Category: Regulation

‘Implementation of Tobacco Act Flawed’
Azim Chowdhury
The U.S. Food and Drug Administration’s implementation of the 2009 Tobacco Control Act, which gave the agency authority to regulate tobacco products, has been fundamentally flawed from the beginning, according to Azim Chowdhury, a partner in the Keller and Heckman law firm.
Writing in Filter, Chowdhury explains that the premarket authorization requirements for “new” products subjects potentially reduced-harm products to nearly insurmountable hurdles while allowing preexisting products, including combustible cigarettes, to mostly escape FDA scrutiny.
In his article, Chowdhury suggests several ways in which the FDA can more effectively implement the Tobacco Control Act.
For example, rather than conducting reviews in silo, the FDA should consider the totality of evidence in a premarket tobacco product application, according to Chowdhury.
“It is also critical that the FDA hamper the spread of counterfeit products, which may be riskier for consumers and are drowning out the small businesses and vape shops that continue to bear the brunt of FDA enforcement,” he writes.
“Finally, the FDA should shift more resources to developing reasonable safety, quality and marketing product standards.”
November 15, 2022
Advocacy Group Suggests FDA Reforms
Photo: Araki Illustrations
The U.S. Food and Drug Administration has “significantly and substantially failed” to fulfill its congressional mandate to protect the public health, Americans for Tax Reform (ATR) told the Reagan-Udall Foundation in a letter.
The Reagan-Udall Foundation is reviewing the FDA Center Tobacco Products’ (CTP’s) policies and procedures following months of criticism over its handling of e-cigarette reviews. As part of its assessment, the foundation offered stakeholders an opportunity to share their input.
In its comment, the ATR suggested seven reforms to improve the agency’s performance:
FDA should introduce cross-disciplinary expert analysis factoring input from fields like psychology and behavioral economics to increase public awareness and engagement in the decision-making process.
FDA must provide an easy, streamlined PMTA pathway as initially promised.
FDA’s PMTA process should focus on product safety and individual risk, not behavioral and population assessments that are better gathered by a singular postmarket surveillance team.
FDA should be in regular, proactive contact with all PMTA applicants as opposed to merely issuing marketing denial orders after year-long periods of silence.
FDA should consider implementing product standards to assist in the streamlining process and look also to countries such as the United Kingdom as a model for a regulatory system that works.
FDA must urgently act to combat significant public misinformation that it admits exists in the community and is a barrier to smoking cessation.
FDA must reform its approach to youth risk behavior. FDA should accept that youth can benefit from harm reduction and properly evaluate the consequences of reduced vape access for both adults and youth.
Tim Andrews, ATR’s director of consumer issues, wrote that the Reagan-Udall Foundation’s review could help the agency better the PMTA review process.
“[The PMTA] process has created impossible administrative burdens on applicants,” he said. “When processes and requirements were changed, FDA failed to notify applicants and is alleged to have applied a new and different standard to certain applicants. FDA’s failures are structural. Our submission is cognizant of that and emphasizes that these issues can’t be solved with increased funding, especially not through user fees on small vape manufacturers.”
November 8, 2022
FDA Rejects First Menthol Product PMTAs

The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) for several menthol-flavored vaping products marketed by Logic Technology Development. The products include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. It’s the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
The move seems inline with the regulatory agency’s goal to ban menthol flavors from tobacco products. The FDA also isn’t expected to approve any flavored vaping product other than tobacco.
“Ensuring new tobacco products undergo premarket evaluation is a critical part of the FDA’s work to reduce tobacco-related disease and death,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP), in a release. “We remain committed to evaluating new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told Tobacco Reporter that the latest move by the FDA to ban menthol vaping flavors is reminiscent of the agency’s “fatal flaw” review of PMTAs that resulted in millions of denials. The term “fatal flaw” was used by the FDA for PMTA submissions that didn’t have specific studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
“The dysfunction at the FDA knows no bounds. For the last year-plus, the FDA has sat back deferred decision making on menthol vaping products,” Conley said. “Lest anyone believe that FDA was hard at work coming up with ways to achieve balance, today they revealed that their big plan for menthol vaping products is to follow the exact same ‘fatal flaw’ review process that has led to dozens of lawsuits being filed against the agency.”
The agency stated that after reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health (APPH), the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.”
The FDA stated that the evidence provided within Logic’s denied PMTAs did not demonstrate that menthol-flavored e-cigarettes are more effective in promoting “complete switching or significant cigarette use reduction” relative to tobacco-flavored e-cigarettes.
Logic must now decide if it will resubmit its applications or submit new applications to address the deficiencies for the products that are subject to the MDOs. However, these acts could prove futile since the FDA states that for non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, “existing evidence demonstrates a known and substantial risk” with regard to youth appeal, uptake and use.
“The FDA conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard,” said King. “In this case, the applicant did not provide sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks to youth.”
A recently accepted manuscript of an article set for publication in Nicotine & Tobacco Research found that flavored vaping and other tobacco sales restrictions in California did not affect youth e-cigarette use.
The MDO letter that Logic received today is not limited to the two products named above, according to the agency. In general, the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.
Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action. These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In March, the FDA authorized several tobacco-flavored e-cigarette products from the company under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.
In addition to ensuring that Logic complies with this order, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the “statutorily required premarket authorization” are marketed unlawfully and their distribution or sale is subject to enforcement action.
Recently, the U.S. Department of Justice filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
Retailers should contact Logic with any questions about products in their inventory.
October 26, 2022
FDA Issues Warning to Puff Bar, MDOs to Hyde

Credit: Puff Bar
New data from the 2022 National Youth Tobacco Survey (NYTS) shows that 2.5 million U.S. youth use e-cigarettes, according to the published findings in the Morbidity & Mortality Weekly Report released by the U.S. Food and Drug Administration in conjunction with the Centers for Disease Control and Prevention.
“The FDA remains deeply concerned about e-cigarette use among our nation’s youth. It’s clear that we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use,” said FDA Commissioner Robert M. Califf. “We cannot and will not let our guard down on this issue. The FDA remains steadfast in its commitment to using the full range of our authorities to address youth e-cigarette use head-on.”
The study shows that about one in 10 middle school (3.3 percent) and high school (14.1 percent) students reported current e-cigarette use; current use is defined as use within the past 30 days. About 85 percent of surveyed students reported using flavored e-cigarettes while 27.6 percent reported daily use. Respondents most commonly used disposables, with Puff Bar being most common (14.5 percent) followed by Vuse (12.5 percent) and Hyde (5.5 percent). Puff Bar and Vuse were pre-specified options on the survey, but Hyde was written in by students as their preferred brand.
Since methodology changes occurred, including in survey administration and data collection procedures due to the Covid-19 pandemic, comparisons between the 2022 NYTS and previous years is limited.
Following the release of this data, the FDA has issued a warning letter to Puff Bar for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. The FDA has requested a response within 15 working days of receiving the letter, detailing how the company intends to address the FDA’s concerns, including the dates on which they discontinued the sale and/or distribution of these tobacco products and plans for maintaining compliance with the Federal Food, Drug and Cosmetic Act. Failure to address the violations puts the manufacturer at risk of regulatory action, such as a civil money penalty, product seizure and/or injunction.
The Puff products subject to this warning letter are nontobacco nicotine products.
After reviewing premarket tobacco product applications for 32 Hyde e-cigarettes, the FDA issued marketing denial orders (MDOs) for these applications submitted by Magellan Technology Inc. In conducting its scientific review, the FDA determined that the applications lacked sufficient evidence demonstrating that the products would provide a benefit to adult users that would be adequate to outweigh the risks to youth. No Hyde products have received marketing authorization orders from the FDA.
“Congress gave the FDA authority to hold manufacturers and retailers who violate the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products. “FDA is actively working to identify violations and to swiftly seek corrective actions, particularly for products popular among youth. We will use all compliance and enforcement tools available to us, as appropriate, to protect our nation’s youth.”
October 6, 2022
Stricter Rules Ahead

Photo: michaeljung
The South African Parliament accepted submission of the Tobacco Products and Electronic Delivery Systems Control Bill, which will replace the Tobacco Products Control Act of 1993, reports Business Insider.
The bill, which was tabled in 2018, aims “to deter people, especially children and youth, from using tobacco products, encourage existing users to quit and protect nonsmokers from tobacco smoke exposure.” Regulation will cover sale, advertising, packaging and labeling of tobacco products as well as where smoking and vaping are allowed.
Under the bill, smoking and vaping in enclosed public spaces will be prohibited. Smoking too close to “an operable window or ventilation inlet of an entrance or exit” of “an enclosed public place, enclosed workplace or in or on a public conveyance” is also prohibited.
The health minister can also prohibit smoking in certain outdoor areas to “reduce or prevent the public’s exposure to smoking.” Smoking in vehicles or enclosed private spaces while in the presence of a child or nonsmoker will be prohibited. Smoking in an enclosed common area of a multi-unit residence will be banned as well.
The bill will also mandate generic packaging for tobacco products; the packaging “must have a uniform plain color and texture” and be of the same “size, type and shape.” The health minister will be responsible for setting standardized packaging and labeling requirements.
The only branding allowed on packaging will be brand name and product name in a standard color and typeface. Packages will be dominated by graphic health warnings.
Additionally, stores will only be allowed to display “a single prescribed notice informing consumers that a list of relevant or related products for sale, along with their prices and quantities, may be requested at the sales counter.” Retailers and wholesalers will no longer be allowed to display tobacco products. They “may make the product available to consumers upon request, provided that the requestor is not a child.”
This bill could also affect flavored vapor products. The health minister can prohibit “any substance or ingredient that creates a specified color, characterized flavor, smell or effect on the consumer.”
“The industry wants to be regulated,” said Asanda Gcoyi, CEO of the Vapour Products Association of South Africa. “We have to be regulated.”
“But we propose that government use [vapes and e-cigarettes] as a tobacco harm reduction product, [and] this bill does not actually go that far.”
October 5, 2022
China: Flavored Vape Ban Takes Effect

Image: Arcady
China’s ban on flavored vapor products takes effect on Oct. 1 along with other new vaping product standards that were decided on earlier this year, reports Vaping360.
In November 2021, Chinese law was amended to bring the vapor industry under control of the State Tobacco Monopoly Administration (STMA), which regulates China’s tobacco products.
Vapers are rushing to buy and hoard flavored vapor products before the ban takes effect on Saturday, according to Vaping360. It is not clear yet if the ban will create a large black market in the country; China is known to punish illicit sellers harshly.
Products meant for export will not have to meet Chinese standards unless the destination country does not have its own specific standards.
China’s new rules also require domestic e-cigarette manufacturers and traders to obtain a license before operating their business, according to The Global Times.
E-cigarettes cannot be sold to customers under 18, and the sale points cannot be near schools or kindergartens. Warning signs must also be placed at the e-cigarette sale points, and self-service sales are banned.
Manufacturers, wholesalers and retailers of e-cigarettes, vaporizers and e-liquid are required to conduct their business on specific platforms that are subject to STMA supervision.
The rules also forbid the advertising of e-cigarettes in the mass media or in public places.
The iiMedia Research Institute expects China’s e-cigarette market to be worth RMB25.52 billion ($3.57 billion) by the end of 2022 and RMB45.43 billion by the end of 2023.
September 28, 2022
CTP Director: Nicotine Salts Show Potential
Brian King (Photo: FDA)
During an exclusive interview with the Associated Press, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), Brian King, said the FDA is well on its way in setting a foundation for substantial reductions in combustible tobacco smoking with the product standards such as a menthol ban and flavor bans for e-cigarettes and cigars.
When asked about several surveys that have shown many adults think e-cigarettes are as dangerous as traditional cigarettes, King said he was fully aware of the misperceptions surrounding vaping products those misperceptions aren’t consistent with the known science.
“We do know that e-cigarettes — as a general class — have markedly less risk than a combustible cigarette product,” King said. “That said, I think it’s very critical that we inform any communication campaigns using science and evidence. It has to be very carefully thought out to ensure that we’re maximizing impact and avoiding unintended consequences.”
King also said he believes “there’s a lot of really important science and innovations” that have occurred in the vaping industry in recent years, adding that the most notable is nicotine salts in e-liquids.
“We know that when you smoke a tobacco product, it’s a very efficient way to deliver nicotine across the blood-brain barrier. So it’s been very difficult to rival that efficiency in another product,” said King. “But in the case of nicotine salts you have the potential to more efficiently deliver nicotine which could hold some public health promise in terms of giving smokers enough nicotine that they would transition completely.
“But you also have to consider the opposite side of the coin, which is the inherent risks of initiation among youth. So I do worry about that … there’s a lot happening and I think that it could be promise or peril. But I think it’s important that the science drives that.”
September 27, 2022
Filter: FDA Cracks Down on Unauthorized Vapes

Photo: svetazi
The U.S. Department of Justice is seeking court orders, threatening lawsuits and demanding the destruction of unauthorized vapor products, according to Alex Norcia, writing for Filter. The actions are remarkable given Center for Tobacco Products Director Brian King’s reluctance to say whether the agency was willing to take unauthorized vaping products off the market during a recent interview with Politico.
Filter says it has confirmed that the Food and Drug Administration, by Sept. 1, advised the Department of Justice (DOJ) that at least two open system vape companies were in violation of the Federal Food, Drug and Cosmetic Act because the manufacturers did not file premarket tobacco product applications and were continuing to sell their products.
“We plan to seek a court order to permanently enjoin you … from, among other things, directly or indirectly manufacturing, distributing, selling and/or offering for sale any new tobacco product at or from any of your facilities, unless and until, among other things, the product receives, and has in effect, marketing authorization from FDA,” reads one letter, signed by DOJ Senior Litigation Counsel Christina Parascandola and seen by Filter.
The two companies known to have received letters have been ordered to physically destroy their own products under FDA supervision.
One industry insider told Filter that the letter was “a clear escalation”—the first time, to his knowledge, that the FDA had gone beyond warnings and explicitly threatened to sue over sales of unauthorized nicotine vapes.
“It is just beyond outrageous that the FDA is now conscripting the Department of Justice in its misbegotten war on vaping,” Amanda Wheeler, a vape shop owner in Arizona and the president of American Vapor Manufacturers, told Filter. “We are talking about hardworking small businesses that are helping ordinary Americans to quit smoking, and they are now facing jaw-dropping threats from federal law enforcement agents.”
September 15, 2022
A Second Chance

Photo: andranik123
How companies can make the most of a recent court ruling requiring the FDA to reassess thousands of PMTA rejection notices.
By Neil McKeganey
It would be hard to overstate the threat that youth vaping in the United States poses to the use of e-cigarettes as a means of tobacco harm reduction. Respected national surveys have shown a rising trend in youth vaping, with the threat to the vaping industry as predictable as night following day.
Former Food and Drug Administration Commissioner Scott Gottlieb could not have been clearer in signaling that threat when he said that the offramp to adult smoking could not be justifiably achieved at the cost of the on-ramp of teen vaping. If anybody was in any doubt about the risks that youth vaping poses to the entire e-cigarette industry, those doubts would have surely been extinguished in the recent ruling against Juul Labs, which required the company to pay in excess of $438 million to compensate states for the harms caused by past marketing practices increasing the likelihood of youth using their eponymously named vaping device.
For vaping companies, the threat of youth vaping may have lifted slightly in a recent U.S. court ruling requiring the FDA to pay attention to what vapor companies are doing in trying to restrict youth access to their products. Odd as it may sound, after having encouraged vapor companies to pay attention to their marketing and sales practices in light of the rising trend in youth vaping, the FDA’s position appears to have been that those efforts were almost certainly doomed to fail, with youth accessing what are often easy-to-conceal vaping products with relatively little difficulty through their social networks.
With vapor companies having invested heavily in age verification software, point-of-sale restrictions and in the removal of flavored e-liquids, it would have been a bitter pill to swallow to be told that the regulators had largely ignored those efforts to reduce youth access to their products.
The logic behind the FDA’s decision seems to have been that it would be easier to expedite the large number of premarket tobacco product applications (PMTAs) by adopting a “Fatal Flaw” approach—rejecting those applications that did not present data from either longitudinal customer studies or randomized trial evaluations and simply ignoring what the companies were doing to lessen the likelihood that their products would be found in the hands of youth.
By ruling against the FDA in legal action initiated by six vapor companies that had received marketing denial orders without the FDA even paying attention to their youth sales restriction efforts, the judges have effectively provided vapor companies with a second chance to have their PMTA applications reassessed.
So, what should vapor companies do given the legal victory that has been dropped in their lap? Clearly, it is going to be important for companies to do all they can to restrict youth access to their vapor products. But actions taken by these companies is not the same thing as being able to present evidence to the FDA that their products are not being used by youth.
To this end, research undertaken by the Centre for Substance Use Research (CSUR) in Scotland may help many of the companies concerned. For the last two years, the CSUR has been measuring the prevalence with which over 200 e-cigarette devices are being used by youth and adults within the United States. This ongoing research provides vapor companies with product-specific data showing the extent to which their products are being used, or more crucially, are not being used by youth.
Valuable as the data from this study undoubtedly are, vapor companies also have to be able to show the benefit of their products to adult smokers. The fastest route to obtaining this data is through an actual use study in which adult smokers using a company’s vapor products are monitored over a number of weeks to determine how many smokers are able to quit or reduce their cigarette smoking through using the company’s vapor products.
To obtain a marketing authorization, vapor companies have to be able to show two things—that their products are not being used by youth and that they can help adult smokers in quitting or reducing cigarette consumption. Succeed in these two things and vapor companies can have a bright future. Fail in either one and the future looks a lot bleaker.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.

September 12, 2022
EU to Decide on Swedish Match Deal by Oct. 11

Photo: Berk
European Antitrust regulators will review Philip Morris International’s $16 million bid for Swedish Match by Oct. 11, reports Reuters, citing a Sept. 6 European Commission filing.
At the end of its scrutiny, the EU competition enforcer can clear the deal with or without remedies or it can open a four-month-long investigation if it has serious concerns.
In August, PMI extended the acceptance period for its offer from Sept. 10 to Oct. 21 following indications that the European regulators needed more time to review the proposed takeover.
The multinational says it has already obtained approvals from other prominent regulators, including those in the United States and Brazil.
September 8, 2022