Keller and Heckman will hold its nineth Annual E-Vapor and Tobacco Law Symposium Jan. 27-28, 2025, in Las Vegas, right before the Total Product Expo. This two-day seminar is designed to provide in-depth knowledge on legal, regulatory and scientific issues that are essential for tobacco, nicotine and CBD/hemp product manufacturers, suppliers, distributors and retailers.
Registration for this seminar, which will be held at the Hilton-Conrad Resorts World Las Vegas, will launch in September 2024.
Keller and Heckman has filed an amicus brief with the U.S. Supreme Court on behalf of members of the electronic nicotine-delivery system (ENDS) industry in support of petitioners in a case to overturn or limit the so-called Chevron deference.
Named after a landmark Supreme Court decision dating from 1984, the Chevron deference is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable.
In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.
In the years since ENDS became subject to Food and Drug Administration regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard, Keller and Heckman wrote on its blog.
Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.
The filers on the amicus brief urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. The Supreme Court will hear oral arguments in the case in its fall 2023 term.
The petition to overturn or limit the Chevron deference was brought by a group of fishing companies challenging the National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors.
The ENDS industry amici include the American Vaping Manufacturers Association, the American Vapor Group and Bidi Vapor.
Eric Gotting and Azim Chowdhury, partners at Keller and Heckman, filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of Avail Vapor’s writ of certiorari petitioning the SCOTUS to review the 4th Circuit’s decision to uphold the U.S. Food and Drug Administration’s marketing denial order of Avail’s premarket tobacco product application for its nontobacco-flavored e-liquids, according to a post on The Continuum of Risk.
The brief, filed on behalf of a group of public health experts, is intended to provide relevant scientific background on comparative health impacts of electronic nicotine-delivery system (ENDS) products with combustible cigarettes.
The brief argues that ENDS are, beyond a reasonable doubt, much safer than cigarettes; ENDS help adult smokers quit and can reach many adults who would not otherwise quit smoking; ENDS flavors are important to adults trying to quit smoking; youth vaping has declined markedly since 2019, with most youth vaping being infrequent, nonaddictive and temporary, and more frequent and intense vaping generally limited to adolescents who are otherwise likely to smoke.
Youth do not generally use the refillable tank devices sold in vape shops but instead use more mass-market products; claims that vaping is a gateway to smoking are based on a misunderstanding of the evidence; and because smoking and vaping are linked, measures like e-liquid flavor bans can cause more smoking or other damaging unintended consequences.
In its petition, Avail asks the Supreme Court to consider the lower court’s legal reasoning and decision.
Among other things, Avail argues in its petition that the FDA’s decisionmaking was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.
The Supreme Court has not yet decided whether it will hear Avail’s case.
The U.S. Food and Drug Administration’s implementation of the 2009 Tobacco Control Act, which gave the agency authority to regulate tobacco products, has been fundamentally flawed from the beginning, according to Azim Chowdhury, a partner in the Keller and Heckman law firm.
Writing in Filter, Chowdhury explains that the premarket authorization requirements for “new” products subjects potentially reduced-harm products to nearly insurmountable hurdles while allowing preexisting products, including combustible cigarettes, to mostly escape FDA scrutiny.
In his article, Chowdhury suggests several ways in which the FDA can more effectively implement the Tobacco Control Act.
For example, rather than conducting reviews in a silo, the FDA should consider the totality of evidence in a premarket tobacco product application, according to Chowdhury.
“It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement,” he writes.
“Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.”
The Keller and Heckman law firm will hold its annual E-Vapor and Tobacco Law Symposium on Feb. 15-16, 2023, at the Courtyard Irvine Spectrum in Irvine, California, USA.
This year’s program will feature topics designed to help vapor and deemed tobacco product manufacturers stay in compliance with rapidly evolving laws and policies, according to Keller and Heckman.
The conference will cover marketing denial orders (MDOs), U.S. Food and Drug Administration proposed rulemakings and youth access prevention plans, among other topics.
For more information, visit the symposium information webpage.
Daniel P. McGee has joined Keller and Heckman’s expanding tobacco and vapor practice as counsel.
Prior to joining Keller and Heckman, McGee worked as in-house counsel for several multinational tobacco, vapor and CBD companies, where he honed his skills advising on compliance and regulatory issues related to tobacco, vapor, nicotine, hemp, CBD and related products.
McGee has experience counseling companies on a broad range of complex tobacco and U.S. Food and Drug Administration regulatory matters and developing strategies to help companies bring new products to market.
“Daniel’s expertise and industry perspective will be invaluable to Keller and Heckman clients who are carefully navigating the challenges and pitfalls of a highly regulated and rapidly evolving legal landscape,” said Azim Chowdhury, a Partner in the firm’s tobacco and vapor and food and drug practices.
“In addition to expanding our tobacco and e-vapor capabilities, we are especially looking forward to utilizing Daniel’s expertise in state law compliance, particularly for clients expanding into the hemp and CBD categories.”
“The addition of Daniel to our practice demonstrates Keller and Heckman’s commitment to helping our clients understand and comply with continuously evolving regulations in this growing field,” said Richard Mann, chair of Keller and Heckman’s management committee.
“I am honored to work with Keller and Heckman’s experienced team of tobacco and e-vapor attorneys and to share the corporate perspective with my new colleagues,” said McGee. “After spending the bulk of my legal career as in-house counsel to the tobacco industry, I made a strategic decision to focus on the industry as a whole and join a law firm that is a leader in tobacco regulatory compliance and public policy initiatives.”
McGee received his J.D. degree from the University of Oregon School of Law and his B.A. degree from Boston College, where he graduated with honors.
President Biden on Tuesday is expected to sign a $1.5 trillion spending bill that funds the government through September and includes a rider that places synthetic nicotine products under the authority of the U.S. Food and Drug Administration. The Senate passed it late Thursday night by a 68-31 margin. Biden signed a stopgap measure Friday that averts a partial government shutdown that would otherwise have occurred midnight Friday.
The rule will become law 30 days after the bill’s signing date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
Azim Chowdhury, a partner with the law firm Keller and Heckman said that the way he interprets the rule is that all synthetic products already on the market or newly marketed within 30 days after the enactment date can continue to be marketed during the 60-day period following the enactment date.
The language of the Tobacco Control Act would change 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,” when Biden signs the bill into law.
Products subject to timely submitted PMTAs can remain on the market for 90 days after the effective date, which is 120 days after enactment. Any product not authorized by FDA within 120 days of enactment must come off the market, according to Chowdhury.
“We do not anticipate FDA authorizing any synthetic nicotine products by the end of the 90-day period, though they may take another fatal flaw approach to quickly deny applications,” said Chowdhury. “Significantly, the rider in its current form indicates that a synthetic nicotine version of a product that already went through the PMTA process and is subject to a Refuse-to-Accept (RTA), Refuse-to-File (RTF), Marketing Denial Order (MDO), or withdrawal of a marketing order would have to come off the market as of the effective date – i.e., after 30 days of the law’s enactment.
“In simpler terms, for products that were previously formulated with tobacco-derived nicotine (and the only change was a switch to synthetic nicotine) and whose PMTAs have already been refused or denied, those products will effectively be banned on the effective date (30 days after enactment) with no opportunity to submit a new PMTA. (This is Congress’ way of punishing companies whose PMTAs were denied and then, in their view, sought to circumvent the law by switching to synthetic nicotine).”
Beyond the PMTA conditions, manufacturers of synthetic nicotine products would be subject to ‘all requirements of the regulations for tobacco products. Chowdhury said he and his team interpret this to include all additional Tobacco Control Act requirements, including tobacco product establishment registration and product listing, ingredient listing, ensuring that labeling is compliant including required warning statements, and health document submissions, among other.
April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA), wrote in a release that her organization is disappointed by the Biden administration’s use of earmarks in a omnibus appropriations bill without giving an adequate amount of time for interested parties to review and discuss the rule.
She stated that the vaping industry has helped millions of American adult consumers that have relied on flavored vapor products for over a decade to successfully remain combustible tobacco-free.
“Sadly, it is those consumers who will pay the ultimate price of this legislation,” she said. “Over the last decade of SFATA’s existence, we have fought diligently to keep flavored products accessible to smokers. Any battle lost means consumers are potentially driven back to deadly combustible cigarettes, and therein lies the real tragedy.
“It is shameful that public health officials prefer to carve legislation with a butcher’s knife, rather than with the skill and precision of a scalpel better served to ensure the nation’s public health.”
On January 1, 2022, two new state laws will become effective in Illinois and Oregon and could cause significant disruption to the vapor industry. According to Azim Chowdhury and Taylor D. Johnson, with the Keller and Heckman law firm, The Preventing Youth Vaping Act, will take effect in Illinois and HB 2261, will take effect in Oregon.
Under the Illinois law, an electronic cigarette is broadly defined as
“Critically, SB 0512 considers an electronic cigarette to be adulterated (and prohibited for sale) if, “it is required by 21 U.S.C. 387j(a) to have premarket review and does not have an order in effect under 21 U.S.C. 387j(c)(1)(A)(i) or is in violation of an order under 21 U.S.C. 387j(c)(1)(A).” In other words, if an e-cigarette is required by the federal Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387j(a)) to have premarket authorization from the U.S. Food and Drug Administration and does not have a Premarket Tobacco Product Application (PMTA) order in effect (or is in violation of such an order), it would be considered adulterated under the Illinois law,” the post states. “Although the law exempts e-cigarettes “first sold prior to August 8, 2016 and for which a premarket tobacco product application was submitted to the U.S. Food and Drug Administration by September 9, 2020” from the adulteration definition, products that are subject to timely submitted PMTAs that FDA has either refused-to-accept, refused-to-file, or have received marketing denial orders from FDA would likely still be considered adulterated by the state (as well as FDA).”
The rules do not apply to synthetic nicotine or CBD products.
In Oregon, the legislation prohibits the shipment of “inhalant delivery systems” to any person in Oregon other than a distributor or a retailer. The legislation effectively prohibits direct-to-consumer (DTC) sales (including online sales) of the vast majority of vapor products in Oregon, according to the blog post.
“Inhalant delivery systems” are defined in the legislation as “a device that can be used to deliver nicotine in the form of a vapor or aerosol to a person inhaling from the device; or a component of a device described in this paragraph or a substance in any form sold for the purpose of being vaporized or aerosolized by a device described in this paragraph, whether the component or substance is sold separately or is not sold separately.”
As such, the legislation would appear to prohibit the DTC sale of most types of vapor products, but likely would not cover non-nicotine closed-system products:
| Type of Vapor Product | Subject to Oregon HB 2261 shipment ban? |
| Bottled e-liquid (with or without nicotine) | Yes – language covers “a substance in any form sold for the purpose of being vaporized or aerosolized by a [inhalant delivery system] device” |
| Open-system/Open-tank ENDS Device | Yes – language covers “a device that can be used to deliver nicotine in the form of a vapor or aerosol to a person inhaling from the device” |
| Open-system ENDS components (e.g., tanks, coils, atomizers, batteries, etc.) | Yes – language cover “or a component of a [inhalant delivery system] device” |
| Closed-system ENDS (e.g.., pod/cartridge or disposables) pre-filled with nicotine-containing e-liquid | Yes – language covers “a substance in any form sold for the purpose of being vaporized or aerosolized by a [inhalant delivery system] device” |
| Closed-system ENDS (e.g.., pod/cartridge or disposables) pre-filled with non-nicotine containing e-liquid | No – this type of product (i.e., a pre-filled CBD or THC vapor device) would not fall within meaning of a inhalant delivery system |
An e-cigarette is also considered adulterated if (A) it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or deleterious substance that may render the product injurious to health; or (B) it is held or packaged in containers composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.
Keller and Heckman will has announced the agenda for its sixth Annual E-Vapor and Tobacco Law Symposium.
The two-day virtual seminar will focus on legal and regulatory issues critical to the vapor, tobacco and CBD industries in the aftermath of the U.S. Food and Drug Administration’s decisions on millions of premarket tobacco product applications (PMTA).
Among other topics, the seminar will cover PMTA marketing denial order challenges, new requirements for PMTAs and substantial equivalence reports and the outlook for synthetic nicotine products. The program will also discuss China’s new vapor regulations.
In addition to Keller and Heckman’s regulatory attorneys and scientists, this year’s program features numerous expert guest speakers, including from Tobacco Vapor Cannabis Group, the American Vaping Association, McKinney Regulatory Science Advisors and the Tax Foundation.
The symposium will take place Feb 2-3 from 10:30 am to 6:30 pm Eastern Time.
China’s recently announced intention to regulate e-cigarettes as tobacco products will reverberate around the world, according to an analyses published on Keller And Heckman’s The Continuum of Risk blog.
On Nov. 26, 2021, China’s State Council announced it would amend the country’s tobacco monopoly law to subject e-cigarettes to the same requirements as traditional cigarettes. On Dec. 2, the State Tobacco Monopoly Administration (STMA) published on its website the draft management rules for e-cigarettes for public comment.
The draft rules define “e-cigarette” as an electronic delivery product that produces nicotine-containing aerosol for human inhalation. The definition does not include heat-not-burn tobacco products, which are already regulated as combustible cigarettes in China, according to Keller and Heckman. The draft rules make clear that e-cigarettes should be regulated like tobacco products by STMA and its local agencies and provide that e-cigarettes must comply with the e-cigarette national standard.
Among other things, e-cigarettes will be subject to premarket registration upon a safety review by the STMA under the draft rules. Producers and sellers of e-cigarettes in China must obtain the same tobacco monopoly licenses as traditional cigarette manufacturers. In addition, all vapor product companies will be required to trade on a national e-cigarette platform to be set up by the SMTA. The draft rules also contain requirements to protect minors such as age-restrictions and warning labels.
Because the draft rules’ registration and production licensing requirements apply to all e-cigarette manufacturers operating in China, they will also impact products sold abroad. China manufactures more than 95 percent of the world’s e-cigarette hardware.
In 2019, China notified the World Trade Organization about its first national standard on e-cigarettes, which covers raw materials, technical requirements, testing methods and labeling, among other topics. On Nov .30, 3021, China published updated draft of the standard for comment.
According to Keller and Heckman, the STMA plans to implement the standard “three to five months after its publication.”
During the transition period, existing enterprises can continue manufacturing and operational activities. However, investors are banned from investing in new e-cigarette enterprises; existing e-cigarette production and operation entities must refrain from constructing or expanding production capacity, and they may not establish new e-cigarette retail outlets and market new products. “New import of e-cigarettes” will also be suspended during this period.
The public comment period for the draft management rules closes on Dec. 17, 2021, 15 days after its publication, and the public comment period for the draft standard closes on Jan. 29, 2022.