End Cigarette Smoke Thailand (ECST) wants Thailand to legalize vapor products to enable smokers to legally switch to less harmful nicotine products, according to an article in The Bangkok Post.
This vaper in Koh Samui, Thailand could face fines or even jail. (Timothy S. Donahue)
Despite a seven-year old ban on e-cigarettes, the number of vapers has steadily increased in Thailand, according to the ECST. While the National Statistical Office estimates there are 78,742 vapers in the country, ECST representative Maris Kranyawath believes there are almost a million, based on the number of people following social media pages that sell vape products.
Maris said legalizing vapor products would allow state agencies to set product standards. “Thailand has had a ban on vaping for seven years, but the number of vapers has continued to increase despite it,” said Maris. “This means the policy has not been effective. If vape products were legal, they could be examined and standardized by state agencies.”
To protect young people, the ECST has proposed regulations to ban minors from buying and using vape products. “A salesperson must provide vape products that are appropriate for each user,” said Maris. “Moreover, each vaper should register for a vape card at a district office first. When a vaper purchases products, he/she must show the card. Also, vape stores must have a machine to scan cards to identify the customer who has a daily limit of no more than 200ml of e-liquid per day.”
The push for permitting vapor products has been gaining momentum in Thailand. Recently, Digital Economy and Society Minister Chaiwut Thanakamanusorn said he would explore ways to legalize the sale of e-cigarettes, citing their comparatively low health risk and the impact of black market sales on tax revenues.
South Africa’s National Treasury has outlined a proposal on the taxation of electronic nicotine delivery systems (ENDS), reports BusinessTech.
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Among other measures, the agency is considering taxes on hardware and e-liquids, with higher-nicotine products attracting higher levies than low nicotine varieties.
While the market for ENDS is still in its infancy in South Africa, the National Treasury expects it to grow. The agency says it wants to learn from the experience of other countries where growth of ENDS has raised concerns about underage consumption. The agency said it is also aware of concerns about the potential of ENDS to undermine global tobacco control efforts and public health.
Vaping products are covered neither by South Africa’s Tobacco Products Control Act nor by the country’s Medicines Act. The government has proposed the Control of Tobacco Products and Electronic Nicotine Delivery Systems Bill in which it hopes to regulate vapor products in a similar way as cigarettes.
The bill was introduced for public comment in 2018, but remains in a draft form.
According to 2021 study commissioned by the Vapor Products Association of SA, the vapor industry in 2019 contributed ZAR2.49 billion to South Africa’s GDP while paying ZAR710 million in taxes. More than 350,000 South Africans use vapor products.
New Jersey Congresswoman Mikie Sherrill, on Dec. 15, introduced the Clarifying Authority Over Nicotine Act of 2021 — a bipartisan bill designed to give the U.S. Food and Drug Administration (FDA) the authority to regulate synthetic nicotine products just as it regulates nicotine products made or derived from tobacco. In a press release, Rep. Sherrill stated, “This bill will ensure all tobacco products, including products made with synthetic nicotine, are regulated by the FDA in order to protect kids in our communities and those who may seek to use these products.”
Credit: DedMityay
In a blog post, Bryan Haynes and Michael Jordan, attorneys with Troutman Pepper, state that, as it stands, the Federal Food, Drug, and Cosmetic Act (FDCA) defines “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” 21 U.S.C. § 321(rr)(1) (emphasis added). As the FDA concedes on its website, “it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product.”
That said, there are other ways FDA might try to regulate synthetic nicotine, whether under its authority to regulate a “component” of a tobacco product or as a “drug.” In November, FDA Center for Tobacco Products Director Mitch Zeller discussed the “component” aspect of the FDCA’s definition of “tobacco product” and suggested “that components and parts could include everything from coils and batteries to all the ingredients comprised in producing e-liquids (such as flavorings and vegetable glycerin) even if the product does not contain nicotine.” He added, “That’s an assessment that we need to make on a case-by-case basis based upon the totality of all the information that we have.”
FDA could also seek to regulate synthetic nicotine as a drug. The FDCA defines drug, among other things, as “articles (other than food) intended to affect the structure or any function of the body.” 21 U.S.C. § 321(g)(1). To the extent synthetic nicotine is intended to affect a consumer’s body, FDA could attempt to assert jurisdiction. Indeed, in the 1990s, FDA tried to regulate nicotine as a “drug” and cigarettes and smokeless tobacco as “drug delivery devices.” The Supreme Court in FDA v. Brown & Williamson Tobacco Corp. found FDA lacked such authority, but one of the Court’s key findings was that Congress had passed “tobacco-specific legislation [that] effectively ratified the FDA’s previous position that it lacks jurisdiction to regulate tobacco.” Today, things are different. The 2009 Family Smoking Prevention and Tobacco Control Act gave FDA the authority to regulate tobacco products. Should FDA regulate synthetic nicotine as a drug today, it could point to recent legislation from Congress giving FDA a role in this space more broadly. So far, however, FDA has not taken this approach.
With FDA having ordered more than five million tobacco-derived, e-cigarette products off the market, several manufacturers appear to have turned to synthetic nicotine to avoid FDA’s rigorous (and costly) premarket review process. In general, that process requires those who seek to market new tobacco products to demonstrate that their sale is “appropriate for the protection of public health” with the support of scientific evidence. 21 U.S.C. §387j(c)(4), (5). After receiving a denial from FDA of his premarket review applications, one vaping company owner took to Facebook to announce the company’s switch to synthetic nicotine, adding: “We never wanted to switch to [synthetic nicotine], but the FDA forced us to make that decision as we have so many adults relying on us [for alternatives to cigarettes].”
Lawmakers have taken notice. In November, a flurry of investigations and calls to regulate synthetic nicotine products reached a new high. On November 16, nine senators sent a letter to the FDA imploring the agency to regulate synthetic nicotine products. The authors expressed concerns that e-cigarette manufacturers like Puff Bar are switching to synthetic nicotine to skirt FDA oversight and pre-market review requirements to continue selling their products — including flavored products — that they assert appeal to youth. That same day, the North Carolina attorney general launched an investigation into Puff Bar for similar reasons. And, on November 8, the House Oversight Committer’s Subcommittee on Economic and Consumer Policy sent letters to e-cigarette manufacturers Puff Bar and Next Generation Labs LLC, requesting extensive records pertaining to the production and marketing of the companies’ synthetic nicotine products.
Time will tell if Congress will pass Rep. Sherrill’s Clarifying Authority Over Nicotine Act of 2021. Given the uptick in scrutiny of synthetic nicotine products, however, there is a strong chance Congress could give FDA a clear mandate to regulate synthetic nicotine in 2022.
Smokers in England continue to be encouraged to quit by being offered free vaping devices. The action will now bring the borough of Kirklees in West Yorkshire, one step closer to fulfilling the UK government’s ambition for England to be smoke free by 2030, a move which could save local National Health Service (NHS) trusts millions of pounds.
The devices are now available from Kirklees Council’s stop smoking services and the charity Yorkshire Cancer Research alongside more traditional forms of Nicotine Replacement Therapies such as patches or gum. The devices are being offered as part of the Kirklees Wellness Service, a council funded initiative that supports over-18 youth in Kirklees to live healthier lives.
Stuart Griffiths, director of research, services and policy at Yorkshire Cancer Research, said his organization is committed to saving lives by helping more people quit smoking for good. “Yorkshire has the highest smoking rate in England, and this causes thousands of smoking-related cancers and needless deaths in our region each year,” he told Yorkshire Live. “When it comes to helping people quit for good, being able to offer vaping products is essential. They are an incredibly effective aid in helping people give up cigarettes.”
A recent review of evidence by global researchers Cochrane has shown that vaping devices are more effective than Nicotine Replacement Therapy (NRT) when supporting smokers to quit. More than 500 people in Kirklees lose their lives to smoking related illnesses every year, yet smoking remains one of the biggest causes of preventable death in the region, according to the story.
Several consumer and harm reduction advocacy groups claiming to represent 16 million Filipino smokers and 1 million vapers, praised the country’s Congress for the passage of the Vaporized Nicotine Products Bill, and appealed to President Rodrigo Duterte to sign the bill into law.
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Vapers PH, Vaper Ako, Smoke Free Conversation PH, Nicotine Consumers Union of the Philippines, Philippine E-cigarette Industry Association, Quit For Good, Heated Equipment as Alternative to Traditional Smoking Philippines, PROVAPE, Philippine Tobacco Harm Reduction Advocates Inc. and Consumer Choice Philippines, stated in a letter to the Duterte that, “with the growing positive scientific evidence coupled with our life-changing experiences, our resolve is stronger that vaping saves lives.”
“We earnestly hope you would consider our humble plea Mr. President and sign the Vape Bill into law,” the groups wrote, according to the Manilla Standard.
The Vape Bill bans the sale to and use by minors of vape products, and the sale, advertising and promotion of vape products within 100 meters of school perimeter and playground. Use of flavor descriptors that unduly appeal to minors in vape products and the display of vape products immediately next to products of particular interest to minors are prohibited. Persons who violate the provisions will be penalized with a fine or imprisonment.
Congress is expected to hold a bicameral conference committee this month to unify the Senate and the House of Representatives’ versions of the bill. The version approved by the committee will be sent to the president for his approval and signature.
Several court cases challenging the U.S. Food and Drug Administration’s issuing of marketing denial orders (MDOs) in response to its review of premarket tobacco product applications are still pending. Last week, three high profile tobacco harm reduction advocates filed their fourth amicus brief in support of companies that are challenging the FDA.
Credit: Sang Hyun Cho
Clive Bates, director of Counterfactual Consulting, David Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, and David Sweanor, adjunct professor of law at the University of Ottawa, filed the latest brief in support of Chicago-based Gripum LLC, which has had its MDO temporarily stayed by the court while the FDA’s actions are reviewed.
“The PMTA process and [appropriate for the protection of public health] APPH test do not apply to combustible cigarettes, which have a much less onerous path to market; accordingly, the most dangerous products are easily accessible throughout the United States, and their manufacturers do not face the threat of financial ruin from FDA’s regulatory burdens and determinations,” the brief states. “FDA’s regime for evaluating ENDS amounts to a major barrier to entry for less harmful products than cigarettes and unjustified regulatory protection of the incumbent combustible cigarette trade. The harms arising from adult and adolescent cigarette smoking far outweigh the harms arising from youth use of ENDS.”
The group also addressed the FDA’s having established an onerous new standard of evidence in PMTAs. The FDA has admitted to using a “fatal flaw” checklist to deny over one million PMTAs without further consideration because they do not provide randomized controlled trials, cohort studies, or other types of (unspecified) evidence that FDA had retrospectively deemed necessary. They also state that the APPH test doesn’t differentiate between adults and youth.
“The APPH test applies to the ‘population as a whole.’ There is no distinction drawn between adolescents and adults in the Act. In some circumstances, ENDS use can be beneficial to adolescents who would otherwise smoke,” the brief states. “As a matter of policy, FDA chooses to take no account of such benefits to youth, but that approach is incompatible with the APPH test in either the PMTA pre-market review process TCA §910(c)(4) or in rulemaking for setting product standards §907(a)(3).”
The group filed similar briefs in three other cases: Triton v FDA – Fifth Circuit (17 Nov 2021), My Vape Order v FDA – Ninth Circuit (24 Nov) and Bidi Vapor v FDA – Eleventh Circuit (24 Nov).
Thee market-share gap between the top-selling U.S. electronic cigarettes remained unchanged with both having a slight decline in the latest Nielsen analysis of convenience store data. The report covers the four-week period ending Dec. 18, according to the Winston-Salem Journal.
Nielsen determined No. 1 Juul was at 37.6 percent, down from 38.2 percent in the previous report.
Meanwhile, the Vuse brand of R.J. Reynolds Vapor Co. had a 33.5 percent market share, down from 34 percent in the previous report. NJoy was at 3 percent, unchanged from the previous report, while Fontem Ventures’ blu eCigs was at 2.3 percent, down from 2.4 percent.
Overall, sales of electronic cigarettes were up 4.8 percent year over year for the latest four-week period, boosted by recent price hikes. Still, e-cigarette sales overall have slumped since February 2020, when the Food and Drug Administration implemented its latest round of heightened regulations on the products.
Those restrictions foremost required manufacturers of cartridge-based e-cigarettes, such as Juul Labs Inc., Reynolds Vapor, NJoy and Fontem, to stop making, distributing and selling “unauthorized flavorings” in February 2021, or risk enforcement actions.
Goldman Sachs analyst Bonnie Herzog said another factor in the slump is “the impact of e-cigarette market denial orders by the FDA as it continues to work through premarket tobacco applications.”
At its most recent meeting, the Redwood City City Council in California unanimously passed a ban on the sale of flavored vaping and other tobacco products.
Credit: Valeriya Zankovych
The ordinance also prohibits the sale of all electronic cigarettes and electronic smoking devices, and bans all pharmacies from selling tobacco products by way of making them ineligible to obtain a tobacco retailer’s permit.
The ordinance does create an exemption for businesses holding a tobacco retailer’s permit that sell flavored tobacco for on-site hookah consumption, provided the business was operational and licensed as of Nov. 22, 2021. The rules do not allow for the exemption to be transferable or assignable to a subsequent owner of the business.
The city joins eight cities in San Mateo County and many more across the state and nation to ban flavored tobacco products over their health impacts, particularly to young consumers. Burlingame, East Palo Alto, Half Moon Bay, Menlo Park, Portola Valley, San Carlos, San Mateo, and South San Francisco have all passed similar ordinances.
On October 28, 2019, the City Council directed staff to research and draft an ordinance for consideration to ban flavored tobacco and electronic cigarettes (e-cigarettes), modeled after the County of San Mateo’s ordinance.
There is no exception for premium cigars in the ordinance. The ban will go into effect on April 1, 2022. Meanwhile, statewide legislation (SB 793) to ban the sale and distribution of flavored tobacco products is currently on hold pending the result of a ballot measure in the Nov. 8, 2022 election.
On Dec. 23, the FDA authorized the marketing of 22nd Century Group’s VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products (MRTP). As part of the MRTP designation, 22nd Century may inform consumers that smoking VLN cigarettes will considerably reduce their exposure to nicotine.
According to Bates, the FDA decision is misguided because the cigarettes retain the tar that is responsible for smoking-related illness. “We have known for a long time that ‘people smoke for the nicotine but die from the tar,’” writes Bates on his blog.
“The only value these products have in public health terms is if smokers don’t use them because they are so unsatisfying, and switch to something with lower risk. If they do use them, they are still exposed to thousands of toxins from smoke,” writes Bates. “However, the purpose of the marketing communication is precisely to encourage people to buy these products.”
If smokers want to reduce their health risks, they are far better advised to switch to a non-combustible vaping or heated tobacco product, according to Bates.
“So for health-conscious smokers, this is a diversion from a strategy that would actually help them. Instead, the authorized claims falsely promote reduced nicotine exposure as a health benefit.”
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.
Photo: Skypixel | Dreamstime.com
Under the Illinois law, an electronic cigarette is broadly defined as
any device that employs a battery or other mechanism to heat a solution or substance to produce a vapor or aerosol intended for inhalation;
any cartridge or container of a solution or substance intended to be used with or in the device or to refill the device; or
any solution or substance, whether or not it contains nicotine, intended for use in the device
“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”
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.
