Category: Regulation

Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

President-elect Donald Trump has nominated Robert F. Kennedy, Jr. to serve as the new secretary of the Department of Health and Human Services (HHS). The effects Kennedy will have on the nicotine market remain unclear. Kennedy must still be confirmed by Congress.
“For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” Trump posted. “The Safety and Health of all Americans is the most important role of any Administration, and HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country.”
As the leader of HHS, Kennedy will oversee the FDA, which regulates vaping, nicotine pouches, and all other nicotine and tobacco products through its Center for Tobacco Products.
Kennedy’s position on vaping, nicotine, and tobacco harm reduction (THR) remains an unknown. During the presidential campaign, Trump promised that, if elected, he would “save vaping” after meeting with Tony Abboud of the Vapor Technology Association.
“I saved Flavored Vaping in 2019, and it greatly helped people get off smoking,” Trump said on his Truth Social platform in September. “I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the country. I’ll save Vaping again!”
November 15, 2024
FDA Renews MRTPs for General Snus

After a scientific review, the U.S. Food and Drug Administration issued a renewal of modified risk granted orders to Swedish Match USA, Inc., for eight General Snus products.
With the renewal, the products may continue to be marketed – as they have been authorized to do so since 2019 – with the following modified risk claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large.
The modified risk granted orders issued by FDA are specific to the products as mentioned above and expire Nov. 7, 2032. If the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.
“The FDA’s review determined that this modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes,” the FDA stated in a release. “FDA found that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.
“In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The available evidence does not indicate significant youth initiation of these products.”
The modified risk granted order does not permit the company to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that the agency deems the products to be safe for use by consumers.
November 7, 2024
Thailand: Push to Ban Smoking in Cars

Image: andranik123
Thailand’s Tobacco Products Control Committee wants to ban smoking in private cars to protect passengers from secondhand smoke, reports The Nation.
Speaking at a seminar on Nov. 5, Rerngruedee Pathanwanit of the Ramathibodi Medical School at Mahidol University said that approximately 70 percent of Thais are affected by secondhand smoke and an average of 20,688 Thais die of health complications caused by secondhand smoke each year.
She also pointed out that Thailand stands fifth in the list of countries where women aged 15 to 49 are affected by secondhand smoke.
Suwanna Ruangkanchasetr, deputy director of the Tobacco Control Research and Knowledge Management Center, told the seminar that recent research found that up to 55 percent of families with children in the one-five age group had smokers in the house.
Researchers also found unsafe levels of nicotine in the hair of children in homes with smokers, she added.
November 7, 2024
FDA Warns Companies For Selling ‘Smart’ Vapes

The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.
The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.
“These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They’re illegal to sell and a flagrant attempt to target kids.”
The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.
“The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug and Cosmetic Act,” the release states.
In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalty.
“FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of the CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”
October 30, 2024
FDA to Review 2ONE Marketing Application
The U.S. Food and Drug Administration has accepted for review 2ONE Labs’ premarket tobacco product application (PMTA) for 2ONE brand nicotine pouches.
According to 2ONE Labs CEO Vincent Schuman, this means that the company’s application will now enter the next critical phase of the FDA review process. “Our company will continue to fully fund this application through to its successful completion, and our wholesale, retail and sponsorship partners should view this ‘acceptance’ as a sign of our ability to navigate this complex PMTA process and our unwavering commitment to support the long-term availability of the 2ONE brand in the U.S. market,” Schuman said in a German-language statement.
“We have developed 2ONE nicotine pouches for adult consumers—21 and older—who find it difficult to switch from combustible or traditional oral tobacco products. The availability of the 2ONE brand in the market over the past five years and the interest and growth our brand has achieved through strong retail partnerships, such as with Circle K, have shown that it is possible even for innovative companies to identify and introduce unique brands that truly offer adults the perfect transition product.”
Earlier this month, 2ONE Labs filed a trademark infringement lawsuit and a preliminary injunction against Imperial Brands subsidiaries’ Zone nicotine pouch trademark. The suit alleges that Imperial’s Zone products willfully infringe the 2ONE nicotine pouch brand.
October 30, 2024
Industry Group Files Amicus Brief in Triton Case

This week, the Coalition of Manufacturers of Smoking Alternatives (CMSA), a trade coalition that represents a diverse array of members who manufacture and distribute smoking harm reduction products, filed an amicus curiae brief before the Supreme Court of the United States supporting White Lion Investments, dba as Triton Distribution, in its case against the U.S. Food and Drug Administration.
In its brief, CMSA argues that FDA violated the Family Smoking Prevention and Tobacco Control Act (TCA) in its wholesale rejection of applications for flavored vaping products by applying a surprise and improperly adopted standard and foregoing the required notice-and-comment process. The brief emphasizes that the U.S. Congress specifically requires the FDA to undergo a transparent rulemaking process before imposing any restriction that amounts to a “tobacco product” standard.
“Importantly, this process tasks FDA with considering the broader public health effects of any such standard, ‘such as creating demand for and increasing the use of unregulated black-market products,’ or other harmful consequences,” the CMSA states. “In its efforts to unilaterally reject flavored vapor product applications based on a new and heightened standard, FDA unlawfully sidestepped this critical regulatory check and operated outside the bounds of its authority.”
The CMSA states that the FDA circumvented the very procedures Congress imposed to check the arbitrary or unreasonable exercise of such delegated power, and causes real harms as the FDA “misleads and whipsaws” manufacturers seeking to provide a robust set of options for consumers seeking to quit smoking,” the CMSA wrote in its brief. Further adding that “the long delays in FDA’s review of the many PMTAs (premarket tobacco product applications) it has received, coupled with the moving goal posts imposed via the review process, creates a level of uncertainty that severely deters investment and innovation in new products with harm-reduction potential.”
Earlier this week, 13 members of Congress, including U.S. Senator Roger Marshall and U.S. Representative Andy Harris, filed an amicus brief supporting the position of Triton Distribution and CMSA. In their brief, the members of Congress write, “There is a clear lack of authority for such a ban. Congress has specifically prohibited the FDA from banning products. Despite this, the FDA imposed a categorical prohibition.”
Also, the Global Action to End Smoking wrote in its amicus brief to SCOTUS that the FDA strayed from a “sensible, science-based harm-reduction approach, adopting an all-or-nothing stance that exalts outright cessation and all but ignores the harm-reduction strategy that Congress mandated…. [ignoring the] overwhelming scientific evidence that e-cigarettes containing flavor additives have an important role to play in moving adult smokers down the continuum of risk.”
SCOTUS announced Dec. 2, 2024 as the date for the U.S. Food and Drug Administration v. Wages and White Lion Investments, LLC, d/b/a Triton Distribution hearing.

October 18, 2024
Taxpayer Group Files Amicus Brief

Image: hafakot
The Taxpayers Protection Alliance (TPA) submitted an amicus curiae brief to the U.S. Supreme Court in support of the Wages and White Lion Investments case, challenging the Food and Drug Administration’s regulation of e-cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA). The TPA argues that the FDA’s actions have been arbitrary, capricious and detrimental to public health.
The brief contends that the TCA’s standard for determining what is “appropriate for the protection of the public health” is unconstitutionally vague, providing insufficient guidance to regulated entities and delegating excessive authority to the FDA. This vagueness has led to unpredictable enforcement, adversely affecting both taxpayers and adults who smoke and are seeking safer alternatives to conventional cigarettes.
Furthermore, the TPA criticizes the FDA for failing to recognize the significant benefits of e-cigarettes as a smoking cessation tool, as acknowledged by leading health organizations such as Public Health England. According to the TPA, the TCA is clear on the need for the FDA to consider the impact of e-cigarettes on smoking cessation, yet the agency has abjectly failed to undertake this analysis. The TPA highlights the FDA’s stringent regulatory approach and high denial rates for new e-cigarette products, which the group says stifle market diversity and limit consumer choice, particularly harming adults who smoke and who might benefit from less harmful alternatives.
The TPA also notes the FDA’s disregard for market realities and consumer preferences, particularly the benefits of open-system e-cigarettes that allow for customization and have been shown to be more effective for quitting smoking.
The TPA urges the Supreme Court to uphold the 5th Circuit’s decision, affirming that the FDA’s regulatory approach under the TCA is arbitrary and capricious and violates due process. The TPA calls for a regulatory framework that adequately considers the benefits of e-cigarettes and gives regulated parties fair notice of how their products will be evaluated.
October 17, 2024
Supreme Court to Hear Avail, Reynolds PMTA Case

TR Archives
The Supreme Court of the United States has agreed to consider another case involving federal approval of vapes at the request of the Biden administration on Friday.
The case arose after the Food and Drug Administration denied R.J. Reynolds Vapor Company’s request to introduce three flavored vapes on the market. The FDA said the company failed to meet federal requirements concerning tobacco products’ marketing, but the company contends that the decision was arbitrary and capricious.
Reynolds is based in North Carolina, and the federal appeals courts located there and in D.C. already had precedent on the books unfavorable to the manufacturer.
Under federal law, companies can challenge the FDA denying of a marketing order for a new tobacco product in Washington, D.C., or where the company’s principal place of business is located, reports The Hill.
The 5th U.S. Circuit Court of Appeals has been more sympathetic to the industry, making it an attractive place for companies to contest their products being denied.
The 5th Circuit’s rule effectively enables it to host any tobacco company’s challenge, so long as its lawsuit is joined by a convenience store or other retail seller within the 5th Circuit’s borders—which span Louisiana, Mississippi and Texas.
Reynolds instead filed its challenge in the 5th Circuit alongside Avail Vapor Texas and the Mississippi Petroleum Marketers and Convenience Stores Association. The federal government attempted to move venues, but the 5th Circuit said the additional challengers meant the case was properly brought.
No matter which way the justices rule, they are not expected to address the merits of the FDA’s denial. The Supreme Court only took up the question of whether the 5th Circuit was a proper venue.
“There is no circuit conflict over the meaning of this venue provision. And other vehicle problems abound,” the company wrote in court filings urging the justices to turn away the appeal.
October 6, 2024
Regulations Decimate Philippine Vape Sector

Image: freshidea
Onerous government regulations have forced about one-fifth of Philippine vaping companies out of business, according to Philippine E-Cigarette Industry Association President Joey Dulay. Importers, he added, have found it easier to comply than their domestic counterparts.
“But we are pushing them to try and comply,” Dulay was quoted as saying by Business World.
Under the Vaporized Nicotine and Non-Nicotine Products Regulation Act, manufacturers or importers must register their products and secure licenses to operate.
They are also required to adhere to packaging standards and pay duties and taxes.
Manufacturers, distributors and importers were given an 18-month transition period to comply with the regulations laid down in the vape law.
Dulay noted that many vape brands and manufacturers have yet to secure their Philippine standard quality and/or safety mark and import commodity clearance sticker.
By the end of August, the Bureau of Customs had confiscated PHP6.5 billion ($115.21 million) worth of illegal vape products, mostly from China.
The government is estimated to miss around PHP5 billion yearly from illicit vape products.
October 3, 2024
At the Crossroads, Again

Photo: jorisvo
There are still more unknowns than knowns about the shape of future European regulation for novel nicotine products.
By Barnaby Page
Europe’s relationship with novel nicotine products has always been a mixed one. On the one hand, the more extreme forms of hysteria about youth vaping or supposed health risks have been relatively absent from the European scene; the U.K. in particular has been regarded as perhaps the most pro-vaping major economy in the world. And regulation—in most countries, heavily shaped by the European Union’s Tobacco Products Directive (TPD)—is in some respects light-touch.
Most notably, rather than following the U.S. model, which in theory requires marketing authorization by the Food and Drug Administration before products can be sold, the EU has eschewed the premarket approval approach and simply asks for products and businesses to be compliant with the TPD’s requirements.
But if Europe (which for the rest of this article mostly means the EU and its member states) has been looser in its regulatory approach than the U.S. in some ways, many of the requirements that it does make are quite onerous: the 20 mg per milliliter limit on nicotine strength, for example. It is also well known that the TPD as originally conceived was going to be far more restrictive and was only scaled back after pressure.
And there have been distinct signs lately of Europe becoming more cautious. Most flavors were banned EU-wide in heated-tobacco products; several countries have enacted, or will enact, disposable e-cigarette bans; the Netherlands, usually famed for its tolerance, is an example of a country that has started showing a lot of skepticism toward novel nicotine products; even in the U.K.—no longer an EU member—government support for tobacco harm reduction seems to be ebbing away a little, though it certainly hasn’t turned into outright opposition yet.
Set against this background, there is concern that the next version of the TPD may make major changes to the EU’s regulatory framework for novel tobacco products, reflecting conservative positions.
So far, nothing is known for sure about the actual content of the next TPD or about any updates to the lesser-known Tobacco Advertising Directive and Tobacco Excise Directive—though a European Commission spokesperson did confirm to Tamarind Intelligence, late last year, that vaping would be a focus of the TPD. The commission’s job with the TPD is essentially to formulate the legislation, which representatives from all the EU member states, in the European Parliament and the Council of the European Union, then vote on.
However, looking at what is already happening across Europe gives some indicators of what’s possible—action against disposable vapes in France and Belgium, for example, or against flavored products in Finland and Hungary. Though it’s true that EU policy certainly does not derive directly from localized policy in member states, there are trends visible that are bound to be reflected in Brussels. It’s also worth noting that the much-anticipated swing to the populist right in the most recent European elections failed to fully materialize, which may well mean that the EU will continue to favor tight, precise regulation and not care too much whether it is seen as “business-friendly.”
First, disposable bans: There have been debates or even legislation in most major European countries over banning disposables, partly because of youth usage but also because of environmental impacts. Even if not all of these come to pass, the fact that an outright prohibition on disposable vapes is so widely seen as a reasonable, proportionate regulatory response—not an unrealistic or extremist one—must make an EU-wide ban a possibility.
Second, flavors: There is a precedent for some kind of vape flavor ban in the existing EU ban on flavors in heated tobacco, and a number of EU health ministers have given such a measure their support. This would be a greater blow to the industry than a disposables ban, though a crucial question would be exactly what is outlawed and what is permitted.
The most draconian position would be a reduction of the market to tobacco and perhaps menthol/mint flavors. There could, however, be a middle ground with some other flavors allowed that still removed the more outre and (supposedly) youth-tempting ones from the market; there have also been suggestions that a ban on extreme flavor descriptions, rather than the actual flavors, could achieve the same end. So there are quite a lot of options on the table when it comes to regulation of flavors, and this is perhaps the area to watch most closely.
Other major areas likely to come under consideration include taxation, and an extension of the existing EU ban on snus (from which only Sweden is exempt) to tobacco-free nicotine pouches.
An equally big question, however, is when any of this will happen. The process of revising the TPD has been underway for more than two years now, suffering several delays and changes in its schedule.
For example, the European Commission’s Directorate-General for Health and Food Safety (DG Sante) had originally promised to finalize its evaluation report on tobacco policy last year, but when the commission published its work program for 2024, it made no mention of revising tobacco policy. Therefore, it seems unlikely that there will be major announcements on the TPD or other Europe-wide tobacco regulation in 2024.
When it eventually does happen, it will be the culmination of a process that started more than two years ago, when the commission launched a call for evidence, which ran from May 2022 to June 2022. This was then followed by a public consultation from February 2023 to May 2023. Eventually, the results of these consultations should be taken into account by the commission when it drafts a directive to be discussed by the Parliament, but so far … nothing.
So it’s been a long period of near silence even though many expected action—and debate—much sooner. The delays may be partly down to divergence in member states’ positions on tobacco control—it’s going to be hard to come up with Europe-wide policies that at least partially satisfy enough member states and enough competing principles.
Although the European Commission will be the one to propose the new policies, it is the legislators in the Parliament (and the Council of the European Union, the other “house” of the European legislature) who ultimately vote for or against it. So, while the commission may well be likely to maintain a conservative or even quasi-prohibitionist stance, it’s very possible that Members of Parliament (MEPs) may disagree. Some MEPs who spoke with ECigIntelligence said that they were prepared to fight conservative approaches to novel nicotine products that may be counterproductive for harm reduction, and the influx of new MEPs after this year’s election adds a further level of uncertainty.
Moreover, positions on novel nicotine products cannot easily be predicted from political affiliation. Generally, the more right-wing a party is, the more easygoing toward novel nicotine products it tends to be (and this would in theory make the broadly rightward trend in politics a positive one for harm reduction’s proponents), but this is far from consistent and there are many exceptions (as indeed there are to that rightward trend).
For example, arguments prioritizing consumer education and freedom of choice over strict policies, historically usually attributed to right-wing parties, are often also shared by left-wing parties. The national origin of a politician may be just as significant as their nominal position on the left-right spectrum—a left-winger from a country with very strict regulation of tobacco products is often likely, we find, to be more sympathetic to that kind of legal regime than a left-winger from a country with a much lighter touch.
So there are plenty of unknowns, and of course the unusual position of the U.K.—the biggest market for novel nicotine products in Europe—is another one. When the last TPD appeared, the U.K. was still a member of the EU, and so it adopted the TPD’s measures into its own domestic legislation (as all EU member states must do with European directives). But it has since left the union, via Brexit. The current British government certainly seems to have a hardline attitude on disposables, but there are also indications that it remains supportive of harm reduction, so how aligned the U.K. will remain with the rest of the EU in the future is very much an open question. One distinct possibility is that even if Britain starts to tighten regulation on some aspects of novel nicotine products, it remains more liberal than an EU that gets even tougher.
Barnaby Page has been covering the tobacco harm reduction business as a journalist for more than 10 years as editorial director at Tamarind Intelligence, a pioneering data intelligence and strategic insight provider offering global market and regulatory data analysis for businesses operating in fast-growing industries. Tamarind currently covers the vapor sector with ECigIntelligence, other tobacco and nicotine alternatives with TobaccoIntelligence, and cannabis with CannIntelligence. This article also incorporates research from other Tamarind staffers.

October 1, 2024