leaps of logic.
• Similar cases advancing similar novel theories, including those involving vaping products,  have faced substantial legal challenges and defeats before reaching the merits.
• To date, the State has not sought to enjoin the sale of these products, but is pursuing this case directly against the named defendants who will mount their defense.

VTA is actively monitoring developments in this case and evaluating potential implications for manufacturers, distributors, and retailers. We are coordinating with legal experts and policy stakeholders to ensure that the interests of responsible industry participants are represented, and will look for opportunities to do so in this case.

We encourage members and industry to remain calm and to continue adhering to applicable age-verification requirements, marketing standards, and regulatory obligations, as compliance remains the strongest safeguard against enforcement risk.

VTA will provide updates as the case progresses.

To stay informed and join our fight, please support our various efforts to fight against government overreach at the federal and state levels. You can do so by joining VTA TODAY!

Alabama and Virginia

These alerts are provided for informational purposes only and do not constitute legal advice. Companies with questions should consult their legal counsel.

🔔 Member Alert: Alabama

Alabama Supreme Court Preserves TRO Blocking ENDS Registry Enforcement

Case Reference: VTA v. Marshall, Civ. No. 3-CV-2025-901284
Applies To: VTA Members, Retailers, and Distributors of ENDS Products in Alabama

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Summary

The Alabama Supreme Court has denied the State’s request to stay a Temporary Restraining Order (TRO) that blocks enforcement of key provisions of Act 2025-403, Alabama’s ENDS PMTA registry law. As a result, the TRO remains in effect during the appeal, and Alabama enforcement officers may not enforce its PMTA registry or U.S.-manufacturing requirements against covered parties (see below) at this time.

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What This Means for Members — Right Now

❌ What the State CANNOT Enforce (For Now)

Alabama may not enforce provisions that require:

• ENDS products to have FDA authorization or a pending PMTA
• Compliance with the PMTA registry created by Act 2025-403
• ENDS products to be manufactured in the United States

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👥 Who Is Covered by the TRO

The TRO applies to:

• Vapor Technology Association (VTA) and VTA members as of 2:00 p.m. on August 12, 2025
• Southside Vapes, LLC

We believe this protection also extends to distributors who sell products to VTA-member retailers.

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What Has NOT Changed

All youth-access and marketing restrictions remain fully enforceable, including:

• Alabama Code § 28-11-13 — Prohibits the sale of ENDS products to minors
• Alabama Code § 28-11-16(d) — Prohibits marketing that appeals to minors

This list is not exhaustive. Members should consult the statute and their legal counsel for full requirements.

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Important Case Developments

• August 15, 2025: Circuit Court issued TRO blocking enforcement of Act 2025-403
• October 16, 2025: Court denied preliminary injunction but extended TRO pending appeal
• December 10, 2025: Alabama Supreme Court denied the State’s motion to stay TRO

Result: The TRO remains in effect throughout the appeal.

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Key Takeaway

Alabama may not enforce its ENDS PMTA registry or U.S.-manufacturing requirements against covered parties while the appeal is pending, but all youth-access and marketing restrictions remain fully enforceable.

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🔔 Member Alert: Virginia

Important Court Ruling Affecting Virginia Nicotine & Vapor Product Enforcement

Case Reference: NOVA Distro v. Miyares, Civil No. 3:25-cv-857 (E.D. Va.)
Applies To: Retailers and Distributors of Liquid Nicotine and Nicotine Vapor Products in Virginia

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Summary

A federal court has temporarily blocked Virginia from enforcing key parts of its liquid nicotine and vapor product registry law. As a result, law enforcement officers within the Commonwealth cannot currently require products to be listed on the state directory or force products off the market based on FDA authorization status.

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What This Means for Members — Right Now

✅ What You CAN Do (For Now)

• Continue selling liquid nicotine and vapor products without regard to Virginia’s product directory
• Operate without fear of state penalties, fines, or product removal based solely on FDA authorization status

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❌ What Virginia CANNOT Do (For Now)

• Enforce the state nicotine/vapor product directory
• Require product removal or issue fines based on FDA authorization status
• Act as an FDA enforcement agency

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What Has NOT Changed

Virginia continues to enforce all other tobacco and nicotine laws, including:

• Age-verification requirements
• Licensing
• Taxes
• Compliance inspections

This ruling does not legalize unlawful sales practices.

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Key Takeaway

Virginia may regulate how nicotine products are sold—but, for now, it cannot force products off shelves by enforcing federal FDA authorization rules.

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Important Reminder:

This court order is temporary, and the case is ongoing. Enforcement rules may change.