President Donald Trump has sent back to Congress a Covid-19 relief bill that included language to ban the U.S. Post Office (USPO) from mailing vapor products.Trump had the authority to use a line item veto on the provision and still pass the larger bill, however, he sent the bill back to Congress in its entirety saying he would not sign the proposal without $2,000 individual payments to taxpayers.
Congress banned all electronic nicotine delivery system (ENDS) products from being mailed by the USPS on Monday. The rule change was lumped into the Covid-19/ omnibus budget bill passed yesterday. The proposal, collectively called the Consolidated Appropriations Act, 2021.
The updated provision redefines the word “cigarette” under the Prevent All Cigarette Trafficking Act (PACT Act), which is part of the federal Jenkins Act, to include ENDS products.
By including ENDS products within the PACT Act, manufacturers and retailers will be banned from shipping vaping products to consumers using the USPS within the next 120 days. All orders of vaping products will be required to ship using an alternate (and considerably more expensive) service that verifies the recipient of a package is at least 21 years old.
Beginning 90 days after enactment, all online retailers also will be required to file monthly reports with native, state and local governments disclosing the identity, address and product received for all customers, as well as remit any excise taxes owed.
Many vaping industry advocates are angered by the text of the proposal because legislators used an expansive definition of what qualifies as an “electronic nicotine delivery system” that seems to include products that may not contain nicotine. The term “means any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device,” the legislation states.
Greg Conley, president of the American Vaping Association, said that despite the inclusion of the word “nicotine,” the definition used in the bill is so broad that it appears to capture vaping liquids containing CBD and standalone devices intended for vaping THC or other substances.
“The sponsors of this legislation repeatedly refused to consider common sense amendments that would have protected youth, while also not needlessly shutting down small businesses. Thanks to their intransigence, the language included in the omnibus is so sloppily drafted that it will also ban the USPS from shipping CBD liquids intended to be vaporized, as well as devices intended for use with THC or other non-nicotine substances,” said Conley. “There are still 36 million American adults smoking combustible cigarettes and over 400,000 will die from smoking-related illnesses this year alone. The American people should start questioning why their government is so intent on making it harder for adults to quit smoking.”
According to its website, UPS prohibits the shipment of all cigarettes and little cigars to consumers, regardless of destination state. Other tobacco product shipments must be made using the “UPS Delivery Confirmation Adult Signature Required service, requiring the signature of an adult 21 years of age or older upon delivery.”
The U.S. Congress has banned all electronic nicotine delivery system (ENDS) products from being mailed by the United States Postal Service (USPS). The rule change was lumped into the Covid-19/ omnibus budget bill passed yesterday. The proposal, collectively called the Consolidated Appropriations Act, 2021, now awaits a signature from President Trump to become law. Trump is expected to sign the bill later today.
Credit: Motion Studios
The updated provision redefines the word “cigarette” under the Prevent All Cigarette Trafficking Act (PACT Act), which is part of the federal Jenkins Act, to include ENDS products.
By including ENDS products within the PACT Act, manufacturers and retailers will be banned from shipping vaping products to consumers using the USPS within the next 120 days. All orders of vaping products will be required to ship using an alternate (and considerably more expensive) service that verifies the recipient of a package is at least 21 years old.
Beginning 90 days after enactment, all online retailers also will be required to file monthly reports with native, state and local governments disclosing the identity, address and product received for all customers, as well as remit any excise taxes owed.
Many vaping industry advocates are angered by the text of the proposal because legislators used an expansive definition of what qualifies as an “electronic nicotine delivery system” that seems to include products that may not contain nicotine. The term “means any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device,” the legislation states.
Greg Conley, president of the American Vaping Association, said that despite the inclusion of the word “nicotine,” the definition used in the bill is so broad that it appears to capture vaping liquids containing CBD and standalone devices intended for vaping THC or other substances.
“The sponsors of this legislation repeatedly refused to consider common sense amendments that would have protected youth, while also not needlessly shutting down small businesses. Thanks to their intransigence, the language included in the omnibus is so sloppily drafted that it will also ban the USPS from shipping CBD liquids intended to be vaporized, as well as devices intended for use with THC or other non-nicotine substances,” said Conley. “There are still 36 million American adults smoking combustible cigarettes and over 400,000 will die from smoking-related illnesses this year alone. The American people should start questioning why their government is so intent on making it harder for adults to quit smoking.”
According to its website, UPS prohibits the shipment of all cigarettes and little cigars to consumers, regardless of destination state. Other tobacco product shipments must be made using the “UPS Delivery Confirmation Adult Signature Required service, requiring the signature of an adult 21 years of age or older upon delivery.”
Trump has the authority to use a line item veto on the provision and still pass the larger bill, though that is not expected.
Australians importing liquid nicotine for e-cigarettes will need to have a prescription from Oct. 1, reports The Sydney Morning Herald, citing the country’s medical watchdog.
The Therapeutic Goods Administration (TGA) said its decision balanced consumer demand for the product as a smoking cessation aid and the potential for nicotine e-cigarettes to lead to addiction.
“A patient’s doctor is uniquely placed to give the support required for long-lasting smoking cessation,” the agency said, adding that it had not yet approved any vapor product as a smoking-cessation aid.
In response to the TGA’s decision, the government will scrap contentious customs regulations, which included a fine of up to $200,000 for those illegally importing nicotine. The regulation was opposed by a large group of backbenchers, and due to kick in from the start of next year.
The possession of nicotine-containing e-cigarettes is illegal without a prescription in every state and territory, besides South Australia.
Health Minister Greg Hunt said it was important to note that any doctor could prescribe nicotine-based e-cigarettes.
“This is not widely understood, and it is an important matter of public information that over 30,000 GPs may currently, and in the future, prescribe nicotine-based e-cigarettes for smoking cessation,” he said.
Critics say Australia’s prescription-only policy is hampered by the reluctance of many general practitioners to prescribe liquid nicotine and by a requirement to seek a special exemption for each patient.
The vapor industry continues to face several regulatory challenges. One of the most challenging of those is the seemingly never-ending battle against flavor bans for e-liquids. As most any vaper will tell you, flavors are instrumental in keeping former smokers from returning to combustible cigarettes. However, flavors are also what many industry regulators and anti-vapor advocates say lure youth to try vaping.
During Vape Live, a three-day virtual trade show and seminar hosted by Ireland-based Vapouround magazine, flavors and flavor bans in the United States, the world’s largest vapor market, were trending topics. Carlo Infurna Wangüemert, a vapor market analyst with ECigIntelligence, a regulatory research resource for the e-cigarette and tobacco alternatives industry, discussed recent market trends and the factors that are influencing the U.S. vapor market.
Wangüemert said that several factors are affecting the U.S. market: the e-cigarette or vaping use-associated lung injury (EVALI) scare, the Covid-19 pandemic and the U.S. Food and Drug Administration’s (FDA) premarket tobacco product applications (PMTAs). He said that Covid-19 didn’t impact market growth as much as it impacted consumer behavior.
Yael Ossowski / Credit: Consumer Choice Center
“We’ve seen a reduction of purchasing occasions and an increase of basket sizes [during the Covid-19 crisis],” he said. “We’ve also observed consumers buying a lot before the crisis in order to have enough stock in case of lockdowns, and it might also have affected the supply side as many independent shops had to close or have suffered an important drop of sales.”
Concerning supplies, Wangüemert sees the PMTAs drastically reducing the amount of variety on the market as many brands will try to keep their offerings as simple as possible. Before the FDA’s ban on prefilled flavored vape pods, those products represented half of the U.S. vapor market. Now, there is a rise in disposable e-cigarettes and refillable pod systems, according to Wangüemert. He said that this has led to several innovations in flavor output, such as better coils in open pod systems.
“Basically, hardware manufacturers are trying to develop new features and improving the functionality of their devices to make them small but complex enough to cover all vapers’ needs,” said Wangüemert, citing innovations that allow vapers to change temperature or change from mouth-to-lung to direct-to-lung with just one button as examples.
Refillable pod systems are the fastest-growing trend in the vapor industry, according to ECigIntelligence data. This is because they offer a larger selection of flavored e-liquids. Prefilled pods, however, are dropping because the only available flavors, tobacco and menthol, generate less complexity.
“Prefilled pods … show fairly well how regulation can have an impact on the market,” he said. “This ban is fully enforced online as only those two flavors are offered currently. We’ve observed an ongoing drop in the complexity of their flavors. Tobacco is [now] probably the most important flavor in prefilled pods.”
The U.S. market has also seen a surge in nicotine strengths, brought on mostly by the growing popularity of nicotine salts. Wangüemert said that nicotine salt-based e-liquids have been continually gaining ground during the last three years to the detriment of freebase liquids. “However, it is also interesting to point out that the average nicotine strength of nicotine salts is slowly going down,” he said.
Fruit flavors are also steadily rising in the U.S. market, according to Wangüemert. He said that fruit e-liquids, dessert and candy flavors all consume the Top 5 positions in flavors for e-liquid sales in 2020. “For the fruit category, which is mainly tropical fruits, mainly mango, are the ones helping the most in the growth of that category,” he said, adding that beverage flavors are also growing quickly, with lemonades experiencing a substantial amount of growth. “This might also be linked to the popularity of fruits, as lemonades are likely to contain them,” he explained.
Carlo Infurna Wanguemert / Credit: ECigIntelligence
Looking at tobacco and menthol flavors, Wangüemert explained that e-liquids containing tobacco generally have tobacco as the main flavor. However, menthol is much more popular as a complement to other flavors, such as fruit.
“Only 13 percent of the products that contain menthol have menthol as the main flavor. But [for] the other 87 percent, menthol is a complement or a cooling agent, being particularly popular in the fruit category,” he said. “Of course, these 87 percent of e-liquids that contain menthol that do not have it as the main flavor are more subject to potential bans than menthol-only flavors, which have been already excluded. However, our 2019 vape shop survey points out that menthol and tobacco represent just a small percentage of vape store revenues, meaning that flavor bans at the state level or even the consequences of the PMTA might strongly reduce their income and the vaping market in general as the offerings and variety of e-liquids were strongly reduced.”
Also speaking during Vape Live, Yael Ossowski, deputy director for the Consumer Choice Center (CCC), a consumer advocacy group, said that flavor bans in many U.S. states have had a major impact on the growth of the vapor market. States with strict flavor bans have seen major declines, with many vapers in those states returning to combustible products.
This prompted his organization to rank states by vaping regulations and the impact those regulations had on the vapor market. The group looked at how all 50 states confronted flavor restrictions, taxes and whether the state allowed for online sales. The CCC gave each state a number of points depending upon how much consumers were subject to the criteria. States that scored between 0–10 points received an F, 11–20 points received a C and 21–30 points received an A.
The states best suited for vaping were colored green on the corresponding chart while the worst states were colored red and middle-ground states were colored yellow. “For green states, we’ve got South Carolina, Georgia; we’ve got Iowa, Virginia, Florida, Texas and Oregon. You’ll notice, obviously, the red states, the places where we’re dealing with partial flavor bans, high taxes, shipping restrictions, there’s six of them.
Places like California, New York. You have New Jersey, Massachusetts, Rhode Island and Illinois,” said Ossowski. “Now we have our states in yellow. These are places that had a flavor ban in the past, and perhaps they’ve gotten rid of it, or it has not yet come into force. You have some taxation. It’s probably a bit more moderate than definitely those red states. And it has fewer shipping restrictions. People are able to order their vaping products online.”
One of the worst states, New York, has a tax rate of 20 percent of the retail price. Online sales are banned and all flavored products, except tobacco and menthol, are banned. These states, with low rankings, are also prone to other negatives for the vapor market, such as a growing black market, according to Ossowski.
California also has a statewide ban that is supposed to go into effect on Jan. 1, 2020. California also has several cities, such as San Francisco, that have banned vapor products entirely. It should be noted that, in California, flavor bans typically are only focused on nicotine vapor products, not marijuana vapor products. This is especially puzzling since the U.S. Centers for Disease Control and Prevention (CDC) has stated that the EVALI lung disease scare was caused by black market marijuana vapor products, not nicotine products.
“There is a lot of work that has been done by some very enterprising young journalists that kind of details everything with the black market when it comes to flavored vaping products. And that’s only just now burgeoning up in New York,” Ossowski explained. “There could be a lot more on this. We’re going to see. There’s not the biggest mainstream coverage on this.”
Credit: Consumer Choice Center
One of the main reasons that the CCC compiled the data and ranked the states is that the consumer group doesn’t want other states to follow behind states like California and Illinois by banning or restricting flavored vapor products. Ossowski said that these bans are detrimental to public health.
“It’s very dangerous. And in a way, by making it more expensive and pushing people often to the illegal market, not only are you seeing your price go higher, you’re also making it more difficult for people to acquire the products that they have transitioned away from tobacco to use. And we thought we’d actually be saving their lives and improving their lives. But what we see more often than not is that legislators make it harder,” he said. “They make it more difficult, and they actually put way more cumbersome barriers in the way so that you and I cannot access those products. We really do need to concentrate on laws, on policies, on studies, on figuring out who are the legislative champions that we can turn to in state legislatures or in the federal bureaucracy to be able to ensure that we have better laws that will enable harm reduction, that will enable us to continue to have vaping products for sale.”
The U.S. Food and Drug Administration (FDA) has given an acceptance letter to the UK-based e-liquid manufacturer Riot Squad for its premarket tobacco product application (PMTA), the company confirmed today.
“We continue to move through the PMTA process and are very happy to get to this stage”, said Ben Johnson Riot Labs CEO. “We remain committed to working with the FDA throughout the process. With our award-winning products and flavors we continue to provide better alternatives to combustible tobacco products and look forward to working in this industry for many more years to come.”
The company confirmed that it had submitted PMTAs for seven flavors in three freebase nicotine strengths (0mg, 3mg and 6mg) and 2 nicotine salt strengths (20mg Hybrid and 48mg). The flavors submitted include:
Pink Grenade
Sub Lime
Tropical Fury
Blue Burst
Cherry Fizzle
Rich Black Grape
Ultra peach Tea
“Receipt of this acceptance letter is a significant milestone, which confirms that Riot Labs products have now met the statutory and regulatory requirements for a PMTA submission, based on Section 910 of the FD&C Act,” a press release states. “The application is now under preliminary scientific review, before going forward to substantive review by the FDA.”
The FDA requires applicants to show their products are appropriate for the protection of public health. Riot Labs began building its PMTA data in 2018. The process has taken over 2 years, with 7 applications and over 1.8 million pages of scientific data submitted, according to Johnson.
Riot Labs was established in 2016 by Johnson who has an extensive background in pharmaceuticals. He set out to build ‘Riot Squad’ into an innovative brand, with the aim of encouraging consumers to find the confidence to give up smoking and engage in a healthier alternative. Riot Squad products are now available in over 86 countries.
San Francisco’s Board of Supervisors on Tuesday rejected a proposed ban on smoking or vaping tobacco in apartments that it voted for just last week, reports The San Francisco Examiner.
The board must approve legislation in two separate votes. Typically, the second vote is perfunctory.
Supervisor Aaron Peskin, who initially supported the ban, said that he heard from many long-term tenants on fixed income raising concerns about the proposal since his vote and he was “remarkably moved in the last week by what I have heard from them.”
Critics expressed concern about the impacts the measure could have on longstanding renters, including fines of up to $1,000 per day and the potential for tenant harassment. The proposal does say a violation could not be grounds for an eviction.
“I really am fearful that the unintended impacts could cause more harm to long term tenants in my district and other districts,” Peskin said. “I do want to address the harm of secondhand smoke in multi-unit residential buildings, but I think there are better ways to address this.”
Approval of the legislation, which controversially exempted marijuana smoking, would have made San Francisco the largest city in the United States to adopt a smoking ban in multi-unit buildings.
Board President Norman Yee’s said he was disappointed by the failure of the measure to pass in the second vote.
“Today’s vote failed to prioritize the health of our most vulnerable community members,” Yee said. “It is completely backwards that we would defend the rights of people to smoke in their own homes over the rights of others to breathe safely.”
The U.S. Food and Drug Administration (FDA) has authorized the commercialization of the IQOS 3 heated tobacco product. Today, the Altria Group said the authorization follows review of the IQOS 3 premarket tobacco product application (PMTA) submitted by Philip Morris International Inc. (PMI).
Philip Morris USA (PM USA), under an exclusive agreement with PMI, commercializes the IQOS system in the U.S. with three HeatStick variants. Unlike cigarettes, the IQOS system heats but does not burn tobacco. IQOS 3 offers several enhancements to the IQOS 2.4 currently being sold in select U.S. markets, including a longer battery life, faster re-charging time, a side opening mechanism, and magnetic closure, according to a press release.
“Altria’s 10-year vision is to responsibly lead the transition of adult smokers to a non-combustible future. IQOS is a key part of that future and we’re excited to build on our first-mover advantage with the enhanced IQOS 3 device which has performed successfully in international markets,” said Jon Moore, president and CEO of PM USA.
IQOS is currently available in the Atlanta, Georgia, Richmond, Virginia and Charlotte, North Carolina markets. With PMTA authorization of IQOS 3, PM USA expects to begin quickly marketing the IQOS 3 device to U.S. adult smokers once the regulatory and U.S. importation logistics have been satisfied.
To secure market authorization under a PMTA, U.S. federal law obligates an applicant to demonstrate that marketing of a new tobacco product is appropriate for the protection of public health and requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.
On March 30, 2020, PMI submitted a supplemental PMTA to the FDA for the IQOS 3 tobacco heating system device. The original IQOS 2.4 device was authorized by the FDA for commercialization in the U.S. on April 30, 2019.
Pending a final vote next week, San Francisco is expected to ban vaping and smoking tobacco in apartments, but only after exempting cannabis in response to a backlash from marijuana advocates.
The Board of Supervisors voted 10-to-1 to approve legislation intended to protect renters from the harms of secondhand smoke in buildings with three or more units on Tuesday night,, The Examiner reported.
Credit: Mohamed Hassan
“The problem is smoke easily moves between units and there is no way to contain it,” said Board President Norman Yee, who introduced the proposal. Yee had wanted to ban cannabis smoke as well, but couldn’t get the votes. The legislation prompted an outpouring of opposition from cannabis advocates.
Supervisor Rafael Mandelman succeeded in amending the proposal in an 8-to-3 vote to provide a blanket exemption for cannabis smoke, before ultimately voting for the proposal.
He said that state law treats tobacco smokers and cannabis smokers differently and without the exemption there would be no legal place for people to smoke cannabis. There are handful of consumption lounges in The City but they are closed during the pandemic.
“Tobacco smokers unable to smoke in their apartment building can go out to the curb or find other public space,” Mandelman said. “There are other public spaces where they are allowed to smoke. Cannabis smokers don’t have that alternative and so I think it is important that we fully exempt cannabis from this legislation.”
Yee had previously amended the initial proposal to exempt those who use cannabis for medicinal reasons with proof of a doctor’s recommendation but opposed the full exemption along with Supervisors Ahsha Safai and Gordon Mar.
He said that while there are benefits from using cannabis “there are still health risks in exposure to secondhand cannabis smoke” and it would be “harmful for young kids and people that have respiration issues.”
Supervisor Dean Preston, the only nay vote, said the board should take more time to work out the issues raised by tenant groups, including concerns over how the ban would largely impact long-term tenants who signed leases before it became the standard for landlords to put no-smoking provisions into the agreements. His motion to postpone the vote, however, was defeated in a 5-to-6 vote.
The Department of Public Health is charged with enforcing the ban. Violators could face fines of up to $1,000 per day. A violation can not be grounds for an eviction under the terms of the legislation.
Dozens of other cities and counties in California already have in place similar no-smoking bans in apartments including San Mateo, Daly City, Berkeley and Santa Clara County.
Philippine Senate President Vicente Sotto III – Credit: Current PH
In the Philippines, Senate President Vicente Sotto III wants safer nicotine products, such as e-cigarettes and heat-not-burn (HnB) products, to be allowed to competitively compete with traditional tobacco. During a senate hearing last week, the senator asked the country’s Food and Drug Administration (FDA) to guarantee that the guidelines it will issue for vapor and HnB products are compliant with the law that allowed the sale of safer nicotine alternatives.
Sotto made the call during recent deliberations on the proposed budget of the Department of Health (DOH), where he stressed that FDA regulations for these nicotine alternatives should not make it difficult for them to compete against cigarettes to lessen the number of smokers in the country, according to an article on philstar.com. “We don’t want it to appear that introducing a cigarette product to the Philippines is easier than introducing a heated tobacco product or a vapor product,” Sotto said.
The FDA was tasked to draft the general guidelines for the implementation of Republic Act 11467, which imposed higher taxes on cigarettes and e-cigarettes; and Executive Order No. 106, which bans the manufacture and sale of such products that are not registered or that are adulterated with other substances.
Sotto said he has received letters from some sectors, particularly the e-cigarette consumer groups, expressing concerns over the FDA’s draft guidelines on vapor products and HnB. “Here in the Senate, we, as usual, are concerned with the implementing rules and regulations and guidelines of some government agencies. It has been a big issue with us, because some agencies appear to go beyond what the enabling law provides,” he said.
He warned that FDA regulations might make it more difficult for vapes and HnB to compete against cigarettes, and therefore defeat the purpose of such products to lessen smoking in the country.
He stressed that HnB products are better than cigarettes. “We don’t want the youth and those who don’t smoke to suddenly think of using e-cigarettes and heated tobacco. What we want is for those who smoke to shift to heated tobacco or e-cigs,” Sotto said.
Sotto said studies have shown that 80 percent of people who switched to HnB products never went back to smoking cigarettes again. “I was in London over a year ago and I saw the differences. We have to admit that [HnB] is far different from cigarettes; [HnB] does not have second-hand smoke, but actual cigarettes have,” Sotto said.
Sen. Pia Cayetano, who was sponsoring the DOH budget, said she will remind the FDA that the Senate “is very conscious of their not exceeding their authority. They should just be guided by the law.” Cayetano said she and Sotto “are of like minds that our biggest concern is the youth and what I learned when I went to London was that the reason that in London they can really push for e-cigs is because they have already been successful in preventing the youth from smoking cigarettes.”
Sotto recognized that the government needs to properly regulate these electronic nicotine delivery systems or ENDS and HnB. He, however, pointed out that certain ingredients considered essential for these products are proposed to be prohibited on the FDA draft guidelines.
“For example, there is the prohibition on the use of glycerol and propylene glycol. These are aerosol formers for these products, so if they are banned, the products will not work anymore. If there is no aerosol to inhale, it will make these products unusable, so in other countries they are not banned in e-cigarettes,” he said.
Cayetano said the FDA only pointed out and banned those that are poisonous. She clarified that “they do not ban the other products or ingredients needed to produce that aerosol.”
Vapor companies that want to place an e-cigarette on the U.K. market will have to send their notifications through different routes after Jan. 1 due to Brexit.
The Medicines and Healthcare products Regulatory Agency (MHRA) will remain the competent authority for the notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland.
From January 2021 producers of nicotine-containing electronic cigarettes and refill containers will be required to:
Submit notifications for Great Britain using the MHRA Submission Portal
Submit notifications for Northern Ireland using the European Common Entry Gate (EUCEG)
Retailers do not need to submit information for any products they sell unless they also qualify as a producer.
The U.K. government has published several guidance documents and videos explaining the process on its website.
