Tag: regulation

Congress May Allow FDA to Regulate Synthetic Nicotine
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.
January 4, 2022
Changes in China

Credit: Tomthy Sean Donahue
China’s domestic vapor market is facing uncertainty after the state tobacco regulator issues proposed vaping rules.
By Timothy S. Donahue
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 China’s tobacco regulator. The move brings vaping products out of a regulatory uncertainty and under the oversight of the state.
The State Tobacco Monopoly Administration’s (STMA) draft rules follow China’s cabinet amending its tobacco monopoly law to include e-cigarettes in late November. The draft management rules define “e-cigarette” as an electronic delivery product that produces nicotine-containing aerosol for human inhalation. Heat-not-burn products are already regulated as cigarettes and subject to the Tobacco Monopoly Law.
According to the draft rules, to sell legal e-cigarettes in China, a company must meet national standards to register with the STMA so it can conduct business. Companies manufacturing any ancillary products specifically for the vaping industry must also receive a special license from the STMA. Companies must also prove that they have the funding available for production and a facility with the required equipment to produce product that meets the country’s newly proposed standards.
The new rules state that the STMA will establish a “unified national electronic cigarette transaction management platform” that all licensed e-cigarette wholesalers and retailers “must sell products through.” Tax collection and payment of e-cigarettes, meanwhile, “shall be implemented in accordance with national taxation laws and regulations,” the proposed rules states.
The government and the tobacco industry are, essentially, one entity in China, with the STMA regulating the industry and China National Tobacco Corporation (CNTC) manufacturing tobacco products. Under China’s Tobacco Monopoly Law, STMA maintains control over virtually all stages of the production, sales, import, export and distribution of tobacco products in China.
To date, the vapor industry in China has operated in a legal gray area. Regulation had been expected; it was just a matter of time before Beijing would take control of the country’s $1.3 billion e-cigarette industry. The size of the Chinese e-cigarette market has grown from rmb550 million ($86 million) in 2013, witnessing an eight-year compound annual growth rate of 72.5 percent, according to iiMedia Research Group. The World Health Organization estimates that China has over 300 million smokers, and more than half of adult Chinese men are current tobacco smokers. By contrast, the e-cigarette penetration rate among Chinese smokers is less than 1 percent.
The news was welcomed by many leading industry players who say the proposed rules remove any uncertainty and help to weed out bad actors. In a press release, Frankie Chen, Chinese hardware manufacturer Smoore International’s global PR manager, stated that he expects the national mandatory standards to significantly improve product safety and provide global vapers with better products. “Since the standards set higher requirements for vaping manufacturing, it is expected that only the responsible manufacturer with comprehensive safety management can be compliant,” Chen stated.
Domestic outlook
While the entirety of China’s new draft rules for the regulation of vaping products are still vague, the country’s standards section does open a window into the future of China’s domestic vapor market. The transcribed 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 many 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 for products to be exported. 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 what those concentration percentages might include. “There’s no legal imports of nicotine as far as we can tell. There 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 OK,” an industry representative told Vapor Voice and asked not 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 OK.”
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 the STMA. All Chinese e-cigarette manufacturing facilities are subject to the registration and production licensing requirements, even if the products produced are for export only. 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 manufacture 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 there’s an emergency management bureau involved, not just STMA, so 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 allow for a maximum amount of 20 mg of nicotine per 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. “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 survive, they are still confused about what is to be expected when the rules are finalized. Stock shares for RLX Technology, China’s largest domestic brand, fell by more than 16 percent after the STMA released the proposed rules.
RLX chairperson and CEO Ying Wang, however, said the company welcomed the new regulatory framework. “We believe the sector will enter a new era of development—an era marked by enhanced product safety and quality, augmented social responsibilities and improved intellectual property protection,” said Wang at the presentation of the company’s third-quarter 2021 results.
RLX Chief Financial Officer Chao Lu added that the company is well prepared for the new operating environment. “The investments we made in products, talents, research and compliance in the third quarter and beyond will place us in advantageous positions under the new regulatory paradigm,” he said.
In Shenzhen, the capital of global vapor manufacturing, the industry is still 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 [the] State Tobacco Monopoly [Association] 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.”

December 28, 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
Denver Becomes 7th Colorado City to Ban Vape Flavors
After months of debate, the Denver City Council approved a controversial ordinance that outlaws the sale of flavored vaping and other tobacco products, including menthol, beginning in July 2023. With Monday’s 8 to 3 vote, Denver becomes the seventh Colorado municipality to enact a ban on flavored e-cigarettes.
Credit: Kevin Ruck
Exemptions are in place for hookah products, natural cigars, pipe tobacco and harm-reduction products. The ordinance also calls for retailers to receive a warning for a first offense, however, subsequent offenses could lead to a store losing its tobacco retail license.
Proponents of the ban argue tobacco companies have long used predatory marketing of menthol to lure people of color, those with low incomes and youth — especially those who identify as LBGTQ+. Companies deny this, according to an article on denverite.com.
“This proposal tonight, it really is about public health,” said council member Jamie Torres, who represents District 3 and voted for the proposal. “Our kids aren’t property owners. They’re not business owners, but they are the ones who are also telling us we need to make this less accessible to them.”
City Council President Staci Gilmore argues that Denver already regulates alcohol and cannabis. “We want to keep kids safe, but we also want to allow adults to be adults,” said Gilmore, who represents District 11, and voted against the measure. Last month, councilmember Kevin Flynn called the bill an overreach affecting adults who want to use these products.
Grier Bailey and Jonathan Shaer, writing for Colorado Politics, state that Denver city councilmembers should consider what’s happened to Massachusetts since it passed a statewide flavor ban of its own in 2020. “The state gave up a well-regulated and enforced network of licensed retailers, lost over $140 million on the sale of menthol cigarettes, and public health advocates can’t claim any empirical health benefits from the ban as the data shows most consumers shifted their purchase habits to other states or other nicotine products and flavors,” they state. “Many Massachusetts retailers have reduced employee hours and even had to cut jobs. The flavor ban has been a failure at every level.”
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
China Draft Rules Require Vape Firms to Obtain Licenses
Draft rules governing e-cigarettes were issued Thursday by China’s tobacco regulator. The move brings vaping products out of a regulatory grey area and under the oversight of the state. The State Tobacco Monopoly Administration’s draft rules follow China’s cabinet last week amending its tobacco monopoly law to include e-cigarettes.
Credit: Timothy S. Donahue
According to the draft rules, companies selling e-cigarettes in China must meet national standards in order to register with the tobacco authority and do business legally, according to Reuters. Companies engaged in the production of e-cigarettes must also receive a special license from the tobacco authority, provided they can prove that they have the funds for production and a facility with equipment that meets standards.
The tobacco authority said that it will establish a “unified national electronic cigarette transaction management platform” that all licensed e-cigarette wholesalers and retailers “must sell products through.” Tax collection and payment of e-cigarettes, meanwhile, “shall be implemented in accordance with national taxation laws and regulations,” the regulator wrote.
A bevy of Chinese companies manufacturing and selling nicotine salt-based e-cigarettes for the domestic market emerged in 2018 following the success of similar products overseas. The largest among them, RELX Technology Inc. went public in New York in January. China’s cigarette industry operates under a state-run monopoly directly controlled by the tobacco regulator, which dictates pricing and distribution for brands and generates tax income for the government.
December 2, 2021
U.S. Lawmaker Scrutinizes Unregulated Synthetic Nicotine

Raja Krishnamoorthi
U.S. Representative Raja Krishnamoorthi, chair of the subcommittee on economic and consumer policy, has sent letters to two companies that manufacture or sell synthetic nicotine products, requesting information about the companies and their sale of these products.
One letter was addressed to Next Generation Labs, the self-declared market leader in the production and sale of synthetic nicotine. The company claims its unregulated synthetic nicotine is used in more than 60 products and projects its sales to increase by 1,800 percent this year.
Synthetic nicotine has been gaining popularity among vapor companies after the FDA denied hundreds of thousands of marketing applications for products made with conventional nicotine.
“In response, some e-cigarette and e-liquid manufacturers, banned from legally selling their products, reportedly plan to switch to synthetic nicotine in an effort to avoid FDA regulation,” Krishnamoorthi wrote in his letter to Next Generation Labs.
“Next Generation Labs appears to support this approach, with its co-founder, Ron Tully, offering the following thoughts on the FDA laws and regulations governing nicotine: ‘If the statute has been ill-conceived, and the regulation has been ill-drafted, it is not the responsibility of the industry to conform to some kind of idea that you can’t innovate in those spaces where the legislation doesn’t occur.’”
Krishnamoorthi also sent a letter to Puff Bar, whose products have replaced Juul as the vape of choice for many young people after Juul Labs discontinued certain flavored products. In 2020, the Food and Drug Administration ordered Puff Bar to pull its products from the market. Earlier this year, the company introduced new versions of its products using synthetic nicotine.
In a recent profile by The Wall Street Journal, Puff Bar co-CEO Patrick Beltran described the Puff Bar ingredient change as “a forced innovation,” saying that the FDA gave the company no choice. Because the Tobacco Control Act specifically gives the FDA authority to regulate nicotine “made or derived from tobacco,” most people believe the agency’s Center for Tobacco Products cannot regulate products that use synthetic nicotine—at least not without serious legal challenges, according to Vaping360.
“You have apparently made the vile decision to continue enriching yourselves by poisoning children,” Krishnamoorthi wrote in his letter to Puff Bar. “Puff Bar’s meteoric rise in popularity among kids resulted in $156 million in sales in 2020 alone. Puff Bar should not be allowed to continue harming children due to FDA’s failure to regulate synthetic nicotine, and I intend to put an end to your predatory practices.”
In his letter to Next Generation Labs, Krishnamoorthi requested information regarding the company’s sales and new business. In his letter to Puff Bar, Krishnamoorthi requested information regarding the company’s ownership and operations as well as support for the company’s assertion that it is using synthetic nicotine, and requested the company’s co-chief executive officers appear for transcribed interviews.
Greg Conley, the president of the American Vaping Association, said Krishnamoorthi lacked evidence that the targets of his investigation have broken any laws. “As per the usual, he is playing politics, and we are hopeful the demands specified in his letter will be resisted,” Conley told Filter.
“With youth vaping numbers and the associated moral panic continuing to decline,” he continued, “it remains to be seen whether Representative Krishnamoorthi’s primary goal—getting media attention focused on Representative Krishnamoorthi—will actually be met with this campaign.”
November 9, 2021
Hong Kong Bans E-cigs, Allows for Personal Use
Hong Kong has banned the sale of e-cigarettes and other heated tobacco products but personal use is still allowed. The ban will come into effect as soon as mid-2022, Secretary for Food and Health Sophia Chan Siu-chee said. The maximum penalty for offenders will be a HK$50,000 fine and six-month imprisonment.
Lawmakers passed the bill banning the import, sale and manufacture of electronic nicotine-delivery systems (ENDS) but some legislators say bill goes too far in targeting the business of vaping, will hurt the import sector and will deny a potential area for innovation.
Credit: TS Donahue
The long-delayed Smoking (Public Health) (Amendment) Bill 2019 passed Thursday, “delivering a major victory for health activists and educators who have blamed the devices for encouraging smoking among young people,” according to the South China Morning Post.
While the new law targets only vape shops and the local business of vaping, consumers will still be free to use the devices, prompting some politicians to call for more aggressive measures to curb tobacco use, including banning smoking in all public places except for designated areas. Others, however, argued Hong Kong should allow reshipment of vaping products and warned the ban would hurt logistics companies.
The bill was approved by a vote of 32 to three in the Legislative Council. Two lawmakers abstained.
October 21, 2021
USPS Vapor, CBD Mail Ban to Take Effect Tomorrow
Credit: blr60
The ban on mailing vapor products through the United States Postal Service (USPS) takes effect tomorrow. After more than six months, the USPS has finally posted for public inspection its rules for mailing e-cigarettes with the Federal Register. The rules will publish tomorrow, Oct. 21, and go into effect immediately.
There is not an exemption for any vaping cannabis products, as many in the industry had hoped. The USPS is leaving it up to the U.S. Congress to carve out an exemption for hemp-based vaping products. The rules were originally set to go into effect in March and then April, however, the USPS held back publishing the rule while it went under agency review.
The rule states that Congress’s use of “nicotine” in the term “electronic nicotine delivery systems,” makes clear that “nonmailable ENDS products include those containing or used with not only nicotine, but also ‘flavor[s]’ or any other substance … It goes without saying that marijuana, hemp, and their derivatives are substances,” the rule states. “Hence, to the extent that they may be delivered to an inhaling user through an aerosolized solution, they and the related delivery systems, parts, components, liquids, and accessories clearly fall within the [Preventing Online Sales of E-Cigarettes to Children Act’s] scope.
“Conversely, THC-containing substances that are excluded from the [Controlled Substances Act] CSA—that is, hemp and hemp derivatives with no more than 0.3 percent THC by dry weight—are not subject to CSA-based mailability restrictions, and items used with such substances (and not with controlled substances) may fall outside the definition of drug paraphernalia … As such, those substances continue to be mailable generally, to the extent that they are not incorporated into an ENDS product or function as a component of one. To the extent that they do comprise or relate to an ENDS product, however, then that product is now nonmailable under the PACT Act and POSECCA, except pursuant to a PACT Act exception.”
Credit: Wolterke
UPS and FedEx already have bans in place for vaping products. Many in the industry have also moved on to new ways of mailing vaping products to customers through third-party shippers. Numerous other companies have since gone out of business since the U.S. Food and Drug Administration started sending out marketing denial orders (MDOs) last month.
When a 5,000-plus page omnibus bill, the Consolidated Appropriations Act of 2021, was signed into law on Dec. 28, 2020, buried deep within the bill (page 5,136) was the Preventing Online Sales of E-cigarettes to Children (PACT) Act. It was a provision that effectively bans the USPS from shipping ENDS products.
Retail customers will no longer be able to receive vaping products by way of USPS delivery, according to the USPS. However, the USPS rule states that the agency will mail vapor products under narrowly defined circumstances:

Noncontiguous states: intrastate shipments within Alaska or Hawaii;

Business/regulatory purposes: shipments transmitted between verified and authorized tobacco industry businesses for business purposes, or between such businesses and federal or state agencies for regulatory purposes;

Certain individuals: lightweight shipments mailed between adult individuals, limited to 10 per 30-day period;

Consumer testing: limited shipments of cigarettes sent by verified and authorized manufacturers to adult smokers for consumer testing purposes; and

Public health: limited shipments by federal agencies for public health purposes under similar rules applied to manufacturers conducting consumer testing.
The USPS rules also state that the listed exceptions cannot feasibly be applied to inbound or outbound international mail, mail to or from the Freely Associated States, or mail presented at overseas Army Post Office, Fleet Post Office, or Diplomatic Post Office locations and destined to addresses in the United States. Because of this inability, all ENDS products “in such mail are nonmailable, without exception.”
Excluded from the statutory definition are products approved by the FDA for sale as “tobacco cessation products or for other therapeutic purposes and marketed and sold solely for such purposes.” The USPS also proposes to treat ENDS as a standalone category, “albeit one generally subject to the same restrictions and exceptions as cigarettes, consistent with the statute.”
According to the PACT Act legislation, anyone selling vaping products must:

Register with the U.S. Attorney General;

Verify age of customers using a commercially available database;

Use private shipping services that collect an adult signature at the point of delivery;

Register with the federal government and with the tobacco tax administrators of the states if selling in states that tax vaping products;

Collect all applicable local and state taxes, and affix any required tax stamps to the products sold;

Send each taxing state’s tax administrator a list of all transactions with customers in their state, including the names and addresses of each customer sold to and the quantities and type of each product sold; and

Maintain records for five years of any “delivery interrupted because the carrier or service determines or has reason to believe that the person ordering the delivery is in violation of the [PACT Act].”
Retailers can be cited by states for not following their individual requirements for tax payments and filings, and they may have to purchase tobacco and other licenses or hire a registered agent in the state. The cost for being PACT Act compliant can range anywhere from $40 to $250 or more per year per state, according to previous news reports.
This story will be updated as the published rules are reviewed
October 20, 2021
Costa Rica Readies to Ban Vaping in Public Spaces
Costa Rican lawmakers this week approved in a second debate a bill that will the ban the use of vaping products such as e-cigarettes in public spaces. The bill, Project 21.658, passed with 33 votes in favor and seven against. Seventeen deputies did not participate in the vote and the bill must still be signed into law and published in La Gaceta before it takes effect, according to the Tico Times.
Credit: Zerophoto
In addition to banning vaping in most public spaces, the bill also sets the grounds for the country to implement a tax on vaping devices and accessories, such as coils and e-liquids. The Health Ministry endorses the bill, which was first introduced prior to the coronavirus pandemic.
“I think this project is extremely important for the country. It has the full support of the Ministry of Health,” a lawmaker supporting the bill said. “It is completely in line with the health alert we already issued regarding the use of vaping devices, where we have even been very clear that there is no study that can show e-cigarettes are a smoking cessation therapy. On the contrary, we have to disincentivize the use of cigarettes and the use of vaporizers.”
The taxes would be allocated to the Costa Rican Social Security Fund (CCSS) and be earmarked for the treatment of diseases related to tobacco consumption.
The Red Nacional Antitabaco (RENATA) – National Anti-Smoking Network – expressed its satisfaction with the approval of the law. Nydia Amador, president of that organization, assured that the new regulations will give substantial support to the Ley de Control de Tabaco (Tobacco Control Law).
“It is important to consider the vulnerability of all consumers of tobacco products, including electronic devices or vapers, to any disease of the respiratory system, since the first studies on the effects of the use of vaporizers and heated tobacco products show negative consequences for the lungs and the immune and cardiovascular systems,” said Amador.
RENATA also stated that vaping advocates “tried to confuse public opinion by claiming that vaping is 95 percent less harmful than tobacco use.”
Many organizations such as the United Kingdom’s Royal College of Physicians and Public Health England (PHE) have released studies that show vapor products have been scientifically proven to be 95 percent less harmful than cigarettes and related tobacco products. This is supported by the U.S. Academies of Science which has also found that e-cigarettes have a lower harm profile compared to their combustible competition.
October 7, 2021