Category: Regulation

U.K. Regulatory Agency Clarifies E-Cig Rules

Photo: Steheap
The government agency overseeing the U.K.’s e-cigarettes and refill containers notification scheme as well as implementing the Tobacco and Related Products Regulations (TRPR) has updated guidance on the sale of vaping products following discussions with the U.K. Vaping Industry Association (UKVIA) and Trading Standards.
The UKVIA decided to intervene after being approached by a significant number of vape product manufacturers, distributors and retailers confused about what could and could not be legally sold in shops, particularly following the recent surge in new disposable vapes entering the U.K. market.
As a result, the Medicines and Healthcare Products Regulatory Agency (MHRA) has now clarified its advice to both manufacturers and distributors of e-liquids and devices and vaping retailers.
The UKVIA took part in discussions with the MHRA and Trading Standards following concerns raised by retailers unsure of their compliance requirements and wary of falling foul of the law.
“Due to the numerous [inquiries] we received about the legality of stocking new-to-the-market products, in particular the surge in new disposables, we decided it was imperative to talk to Trading Standards and raise this with the MRHA to seek clarification,” said John Dunne, director-general of the UKVIA, in a statement.
“Since then, we have been working with the MHRA to clarify the process around when products can legally be placed on the market for sale.
“The first part saw the MHRA issue an e-bulletin clearly setting out the process and making it unambiguous that it is illegal to place products into the market until the ‘ECID’ numbers are published on the MHRA website as ‘approved/declared.’
“Next the MHRA updated its online advice for retailers, which is a highly satisfactory outcome as it effectively closes the loophole for when brands can place the product on the market and when a retailer can legally sell the product.”
The MHRA’s guidance for vaping retailers previously read:
“When sourcing new supplies of any e-cigarette or e-liquid product, check that details of the notification for the product have been published in the list of Notified Products.
“If you cannot find the product on the MHRA’s website, ask your supplier to confirm that the product complies with the TRPR and has been notified to the MHRA. If a producer has not notified the product or it does not comply with the TRPR, they may not supply it to you.”
The new wording says:
“When sourcing new supplies of any e-cigarette or e-liquid product, check that a compliant notification has been published in one of the Notified Product lists above.
“If you cannot find the product on the MHRA’s website, ask your supplier to confirm that it has been published and provide details to enable you to confirm the product’s status. If a product has yet to achieve publication status, they may not supply it to you.”
Dunne said the clarification demonstrates the effectiveness of open dialogue.
“We want our sector to be known for upholding strict standards when it comes to the manufacture, distribution and sale of vaping products, and this clarification from the MHRA can leave no one in any doubt about where their responsibilities lie,” he said.
The MHRA’s full wording on the sale of vaping products is available here.
August 12, 2021
New Taipei Prepares To Ban Underage Vaping

Photo: BUSARA
Starting in August, people under the age of 18 will be banned from buying or smoking electronic cigarettes in New Taipei, reports Focus Taiwan, citing local government sources.
Passed by the New Taipei City Council on April 29, the new ordinance is expected to take effect Aug. 6.
After that date, people under the age of 18 caught vaping or carrying e-cigarettes will be required to enroll in a program to help them quit, the city’s health department said in a statement.
Violators who skip the programs without a valid reason will be fined between TWD$2,000 ($71) and TWD$10,000, the department warned.
Individuals or businesses caught selling vapor devices to people under the age of 18 will risk a maximum fine of TWD$100,000.
Taiwan’s current law defines minors as people under 20, but an amendment that was passed last December will lower the age to 18 with effect from 2023.
Meanwhile, the New Taipei health department said city regulations prohibit the manufacture, importation, sale, display and advertisement of e-cigarette products without the relevant permits.
The maximum fine for violation of that regulation is TWD$100,000 and the businesses involved may be closed or suspended, the department said.
July 22, 2021
Push to Exempt Soldiers from ‘Tobacco-21’

Photo: Getmilitaryphotos
Members of the U.S. military under 21 years old would again be allowed to buy and use tobacco products on military bases under a proposal being pushed by Senator Tom Cotton, reports The Military Times.
In late 2019, Congress passed legislation raising the federal minimum age to purchase tobacco from 18 to 21. Last summer, military commissaries ended all sales of tobacco products to individuals under 21, although military officials at the time acknowledged they would not strictly police use of the products among underage troops.
Cotton’s proposal would reverse those changes just for members of the military. Any store on Defense Department property that sells tobacco products would be allowed to sell to individuals as young as 18 years old, and “any such member may consume such products on the installation.”
“Tobacco doesn’t impair one’s judgment, so if young troops want a smoke or a dip on an overnight shift or off-duty hours, why should politicians or nanny-state bureaucrats tell them no?” Cotton told Military Times.
Military officials have strongly discouraged use of tobacco products in recent years, spending billions on smoking cessation campaigns. A 2015 federal study found the Defense Department spends more than $1.6 billion per year on tobacco-related medical care, hospitalization and lost workdays.
Among troops, vaping is now more popular than smoking.
July 22, 2021
Brookline Bans Sales to Those Born After 2000

Photo: Ryan
The town of Brookline, Massachusetts, will prohibit the sale of all tobacco-related products to anybody born after Jan. 1, 2000, reports Filter. The restriction, the first of its kind in the United States, is designed to prevent future generations from using not only tobacco but also nicotine.
The law also prohibits individuals and companies from selling vapor products to anyone in that age category.
In November 2020, Brookline officials voted overwhelmingly for the “first-in-the-nation tobacco-free generation,” paving the way for the current ban. On July 19, Massachusetts Attorney General Maura Healey confirmed that the measure did not interfere with any state laws or the constitution of the Commonwealth of Massachusetts, ensuring its legality.
Public health groups lauded Brookline’s decision, which they view as a potential model for others to follow.
“In addition to preventing a new generation from being addicted to nicotine—and facing the long-term health issues that come with it—Brookline citizens who smoke will be further motivated to quit as smoking becomes rarer around them,” said Lauren Huber, the executive director of Action on Smoking and Health (ASH), in a statement.
Harm reduction proponents, by contrast, lambasted the idea. “Not only will enforcement of this become a nightmare, but it continues to push prohibitionist policies that inevitably send people to underground, unregulated markets,” said Matt Sutton, the director of media relations for the Drug Policy Alliance.
“The whole measure is ridiculous, especially if you imagine how it will function in 2030 or 2040,” echoed Clive Bates, a tobacco control expert and former director of ASH (U.K.). “It infantilizes adults, sets up illegal trade between older and younger age groups, and ultimately aims at creeping prohibition, with all the crime and abuse that will bring.”
Brookline has a history of aggressive tobacco control. The suburb was an early adopter of indoor smoking bans, raised the legal age to purchase tobacco to 21 in 2014 and capped the number of tobacco licenses for retailers in the market. In the spring of 2019, Brookline banned the sale of flavored tobacco and vaping products, including menthol. Six months later, Massachusetts passed the same kind of flavor ban statewide.
July 22, 2021
Rwanda Working on Anti-Tobacco Laws

Photo: Taco Tuinstra
Rwanda’s Parliament has ordered the Ministry of Health in the next three months to formulate a strategic plan on how it intends to raise awareness about the negative effects of tobacco and its prohibition among minors, reports The New Times.
Although one must be at least 18 years old to purchase or consume tobacco products, research indicates that those as young as 15 are also consuming them. Member of Parliament Germaine Mukabalisa noted that some children are exposed to cigarette consumption at an early age in markets and boutiques, which could influence children to believe that cigarette smoking is acceptable across all age groups.
Mukabalisa proposed that the government tackle the promotion of tobacco use on social media platforms where youth are present. Rwanda does have high cigarette import duties, which do reduce cigarette imports, according to Uwamariya. MPs have also recently asked the government to designate public smoking areas.
July 19, 2021
FDA Urged to Extend Enforcement Deadline

Photo: Oleksandr Moroz
A coalition of 23 organizations has asked the U.S. Food and Drug Administration to follow the recommendations of the Small Business Administration (SBA). Earlier this year, the SBA urged the FDA to allow nicotine products to remain on the market for another year after the current Sept. 9, 2021, deadline while their premarket reviews are in progress.
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—the FDA will unlikely be able to process all submissions before manufacturers are required to pull their products off the market, according to the SBA.
In a letter to the FDA prepared by the Americans for Tax Reform (ATR), the 23 organizations say that the FDA’s promise to exercise discretion in its enforcement provides insufficient certainty for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by the FDA.
If an extension is not granted, the letter cautions, 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, according to the authors.
The letter also argues that “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 only way to avert such an adverse 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, according to the letter writers.
“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.”
July 4, 2021
Filling the Gaps
Photo: fizkes
The FDA gifted you a PMTA deficiency letter … what’s your strategy?
By Willie McKinney and Cheryl K. Olson
“I read it. And I thought it was over.”
Anne* held the letter she’d just pulled from the brown and white UPS Express envelope marked U.S. Food and Drug Administration. She recalled last September’s frantic scramble to submit a premarket tobacco product application (PMTA) to keep her specialty vape product on the market. Her little team did the best they could to meet the deadline; she knew there were gaps.
Now the FDA’s review of her product had reached a new milestone, marked by the small all-caps header at the top of the letter: DEFICIENCY. “Additional information is needed for FDA to make a determination,” it said.
She stared, speechless, at the 25 pages of highly technical questions—what was HPHC? Puff topography? Abuse liability?—that she had 90 days to answer.
Hundreds of companies, big and small, submitted PMTAs to comply with a court-ordered Sept. 9, 2020, deadline and to keep their novel tobacco products on the market. At a June 11 virtual meeting with the FDA’s Center for Tobacco Products (CTP) Office of Science, we learned that PMTAs for 6.5 million products from over 500 companies have been processed, with more awaiting attention. Given this crush, there are many people waiting and worrying, with the future of their businesses at stake.
This article will help you get your bearings in this confusing review process. We’ll explain how to read and interpret a deficiency letter and how to develop a response strategy. Also, you don’t have to wait for that letter; there are things you could do now to prepare.

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So what is a deficiency letter?
Let’s step back and review what happens after you submit your PMTA. First comes an acceptance review, typically a low administrative bar to clear. Does the product fall under the CTP jurisdiction? Is your application in English? Does it contain an Environmental Assessment? If it’s all yes, you’ll get an acceptance letter.
Then comes filing. This involves a preliminary scientific review that ensures the application contains all the items under section 910(b)1 of the Family Smoking Prevention Tobacco Control Act. If it does, you’ll get a filing letter. Your application will move into phase three: substantive review. A team of specialists evaluates the scientific information and data in your application. If there are gaps or questions, the FDA can ask for more information to help them make a marketing authorization decision. That request comes in the form of a deficiency letter.
Not everyone gets one. But at the June 11 meeting, Office of Science director Matt Holman said the FDA has issued “many” deficiency letters.

Should I feel happy or panicked?
If you, like Anne, have a deficiency letter in hand, the answer is both. You should feel excited because you’re well on your way; the FDA has given your application a pretty through review. You should feel nervous because you have 90 days to respond. You’ve got to get cracking!
How you feel will also depend on what they’re asking you. If, whether by strategy or necessity, your application was light on data, you may get 25 or 30 technical questions. FDA staff need all of that information to finish their evaluation of your application. If you don’t supply it, their decision is easy.
Many companies were brand new to this regulatory process and invested just enough in their PMTAs to pass the first two phases of review. If that was your strategy, it may not have been a bad one.
Some people in the tobacco products industry felt the FDA did not want any of these products on the market. They believed the PMTA process was designed for failure. If that’s your fear, and you have a lump sum you’ve made sitting in the bank … do you spend it on expensive tests and studies for an unknown process with an agency that may not like you? Or do you just dip a toe in and see what the response is?
One client we know said, “I’m not in this for the money. I was a smoker.” The vape product he developed changed his life and the lives of friends and neighbors in his town. So he concluded the PMTA was worth the investment on principle despite the uncertain return.
But as Anne found, when you get that deficiency letter, there’s no way you can respond on your own. This is a communication from a team of FDA experts, saying what they need from a scientific perspective. You have to decide whether to invest in your own team of experts to address these questions or to say, “I had a good run,” pack up and be done.
The key point is that you will have 90 days to respond. The FDA has made it clear that during this crunch time, they will send only one deficiency letter. Ninety days is not a lot of time, especially if the letter is requesting additional data—that means new studies and tests.
Can you get an extension? Maybe. It’s at the FDA’s discretion whether to grant one. It is likely that your odds get better if you can give a rationale for the extension by explaining in detail the work you’re doing to fill those gaps.

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What’s the best way to answer questions raised in my deficiency letter?
Both what you say and how you say it are important. First, your narrative. A PMTA is an opportunity to explain to the FDA why having your product on the market is appropriate for the protection of public health (APPH); it’s essentially storytelling supported by data.
Don’t just contact a lab, get pages of numbers and toss them at the FDA, saying, “We include the data you requested.” You need to understand what data you need, what it shows and how it supports your APPH story. For example, highly variable product data could suggest that you don’t have control of your manufacturing process.
Second, set the right tone. As the CEO at a company one of us worked for told the FDA, “We may disagree. However, we will not be disagreeable.” That helped build rapport.
FDA staff deserve respect for their expertise and dedication. But they are human too. They may make a statement about your product that is wrong (especially given the plethora of PMTAs received). Respectfully making them aware of their error is perfectly acceptable.
Do I have to wait for my letter, or can I respond proactively?
Prepare in advance and avoid a panicked sprint against that 90-day clock. You may already have a pretty good idea of where your PMTA was lacking. You can check FDA guidance documents for more clues (see “Perception and Intention Studies,” Tobacco Reporter, February 2021, and “Gold Nuggets,” Tobacco Reporter, March 2021). Make sure you’ve done enough to address sensitive issues, such as flavors, youth access, acceptability of ingredients and the ability to switch smokers to your product. Get expert feedback to identify gaps; give priority to filling the ones that take time to address. Then, when your letter comes, the workload will be manageable. And you can get some sleep.
However, there are no guarantees. This is not a check-the-box exercise. The FDA has made it clear that getting authorized depends on both the information in your original PMTA and your response to questions. If you’ve made a solid data-based case that your product is APPH, the agency will probably come to that conclusion too. If you don’t give them what they need to evaluate, they can’t.
As of this writing, everyone is still somewhere in the process; FDA had not issued any marketing authorizations for PMTAs submitted in September 2020. But if you haven’t heard about acceptance of your application soon after you read this (by mid-July to late July), reach out to the CTP for an update.
*A pseudonym
Common PMTA Gaps Raised in Deficiency Letters
As consultants, we’re seeing some patterns in the letters our clients receive. Here’s what your PMTA may be missing:
Behavioral science: Perception and intention studies and actual use studies. Confused about what the FDA wanted, many companies submitted marketing research data, information on their product category (e.g., consumer perceptions of vaping instead of views on their vape) or just skipped these parts.
HPHC (analytical chemistry): A common oversight was testing liquids for toxicants but not testing the aerosol.
Limited toxicology review: Either not enough tests or not good enough explanations to show that it’s OK to inhale the ingredients (e.g., there are no carcinogens, or they’re at very low levels).
Proof of action: Many PMTAs we’ve read talk about great stuff people do to make their product and to keep it out of the hands of youth. But it’s all talk. They provide no certificates of analysis or data to support what they say. You need details and “teeth.” For example, how and when will you monitor youth purchase attempts? And what are the penalties for failure?
Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.

Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.
July 1, 2021
Bhutan Moves to Legalize Tobacco

Photo: s_jakkarin
The National Assembly of Bhutan has taken a first step toward lifting the country’s ban on tobacco products, reports East Mojo.
Passed on June 25, the Tobacco Control (Amendment) Bill 2021 and Tax Bill of Bhutan 2021 would legalize the selling, buying, possession, distribution and transportation of tobacco and tobacco products in the country. Manufacturing tobacco would remain illegal, however.
By legalizing tobacco, legislators hope to help check the spread of Covid-19, which they believe has been worsened by the continuous smuggling of tobacco products through Bhutan’s porous southern border.
The act also mandates that the government provide counselling and treatment to facilitate tobacco cessation. Premised on the physical health and well-being of the Bhutanese people, the legislation recognizes the harmful effects of tobacco consumption and exposure to tobacco smoke on both spiritual and social health.
The bill will now be referred to the National Council for endorsement.
Bhutan banned tobacco sales in December 2004. Tobacco Reporter was the first to report from the world’s only officially smoke-free nation.
June 28, 2021
WHO Details “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
Trade Body Slams German Vapor Tax

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The German association for the e-cigarette trade, VdeH, has sharply criticized the passage by the financial committee in Parliament of a tobacco tax reform bill that calls for significant tax hikes on vapor and tobacco-heating products, including nicotine-free variants.
Until now, e-cigarettes have been subject only to value-added tax. Tobacco-heating products will reportedly be taxed at the same level as combustible cigarettes.
The plans will not only boost the black market but also destroy numerous small and medium-sized businesses, according to VdeH.
“The mere fact that e-cigarette liquids are generally taxed more heavily than tobacco cigarettes and thus ignore the 95 percent lower potential for damage is insane health policy,” said VdeH Managing Director Michal Dobrajc in a German-language statement. Taxing nicotine-free products as well as cigarettes defies common sense, he added.

If you are serious about reducing the smoking rate, then you have to support the industry that is making a significant contribution to reducing it instead of destroying it.
Michal Dobrajc, managing director, VdeH
Dobrajc said Germany should learn from the experience of other countries that were forced to lower their vapor taxes as vapers returned to smoking and anticipated revenues failed to materialize.
“The Tobacco Tax Modernization Act is a disaster in both health and economic terms,” said Dobrajc. “If you are serious about reducing the smoking rate, then you have to support the industry that is making a significant contribution to reducing it instead of destroying it.”
June 10, 2021