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.
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.
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 - 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.
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.
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 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.
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.
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 - 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.
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.
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: 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 - 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: 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.
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.
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.
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.