Category: Regulation

Shaking off the Shackles

Photo: prakasit khuansuwan/EyeEm
The Philippines is rebuffing outside forces seeking to derail its tobacco harm reduction policies.
By Stefanie Rossel
The Philippines is about to become the first country in the Asia-Pacific region to introduce risk-proportionate vaping legislation. By doing so, it is defying the World Health Organization, which has been skeptical about tobacco harm reduction (THR). The Philippines is part of a small group of nations that have started scrutinizing the influence of big WHO donors on national tobacco control policies.
In December 2020, two Filipino congressmen called for a congressional investigation into the Philippines Food and Drug Administration’s (PFDA) acceptance of funding from the International Union Against Tuberculosis and Lung Disease, which is popularly known as The Union. The Union is a major beneficiary of Bloomberg Philanthropies, a foundation created by U.S. billionaire Michael Bloomberg, that is known for its anti-vaping agenda. By accepting funding from Bloomberg, the representatives argued, the PFDA violated a number of critical regulations in the public sector. These include the Anti-Graft and Corrupt Practices Act, the Code of Conduct and Ethical Standards for Public Officials and Employees, the Tobacco Regulation Act, the Lobbying Act and the Foreign Agents Registration Act. The PFDA’s director general had previously admitted during a public hearing that the agency had received more than $150,000 from The Union, essentially to hire employees to outline the Philippines’s tobacco control policy.
Since 2006, Bloomberg Philanthropies has invested $1.1 billion to advocate for tobacco control policies worldwide. These policies are largely based on MPOWER, a set of demand-reduction strategies derived from the WHO Framework Convention on Tobacco Control (FCTC). A substantial portion of Bloomberg Philanthropies’ work has advanced tobacco control in many countries. However, support for adult smokers to quit—a component of MPOWER—has been completely ignored by the organization and its partners, according to Derek Yach, founder and president of the Foundation for a Smoke-Free World (FSFW). “These organizations see THR as a ploy of the tobacco transnationals,” he says. “With this perception, they ignore the vast benefits of THR and its potential to end smoking in this generation.”
Bloomberg Philanthropies and its partners are not investing to develop research and capacity in low-income and middle-income countries (LMICs) on THR and the safety of associated products, notes Yach. “By continuing to ignore the growing evidence, including from the Royal College of Physicians, showing e-cigarettes and other reduced-risk products are much less harmful than combustibles, Bloomberg and others are impeding important progress in the fight to end smoking,” he says.
Far-Reaching Influence
Around 80 percent of the more than 5 trillion cigarettes smoked globally each year are consumed in LMICs. By its own reckoning, Bloomberg Philanthropies is present in 110 LMICs through its Bloomberg Initiative to Reduce Tobacco Use. These include India and China, which together account for nearly 40 percent of the world’s smokers. The initiative, Bloomberg Philanthropies claims on its website, “is helping cities and countries implement measures that are proven to reduce [tobacco] use and protect people from harm.”
Michelle Minton
The initiative’s influence extends through all levels of society, media and government. According to an analysis by Michelle Minton, senior fellow at the Competitive Enterprise Institute (CEI), it seems to be aimed at imposing its will on the developing world. Minton’s findings are based on a leaked document obtained by CEI, which detailed the 2017 LMIC strategy of the Campaign for Tobacco-Free Kids (CTFK), Bloomberg Philanthropies’ largest beneficiary. The CTFK is part of a complex network of Bloomberg Philanthropies-funded organizations, all of which pursue a zero-tolerance approach to all tobacco use.
For these organizations, the term “tobacco” includes reduced-risk products (RRPs)—essentially, anything containing nicotine that is not a pharmaceutical nicotine replacement-therapy product. The CTFK has attempted to influence political processes and key players in various countries with the help of partnerships and often financial collaborations with activists, think tanks, professional associations, media, universities and governments. According to Minton, the CTFK and its grantees pay to manipulate news coverage. She calls the CTFK’s strategy “a highly synchronized chorus of interdependent interest, coordinated from afar.”
Lacking the funds to conduct their own THR research, most LMICs follow the WHO’s guidelines unquestioningly. In recent years, their delegates have continued to confirm the WHO’s anti-THR stance during the FCTC Conference of the Parties (COP) sessions. The next summit, COP9, which was postponed due to Covid-19, will now take place in November 2021 and presents another opportunity for delegates to make a change.
The influence of Bloomberg and his fellow WHO sponsor, Bill Gates, has also been brought to light by a number of recent articles. A study by Mitsuru Mukaigawara et al., published by Wellcome Open Research, examines the extensive use of media and academic influence by Bloomberg and the Gates Foundation to drive the global tobacco control agenda. “Highlighted by their influence over the World Bank and WHO, the authors show that the two organizations have been able to create a multilayered approach that touches many of the key stakeholders and undermines national sovereignty in tobacco control,” Yach explains. “Their broad and tight grip on various tobacco control activities will be tough to overcome. What may well happen, though, is that the weight of scientific evidence favoring THR will in time break through into the corridors of future WHO COP sessions.”

Due to the travel restrictions, the ninth Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control will be a virtual event. Discussions about tobacco harm reduction have essentially been tabled until COP10 in 2023. (Photo: olrat)
THR Discussions Postponed
Yach is less optimistic that such evidence will change minds among participants in the upcoming COP. “Unfortunately, due to the travel restrictions, FCTC-COP9 will be a virtual event with limited technical discussions, essentially tabling THR discussions until COP10 in 2023,” he says. “Even before this announcement, the WHO’s lack of transparency in its reports on novel products reveals a prohibitionist stance on THR.”
Over the past decade, Yach observes, media access to the FCTC has been constrained, and documents are published by the secretariat without formal member state input. “In fact, for the upcoming COP9 meeting, documents containing serious implications for THR are presented to be ‘noted’ without being subject to the usual United Nations practice of being thoroughly discussed and revised,” he says. “Many LMICs may well be persuaded by Bloomberg grantees to go ahead with bans and prohibitions of THR products supported or encouraged by WHO documents. These decisions will undermine the long-term health of their smokers.”
Derek Yach
In the run-up to the conference, the FSFW has started a campaign to inform COP9 delegates on the potential of THR. “Our goal is simple: Ensure that all involved directly or in advisory roles to member states engaged in COP9 are equipped with the best scientific data and information,” says Yach.
The FSFW’s new Commission Report: Reignite the Fight Against Smoking, created by an international team of experts, highlights the opportunities to reduce the death and disease caused by smoking through use of THR and, in time, more effective cessation, Yach says. “The report provides member states with up-to-date data and insights about the value of innovation in driving changes in some companies. It spotlights which countries are making the most progress and which are badly lagging.” The report also highlights the need for doctors to take a more supportive role in advancing use of cessation and THR in LMICs, and the need for industry to be more aggressive in addressing youth access and marketing, according to Yach.
The Commission Report, available at www.fightagainstsmoking.org, is complemented by the Patent Landscape Report, which is available on the FSFW website and presents an overview of current patents for THR technologies. “The FCTC failed to recognize importance of intellectual property and technological innovation,” says Yach. “Both are now driving change in the industry and further exacerbating the advantages developed countries have over LMICS as patenting activities in developing and least-developed countries are not comparable to those in the developed world.”
Progressive Stance
The Philippines is not the first country to reject the influence of Bloomberg Philanthropies on its tobacco control policies. In 2017, the government of India prevented two not-for-profit organizations funded by Bloomberg Philanthropies from carrying out tobacco control work in New Delhi after they failed to disclose their financial backers. In March 2021, a Mexican activist revealed that a proposal to prohibit the import, distribution and sale of vaping products had been formulated by CTFK’s legal advisor for Latin America.
THR proponents hope that the Philippines will become a model for other Asia-Pacific countries where smoking prevalence is high and RRPs are currently either banned or restricted. After years of opposition to RRPs, the Philippine House of Representatives in early 2021 proposed House Bill 9007, which will regulate electronic nicotine-delivery systems (ENDS). If approved, the Philippines Department of Trade and Industry, in consultation with the PFDA, will be assigned oversight of ENDS regulation.
Among other things, the bill stipulates that only retailers will be allowed to sell electronic nonnicotine delivery products and heated-tobacco products (HTPs). Retailers will be required to check buyers for a valid government-issued ID. Manufacturers, importers and distributors will need to comply with certain packaging and health requirements. Use of RRPs will be allowed only in designated areas, and the sale or distribution of these products will be prohibited within 100 meters of schools, playgrounds and other facilities frequented by minors. (Currently, the minimum age for purchase of ENDS and HTPs in the Philippines is 21.) Bill 9007 passed the House in May with a comfortable majority of votes; the Senate was expected to vote on it this fall.
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

October 1, 2021
Morocco Sets Cigarette Emission Limits

Photo: nikkytok
Cigarettes sold in Morocco will be subject to new emission limits starting in January 2024, reports Morocco World News.
From that date, the emissions of cigarettes imported or manufactured in Morocco and marketed across the country should be at levels not exceeding 10 mg of tar per cigarette, 1 mg of nicotine per cigarette and 10 mg of carbon monoxide per cigarette.
Tobacco companies will be required to declare clear the deliveries on cigarette packages.
The percentages of tar, nicotine and carbon monoxide are measured on the basis of NM ISO 4387 standards for tar, NM ISO 10315 for nicotine and NM ISO 8454 for carbon monoxide. The accuracy of the percentages of tar and nicotine is verified according to the standard NM ISO 8243.
Compliance will be monitored by the Department of Customs and Indirect Taxes. The primary objective of the decree is to align national legislation with international standards.
An estimated 18 percent of Moroccans aged 15 smoke, with nearly 41 percent of the country’s population exposed to secondhand smoke.
September 29, 2021
FDA Issues More Marketing Denial Orders

Photo: pololia
The U.S. Food and Drug Administration has updated its list of marketing denial orders (MDO). The latest round of denials includes products from prominent players such as Turning Points Brands, Humble Juice Co., Beard Vape Co. and Avail Vapor.
As of Sept. 17, 2021, the agency has issued a total of 295 MDOs for more than 1,089,000 flavored electronic nicotine-delivery system (ENDS) products. The move has sent shockwaves through the industry and crippled many vapor industry businesses, ranging from prominent players to small business owners. All of the MDOs were for flavored e-liquids that were not either tobacco or menthol flavors.
The letters are straightforward, according to James Xu, founder of Avail Vapor. “It just says you failed to demonstrate in your application for a flavored [electronic nicotine-delivery system] ENDS product [that the benefits] outweigh the known risks of youth appeal,” Xu told Tobacco Reporter’s sister publication, Vapor Voice. “Then it goes on to say that it can be corrected with some form of a randomized controlled trial or longitudinal cohort studies that the FDA had previously stated weren’t required.”
Industry experts believe the FDA will approve only tobacco and menthol flavors, most expected to be in closed system formats. The FDA has yet to decide on the marketing applications of market leaders such as Juul, Logic, Vuse and Blu.
Many companies are moving toward using synthetic nicotine in their products in hopes to avoid current FDA regulations. Synthetic nicotine is a legal gray area. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”
Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.
September 20, 2021
In the Lurch

Photo: ltummy
By Paul Hardman
Electronic nicotine-delivery system (ENDS) companies in the U.S. have found themselves in limbo following the FDA’s recent statement on the regulation of e-cigarette products.
The long-awaited deadline for the review of manufacturers’ premarket tobacco product applications (PMTAs) was somewhat of an anticlimax, leaving many none the wiser as to whether they could continue to sell their products.
The result left company executives frustrated—and in a predicament when it comes to their responsibilities to public health versus their legal obligations.
The lead-up to Sept. 9, 2021, saw companies that had submitted PMTAs given a year’s grace to continue to sell their products until a decision on their future could be taken.
For many, that decision is yet to materialize, with the FDA announcing it had not managed to get through the sheer volume of applications received by the court-imposed deadline.
So, what has the FDA done? Its statement said that as of Sept. 8, the organization had completed acceptance review for all of the applications and completed filing review for about 90 percent of applications submitted by the Sept. 9, 2020, deadline.
Many of these applications were ultimately knocked back at the first hurdle, receiving a refuse to file (RTF) letter at the filing stage due to missing some of the required information, with 4.5 million products receiving refusal to file from just one company’s application. The FDA said this included the lack of ingredient listings, labels for each product and adequate environmental assessments.
As of Sept. 8, the FDA said it had issued substantial equivalence (SE) marketing orders covering more than 120 (non-ENDS) products and exemption from substantial equivalence requests marketing orders covering more than 230 products. Some companies had bad news in the form of the first marketing denial orders (MDOs), which were issued on Aug. 26 for about 55,000 flavored products. The FDA’s responsibility is with public health, weighing the potential benefits for adult smokers of using ENDS products to wean themselves off cigarettes against the potential appeal to teenagers or new users who may go straight to ENDS, potentially attracted by flavored varieties.
These companies will now have to remove their products from shelves or risk enforcement action. With limited resources, the FDA has suggested it will prioritize the enforcement of those that have received MDOs as well as products with no pending application while processing the backlog of applications and any new PMTAs.
That leaves a quandary for those who submitted their applications by the Sept. 9, 2020, deadline but who haven’t yet received an MDO. They can effectively continue to sell their products as no ruling has been made on them; however, the FDA has made it clear that any company that does continue to sell these products will be doing so unlawfully, although it is clear that they are not likely to face any enforcement action.
And there lies the difficult part. Many of these companies cleaned up their acts in recent years, putting in place codes of conduct setting out their ultimate aims of improving public health through promoting the replacement of combustible tobacco. If those that have submitted PMTAs have demonstrated and believe that their products are doing good in the world, then to follow the letter of the law by removing their products from shelves could potentially harm users by pointing them back in the direction of cigarettes—going against their codes.
That brings them to a decision between their obligations to the law and their responsibilities to the overall safety of users. The naysayers may suggest these manufacturers are putting profits first, but, as an extreme example, if all the companies out there decided to take their products off the market, there would ultimately be limited choices for users, which may make a return to tobacco an attractive prospect for them. There is also a risk that some may choose to fly under the radar by turning to the black market to sell their products.
Companies must decide whether they take a chance and wait for the FDA to take enforcement action against them.
One positive for ENDS companies from the statement is that the reason given for some of the MDOs was not that they were necessarily worse for health than cigarettes, but that the application lacked sufficient evidence provided within the submission. We know that the FDA is very much open to ENDS products having the potential to protect public health. I am sure that, with adequate evidence resubmitted, many of these products will receive marketing orders in time.
This is where specialized companies, such as Broughton Nicotine Services, can assist, working with businesses to provide the evidence needed to complete this process. The FDA’s delay in processing applications provides an opportunity, too, to those companies whose PMTAs have not yet reached the substantive review stage. There is still time to bolster an application that has yet to reach this stage if you believe additional evidence would be beneficial—but time is of the essence.
The PMTA process, as is evident, is complex, perhaps favoring the larger companies with the resources to navigate the system and submit detailed information. Juul Labs, for example, was able to take action by reducing its products to only tobacco and menthol flavors, removing fruit options from the market, yet we are still to hear the outcome of their application.
The next step will be to discover how frequently the FDA plans to announce the results of PMTAs. My preference would be monthly to ensure ENDS companies and the industry feel a little less in the lurch.
FDA Postpones Decisions on High-Profile Marketing Applications
The much anticipated deadline for the U.S. Food and Drug Administration to decide on millions of premarket tobacco product applications (PMTAs) passed without bringing the clarity about the future of tobacco harm reduction that many health advocates and industry representatives had hoped for.
On Sept. 9, the agency issued marketing denial orders (MDOs) to more than 130 companies requiring them to pull an estimated 946,000 products from the market. However, despite a court order to complete the PMTA review process by that date, the FDA failed to make decisions on some of the bestselling vapor products on the U.S. market.
There were no updates on high-profile submissions, such as those submitted by Juul Labs, Reynolds American Inc. and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” acting FDA Commissioner Janet Woodcock and FDA Center for Tobacco Products Director Mitch Zeller wrote in a joint statement.
Interestingly, the agency saw fit to issue marketing orders for more than 350 combustible tobacco products under the standard equivalency pathway, many of which, hookah tobacco for example, are flavored tobacco products. All of the issued MDOs were for flavored electronic nicotine-delivery systems (ENDS) products.
“This looks like being a public health own-goal of historic proportions,” Jonathan Foulds, professor of public health sciences and psychiatry at the Penn State University College of Medicine, wrote on Twitter. “Will be interesting to see whether the stock value of cigarette manufacturers goes up.”
Amanda Wheeler, president of the American Vapor Manufacturers Association, noted that the FDA ruling criminalizes thousands of longstanding businesses across the United States. “Those entrepreneurs have to junk their inventories, fire their employees and stiff their investors,” she said during the recent GTNF conference in London.
Vuse owner BAT, for its part, was sanguine. “We remain confident in the quality of our applications, which are supported by scientific evidence that our Vuse and Velo products are appropriate for the protection of public health,” the company wrote in a statement.
Vapor industry representatives have long complained that the PMTA system favors big players. In 2019 court filings, the Vapor Technology Association noted the expenses greatly exceeded the $300,000 to $500,000 per product that the FDA estimated in its regulatory impact analysis. Such a burden, say critics, can be borne only by the best-resourced players—i.e., the established tobacco companies.
Meanwhile, MDO recipients have started looking for ways to continue serving their customers, with some of them turning to synthetic nicotine. The FDA currently defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”
Whether the FDA will allow products with synthetic nicotine to remain on the market remains to be seen. Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, suggested that as more vapor companies move in this direction, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.
How the ENDS market will evolve from here is anyone’s guess. Since the Sept. 9 deadline, the FDA has continued issuing MDOs, including to products submitted by prominent companies such as Turning Point Brands, Avail Vapor and Bidi Vapor. At press time, the number of MDOs exceeded 1.16 million products from 323 companies.
A big question is whether the agency will grant marketing orders to the applications submitted by the market leaders. Previously, the FDA had indicated it would prioritize those products because doing so would have the greatest impact on the market. Even in the wake of substantial share losses, Juul alone still accounts for 40 percent of the U.S. vaping market.
Whatever happens, the FDA is certain to catch flak from industry critics and vapor companies alike. At GTNF, Wheeler announced a public campaign. “We will be at FDA’s doorstep demanding answers or forcing them through freedom-of-information laws and in the courts,” she said. “We are not going to sit still while the FDA endangers our health, crushes our livelihoods and treats the American people like gullible idiots.”
The Campaign for Tobacco-Free Kids (CTFK), which helped set the Sept. 20, 2021, deadline through litigation, hinted it might resume legal action to have the court enforce its order requiring the FDA to begin to remove unauthorized products.
“While FDA has said it has ruled on 93 percent of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic,” said CTFK President Matthew Myers. “Every day those products remain on the market, our kids remain in jeopardy.”
Paul Hardman is head of scientific affairs at Broughton Nicotine Services.

September 17, 2021
New Tobacco Retailer Webinars Available
The U.S. Food and Drug Administration Center for Tobacco Products has published two new tobacco compliance webinars—one on the Office of Small Business Assistance (OSBA) and one providing an overview of warning letters for online retailers.
The first webinar provides tobacco retailers, manufacturers and stakeholders with information about the OSBA, including the office’s free online resources and how to submit tobacco-related questions to the OSBA.
The “Overview of Warning Letters for Online Retailers” webinar outlines the FDA’s internet and publication surveillance. It provides information such as why online retailers might receive warning letters and how online retailers should respond to the FDA’s warning letters.
September 17, 2021
Marketing Denial Order for Turning Point Brands

Turning Point Brands (TPB) received a marketing denial order (MDO) from the U.S. Food and Drug Administration in response to a premarket tobacco product application (PMTA) covering certain of the company’s vapor products.
In a press note, the company said it stands behind the high quality of its PMTA, which it believes established that the products’ continued marketing would be “appropriate for the protection of public health,” the standard established by the Family Smoking Prevention and Tobacco Control Act of 2009. “These products are crucial to improving public health by helping adult smokers migrate to less harmful products,” the company wrote. “TPB will continue to engage with the FDA and other stakeholders as we consider options moving forward, including a formal appeal of the decision and potential legal relief.”
The PMTA denied by this MDO included an in-depth toxicological review, a clinical study and studies on patterns and likelihood of use. According to TPB, the data demonstrated that TPB products do not appeal to never-users, youth or former users and that a significant majority of users of TPB products had completely ceased use of combustible cigarettes. “The scientific literature on lower risk nicotine-delivery systems shows that these products can significantly improve public health by providing alternatives that are much less harmful than combustible cigarettes,” the company stated.
“While we believe the FDA’s current conclusion is misguided, we will continue our dialogue with the agency in search of a path forward,” said Larry Wexler, president and CEO of Turning Point Brands. “As we explore options for appealing this decision, we are hopeful that the agency reaffirms its commitment to science-based decision-making and to its announced Comprehensive Plan, which includes fully transitioning adult consumers down the continuum of risk in order to reduce the morbidity and mortality associated with combustible cigarette use by preserving the diverse vapor market.”
The company says it continues to monitor regulatory developments and intends to take appropriate measures to manage and mitigate any risk exposure that may result from these and any future MDOs.
September 17, 2021
Iowa AG Worried About FDA Marketing Denials
Tom Miller
Iowa Attorney General Tom Miller has expressed unease about the U.S. Food and Drug Administration’s Sept. 9 decision to deny large numbers of e-cigarettes access to the marketplace.
“We are concerned about the impact of the FDA’s actions, particularly the unintended consequences of pulling from the market less harmful alternatives to cigarettes,” Miller wrote in a statement. “We believe the best information available indicates that most youths are not getting e-cigarettes from vape shops and that a significant number of adults are using products from vape shops to move away from combustible cigarettes.
“Let’s not forget the overwhelming risk to public health: The CDC estimates the burden of tobacco use in the United States is 480,000 lives a year, all of which is due to the use of cigarettes.
“We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policymakers must strike the right balance between making accessible potentially lifesaving lower risk nicotine products while discouraging use by those who wouldn’t smoke, especially youth.”
On Sept. 9, the FDA issued marketing denial orders to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The next day, the agency denied another set of applications, bringing the total to 946,000 products and 168 companies.
The regulatory agency released a revised list of MDOs that includes 125 company names but not any specific products that were denied.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
September 13, 2021
FDA Issues Another Round of Denial Orders

Photo: Surendra
The U.S. Food and Drug Administration has now issued 168 companies marketing denial orders (MDOs) for an estimated 992,000 products. According to a press release, the regulatory agency on Sept. 10 released a revised list of MDOs that includes 125 company names but not any specific products that were denied.
“Several of the MDOs were issued to companies that are not confirmed to be currently marketing their products. To protect confidential commercial information (CCI), we cannot release additional information about those actions,” the agency stated.
On Sept 9, the FDA announced it had issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. There were no updates provided on several high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” the agency wrote in its announcement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
September 13, 2021
States Urged to Act Absent Action on Majors

Photo: steheap
The Campaign for Tobacco-Free Kids (CTFK) is urging U.S. states and cities to step up their efforts to eliminate all flavored nicotine products, including e-cigarettes, in the wake of the Food and Drug Administration’s failure to rule on the premarket tobacco product applications (PMTAs) of market leaders Juul, Vuse, NJOY, Blu and Logic by yesterday’s deadline.
On Sept. 9, the FDA announced it had denied market access to nearly 1 million electronic nicotine-delivery devices owned primarily by smaller vapor companies. At the same time, the agency indicated it would require more time to process the remaining PMTAs, including those submitted by Juul Labs, BAT, NJOY, Imperial Brands and Japan Tobacco International, which account for the lion’s share of U.S. e-cigarette sales. Juul alone has a U.S. market share of more than 40 percent.
“The FDA will leave our kids at risk unless it acts quickly on the remaining applications, including for products like Juul that have driven the youth e-cigarette epidemic, and eliminates all flavored e-cigarettes, including menthol-flavored products that are widely used by kids,” wrote CTFK President Matthew L. Myers in a statement. “Every day these products remain on the market, our kids remain in jeopardy.”
The FDA’s failure to act on the market leaders is remarkable given that the agency had previously indicated it would prioritize those brands while processing marketing applications. Decisions on the best-selling brands would likely have the greatest impact on public health, the agency explained in earlier communications. The failure also raises legal questions, considering that the Sept. 9 deadline was ordered by a court following litigation from public health groups, including the CTFK.
The CTFK indicated if the FDA does not decide on major applications soon, it would return to court to have the court enforce its order requiring the FDA to begin removing unauthorized products.
September 10, 2021
No Clarity for Top Brands at FDA Deadline

Photo: Araki Illustrations
The much-anticipated deadline for the U.S. Food and Drug Administration to decide on millions of premarket tobacco product applications (PMTAs) passed without bringing the clarity about the future of tobacco harm reduction that many health advocates and industry representatives had hoped for.
On Sept. 9, the agency issued marketing denial orders (MDOs) to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. However, despite a court order to complete the PMTA review process by that date, the FDA failed to make decisions on some of the best-selling vapor products on the U.S. market.
There were no updates on high-profile submissions, such as those submitted by Juul Labs, BAT and Japan Tobacco International. The agency also offered no response to any submitted open-system hardware products or tobacco-flavored e-liquids.
“We continue to work expeditiously on the remaining applications that were submitted by the court’s Sept. 9, 2020, deadline, many of which are in the final stages of review,” acting FDA Commissioner Janet Woodcock and FDA Center for Tobacco Products Director Mitch Zeller wrote in a joint statement. “For premarket tobacco product applications, our responsibility is to assess whether applicants meet the applicable statutory standard for marketing their new products. As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
Interestingly, the agency saw fit to issue marketing orders for more than 350 combustible tobacco products under the standard equivalency pathway, many of which, hookah tobacco for example, are flavored tobacco products. All of the issued MDOs were for flavored electronic nicotine-delivery system products.
The FDA’s announcement baffled health advocates and vapor industry representatives alike.
“This looks like being a public health own-goal of historic proportions,” Jonathan Foulds, professor of public health sciences and psychiatry at the Penn State University College of Medicine, wrote on Twitter. “Will be interesting to see whether the stock value of cigarette manufacturers goes up.”
“I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized,” echoed Greg Conley, president of the American Vaping Association. “But to see them likely get more time from @FDATobacco after good small businesses spent the last month getting wrecked … Just wrong.”
Vuse owner BAT, for its part, was sanguine. “We remain confident in the quality of our applications, which are supported by scientific evidence that our Vuse and Velo products are appropriate for the protection of public health,” the company wrote in a statement. “In addition, we believe that these categories of important, innovative products may be potentially less harmful than traditional tobacco products.”
Vapor industry representatives have long complained that the PMTA system favors big players. In 2019 court filings, the Vapor Technology Association noted the expenses greatly exceeded the $300,000 to $500,000 per product the FDA estimated in its regulatory impact analysis. Such a burden, say critics, can be borne only by the best-resourced players—i.e., the established tobacco companies. As a result, the products denied market access on Sept. 9 are unlikely to have been rejected because they present a greater health risk than any approved products. Rather, they failed because their manufacturers were unable to navigate the FDA’s complex and costly system.
Meanwhile, the Campaign for Tobacco-Free Kids (CTFK), which helped set the Sept. 20, 2021, deadline through litigation, hinted it might resume legal action to have the court enforce its order requiring the FDA to begin to remove unauthorized products.
“While FDA has said it has ruled on 93 percent of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic,” said CTFK President Matthew Myers. “Every day those products remain on the market, our kids remain in jeopardy.”
September 9, 2021