Category: Regulation

Two New State Laws Could Disrupt the Vapor Industry

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

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”
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.

December 29, 2021

US FDA Gives MRTP to Low Nicotine Combustible Cigarette
Today, the U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.’s “VLN King” and “VLN Menthol King” combusted, filtered cigarettes as modified risk tobacco products (MRTPs). The FDA has not yet granted a MRTP to a vaping product, even though the agency has said e-cigarettes are less harmful than combustible cigarettes. Many experts have said the low-nicotine cigarettes from 22nd Century will actually cause people to smoke more cigarettes.
These are the first combusted cigarettes to be authorized as MRTPs by the agency and the second tobacco products overall to receive “exposure modification” orders, which allows them to be marketed as having a “reduced level of, or presenting a reduced exposure to,” a substance, according to a press release.
“Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”
The exposure modification orders specifically authorize the manufacturer to market “VLN King” and “VLN Menthol King” with certain reduced exposure claims regarding nicotine, including:
“95% less nicotine.”
“Helps reduce your nicotine consumption.”
“…Greatly reduces your nicotine consumption.”
When using any of the reduced exposure claims in the product label, labeling or advertising, the company must include, “Helps you smoke less.” The FDA also recommends that the labeling and advertising include the statement, “Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death.”
Despite today’s action, these products are not considered safe or “FDA approved.” There are no safe tobacco products, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product, according to a press release. The exposure modification orders do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers. These orders do not allow the company to market these products with therapeutic or cessation claims.
December 23, 2021
Philippines Senate Approves Proposed Vaping Bill

Photo: Oleksii
The Philippine Senate on Dec. 16 approved the proposed Vaporized Nicotine Products Regulation Act, reports The Philippine Inquirer.
Senate Bill 2239 transfers regulatory authority over vapor products from the Philippines Food and Drug Administration’s authority to the Department of Trade and Industry.
,The move was prompted partly by outrage over news that groups supported by Bloomberg Philanthropies had funded the FDA in an effort to influence the agency to impose harsh vaping restrictions.
The legislation prohibits the sale of vapor products to people below the age of 18 and bans e-cigarette sales within 100 meters from “any point of the perimeter of” a school, playground, or other facilities frequented by minors.
The bill also prohibits celebrities or social media influencers from endorsing vapor products.
Physical and online retailers or distributors must register with the Department of Trade and Industry and the Securities and Exchange Commission.
Senate President Pro Tempore Ralph Recto, the sponsor of the bill, said shifting to vaporized nicotine products “is a good public policy.”
“There will be less death and less expense on the part of society in treating patients. And that is the direction where many countries, more developed economies are moving toward,” Recto added.
The Philippines House of Representatives overwhelmingly passed a similar bill in May. The two bills will now go to a conference committee where they will be reconciled, and both houses will vote on the final version. Then the unified bill will go to President Rodrigo Duterte to sign into law or veto.
Tobacco control groups are lobbying the president to veto the bill when it reaches his desk. A veto can be overridden with a two-thirds vote of both houses.
December 17, 2021
Califf to Take on Synthetic Nicotine if Made FDA Chief

Robert Califf vowed to close the synthetic nicotine loophole if appointed commissioner of the U.S. Food and Drug Administration, according to a report by Vaping360.
During Califf’s nomination hearing on Dec. 14, Wisconsin Senator Tammy Baldwin expressed concern over reports that companies are switching to making flavored synthetic nicotine products in the wake of FDA marketing denial orders.
“As FDA commissioner, how would you work to address the rise in youth use of synthetic nicotine, and will you commit to working with Congress to ensure that the FDA has the authorities and resources it needs to crack down on these products?” Baldwin asked.
In response, Califf first noted that is crucial to appoint the right person to succeed Center for Products Director Mitch Zeller, who plans to retire in April 2022.
“Secondly,” Califf continued, “this is not limited to children. I may have some family members using synthetic nicotine, I learned as I was going through the paces here. And what people don’t realize is that there are two enantiomers of nicotine—one of which is not occurring in nature—that are in this product, and its properties are not known.
“So we’ve got to close this loophole,” Califf added, “so that we make sure that we understand the risks and benefits, and particularly deal with the issues in children.”
The Senate Health, Education, Labor & Pensions Committee will vote soon on whether to recommend Califf’s nomination to the full Senate. If the committee approves him, the former commissioner can expect full Senate confirmation to be the new commissioner soon, probably in January.
December 15, 2021
China’s New Rules Offer Insight Into Future Domestic Market

China’s domestic e-cigarette market is going to look very different next year. Draft rules governing e-cigarettes were issued on Dec. 2 by the country’s tobacco regulator, the State Tobacco Monopoly Administration (STMA). While the entirety of China’s new draft rules for the regulation of vaping products are vague and still being reviewed by interested parties, the included standards for the manufacturing of vapor products do open a window into the future of China’s domestic vapor market.
The National Standards of the People’s Republic of China for e-cigarettes allows only for closed pod systems with tobacco-derived nicotine and tobacco-derived nicotine salts. Flavors will be allowed and cartridges can’t leak, according to a translated copy of the proposed rules.
Unlike other countries, China will only allow tobacco-derived nicotine. The rules do not allow for a synthetic nicotine. “Nicotine extracted from tobacco should be used, and the purity should not be less than 99 percent,” the standards state. “Benzoate, tartrate, lactate, levulinate, malate and citrate of nicotine are allowed, and nicotine for preparing the above nicotine salts shall meet the requirements of [the previous statement].”
However, synthetic nicotine will still be allowed in products for export. What isn’t clear is if that synthetic nicotine must be shipped into China premixed in PG and/or VG and held in bond or if a pure synthetic can be imported. “There’s no legal imports of nicotine as far as we can tell. There’s seems to be no leeway for legal imports of a pure synthetic nicotine. However, we think if people import e-liquids with nicotine as a certain percent of that, that’s okay,” an industry representative told Vapor Voice and asked not to be named because they didn’t have permission to speak on the matter. “We don’t know if it’s 10 percent or 20 percent and it can only be brought into the country to be manufactured for re-export, that appears to be okay. That is just how we are interpreting the rule though, maybe someone else is seeing it differently.”
It also seems that the proposed rules also do not allow for a company to import finished vaping products into China and then sell them domestically without having a license and being registered with STMA (local companies will also need licenses). However, the country will continue to encourage exports, and wants domestic manufacturers to develop markets overseas.
“What they’ve really done is they’re clamping down on anything that is destined for the domestic market,” the source said. “They’ve also tapped into the tax department. Any time a manufacturer wants to manufacturer an e-cigarette or parts for an e-cigarette, they have to have a local representative from the taxation bureau there. And each day’s production that they run, they have to pay tax on those products at the end of that day. They’re clamping down in terms of what people can do as well as trying to ensure that they collect relevant taxes from all the manufacturers.”
Chinese vapor manufacturers are still waiting to understand what needs to be done officially for a company to produce vaping products for the international and/or domestic market. “We’re still waiting on that. The important piece isn’t the product standards,” the source said. “What I’m really interested in is the registration process, who’s allowed to do what, who has to issue licenses, because now there’s an emergency management bureau involved, not just STMA, so it’s a lot of people. We’re also trying to figure that piece out.”
China’s product standards do clarify what types of products China will allow domestically. The country will only allow closed-pod systems to be sold, stating that “devices and cartridges using e-liquid should have a closed structure to prevent artificial filling.” Additionally, flavors will be allowed for now, but flavors are only approved under a “temporary permit for additive in e-vapor matter” and any substance or flavor not listed “shall be used only after being proved to be safe and reliable by risk assessment,” the standards state. The listed additives include numerous flavoring extracts such as coffee, cocoa, prune and vanilla bean.
The standards only allows for a maximum amount of nicotine of 20 mg per milliliter (mL). The source also said that the way he interprets the rules is that vape symposiums, such as the recently held 2021 IECIE Shenzhen eCig Expo (held Dec. 6-8), wouldn’t make sense to be held in China anymore.
2021 IECIE Shenzhen eCig Expo (Credit: IECIE)
“I can’t imagine, if they’ve really taken bookings and got one on the cards currently, that they will cancel it, but we’ll see shortly,” the source said. “The Chinese domestic market is off limits to outsiders now. Moving forward, I don’t see a place for [trade shows] in this market anymore.”
For China’s domestic manufacturers the outlook is grim. While international players will still survive, they are still confused about what will be expected when the rules are finalized. Stock shares for RLX, China’s largest domestic brand, fell by more than 16 percent after the SMTA released the proposed rules. In Shenzhen, the capital of global vapor manufacturing, the industry is in a state of shock, according to the source.
“Everybody, from big to small, is scrambling to try and find out how this relates to them,” the source said. “They all have to register immediately with State Tobacco Monopoly to continue doing business. They have to register what they’re going to be manufacturing, what their exports are, where they are going. It’s a complete disaster.”
A more detailed version of this story will appear in the next issue of Vapor Voice.
December 10, 2021
Spain Takes Control of All Vapor Sales, Distribution
The Spanish government has taken control the country’s sales and distribution of vaping products. Authorities say the move was needed because there is currently no clear and effective system of control regarding the sale of e-cigarettes.
Credit: Oleksii
The Ministry of Health has a new objective: to reformulate the anti-smoking legislation that was approved by José Luis Rodríguez Zapatero in 2006, according to Euro Weekly. The Spanish government’s new proposal aims to restrict the use of e-cigarettes, as the government says that they cause “harmful short-term effects”.
Fernando Fernández Bueno, surgical oncologist at the Gómez Ulla Military Hospital and member of the Platform for the Reduction of Harm caused by Tobacco, explained that “vaping is 95 percent less harmful than traditional tobacco because e-cigarettes do not emit the carcinogens that tobacco does.” He added, “some people still say that vaping is worse than smoking. But there is nothing worse than smoking.”
The government’s greatest concern is that these devices could “encourage experimentation in young people and non-smokers”, who may be drawn to smoking e-cigarettes due to the “colors of the vaporizers or the flavors used.”
The Ministry of Health, headed by Carolina Darias, has manifested concern regarding the sale of these devices, explaining that “there is a large number of websites where nicotine-based devices can be bought online, and the methods for preventing access to minors are neither sufficient nor effective”.
The government’s goal is to prevent the sale of e-cigarettes online and support the sale of vaping products only in specialized tobacco shops, according to the story. The government also warned vapers that the new rules will raise e-cigarette prices when they go into effect.
December 10, 2021
Zeller to Retire from Center for Tobacco Products in April
Mitch Zeller, the director of the Food and Drug Administration’s Center for Tobacco Products, plans to retire in April 2022 after serving in the post since 2013, reports The Washington Post. In a letter to staff, acting FDA Commissioner Janet Woodcock praised his work as “invaluable and instrumental” to advancing “numerous historic public health milestones in tobacco regulation.”
A graduate of Dartmouth College and the American University Washington College of Law, Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest (CSPI). In 1988, Zeller left CSPI to become counsel to the human resources and intergovernmental relations subcommittee of the House of Representatives’ government operations committee, where he conducted oversight of enforcement of federal health and safety laws.
In 1993, Zeller joined the staff of then FDA Commissioner David Kessler. What began as a two-week assignment by Kessler to examine the practices of the tobacco industry led to his serving as associate commissioner and director of the FDA’s first Office of Tobacco Programs. Instrumental in crafting the agency’s 1996 tobacco regulations, Zeller also represented the FDA before Congress, federal and state agencies. Zeller also served as an official U.S. delegate to the World Health Organization working group for the Framework Convention on Tobacco Control.
In 2000, Zeller became executive vice president of the American Legacy Foundation. His responsibilities there included marketing, communications, strategic partnerships and, in 2002, creating the foundation’s first Office of Policy and Government Relations. That year, Zeller joined PinneyAssociates, where, as senior vice president, he provided strategic planning and communications advice.
He left PinneyAssociates in 2013 to begin his second stint at the FDA.
December 9, 2021
FDA Issues Warning Letters to Four ‘Wellness’ Vape Firms
The U.S. Food and Drug Administration has issued warning letters to four companies marketing “wellness” vaping products. The FDA says the vaping devices contain vitamins and/or essential oils and the companies are making unproven health claims about them. Currently, no vaping products are approved by the FDA to prevent or treat any health conditions or diseases. The devices in question do not contain nicotine. The FDA calls the products “unapproved new drugs” sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act.
Credit: FDA
“The FDA issued warning letters to companies for illegally selling these vaping products with unproven health claims. The letters provide the companies notice and request that they take prompt action to address any violations of the law,” according to an FDA press release. “If companies refuse to comply, the FDA may take enforcement actions to prevent the products from reaching consumers.”
The FDA stated that it had received complaints concerning several “wellness” products being advertised and sold to minors. “Online advertising, especially social media posts, often make false claims and cite the latest ‘scientific study,’ or do not include important details that may apply to you or allow you to make an informed decision,” the release states. “Other red flags include claims like “miracle cure” or “guaranteed results.” Remember, if a company really made a breakthrough, revolutionary health-related discovery, the news, researchers, and the government would discuss it in depth.” The letters were issued through the FDA’s Center for Drug Evaluation and Research (CDER).
The letters to Vitastick, Vitacig, NV Nutrition (NVN) and Vitamin Vape were issued on Dec. 1. Some of the unproven health or wellness claims include improving mental clarity or treating tumors or asthma. Some examples of the fraudulent product claims are:

“Fight off tumors and alleviate symptoms of chemotherapy!”

“It’s been used as a [sic] organic asthma remedy, ADHD remedy, and dementia treatment.”

“Helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.”

“Neroli oil… has long been used as a treatment against anxiety and depression, to calm the mind and soothe away tension.”
The FDA, Centers for Disease Control and Prevention, state and local health departments, and other clinical and public health partners are continuing to monitor and research vaping-associated lung injury. The FDA warns consumers to not be misled by vaping products claiming to contain “vitamins” and other “natural” ingredients or being advertised for “wellness” purposes.
December 8, 2021
China’s New Vapor Rules Could Have Global Fallout
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.
December 7, 2021
Bloomberg Group Accused of Lying to Kill Filipino Vape Bill
A congressional investigation has identified Bloomberg Philanthropies as the source of funding for local anti-vaping groups that are accused of spreading lies to discredit a Senate bill that aims to regulate e-cigarettes and heated tobacco products in the Philippines, according to consumer advocates.
Credit: Pathdoc
The National Consumers Union of the Philippines (NCUP) and Vaper AKO in a joint statement challenged anti-vaping organizations to substantiate their allegations against Senate Bill No. 2239 with scientific evidence, and “not with pure insinuations,” according to the Inquirer. The joint statement was issued as the Senate continues to deliberate on the bill that aims “to objectively regulate” next generation tobacco products.
“Stop twisting facts and demonizing SB 2239 whose very purpose is to objectively regulate a much better option to cigarettes. Stop misinformation that causes unfounded fear that drives people away from abandoning smoking. If the vaping bill is not passed into law, 1 million vapers will be driven back to smoking,” NCUP president Anton Israel said.
NCUP and Vaper Ako also questioned the agenda of the anti-vaping groups. “It’s ironic that these anti-vaping organizations, some led by doctors, are dismissing the voluminous scientific data supporting the merits of vaping and HTPs. Instead of objectively looking at the evidence, they use exaggerated scare tactics to keep adult smokers from having access to better alternatives,” Israel said, adding, “Whose interest are they promoting?”
Vaper AKO spokesman Joaqui Gallardo agreed, saying that the anti-vaping advocates are oversimplifying the smoking problem by stating that smokers can simply quit. “DOH data itself reflects only 4 percent of smokers are quitting despite existing approaches, while nations like UK, Japan, and numerous European countries are seeing a significant decline in smoking rates with the introduction of e-cigs and HTPs,” he said.
Israel said a convener of an anti-vaping group publicly contradicted herself by saying vaping causes cancer, while at the same time noting that it takes 20 years for cancer to develop. “How can they make this hasty conclusion when clearly vaping has not been commercially available 20 years ago. She also said COPD (chronic obstructive pulmonary disease) develops faster with vaping without citing scientific evidence. These reckless pronouncements will prevent smokers from moving away from the deadly cigarette instead of switching to a less harmful alternative that can potentially save lives.” he said.
Gallardo also expressed doubts about the credibility of the support the anti-vape group is getting.
“It’s impossible to believe that their baseless views, supposedly supported by different health associations, reflect the collective and honest stance of all the organizations’ members. It’s a fact that there are many local doctors who use and recognize that e-cigarettes are less harmful than smoking. And it’s lamentable that their voices are drowned out by these noisy minority who are peddling the narrative of their foreign funder,” Gallardo said.
The vape bill, according to Israel clearly states that minors are prohibited from accessing e-cigarettes and HTPs. He noted that a third of the version deliberated in the Senate is dedicated to protecting minors. He also dismissed the claim that the Department of Trade and Industry has no capacity to regulate vapor products while raising the objectivity issues of the Food and Drug Administration (FDA).
“Have we forgotten already that the FDA has been exposed during a congressional investigation to have received money from Bloomberg to fund the drafting of regulation on vapor products and HTPs?,” he asks. With their clear as day biased stance on e-cigs and HTPs, how can we expect the agency to implement a balanced regulation on these products?”
December 6, 2021