Category: Regulation

Australia Sets $8.2 Million Max Fine for Nicotine Vape Sales
Beginning in October, Australian businesses will face fines of up to AUS11 million ($8.2 million) if they are caught selling illegal nicotine vaping products. That’s when a strict new set of safety guidelines from the medicines regulator will come into effect for vaping products that are supplied into Australia and are not registered in the Australian Register of Therapeutic Goods. There are currently no nicotine vaping products in the register.
Credit: Belyay
The move comes as part of an overhaul of the country’s vaping regulations. The rules state Australians must have a prescription before buying e-cigarettes and vaping products online from overseas, according to the Sydney Morning Herald.
The new quality rules specify that the products must not contain any active ingredients other than nicotine. They also detail set labelling and packaging rules, including warnings to keep the goods out of reach of children. The rules also ban certain flavoring additives such as cinnamaldehyde, which is used to create a cinnamon flavor, and acetonin, which is used to create a creamy flavor.
A Therapeutic Goods Administration (TGA) spokesperson said supplying non-compliant products was a criminal offence and could also result in civil penalties and fines “up to 5,000 penalty units for an individual – up to AUS1,110,000 – and 50,000 penalty units for a corporation – up to AUS11,100,000.”
The federal Department of Health held widespread consultation on the new standards, with advocacy group Quit arguing in its feedback that the regulator should be regularly tracking and updating restricted ingredients in line with new evidence about the risks they might pose. “The TGA will revise the list in Schedule 1 to TGO 110 if and when more evidence becomes available showing that other ingredients used in nicotine vaping products carry demonstrable health risks associated with inhalation,” the TGA spokeswoman said.
July 12, 2021
FDA Falsely Issued Warning Letters, Other PMTA Problems
The U.S. Food and Drug Administration’s process for premarket tobacco product applications (PMTAs) has not been perfect. The regulatory agency has been accused of falsely issuing warning letters, leaving companies off of its list of accepted PMTAs and of having issues with its PMTA filing software.
As of July 9, the FDA has issued 130 warning letters for the marketing of illegal vaping products. The majority of those letters centered on e-liquids produced and sold online by small-sized vape shops. As the FDA continues its blitz, however, there is some confusion as some companies who have submitted PMTAs by the Sept. 9, 2020 deadline have received warning letters.
According to Facebook posts from the American Vaping Manufacturers Association (AVM), at least two companies have received warning letters for products that submitted timely PMTAs. Posts acknowledged that the FDA corrected its mistake in a follow-up letter after receiving complaints from the companies. While the number may be small, it does show that the regulatory agency is overwhelmed by the number of submissions it is reviewing.
The FDA also had recently started listing closeout letters for companies that had responded to warning letters. Recently, however, the agency removed those letters from its website. The FDA offered no explanation for the removal of the closeout letters.
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. A court order requires the FDA to complete review of all submitted PMTAs by Sept. 9, 2021.
If a negative action is taken by the FDA on a PMTA application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
There are other issues with the FDA PMTA process, as well. The FDA released its list of products that are legal for sale in the U.S. A total of 360 companies (on the original list) filed PMTAs. However, at least five companies that filed PMTAs were erroneously left off the list, according to posts by Amanda Wheeler of the AVM.
In its own investigation, Vapor Voice found that Humble Juice Co. submitted a timely PMTA, received an acceptance letter and was subsequently misidentified on FDA’s list of approved products. The FDA has corrected the error for Humble. The AVM did not name what companies were left off the list or had falsely received warning letters.
The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on the current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed. It is possible companies were left off the list because they did not respond to the FDA before publication of the list.
Other issues with PMTAs include errors in submitting them electronically. Several companies have complained that the FDA’s software that manufacturers must download in order to submit PMTA data has randomly left out some of files that the companies are uploading. At least two companies that have helped prepare more than 500 PMTAs have acknowledged the issue and have presented the problem to the FDA.
“We did 15 PMTAs for various clients and just all of a sudden had somebody come up and they got a deficiency letter asking for information that was included in their submission. We started looking through it and it’s missing. We then spent a bunch of time going through every single one and found several others that were missing one or two files,” one of the companies that discovered errors told Vapor Voice. “We reached out the FDA, got a basic response … we’re aware of this, we’ll get back to you type of thing. We believe it’s a bug in the agency’s eSubmitter program.”
Because of these issues, some companies are offering free PMTA deficiency reviews for companies that submitted them to the FDA. Delphinus Consulting and Blackbriar Regulatory Services have said they have programs to help companies find faults in their PMTA submissions.
Warning letters are expected to continue to be issued for illegal vapor products as the deadline for FDA action moves closer. The FDA has not said if it intends to ask for an extension on the deadline, however, the U.S. Small Business Administration recently sent a letter to the FDA asking the regulatory agency to request an extension.
The FDA often only lists a few products that a company is selling as illegal in a warning letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
A more in-depth analysis of these issues will be in the next issue of Vapor Voice.
July 9, 2021
Jamaican Tobacco Company Warns Against Vape Rules
Jamaica’s largest tobacco distribution company Carreras Limited has cautioned the Government against an excessive regulatory regime for vaping and other tobacco products. Managing director of Carreras, Raoul Glynn, says the regulations will be tough to implement and enforce, and will impose provisions that will put the industry at a disadvantage.
Credit: Miro Novak
He stressed that the company took no issue with lawful, evidence-based regulation. However, excessive regulation will cause more revenue losses, pointing out that government revenue lost to the tobacco black market in 2020 was $2.1 billion.
“Jamaica is one of those markets that have a significant illicit component, not just on tobacco but other products [too],” Glynn told a joint select committee that is reviewing the country’s proposed Tobacco Control Act, according to the Jamaica Observer. “What we saw happening in 2017 when there was a significant increase in the excise, you had an almost immediate jump in the illicit volume, so consumption remains the same because of a proliferation of very cheap products that doesn’t pay the taxes.”
The company’s view is that new category products, such as e-cigarettes, and combustibles should be regulated separately. Lumping them with the same regulations for tobacco products would send an “incorrect and unhelpful message that both product categories have the same risk profile and perpetuate the misconception that tobacco and nicotine carry same risks,” according to Glynn.
The proposed legislation goes beyond traditional tobacco products to include prohibiting the use of electronic nicotine delivery systems (ENDS) in public spaces. This and other changes to the legislation is supposed to make Jamaica fully compliant with the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC).
Glynn pointed to evidence that new category products have contributed to reduced smoking prevalence in countries with a more flexible regulatory landscape. It referenced the United Kingdom’s House of Commons Science and Technology Committee, which found that e-cigarettes could significantly accelerate already declining smoking rate and are about 95 percent less harmful than conventional cigarettes due to the absence of tar and carbon monoxide.
He noted that the Canadian Government says switching from tobacco cigarettes to vaping products will reduce exposure to many toxic and cancer-causing chemicals. The tobacco company’s view is that e-cigarettes should be regulated proportionately on an evidence-based approach, taking into consideration freedom to innovate, dialogue and responsible marketing freedoms, according to Glynn, who said also that the legislation, technically, places a ban on the sale of cigarettes in all public spaces, despite arguments that it does not.
Glynn also cautioned that the law puts small businesses at a severe disadvantage by prohibiting retailer incentives and promoting discounted products.
July 6, 2021
23-Member Coalition: FDA Must Request PMTA Extension
A coalition of 23 organizations have written a letter to the U.S. Food and Drug Administration (FDA) to follow the common-sense recommendations of the Small Business Administration (SBA). The SBA had recommended companies seek a court order to allow vaping manufacturers to keep products on the market while their premarket tobacco product application (PMTA) submissions are being reviewed.
Credit: Tanasin
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. All products must be removed from market on Sept. 9, 2022 without FDA approval, according to a court order.
The coalition letter, organized by the Americans for Tax Reform (ATR) acknowledged that FDA promised to exercise discretion in enforcement, stating that “this does not provide the degree of certainty necessary for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by FDA. If an extension is not granted, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality.”
The letter also argues that there “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The coalition states that the only way to avert a disastrous outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year.
“The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”
The full letter and list of signatories can be read here.
July 3, 2021
BRS Offering Companies a Free PMTA Gap Analysis
The premarket tobacco product application (PMTA) process has been a struggle for vapor industry companies that took on the time, effort and expense to keep their products on the market. During the Tobacco Plus Expo (TPE), Vapor Voice sat down with Blackbriar Regulatory Services (BRS), a firm specializing in helping small-sized to mid-sized companies navigate the regulatory landscape to bring their FDA-regulated product concepts to market, to discuss the lessons it learned while filing 365 PMTAs for its clients. BRS has helped several clients garner acceptance and filing letters from the FDA.
Credit: Coloures Pic
BRS did not exhibit at the TPE. Don Hashagen, VP of business development, and Kristina Rogers, director of marketing and brand management, attended the show to support its partners that were exhibiting. Some of these partners include the Charlie’s Chalk Dust, The Beard and Humble brands. The pair was also testing the waters for how secure other companies felt about their PMTA submissions.
“If they wait until they get a deficiency letter, that’s too late. That’s 90 days,” said Hashagen. “We want to support the industry whether they have worked with us on their PMTA or not. The more people that make it through PMTA, the better it is for everybody in the industry.”
BRS is offering any company that submitted a PMTA a free gap analysis of their submission. Hashagen said that many companies that submitted PMTAs have yet to complete clinical trials, for example, and the FDA has been clear that it’s a requirement for approval. It’s also time-consuming and expensive.
“The other one is perception and behaviors. We’ve got about 45 people that specialize in PMTAs. Now that we’ve seen enough deficiency letters coming through, we have an understanding of how to respond to those letters,” he said. “Our team can read a PMTA and very quickly say, ‘All right, here’s some major issues you’re going to need to attack. Now, you don’t want to wait too long to get started on a deficiency letter. It’s going to take you more than 90 days to remediate.”
Several manufacturers have received filing letters for their PMTA submissions. This is the stage that the FDA will ask a company to respond to questions the FDA has as well as receive deficiency letters. Because the PMTA is a “living process,” BRS can help a company potentially address a known or found deficiency often before a deficiency letter is even issued.
“Submitting your PMTA is really the first step in a very long, lengthy process. You have multiple audits afterwards with people looking into your manufacturing, into registration, into your PMTA, into post-market surveillance … even after you are authorized for marketing authorization,” explains Rogers. “It’s a long year-to-year process. This is just the beginning of something that’s going to last the length of your product lifetime.”
Having an organization like BRS managing a company’s PMTA allows the client to have access to experts that know what’s coming, says Rogers. BRS knows what’s needed to help take a brand and make it successful in the market while complying with regulatory requirements.
“You spend all this money, you get a market authorization, you’re doing well. But four months later, you trip over your own shoelaces because you did something that could hurt your brand from a marketing standpoint … how you positioned it. Maybe your brand is suddenly considered youth-friendly as FDA guidelines change,” said Rogers. “You can be taken off market almost instantly. As this evolves, you want somebody who’s talking to the [FDA] frequently. We’ve built a working relationship with the agency.” Hashagen says the main reason BRS is offering the free gap analysis is because they really want the industry to not just survive but thrive. “We really want to help people,” he said. “This industry is about helping adult smokers quit combustible tobacco for good. That’s really, really important to us.”
July 2, 2021
Washington DC’s 2nd Reading for Flavor Ban Tomorrow
The District of Columbia’s City Council will have the the second reading on its bill to ban flavored vaping products tomorrow. If the resolution passes, it will be sent to Mayor Muriel Bowser’s desk to be signed into law. The mayor has indicated that she intends to sign the bill.
Credit: Makcoud
This ban would apply across the full spectrum of tobacco products, including combustible, non-combustible and electronic nicotine delivery systems (ENDS). Notably, the Council skipped holding a public hearing on the bill, which is a departure from governing body’s standard processes.
The bill includes a provision that allows the Attorney General to investigate and prosecute suspected violations of the ban as well as fines associated with the sale of flavored products. The Council Office on Racial Equity reviewed the bill and determined that while it “has the potential to advance racial equity by improving health outcomes, enforcement of the bill has the potential to exacerbate racial inequity in economic and social justice outcomes.”
A recent study showed that after San Francisco banned all flavored tobacco products there was a significant increase in youth use of combustible cigarettes compared to cities without flavor bans. The Council voted 9-3-1 during the bill’s first reading during its June 15 legislative session. Bars and restaurants that offer hookah will be exempt.
June 28, 2021
Connecticut Cannabis Bill Bans Vaping in Many Public Places
The new bill in Connecticut that legalizes cannabis comes with a surprise. The legislation also bans vaping in many public places. In addition to being banned in health care settings, restaurants, state buildings and more, vaping and smoking tobacco or marijuana will now be prohibited in hotels, motels and other places of lodging, as well as in correctional facilities and halfway houses.
Credit: Andy Dean
Additionally, in all places where vaping is prohibited it will be restricted not only indoors but also outside within 25 feet of a doorway, window or intake vent, according to the Hartford Courant. That means, for example, a restaurant worker who takes a smoke break outdoors will have to do so at a 25-foot distance from the building itself.
The full list of places where smoking is banned in Connecticut now includes:

Any building, rail platform or bus shelter operated by the state (with the exception of public housing)

Any health care institution

Any retail food establishment accessed by the general public

Any restaurant

Anywhere alcohol is sold

In or on the grounds of any school

In or on the grounds of any child care facility

In any elevator

In any hotel room

In any correctional facility or halfway house

In any college dormitory
Landlords and building managers will not be allowed to prohibit the possession or consumption of cannabis but will be allowed to ban residents from smoking it. Connecticut recently joined 18 other states in legalizing recreation cannabis, after a multi-year effort in the state legislature.
Marijuana possession will be legal in Connecticut as of July 1, while retail sales are likely to begin next year. The bill lets people from cities that have borne the brunt of the war on drugs qualify for expedited licenses, in an attempt to reverse disproportionate impacts of marijuana prohibition.
“We had a chance to learn from others and I think we got it right here in the state of Connecticut,” Gov. Ned Lamont said before signing the legislation. “We weren’t the first but we were the first to show we can get it right.”
June 27, 2021
Senator Durbin Blasts FDA Over E-Cigarette Oversight
U.S Senate Majority Whip Dick Durbin yesterday testified at a House Oversight and Government Reform Subcommittee on Economic and Consumer Policy hearing that focused on youth vaping and the role of the Food and Drug Administration (FDA) in regulating e-cigarette products.
During his testimony, Durbin blasted the shortcomings of the FDA’s tobacco oversight over the last several years and urged the agency to rectify its missteps and put public health and the safety of children at the forefront of its mission, according to a press release.
“Flavored e-cigarette products have exploded in popularity among our kids—nearly four million now vaping, a 361 percent increase in just eight years when only 800,000 kids were vaping,” Durbin said. “Who is the cop on the beat to whom we entrust our children? It’s the Food and Drug Administration. And this agency has been timid and reluctant for way too long.”
All e-cigarette manufacturers were required to submit Premarket Tobacco Product Applications (PMTAs) to FDA by September 9, 2020, in order to legally stay on the market. FDA is now evaluating those applications based upon a public health framework and is required to complete review by September 9, 2021. FDA’s decisions on the PMTA applications will determine the course of the youth vaping epidemic.
In his testimony, Durbin urged the FDA to finally apply the public health standard that Congress passed in 2009 under the Tobacco Control Act and evaluate whether a product can stay on the market if it is, “appropriate for the protection of public health.” Durbin said he feared the FDA will over-value the unproven potential benefit of cessation for adult smokers, while under-valuing the clear evidence and experience we’ve had over the past several years on how flavored products hook kids.
“Only four percent of adults use e-cigarettes [compared] to 20 percent of high-school students. Kids who never would have picked up a tobacco product are vaping. It’s simple: any product with a history of increasing youth use must be rejected by FDA—especially flavored products that we know hooks the kids. This is the Super Bowl for the FDA’s tobacco effort and I’m afraid they aren’t ready for primetime. I hope they prove me wrong,” Durbin said.
Durbin went on to describe how despite promises from the Trump Administration to crack down on kid-friendly e-cigarette flavors, the FDA still left loopholes that have been exploited by the vaping industry to continue to hook kids onto new and illegal products.
“The result? Kids migrated…to the products that remained unregulated on the market: menthol flavored e-cigarettes and disposable vaping products. The use of disposable e-cigarettes… which were exempted from FDA’s January 2020 action, increased 1,000 percent last year. Make no mistake: kids get it. If we don’t take this seriously they will find those loopholes continue their addiction,” Durbin said. “And because FDA allowed menthol-flavored cartridges from JUUL and others to stay on the market, their use…increased from 11 percent to 62 percent of the [cartridge] market. Another failure by the FDA.”
June 24, 2021
WHO Details “Industry Attempts to Avoid Regulation”
Photo: Olrat
The World Health Organization has published a report detailing what it describes as attempts by manufacturers to avoid regulation of e-cigarettes and heated-tobacco products.
Titled “Litigation relevant to regulation of novel and emerging nicotine and tobacco products: comparison across jurisdictions,” the report offers governments examples of the legal arguments that the industry has used in attempts to minimize regulation as well as how courts have addressed those arguments.
The emergence of products such as heated-tobacco products (HTPs) and electronic nicotine-delivery systems (ENDS) and their market growth has raised questions about how they should be regulated and how that regulation might affect comprehensive tobacco control.
The WHO previously published its position on regulation of these products but has not addressed legal issues, such as how those regulations are being challenged in different jurisdictions. The new report and the accompanying case summaries close this gap and provide the facts, discussion of legal issues, arguments advanced and the reasoning of the courts.
The key messages highlighted in the publication are:
ENDS and HTP manufacturers attempt to avoid products being regulated so as to fall within regulatory or legislative gaps.
Manufacturers can be expected to deploy arguments concerning the relative risk of different product categories and the need for coherent regulation along a continuum of risk.
Not all courts are receptive to arguments about relative risk, either because regulations are justified by reference to absolute risk or because the concept of relative risk must be judged at the population level and taking into account factors beyond relative toxicity.
Technological advances employed for the manufacture of novel and emerging nicotine and tobacco products will raise questions of whether a product falls within the ambit of the national legislation of the country.
There are relatively few cases addressing misleading marketing of ENDS, or enforcing restrictions on advertising, promotion and sponsorship, but important cases have been decided, including on how social media posts may constitute advertising and on whether advertising of an HTP device also constitutes advertising of a tobacco product.
June 22, 2021
Tennessee City to Ban Vaping on Most Public Properties
Getting caught smoking vaping in most Johnson City, Tennessee, public properties may soon face a $50 fine. On Thursday, city commissioners approved on first reading an ordinance banning the use of vapor and tobacco products in public parks, public playgrounds, public greenways and any public property accessible to youth.
Credit: Andre Ykr
Smoking is already prohibited in parks as a result of city policy, but because it’s not an ordinance, the restrictions are not comprehensively applied and can be difficult to enforce, according to the Johnson City Press.
Assistant City Manager Charlie Stahl said tobacco was originally prohibited in the park system because officials were receiving complaints about parents smoking in the bleachers at sporting events, which would disturb other spectators and their children.
A law passed by the Tennessee General Assembly this year gives local governments the authority to prohibit the use of tobacco products on public property by ordinance. Gov. Bill Lee signed the bill on May 27, and the law becomes effective on July 1.
If commissioners approve the changes on three readings, the ordinance would become effective after July 15.
June 21, 2021