US - Federal: The US Food and Drug Administration (FDA) has administratively stayed its marketing denial order (MDO) against Juul Labs, says “there are scientific issues unique to the Juul application that warrant additional review”. This only suspends the MDO but does not rescind it -- all e-cigarette products need FDA authorisation in order to be legally marketed.
NEW FORMAT
From February of 2022, subscribers will be able to view and filter individual regulatory alerts per region. If you want to get our monthly compilations, visit our alerts Round-up section.
LATEST ALERTS
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Philippines New president yet to give a view on vaping regulation bill… - Romania Finance ministry proposes progressive tax rises…
- United States FDA suspends its own Juul ban…
- Brazil Anvisa holds public meeting on possible e-cig regulation…
- France Notified e-cigarette list updated…
- Michigan - United States Bill would put heating element in glass or ceramic…
- Luxembourg ‘Unpaid notification fees mean disposables are illegal’…
- United States SFATA tells FDA too many MDOs risk a black market ‘epidemic’…
- Europe Big firms required to report on environmental impact…
- Portugal Cancer strategy includes e-cig regulation and prices…
- Portugal Nicotine e-liquid tax goes up…
- Egypt Warning against sales without tax stamps…
US - Michigan: Senate Bill 1109 has been introduced. This bill would prohibit the sale of vapour products with any heating element not made of or encased in glass and/or ceramic.
US - general: The Smoke-Free Alternatives Trade Association (SFATA) met up with the FDA Center for Tobacco Products (CTP) to discuss the future of the vapour industry and what the association called the “pending illicit sales epidemic”. In a meeting well attended by FDA and CTP representatives, the SFATA challenged the mass issuing of marketing denial orders (MDOs) by the FDA, saying it presented the threat of an unregulated illicit market developing. It said that in the cause of reducing youth vaping, the FDA had spread the belief that vapour products are at least as harmful as combustible tobacco. The SFATA, whose presentation used data provided by ECigIntelligence, called on all interested parties to join it in its work of “advocating for a reasonably regulated marketplace”.
US - California: San Jose’s ban on flavoured tobacco becomes effective today, 1st July, prohibiting the sale of any tobacco products and e-cigarettes with an artificial flavour, natural flavour, aroma, herb or spice, including menthol-flavoured products. The ban exempts shisha, hookah and premium cigars from the restrictions. San Jose is the most populated city in the San Francisco metropolitan area, which means that the ban could affect around 1m people.
US - Indiana: As of today, 1st July 2022, a tax on e-cigarettes will become effective, as enacted by House Bill (HB) 1001, establishing a tax on the retail sale of closed-system cartridges and vapour products of 15% of the gross retail income received by the retail dealer for its sale. While originally closed-system cartridges were to be taxed at 25%, Senate Bill (SB) 382 was enacted in order to establish the same rate as for vapour products.
US - California: As written in Senate Bill (SB) 395, enacted last year, beginning today, 1st July 2022, “a purchaser shall pay a tax on the purchase for use in this state of an electronic cigarette from a retailer at the rate of 12.5 percent of the sales price of the electronic cigarette”. The bill requires a retailer to collect the tax from the purchaser at the time of the retail sale of an e-cigarette. This tax was aimed at bringing closer tax parity between e-cigarettes and traditional tobacco products and found support from the California State Association of Counties, among others, stating: “The bill will place an additional retail tax on e-cigarette and vaping products to help support safety-net services across early childhood, public health, and health care systems.”
US - General: The US Food and Drug Administration (FDA) has submitted a brief to the US Court of Appeals for the Columbia Circuit in Washington DC opposing Fontem’s court-issued stay allowing their Myblu products to continue to be legally sold in the US market. The FDA argues that the “irreparable harm” that Fontem has asserted (the inability to market its products lawfully) comes from the Tobacco Control Act itself; a stay of Fontem’s marketing denial order (MDO) would not make the marketing of petitioner’s products lawful.
US - federal: The Food and Drug Administration (FDA) has issued new warning letters to manufacturers and distributors of e-liquid products that are classed as “new tobacco products” lacking the required FDA marketing authorisation to remain on the market.
Hawaii: House Bill (HB) 1570 passed the Senate and was sent to the governor on 4th May. A notice of intent to veto by the governor was issued yesterday, 27th June. The version as it currently stands would ban the sale of flavoured tobacco products and would also make it unlawful to mislabel as nicotine-free any e-liquid product that contains nicotine. The first versions of the bill explicitly banned the sale of flavoured synthetic nicotine products, but the current version, after amendments, does not contain such a ban.
Canada: Canada’s 2022 budget has received royal assent, introducing federal excise duty on vaping products effective 1st October 2022. The rate would be CAD1.00 (USD0.80) per 2 ml, or fraction thereof, for containers with 10 ml or less of e-liquid. For containers with more than 10 ml, the applicable rate would be CAD5.00 (USD3.90) for the first 10 ml, and CAD1.00 (USD0.80) for every additional 10 ml, or fraction thereof.
US - federal: A federal court has temporarily blocked the US Food and Drug Administration (FDA)’s marketing denial order (MDO) banning Juul from the US market. The company filed an emergency motion with the US Court of Appeals in Washington DC as it prepares an appeal against the FDA’s decision. In its petition for the stay Juul said the “FDA cannot credibly argue that there is a critical and urgent public interest in removing [Juul Labs’] products from the market right now, rather than after this Court reviews FDA’s action”.
US - federal: The US Food and Drug Administration (FDA) today announced that it has issued marketing denial orders (MDOs) to Juul Labs for all of its products currently on sale in the US and that the company must stop selling and distributing them. In addition, those already in the market must be removed, or risk enforcement action.
US - New Jersey: Assembly Bill 4316 has been introduced, which would prohibit the use of e-cigarettes and tobacco products by drivers engaged in delivery of food.
Canada: The government has proposed changes to the Vaping Products Reporting Regulations, requiring manufacturers of vaping products with and without nicotine to provide Health Canada with information on ingredients and sales data. Retailers would not be required to report information unless they also manufacture vaping products. Reports on ingredients of products sold in Canada would be required a month after the first complete quarter of the year after the coming into force of the proposed regulation for each brand of vaping product or kit sold in Canada. Ingredients reports for new vaping products would have to be made on or before the day they are first sold in Canada.
Mexico: The company Tabacos Desvenados has filed an appeal trial (amparo) against the presidential decree that prohibits the sale of electronic cigarettes and heated tobacco products in the country, press reports. One of the administrative courts in Mexico City has allowed the processing of the appeal. The court has set the constitutional hearing for 22nd July, when it will decide whether or not to grant the “amparo”.
US - Michigan: House Bill (HB) 6108 has passed the House and is now in the Senate. This bill would amend state law to raise the legal age to purchase a tobacco product, vapour product or an alternative nicotine product from 18 to 21, in accordance with federal law.
US - general: A jury at the federal US District Court in Virginia has awarded Philip Morris International (PMI) $10.7m in a patent case against RJ Reynolds Vapor Company, finding that both Vuse Alto and Vuse Solo G2 e-cigarettes infringe PMI patents.
US - Michigan: House Bill 6108 has been referred to a second reading. The bill would amend state law to raise the legal age to purchase a vapour, tobacco or alternative nicotine product from 18 to 21, in accordance with federal law.
Canada: An industry pilot project on recycling of cannabis vape products to tackle consumer waste has ended due to a lack of participation, media reports. The programme, which began in December 2020, aimed to equip over 200 stores in British Columbia, Alberta and Ontario with countertop collection boxes, which would then be managed by Quantum Lifecycle Partners, specialists in recycling electronic goods.
US - Federal: The FDA has issued both authorisation and denial orders to various Njoy disposable e-cigarettes. Marketing Granted Orders were issued for the company’s Daily Rich Tobacco 4.5% and Daily Extra Rich Tobacco 6%". Meanwhile, a number of denial orders were handed out for other Daily products, the FDA stating that “retailers should contact NJOY with any questions about products in their inventory”. Applications for two menthol-flavoured Daily products remain under FDA review.
US - Michigan: House Bill (HB) 6108 has been scheduled for a hearing on 14th June, in the House Judiciary Committee. The bill would amend state law to raise the legal age to purchase a tobacco product, a vapour product or an alternative nicotine product from 18 to 21, in accordance with federal law.
US - Federal: The US Food and Drug Administration (FDA) has announced the launch of the “Next Legends” Youth E-cigarette Prevention Campaign, which "will educate American Indian/Alaska Native (AI/AN) youth, ages 12-17, about the harms of vaping through unique branding and tailored messaging created to inspire a new generation to live Native strong and vape-free".
US - Federal: The Food and Drug Administration (FDA) has issued new warning letters to manufacturers and distributors of e-liquid products that are "new tobacco products" without the required FDA marketing authorisation to remain in the market.
Mexico: Yesterday, 7th June, the government published in the bulletin of the state the decree prohibiting the sale of e-cigarettes and e-liquids nationwide. The decree is now in force. This comes after a ruling from the Supreme Court in October 2021 declared unconstitutional a similar decree issued by the president in 2020, which prohibited the sale of those products. The sale is also forbidden by Article 16 of the Tobacco Law, although the industry has been able to obtain individual court injunctions (amparos) to sell these products. The government had also previously prohibited their import through a decree. ECigIntelligence believes there is a high chance that this new decree will also be brought in front of the Supreme Court.
US - Texas: Rule 34 TAC (Texas Administrative Code) 1.21 has been recently published and will be effective as of 8th June 2022. This rule establishes that a permit holder receiving a written notice of a violation of §161.0901 of the Health and Safety Code (establishes penalties related to youth access laws) may file a written request for a hearing on or before the 20th day after the date on the written notice of violation.
US - California: The Los Angeles City Council voted an overwhelming 12 to 0 to pass an ordinance to prohibit the sale of flavoured tobacco in the city, including all flavours except tobacco – with an exception for shisha tobacco at hookah lounges. The ordinance moves to the mayor’s desk for consideration to be signed into law and would become effective on 1st January 2023. The interim president, Mitch O'Farrell, made a heart-felt speech about tobacco policies after the voting, stating that everyone listening surely had someone who had been affected by tobacco or nicotine. He emphasised that the bill doesn't ban the possession or use of flavoured tobacco for people over 21, as their aim is to protect the youth from such policies.
US - Tennessee: Senate Bill (SB) 2219 was signed into law by the governor yesterday, 1st June. This bill would authorise local governments to regulate smoking and vaping, including the prohibition of smoking and the use of vapour products in age-restricted venues.
US - Wyoming: In communications with the Wyoming Department of Revenue, ECigIntelligence has been made aware that nicotine pouches do not currently fit the definition of “nicotine product” within the state and are considered tangible personal property; thus, no specific excise tax applies to nicotine pouches. However, the department added a reminder that sales of nicotine pouches as well as nicotine products to retail customers are subject to sales tax in the state. E-cigarettes and vapour material are included within the definition of nicotine products in Wyoming.
Mexico: The president of Mexico, Andrés Manuel López Obrador, has signed a decree prohibiting the sale of e-cigarettes and e-liquids nationwide. This comes after a ruling from the Supreme Court in October 2021 declared unconstitutional a similar decree issued by the president in 2020, which prohibited the sale of those products. The sale is also forbidden by Article 16 of the Tobacco Law, although the industry has been able to obtain individual court injunctions (amparos) to sell these products. The government had also previously prohibited their import through a decree. In the view of ECigIntelligence, there is a high chance that this new decree will also be brought in front of the Supreme Court.
US - Alaska: Senate Bill 45, which passed both the Senate and the House, is still awaiting transmittal to the governor. This bill would raise the legal age to purchase, sell, exchange, or possess tobacco, a product containing nicotine, or an electronic smoking product from 19 to 21. It would further levy a tax as follows: 35 % of the wholesale price of "(A) a closed-system electronic smoking product; (B) a vapor product sold as part of an open-system electronic smoking product; (C) a vapor product sold separately from a closed- or open system electronic smoking product".
Mexico: Hugo López-Gatell, the undersecretary of prevention and health promotion, has announced that the ban on the sale of e-cigarettes and heated tobacco devices will be maintained, press reports. He said that the government is working on regulation to ensure that no new tobacco products are introduced in the country.
US - Tennessee: Willson County School resource officers (SROs) are confiscating vape pens at an alarming rate, local media reports. Captain Scott Moore with the Sheriff's Office stated that they started keeping a record three years ago, and that he "would call it more of an explosion than a rise".
US - Michigan: House Bill 6108 has been recently introduced and referred to the Committee on Judiciary. The bill would amend state law to raise the legal age to purchase a tobacco product, vapour product or an alternative nicotine product from 18 to 21, in accordance with federal law.
US - Federal: The FDA has come in for some strong criticism after its first court-ordered update revealed the agency did not expect to finish reviewing the remaining PMTA applications until at least June 2023.
US - Federal: The Food and Drug Administration (FDA) has issued several new warning letters to manufacturers and distributors of e-liquid products that are considered “new tobacco products” without the required FDA authorisation to remain on the market.
US - Federal: Brian King, regarded as the man who coined the term “e-cigarette or vaping use-associated lung injury” (EVALI), is to be the new head of the US FDA’s Center for Tobacco Products (CTP). He will take over the position on 3rd July after spending more than a decade at the Centers for Disease Control and Prevention (CDC). While the appointment has been met with dismay among the vaping industry, FDA commissioner Robert Califf emphasised that King has detailed knowledge of premarket review pathways and tobacco product applications.
New Jersey: Senate Bill S 2667 has been introduced. It would prohibit the sale of menthol cigarettes and the sale or distribution of e-cigarettes and related products in all flavours but for tobacco.
Mexico: The Federal Commission for the Protection against Sanitary Risks (Cofepris) and the Ministry of the Interior (Segob) have issued an alert about electronic cigarettes. According to Cofepris, these products contain carcinogens and toxic substances that pose a serious risk to health. In particular, they identified vitamin E acetate to be a toxic substance that can cause acute respiratory illnesses and even death.
US - California: The Scotts Valley City Council passed an ordinance on Wednesday 18th May with a favourable vote of 5-0, local media reports. The ordinance would ban the sale of flavoured tobacco products in the city, and also prohibit smoking or vaping in any designated seating areas of restaurants or outdoor eating establishments. We see yet another locality enact a flavour ban, while the referendum at state level to enact the state-wide flavour ban is still pending. Scotts Valley City is within the Santa Cruz county and has a population of around 12,000.
US - Federal: The Food and Drug Administration (FDA) has issued several new warning letters to manufacturers and distributors of e-liquid products that are "new tobacco products" without the required FDA marketing authorisation to remain in the market.
US - California: The San Diego Council passed an ordinance (the SAAFE Act) yesterday, which will ban the sale of all flavoured tobacco products (including menthol) in the city starting 1st January 2023, local media reports. The ordinance does not apply to the sale of shisha, premium cigars or loose-leaf tobacco and unflavoured or tobacco-flavoured e-cigarettes. Food and Drug Administration (FDA)-approved cessation devices will also be exempt from the ban.
US - California: Assembly Bill (AB) 1690 has been ordered to the inactive file, meaning that the bill is ready to be heard on the floor but for some reason is dormant; an author of the bill may move it off the inactive file at a later date. AB 1690 would prohibit a person or entity from selling, giving, or furnishing to another person of any age in this state a cigarette utilising a single-use filter made of any material, a single-use plastic device meant to facilitate manual manipulation or filtration of a cigar, a single-use e-cigarette, or a single-use integrated cannabis vaporiser.
US - Rhode Island: Senate Bill 2117, which would provide for penalties for selling flavoured electronic nicotine delivery systems (ENDS) or for operating without a dealer’s licence, is scheduled to be heard tomorrow, 17th May, in the Senate Judiciary Committee.
US - reminder: 14th May is the deadline for submitting premarket tobacco product applications (PMTAs) for all synthetic nicotine products that were placed on the market on or before 14th April. Companies not planning to use the online portal and wanting to physically submit the PMTA should do so by today, 13th May, at 4pm.
US - Federal: The Food and Drug Administration (FDA) has authorised six new tobacco products through the premarket tobacco product application (PMTA) pathway. It issued marketing granted orders to R.J. Reynolds for the company’s Vuse Vibe and Vuse Ciro e-cigarette brands, including e-cigarette devices and tobacco-flavoured closed e-liquid pods. While the FDA determined the potential benefit to adult smokers who switch would outweigh the risk to youth, this authorisation imposes strict marketing restrictions on the company to greatly reduce the potential for youth exposure to tobacco advertising for these products. The FDA also issued the company with marketing denials for multiple other Vuse Vibe and Vuse Ciro e-cigarette products.
US - Colorado: The City of Boulder is preparing an ordinance that would exclude nicotine-free or tobacco-free products from the city's 40% sales tax on e-cigarettes, local media reports. “From my perspective as a tax administrator, the problem is we have a code that is causing confusion,” tax and special projects manager Joel Wagner said. “The language in the code that says that an electronic smoking device is something that simulates smoking of nicotine or any other substance opens that tax up to interpretation.”
US - Colorado: House Bill 22-1064 failed to pass the Senate Appropriations Committee, which rejected it yesterday by a 5-2 vote, local media reports. The bill would have banned the sale of flavoured cigarettes, tobacco products, and nicotine products. The senators also explained the bill's failure by saying that the ban would just lead to tobacco and nicotine users buying flavoured products online or out of state, describing youth tobacco use as inevitable but improving.
US - Colorado: House Bill 22-1064 has passed the Senate Committee on Finance after amendments and has been referred to the Senate Committee on Appropriations. This bill would prohibit the distribution of flavoured cigarettes, tobacco products, or nicotine products, and would amend the definition of cigarette, tobacco product, or nicotine product to include products containing synthetic nicotine.
US - California: The El Dorado County Office of Education recently hosted a student training day for the Tobacco-Use Prevention Education (TUPE) Program, which included students from El Dorado, Independence, Union Mine, and Black Oak Mine Unified School District, local media reports. The purpose of the TUPE Program is to reduce youth usage of tobacco products through tobacco-specific educational instruction and activities that build knowledge as well as social skills and youth development assets. Melissa Kistler, director of District and Program Support and TUPE liaison emphasised the fact that the “training is unique because it is the first time we have cross collaboration between school districts in this county”.
US-Connecticut: A flavour ban fails to win passage in Connecticut for the third year in a row, local media reports. The bill, which came out of the Public Health Committee in a divided vote in March, aimed to reduce youth vaping by prohibiting the sale of electronic nicotine delivery systems and vapour products that are flavoured or that have a nicotine content that is greater than 35 mg/ml. Senator John Fonfara, a co-chair of the Finance Committee, explained the bill's failure by saying that the ban would create a flourishing “underground” market for vaping products which would become even more attractive to minors.
US - New Mexico: The New Mexico Department of Health has launched Live Vape Free, a text-based programme to help addicted teens stop using e-cigs. The programme is designed to help teens aged between 13 and 17 to quit e-cigarettes, and it provides adults with the tools they need to support teens as they quit. “New Mexico is one of only five states to launch both the youth and adult components of the program, out of the just 13 states using the Live Vape Free program,” local media reports.
US - Colorado: House Bill 22-1064 was approved by the state House yesterday and sent to the Senate for consideration, local media reports. The bill would prohibit the distribution of flavoured cigarettes, tobacco or nicotine products, including those containing synthetic nicotine. Since its introduction, the bill has been changed to exempt hookahs, premium cigars and pipe tobacco.
US - Federal: New warning letters have been issued by the FDA Center for Tobacco Products (CTP) to a number of manufacturers and distributors of e-liquid products that are “new tobacco products” without the required marketing authorisation.
US - Hawaii: House Bill 1570 passed its final reading yesterday on a 36-15 vote. The bill to ban the sale of all flavoured tobacco products, including e-cigarettes, combustible menthol cigarettes and flavoured cigars, has now been passed by both chambers of the Legislature and requires only the signature of governor David Ige to become law.
US - Maryland: Anne Arundel Public Schools, one of the largest school districts in Maryland, is bringing a suit against Juul Labs, alleging its products are marketed to students and claiming gross negligence by the company, media reports. ”You’ve created this whole generation of young people who are now addicted to nicotine because it delivers four to five times the nicotine of a cigarette,” Anne Arundel Schools attorney Phil Federico said.
US - Hawaii: Many bills are currently sitting in the legislative process that would ban flavoured tobacco products. Among them, House Bill 1570 has passed both the House and the Senate, but the House seems to disagree with some amendments and so it may still take a while. The ban of flavoured tobacco products is a current political debate: representatives supporting the bill state they are only banning flavours and not vaping, whereas shop owners state that flavours are 99.9% of the business.
US - Federal: The first report on the status of the US Food and Drug Administration (FDA) premarket tobacco product applications (PMTAs) is expected today (29th April) following an order from a federal judge. More information can be found in our news briefing.
US - Federal: Yesterday, the Food and Drug Administration (FDA) announced two proposed product standards: one to prohibit menthol as a characterising flavour in cigarettes and one to prohibit all characterising flavours (other than tobacco) in cigars; e-cigarettes are not included in either of the proposed rules. The reason behind proposing these rules is to reduce the appeal of those products to youth. The FDA has emphasised that enforcement against individual consumers for possession of menthol cigarettes or flavoured cigars will not be pursued.
US - Federal: The Food and Drug Administration (FDA) has authorised the marketing of four new tobacco products by Njoy LLC, including its Ace closed e-cigarette device and three accompanying tobacco-flavoured e-liquid pods. The FDA also issued marketing denial orders to Njoy for multiple other Ace e-cigarette products. Applications for two menthol-flavoured Ace e-liquid pods remain under FDA review.
Canada: Health Canada’s consultation on the Tobacco and Vaping Products Act ends tomorrow, 27th April. The government has outlined five objectives for vaping products – restricting access to e-cigarettes, preventing misconceptions about the health hazards of vaping, enhancing public awareness of those hazards, preventing initiation into vaping, and protecting people from exposure to vaping. Final submissions can be sent to [email protected].
California: San Diego City Council voted 7-2 at a special meeting yesterday to approve the SAAFE (Stop Adolescent Addiction to Flavored E-cigarettes) Act, which would prohibit the sale of all flavoured tobacco and e-cigarette products in the city, local media reports. The issue will come before the council again in 30 days.
US - California: On today’s agenda for San Diego City Council was Item 600, the approval of the SAAFE (Stop Adolescent Addiction to Flavored E-cigarettes) Act, which would prohibit the sale of flavoured tobacco products in the city. If passed, the ban will include all flavours but for tobacco from 1st January 2023.
US - General: Horry County Schools has filed a federal lawsuit this week against Juul, alleging that its "products have created a public health crisis in local schools", according to local news. Horry County is the fourth most populous county in South Carolina, with a population of around 290,000 inhabitants.
US - Connecticut: Senate Bill 367 has been advancing through the legislative process since its introduction on 8th March 2022, and it's meant to be heard today by the Senate Finance, Revenue and Bonding Committee. This bill would prohibit the sale of electronic nicotine delivery systems and vapour products that are flavoured or that have a nicotine content that is greater than 35 mg per ml.
US - Maine: The Campaign for Tobacco-Free Kids has issued a public statement praising Brunswick Town Council after it passed an ordinance on Tuesday prohibiting the sale of flavoured tobacco products, including e-cigarettes, from 1st June. The pressure group is urging the state legislature to enact a state-wide flavour ban by passing bill LD 1550.
US - New York: Assembly Bill 9879 has been introduced, which would make it illegal for anyone under 21 to possess vaping or tobacco products. Their sale to under-21s is already prohibited.
US - federal: The US Food and Drug Administration (FDA) will be required to give premarket tobacco product application (PMTA) status reports every 90 days according to a revised judicial order, media reports. The revised order, signed on Friday by judge Paul Grimm of the US District Court for the District of Maryland, requires the FDA to “forecast the percentages of such products for which it expects to have taken ‘action’ by June 2022 and quarterly thereafter”.
US - General: A settlement has been reached between Juul Labs and the state of Washington, by which Juul has agreed to pay $22.5m. The lawsuit claimed Juul broke the law by marketing its products to appeal to minors and also deceived consumers over the addictiveness of the product. Washington attorney general Bob Ferguson said Juul would not only have to pay, but also ”stop its unlawful conduct and implement a slate of reforms, including: Stopping all its advertising that appeals to youth; Stopping most social media promotion; Accurately marketing the content and effects of the nicotine in its products; Strict practices to confirm the age of consumers who purchase Juul products”.
US - federal: Today, April 14th, is the first deadline in the new federal legislation on synthetic nicotine. Fropm today, new synthetic nicotine products may not enter the market without first obtaining a PMTA. Further, synthetic nicotine versions of tobacco-derived nicotine products whose PMTAs have been denied may not be be marketed.
US - Federal: The Food and Drug Administration (FDA) has issued several new warning letters to manufacturers and distributors of e-liquid products that are “new tobacco products” without the required FDA marketing authorisation to remain in the market.
US - Arkansas: Senate Bill 45 is advancing through the legislative process. It would raise from 19 to 21 the legal age to purchase, sell, exchange, or possess tobacco, nicotine products or any “electronic smoking product”, and ban their online sale. It would also levy a tax on all nicotine-containing electronic smoking products at 75% of their wholesale price.
US - Federal: The FDA has issued Marketing Denial Orders (MDO) to Fontem for several e-cigarette products in the company’s Myblu line, saying their applications lacked sufficient evidence to show that permitting the marketing of them would be appropriate for the protection of the public health. Specifically, the agency did not find the benefits significantly outweighed the risk to youth. Aside from the MDOs to products listed in the publicly available Deemed New Tobacco Product Application List, the FDA has also issued MDOs to additional Myblu products that do not appear in the list, because it will only publicly name products that are confirmed as being currently on the market.
Canada: According to the Federal Budget 2022, e-liquid with or without nicotine will be taxed at a rate of CAD1 ($0.79) per 2 ml, or fraction thereof for the first 10 ml of vaping substance, and CAD1 ($0.79) per 10 ml, or fraction thereof, for volumes beyond that. If a province or territory decides to participate in a coordinated vaping taxation regime administered by the federal government the rates would double, meaning the proposed combined rate would be CAD2 ($1.58) per 2 ml, or fraction thereof, for the first 10 ml of vaping substance, and CAD2 ($1.58) per 10 ml, or fraction thereof, for volumes beyond that. More information can be found in our latest news briefing.
US - Tennessee: Senate Bill 2219 has passed the Senate and is ready for transmission to the House. This bill would authorise local governments to regulate, including the prohibition of, smoking and the use of vapour products in age-restricted venues.
US - Federal: The Food and Drug Administration (FDA) has issued several new warning letters to manufacturers and distributors of e-liquid products that are "new tobacco products" without the required FDA marketing authorisation to remain in the market.
Mexico: The Senate has approved a decree amending the Customs Duty Act in order to prohibit the importation of e-cigarettes, both with and without nicotine. The decree has been submitted to the Chamber of Deputies for further approval.
US - federal: Senate majority leader Dick Durbin has revealed that he spoke yesterday with US Food and Drug Administration (FDA) commissioner Robert Califf about what he called “the agency’s delay in comprehensively regulating the e-cigarette marketplace to protect public health”. Durbin said he urged the FDA to conclude the premarket tobacco product application (PMTA) review for e-cigarettes, now past the seven-month court-ordered deadline.
US - Colorado: The Finance Committee held a hearing yesterday on House Bill 22-1064, which would prohibit the distribution of flavoured cigarettes, tobacco products, or nicotine products, including those containing synthetic nicotine. Opponents of the bill, which was introduced early this year, argue that the pre-kindergarten (pre-K) program would take a big funding hit as it is currently supported by the state nicotine tax, following a 2020 ballot vote. Democrat representative Kyle Mullica said: “We always run that risk when we want to fund these important programs off of taxes like this that are vices. I think hopefully we start maybe getting away from that because I don’t think that’s probably the most appropriate way to fund these programs.”
Pennsylvania: House Bill 2466 has been introduced, which would include “electronic smoking devices” – “An electronic device that contains or delivers nicotine or another substance to an individual inhaling from the device” – within the definition of “smoking” for purposes of the Clean Indoor Air Act. This legislation would also give all localities the right to enact smoke-free ordinances that are more protective than current state law.
Canada - New Brunswick: Yesterday, the Court of Queen's Bench of Fredericton rejected a motion filed by a group of vape stores to suspend the province's ban on flavoured e-cigarettes introduced in September 2021, local media reports. The plaintiffs were also seeking to halt a requirement for vape stores to obtain a licence, which enters into force today.
US - Texas: During a meeting on 30th March, Houston City Council unanimously approved an ordinance banning the use of electronic smoking devices in public spaces, local media reports. The original ordinance, passed in 2006, bans smoking in enclosed public places, within 25 ft of a public building’s entrance or exit, and other public areas, including outdoor seating areas and covered public transport facilities. Now those rules are extended to electronic smoking devices, which include e-cigarettes and cigars, vapes and any other device that uses vapour or aerosol liquids.
US - Hawaii: House Bill 1570 will be included in the public consultation that both the Senate Committee on Ways and Means and the Senate Committee on Commerce and Consumer Protection will hold tomorrow. This bill would ban (1) the sale of flavoured tobacco products and (2) mislabelling as nicotine-free any e-liquid product that contains nicotine.
US - Federal: The Food and Drug Administration (FDA) has issued new warning letters to manufacturers and distributors of e-liquid products that are "new tobacco products" without the required FDA marketing authorisation to remain in the market.
US: Michele Mital, deputy director of the US Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) since 2018, is to become acting director of the CTP following the retirement of Mitch Zeller in April, an FDA spokesperson confirmed to ECigIntelligence today.
US - Maine: There is still an ongoing dispute between proponents and opponents of Legislature bill LD 1550, which was introduced last year, local media reports. The bill would ban the sale and distribution of tobacco products, including e-cigarettes, in any flavour other than tobacco.
Canada - New Brunswick: A judge will give a decision tomorrow, 31st March, on a bid by a group of vape stores to suspend the province’s ban on flavoured e-cigarettes, introduced in September 2021, local media reports. The plaintiffs are also seeking to halt a requirement for vape stores to obtain a licence, due to come into force on Friday, 1st April.
US - Texas: Houston City Council will today consider a proposal that would add vaping to the city’s existing ban on smoking in public spaces, local media reports. Quality of Life Committee chairman Robert Gallegos yesterday urged his colleagues to support the proposal. The original ordinance, passed in 2006, bans smoking in enclosed public places, within 25 ft of a public building’s entrance or exit, and other public areas, including outdoor seating areas and covered public transport facilities.
US - Federal: Yesterday, 28th March, the US Food and Drug Administration (FDA) announced it is requesting “a total budget of $8.4 billion as part of the President’s fiscal year (FY) 2023 budget – a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level”. FDA commissioner Robert Califf stated: “The FDA has focused our budget request on some of today’s most urgent needs such as human and animal food safety, medical device security and e-cigarette oversight.” Specifically, it requested a $100m increase in user fees to support the FDA’s mission to reduce the use and harm of tobacco, including funding on e-cigarette oversight, “which remains a high priority and is critical to the agency’s public health mission, especially, to protecting kids from the dangers of nicotine addiction and other harmful health consequences”.
US: Walmart, the world’s largest retailer, has confirmed to ECigIntelligence its decision to stop selling tobacco products in a number of its stores. The company did not say how many of its 5,000 US stores would be affected. Walmart announced in 2019 that it would no longer sell vaping products.
US: VPR Brands has announced the settlement of a patent infringement case against three companies, which have agreed to pay $155,000 for a fully paid-up, royalty-free, non-exclusive licence to use VPR’s e-cigarette technology, patented in 2009. This is the third such case brought by VPR, which agreed settlements of $275,000 and $85,000 with other companies in December 2021 and claims to have identified over 50 more that it says are using its Auto Draw Technology. Fort Lauderdale, Florida-based VPR said: “Additional lawsuits will continue to be filed as necessary to protect the company’s Intellectual Property rights.”
Canada - Northwest Territories: E-liquids of any flavour other than tobacco are now banned, as of 25th March, under amendments to the Tobacco and Vapour Products Control Regulations.
US - Federal: The US Food and Drug Administration (FDA) has taken action on additional e-cigarette products: it has authorised several tobacco-flavoured products from Logic Technology Development, and has also issued marketing denial orders to Logic for multiple other electronic nicotine delivery system (ENDS) products. The agency said it is close to making further decisions on applications for “popular ENDS products that account for a large part of the market”. Read more in our latest news story.
US - Connecticut: Senate Bill 367 was heard yesterday in the Senate Public health Committee, where it received a favourable vote 20-11. The bill would prohibit the sale of electronic nicotine delivery systems and vapour products that are flavoured or that have a nicotine content above 35 mg/ml.
US: New warning letters have been issued by the FDA to manufacturers and distributors of e-liquid products that are “new tobacco products” without the required FDA marketing authorisation to remain in the market.
US - Idaho: Senate Bill 1285 has been delivered to governor Brad Little for signature. This bill denies local government authorities the right to adopt or enforce requirements for the regulation, marketing, or sale of tobacco products or e-cigarettes that are more restrictive than state law. It would also prevent them from imposing or enforcing a tax or fee on tobacco products or e-cigarettes.
US - California: The 9th Circuit Court of Appeals has ruled against RJ Reynolds’ case against Los Angeles County’s flavour ban, which includes menthol cigarettes and other flavoured tobacco products. Reynolds argued that, under the Tobacco Control Act (TCA), states and local jurisdictions could not ban the sale of tobacco products. However, the federal judge said the TCA included a preemption clause with an exception (“requirements relating to the sale, distribution, possession, information reporting to the State, exposure to, access to, the advertising and promotion of, or use of, tobacco products”), a broad preservation of state and local authority which the ban would fit.
US: Zanoprima Lifesciences Ltd. filed a complaint for patent infringement against Hangsen International Group Ltd. in the US District Court in the Western District of Texas, on 12th March. Per a Zanoprima Lifesciences press release, Hangsen has violated Zanoprima’s patent entitled “Process for Making (S)-Nicotine” (US Patent No. 10,913,962) through Hangsen’s manufacture and importation into the US market of products containing synthetic nicotine. In addition to seeking damages for infringement, Zanoprima’s complaint seeks preliminary and permanent injunctive relief to prevent Hangsen from continuing its infringing actions.
US - New York: Assembly bill A 9576 has been introduced, which would prohibit smoking and vaping on the grounds of public colleges and universities.
US - California: The Monterey County Board of Supervisors passed last Tuesday, 15th March, the ordinance containing a ban on flavoured tobacco products (including e-cigarettes) and single-use electronic cigarettes. “Michelle House, a program coordinator for the county Health Department, said the new regulation will be posted for 30 days before it officially becomes a Monterey County ordinance,” local media reports. Retailers thus have 30 days to sell their stock until the ban becomes effective. This ban comes just two weeks after the Santa Ana City Council also approved an ordinance to end the sale of flavoured tobacco products, which is set to take effect on 14th April. Santa Ana mayor Vicente Sarmiento said that would be sufficient notice for retailers.
US - Federal: New warning letters have been issued by the FDA to manufacturers and distributors of e-liquid products that are “new tobacco products” without the required FDA marketing authorisation to remain in the market.
US: Senate majority whip Dick Durbin of Illinois yesterday, 15th March, called out the FDA in a speech on the Senate floor for the six-month delay in reviewing e-cigarette applications, the deadline for which was 9th September 2021. He said the FDA had turned a blind eye for years to e-cigarettes, which, in his opinion, cannot meet the standard to stay in the market. He said e-cigarette manufacturers were trying to circumvent regulation under the guise of synthetic nicotine, that he and senators Susan Collins and Patty Murray had “led efforts to close this loophole in the Fiscal Year 2022 omnibus appropriations bill”, which finally passed. He concluded by calling on the FDA to “protect America’s children from Big Tobacco and their candy-flavoured, sickness-causing e-cigarettes”.
US - Connecticut: Senate Bill 367, which was introduced last week, would prohibit the sale of electronic nicotine delivery systems and vapour products that are flavoured or that have a nicotine content above 35 mg per ml. Even with the federal restrictions on flavours in place, supporters of the bill say the state needs to pass its own ban in order to reduce youth use of vapour products, testifying to that effect at a public meeting on Monday. Opponents disagree, saying it would not reduce youth usage, but would hurt small businesses.
US – Hawaii: A new batch of bills have recently been introduced in Hawaii, all of them shown in our US regulatory tracker. One of those bills, House Bill 1570, which would ban the sale of flavoured tobacco or synthetic nicotine products, has raised some concerns. Some representatives reportedly described some of the amendments made by the House Health, Human Services and Homelessness Committee as “poison pills”, which would jeopardise the bill’s passing. It was originally supported by the state attorney general and the Hawaii Department of Health (DOH), but has lost their support following the amendments. The lack of support by the enforcement agencies may end up in a veto by the governor, should the bill pass as it now stands. Among the amendments added, one requires the health department to implement a standardised testing process to detect flavours; advocates say this is not found in other jurisdictions and is not necessary, while the DOH found it unreasonable.
US - Federal: Last Friday, 11th March, the US Food and Drug Administration (FDA) issued a modified risk granted order authorising Philip Morris Products S.A. (PMPSA) to market the Iqos 3 System Holder and Charger with the following reduced-exposure information: (1) The Iqos system heats tobacco but does not burn it; (2) This significantly reduces the production of harmful and potentially harmful chemicals; (3) Scientific studies have shown that switching completely from conventional cigarettes to the Iqos system significantly reduces your body’s exposure to harmful or potentially harmful chemicals. These claims do not differ from the ones included in the reduced exposure information of the “IQOS Tobacco Heating System”. Note that, as the FDA reminds, “IQOS and Heatsticks are currently subject to a limited exclusion order and cease-and-desist order issued by the U.S. International Trade Commission which restricts the sales, distribution and marketing of the products in the United States”.
US: The 2022 Omnibus Bill passed the Senate last night and includes language that would give authority to the FDA to regulate products containing nicotine from any source, including products containing nicotine not derived from tobacco (synthetic nicotine). The bill is now on its way to president Biden’s desk to be signed. Dianne Feinstein, Democratic senator from California, issued a statement applauding the passage of the bill by the Senate. Among the provisions passed, Feinstein highlights that nicotine products “cannot go unregulated because of a loophole in law, and this provision will fix that”.
US: In March 2022, the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) published a study on youth use of tobacco products in the Morbidity and Mortality Weekly Report. The study was based on data from the 2021 National Youth Tobacco Survey obtained by interviewing middle school and high school students. The results showed that the most commonly used tobacco products were e-cigarettes, followed by cigarettes, cigars, smokeless tobacco, hookahs, and nicotine pouches. This year’s study cannot be fully compared with the previous one due to methodological changes in the conduct of the survey. The study demonstrates that there is still an ongoing concern of widespread usage of e-cigarettes among students, the number of which is more than 2 million higher than in 2020.
US - South Carolina: Senate Bill 1129 has been introduced. The bill redefines e-liquid to be nicotine-containing products only. The bill would prohibit the sale and distribution of a flavoured vapour product, which would include all flavours except tobacco and menthol. The sale of any vapour products that have been granted a premarket tobacco application and the transportation of flavoured vapour products within the state intended for sale in another state would be exempt from this provision. This bill would provide for the formation of a vapour product dispensary.
US: The 2022 Omnibus Bill passed the House last night. It includes language that would give authority to the FDA to regulate products containing nicotine from any source, also including products containing nicotine not derived from tobacco (synthetic nicotine). In a last-minute discussion, the Covid-19 relief measures were stripped out from the bill in order to pass the budget bill, and a standalone Covid-19 relief bill was introduced separately instead. The Senate is expected to act on the bill by Friday 11th March at midnight, which is when government funds would expire. In order to prevent a government shutdown, the House further voted on a stopgap bill that provided funding to government agencies through 15th March.
US - Connecticut: Senate Bill 367 has been introduced. It would prohibit the sale of electronic nicotine-delivery systems and vapour products that are flavoured or that have a nicotine content greater than 35 mg/ml.
US: Bantam Vape has announced that United States Postal Service (USPS) has granted their application for a business purposes exception under the Prevent All Cigarette Trafficking Act (PACT Act), so that they may ship their e-liquid products to select vape retailers and distributors throughout the US.
Rhode Island: Several new bills have been introduced. Among them, House Bill (HB) 7881, HB 7871, HB 7870, and HB 7869, which would provide for penalties for selling flavoured electronic nicotine delivery systems or for operating without a dealer’s licence.
US - California: At its latest meeting, the Monterey County Board of Supervisors approved the first reading of an ordinance to ban sales of single-use e-cigarettes and flavoured tobacco products of any flavour other than tobacco. The ban would include all products containing tobacco leaves and any product containing nicotine. The second vote is set for 15th March.
US - Arizona: House Bill 2125 has failed the House third reading. This bill would have required tobacco vendors to have a valid tobacco retail sales licence in order to distribute tobacco products. E-cigarettes would be included in the definition of “tobacco products” for purposes of this bill.
US - Virginia: Senate Bill 223 has passed the House after minor amendments. This bill prohibits student athletes from earning compensation for the use of their image in connection with tobacco, tobacco products, alternative nicotine products, nicotine vapour products, and similar products and devices.
US: The FDA has issued new warning letters to manufacturers and distributors of e-liquid products that are “new tobacco products” without the required FDA marketing authorisation to remain on the market.
US - Georgia: Senate Bill (SB) 572 has been introduced. This bill would require vapour product manufacturers and sellers to deliver an attestation to the attorney general stating that the product has received a marketing granted order by the FDA; it would require the attorney general to develop a vapour product directory, which would be publicly available for inspection; and it would ban any vapour product manufacturer from manufacturing or selling any vapour product not included in such a directory.
Canada - Ontario: France Gélinas, a member of the New Democratic Party, which is part of the minority coalition, tabled Bill 85 “Vaping is not for Kids”. The proposal aims to restrict the sale of vapour products to speciality vape stores, prohibit the promotion of e-cigarette products, and raise the minimum age for purchasing vaping products from 18 to 21.
Canada - Alberta: The provincial government will not introduce a standalone provincial tax for vapour products through the Budget 2022 (page 181). Alberta will work with the federal government to explore a coordinated taxation approach to collect a provincial tax on vaping products. According to the Budget 2022 documents, a coordinated tax structure would minimise the burden on Alberta businesses and could also reduce the risks of interprovincial smuggling and tax leakage.
Missouri: House Bill 2786 has been introduced. This bill would raise the minimum age from 18 to 21 for purchasing and possession of tobacco products, alternative nicotine products, and vapour products.
Mexico: The National Commission against Addictions (CONADIC), the Pan American Health Organization (OPS), and the organisation Salud Justa have shown their concern over the new General Custom Duty Act, press reports. The organisations say that the Act does not prohibit the import of the third category of electronic cigarettes (known as “alternative systems of nicotine consumption”) and that it only prohibits the import of the other two categories of electronic cigarettes: “electronic devices of nicotine administration” (SEAN) and “similar devices without nicotine” (SSSN). According to the organisations, the bill would contradict the October 2021 presidential decree that prohibited the import of all electronic cigarettes.
US - General: The Federal Trade Commission announced yesterday: “In an Initial Decision announced on Feb. 24, 2022, Chief Administrative Law Judge D. Michael Chappell dismissed the antitrust charges in a complaint issued by the Federal Trade Commission staff against tobacco company Altria Group, Inc., and electronic cigarette maker JUUL Labs, Inc.” The judge concluded that the complaint failed to prove antitrust violation of the non-compete provisions of the agreements between Juul and Altria.
California: An ordinance has been approved in the city of Antioch in Contra Costa County to prohibit characterising flavours in tobacco products, impose packaging restrictions on cigarettes and cigars, and ban the sale of e-cigarettes for use with tobacco or tobacco products, local press reports. At the meeting which took the decision, councilmember Mike Barbanica expressed strong opposition, saying: “We have a city that allows cannabis sales...but you cannot buy some bubblegum vaping pen”. Another councilmember put a motion to waive the first reading and read by title only, which passed 3-2.
Idaho: Senate Bill 1284 has been introduced. It would raise the age of legal possession and use of e-cigarettes and tobacco products from 18 to 21.
Connecticut: Senate Bill 139 has been introduced. It would ban all flavours but for tobacco in electronic nicotine delivery systems and vapour products. It would also amend the definition of “electronic cigarette liquid” to include products with synthetic ingredients.
US: The Food and Drug Administration (FDA) issued on Thursday a new batch of warning letters to manufacturers and distributors of e-liquid products classed as “new tobacco products” without the required FDA marketing authorisation to remain on the market.
West Virginia: Senate Bill 635 has been introduced, which would amend the Tobacco Products Excise Tax Act. It would change the definition of “electronic smoking devices” for the purposes of this Act, to include synthetic nicotine within its definition. It would further modify the definition of “other tobacco products” to include: nicotine-containing products (including synthetic nicotine products); and "electronic smoking devices". The bill would raise the tax on tobacco products other than cigarettes from 12% to 51% of the wholesale price, effective from 1st July 2022. The current tax on e-cigarette liquid would be repealed and thus substituted by this one.
Maryland: House Bill 1227 has been introduced. It would specify that a “tobacco product” includes certain products that are made of, derived from, or contain nicotine from any source, including synthetic nicotine.
US: Altria has announced that an administrative law judge has dismissed the Federal Trade Commission (FTC)’s claims against Altria and Juul Labs over the tobacco giant’s 2018 investment in the e-cigarette company, which allegedly violated anti-competition laws. This preliminary decision is subject to review by the FTC and may be appealed.
US: The US Senate has confirmed Robert Califf to be commissioner of the FDA by a 50-46 vote, as expected following the recent cloture vote.
Federal: The US Senate was set to vote today on Robert Califf's nomination as Food and Drug Administration (FDA) commissioner. At the end of debate yesterday, a cloture motion was agreed to by a close vote (49-45, with six not voting). A cloture motion is invoked to end a debate quickly, limiting further consideration of a pending proposal to 30 hours.