The U.S. Food and Drug Administration (FDA) today opened a public comment period on Philip Morris International’s application seeking authorization to market the IQOS 3 electrically heated tobacco system as a modified risk tobacco product (MRTP).
PMI’s application requests the same reduced exposure modification orders granted on July 7, 2020, for the IQOS 2.4 system—the first, and only, electronic nicotine product to be granted marketing orders through the FDA’s MRTP process. To authorize MRTP consumer communications, the FDA’s Center for Tobacco Products is required by law to conclude that a product is appropriate to promote the public health.
The IQOS 3 device contains a number of technological advancements, compared to the IQOS 2.4 device, including longer battery life and quicker recharge between uses. It was authorized for sale in the U.S. via the FDA’s pre-market review process on Dec. 7, 2020, having met the standard that permitting its sale is appropriate to protect public health.
This application underscores PMI’s ongoing commitment to make new innovations available to American adult smokers through the FDA process.
“PMI is fully committed to a smoke-free future, one where we completely replace cigarettes with scientifically substantiated smoke-free alternatives that are a better choice for adults who would otherwise continue smoking,” said PMI CEO Jacek Olczak.
“Our commitment to a science-based future is unmatched, having invested more than $8 billion since 2008 on smoke-free products. This application underscores PMI’s ongoing commitment to make new innovations available to American adult smokers through the FDA process; the confidence we have in our science; and our belief that public scrutiny and open engagement with governments is vital to achieving a smoke-free future.”
The U.S. Food and Drug Administration Center for Tobacco Products (CTP) will host a virtual meeting June 11 from 13:00 to 15:30 Eastern Daylight Time. The meeting will discuss the scientific review of tobacco marketing applications received by Sept. 9, 2020. It will focus on the application intake process, review progress and allocation of review resources. There will be time allotted for audience questions as well.
Matt Holman
The meeting will feature a presentation from CTP Office of Science Director Matt Holman and include a question-and-answer session. Other Office of Science staff participating in the meeting include Todd L. Cecil, deputy director for regulatory management; Crystal Allard, director for the division of regulatory science and informatics; Joanna C. Randazzo, D.C., acting chief for the science policy branch; and Cristi Stark, director of the division of regulatory project management.
The CTP Office of Science is responsible for identifying, developing and enhancing the science related to tobacco products, their use, and the resulting morbidity and mortality so that regulatory decisions will have the greatest impact on improving public health.
The Office of Science provides the scientific support for regulations and guidance, reviews tobacco product applications, evaluates the knowledge basis for regulatory decisions and carries out research to fill the gaps in scientific knowledge related to tobacco product regulation.
The agency isn’t slowing down. In the U.S. Food and Drug Administration’s (FDA) quest to relieve the market of illegal vapor products, the regulatory agency has issued 104 warning letters since Jan. 1, 2021. The latest recipient is Texas-based The Smoker’s Alternative. The letters were sent today May, 11, and posted the FDA’s website the same day.
The FDA states that The Smoker’s Alternative did “manufacture, sell, and/or distribute to customers in the United States The Smoker’s Alternative Vanilla Custard 60 ml 3mg e-liquid product without a marketing authorization order.” In order to legally sell vaping products, a company must have submitted a premarket tobacco product authorization (PMTA) to the FDA’s Center for Tobacco Products by Sept. 9, 2020.
The FDA often only lists a product or two that a company is selling as illegal. 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 have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
:Your firm is a registered manufacturer with over 1,800 products listed with FDA,” the FDA letter to The Smoker’s Alternative states. “It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.”
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.
Since Jan. 1, 2021, the U.S. Food and Drug Administration (FDA) has issued a total of 103 warning letters to firms selling or distributing over 904,000 unauthorized vaping products and who did not submit premarket tobacco product applications (PMTAs) by the Sept. 9 deadline.
Credit: Marcus Krauss
In April alone, the regulatory agency issued a total of 24 warning letters to companies that manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S. While each of these 24 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 154,000 products with the FDA, according to an FDA statement.
The 103rd warning letter was issued on March 6 and posted to the FDA’s website on the same day. The 103rd letter was received Mississippi-based Custom Vapes. The FDA states that the company did “manufacture, sell, and/or distribute to customers in the United States Custom Vapes Amaretto 3MG 3ML 70VG/30PG e-liquid product without a marketing authorization order.” The company is a registered manufacturer with over 2,300 products listed with the regulatory agency.
Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products.
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.
It is now at 102 in 2021. Posting on its website on April 30 that it has issued six more warning letters to companies for marketing illegal e-liquids, the U.S. Food and Drug Administration (FDA) continues its blitz to pull any vaping products from the U.S. market that haven’t submitted a premarket tobacco product application (PMTA) to the FDA’s Center for Tobacco Products.
Credit: Yuri Hoyda
Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. 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 companies receiving the letters on April 9, the products they were cited for and the number of products each has registered with the FDA include:
Smoking Fire Vapor: e-liquid products without a marketing authorization order including: Smokin’ Fire Vapor Captain Custard and Smokin’ Fire Vapor Wrecking Ball; registered manufacturer with over 180 products listed with FDA.
Simply E-Juice: e-liquid without a marketing authorization order including: Simply Bodacious Blueberry and Simply Glorious Grape; registered manufacturer with over 200 products listed with FDA.
Smokecignals: e-liquid products without a marketing authorization order including: Blue Puppet and Black Frost; registered manufacturer with over 100 products listed with FDA.
Rocky Top Vapor: e-liquid products without a marketing authorization order including: RTV LTD Berry Shake and RTV LTD Pink Lemonade; registered manufacturer with over 470 products listed with FDA.
VaporBombCOM: e-liquid products without a marketing authorization order including VaporBomb.com: Cafe Mocha and Cinnamon Danish Swirl; a registered manufacturer with over 2,200 listed with FDA.
B-X Vapor: e-liquid products without a marketing authorization order including: B-X Vapor Dad’s Milk and B-X Vapor Watermelon Crack; registered manufacturer with over 1,100 products listed with FDA.
The regulatory agency has now issued warning letters to 102 companies in 2021 for violating PMTA rules. 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.
In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.
The U.S. Food and Drug Administration has stated its intent to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors (including menthol) in cigars. In a statement released today, the agency said it is working toward issuing proposed product standards within the next year. The plan does not include noncombustible products, such as e-cigarettes.
“This decision is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important previous actions that banned other flavored cigarettes in 2009,” the FDA wrote in its press release.
“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” said acting FDA Commissioner Janet Woodcock.
“With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers and address health disparities experienced by communities of color, low-income populations and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.”
According to the FDA, there is strong evidence that a menthol ban will help people quit. “Studies show that menthol increases the appeal of tobacco and facilitates progression to regular smoking, particularly among youth and young adults,” the agency stated. “Menthol masks unpleasant flavors and harshness of tobacco products, making them easier to start using. Tobacco products with menthol can also be more addictive and harder to quit by enhancing the effects of nicotine.”
One study cited by the FDA suggests that banning menthol cigarettes in the U.S. would lead an additional 923,000 smokers to quit, including 230,000 Black Americans in the first 13 to 17 months after a ban goes into effect. An earlier study projected that about 633,000 deaths would be averted, including about 237,000 deaths of Black Americans.
These flavor standards would reduce cigarette and cigar initiation and use, reduce health disparities and promote health equity by addressing a significant and disparate source of harm.
“For far too long, certain populations, including African Americans, have been targeted and disproportionately impacted by tobacco use. Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
“These flavor standards would reduce cigarette and cigar initiation and use, reduce health disparities and promote health equity by addressing a significant and disparate source of harm. Taken together, these policies will help save lives and improve the public health of our country as we confront the leading cause of preventable disease and death.”
The FDA stressed that, if implemented, enforcement of any ban on menthol cigarettes and all flavored cigars will address only manufacturers, distributors, wholesalers, importers and retailers. “The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product,” the agency stated.
Racial justice groups have expressed concern that by outlawing menthols, the FDA would set the stage for more negative interactions between law enforcement and people of color, who smoke a disproportionate share of menthol cigarettes.
Earlier this week, the National Newspaper Publishers Association (NNPA), representing more than 200 African American-owned community newspapers from around the United States, and leading Black and Hispanic law enforcement executives, too, sent a letter urging the FDA to keep menthol cigarettes legal.
In acting on menthol, the FDA granted a citizen’s petition requesting that the agency pursue rulemaking to prohibit menthol in cigarettes, affirming its commitment to proposing such a product standard.
The 2009 Tobacco Control Act (TCA) did not include menthol in its ban on characterizing flavors in cigarettes, leaving menthol cigarettes as the only flavored combusted cigarettes still marketed in the U.S. The law instructed the FDA to further consider the issue of menthol in cigarettes.
Since then, the FDA sought input from an independent advisory committee as required by the TCA, and further demonstrated its interest by issuing an Advance Notice of Proposed Rulemaking, undertaking an independent evaluation and supporting broader research efforts—all to better understand the differences between menthol and nonmenthol cigarettes and the impact of menthol on population health.
In the U.S., it is estimated that there are nearly 18.6 million current smokers of menthol cigarettes. But use of menthol cigarettes among smokers is not uniform: Out of all Black smokers, nearly 85 percent smoke menthol cigarettes compared to 30 percent of white smokers who smoke menthols. In addition, among youth, from 2011 to 2018, declines in menthol cigarette use were observed among non-Hispanic white youth but not among non-Hispanic Black or Hispanic youth.
After the 2009 statutory ban on flavors in cigarettes other than menthol, use of flavored cigars increased dramatically, suggesting that the public health goals of the flavored cigarette ban may have been undermined by continued availability of these flavored cigars, according to the FDA.
Flavored mass-produced cigars and cigarillos can closely resemble cigarettes, pose many of the same public health problems and are disproportionately popular among youth and other populations. In 2020, non-Hispanic Black high school students reported past 30-day cigar smoking at levels twice as high as their white counterparts.
Nearly 74 percent of youth aged 12 to 17 who use cigars say they smoke cigars because they come in flavors they enjoy, according to the FDA. Among youth who have ever tried a cigar, 68 percent of cigarillo users and 56 percent of filtered cigar users report that their first cigar was a flavored product. Moreover, in 2020, more young people tried a cigar every day than the number of young people who tried a cigarette.
Pamela Kaufman
Pamela Kaufman and Sanath Sudarsan of Morgan Stanley said that while the absence of a proposed rule in today’s statement was “somewhat better than the market had feared,” the FDA’s plan is likely to remain an overhang for the sector. They also noted the agency did not indicate plans to ban menthol in noncombustible products such as e-cigarettes, heat-not-burn products and nicotine pouches, which could help incentivize smokers to move away from cigarettes and toward reduced-risk alternatives.
Menthol regulation will have to follow the FDA’s multi-step/multi-year rulemaking process. The next step is a preliminary rule that would be subject to a comment and review period, typically lasting 90 days. The FDA would then review stakeholder responses and publish a final rule, which would require review from the Department of Health and Human Services and the Office of Management and Budget. Once a rule is finalized, the industry would have additional time to implement the change.
Kaufman and Sudarsan expect the tobacco industry to challenge a final rule, questioning its scientific basis and stressing the risk of creating an illicit market for menthol cigarettes.
Four more companies have received warning letters for violating marketing orders for the sale of e-liquids. The U.S. Food and Drug Administration (FDA) says the companies failed to submit a premarket tobacco product applications (PMTA) by the Sept. 9, 2020 deadline. The regulatory agency posted the letters to RP Vapor, DIY Vapor Supply, Electric Freedom (Crown7) and KV Liquids were received on April 23 and posted to the FDA website on April 27.
RP Vapor has over 4,600 products listed with the FDA. DIY Vapor Supply is the registered manufacturer for over 73,300 products listed with FDA. Electric Freedom has over 80 products listed with the FDA, while KV Liquids has more than 300. The FDA states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter. This means that the company may or may not have submitted a PMTA for some of its registered products.
The regulatory agency has now issued warning letters to 96 companies in 2021 for violating PMTA rules. 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.
In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.
Beard Management announced that its premarket tobacco product application (PMTA) has advanced to the filing stage of the regulatory review process. Beard submitted 45 of its nicotine-based e-liquids to the U.S. Food and Drug Administration (FDA), including its The One and Beard Vape Co. brands. Blackbriar Regulatory Services (BRS), the company’s manufacturing partner and FDA agent of record, will be responsible for assisting Beard throughout the next steps of the FDA regulatory process.
“We are pleased to see our application moving through the PMTA process in order to scientifically demonstrate our products are appropriate for the protection of public health,” said Casey Bates, CFO at Beard, stated in a press release. “Partnering with BRS as our manufacturer gives us much broader access to a multitude of regulatory and scientific data that is critical to our ongoing PMTA work.”
BRS is providing Beard with cost-effective, turnkey solutions for manufacturing and regulatory needs, using a science-driven approach to testing for harmful and potentially harmful constituents, demonstrating good manufacturing practices, as well as providing additional analytical lab testing critical to the PMTA process, according to the release.
“We are very happy to be managing Beard’s PMTAs,” said Russ Rogers, CEO at BRS. “We have strong respect for the quality and brand marketing of their products, and we are confident that we can help Beard to achieve a marketing order from the FDA.”
The Artisan Vapor & CBD company announced that its premarket tobacco product application (PMTA) has been accepted by the U.S. Food and Drug Administration (FDA). The company submitted 39 e-liquid products, seven of which are nicotine salt blends, according to its website.
Credit: Artisan Vapor & CBD
The company announced in a press release that its research included in the submission offered “detailed scientific research demonstrating that their products are appropriate for adult use.” No specific date was given for when Artisan received its acceptance letter, only that the letter was received in April.
Founded in Texas in 2013, Artisan Vapor & CBD has grown to become one of the largest vapor retailers in the world, with more than 70 stores operating across three continents, according to its website. The company now waits for a filing letter from the FDA. Artisan’s application would then move on to the Substantive Review phase where the scientific data is analyzed.
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
Misinformation continues to be a challenge for the vaping industry. After the U.S. Centers for Disease Control and Prevention (CDC) announced that vitamin E acetate in black market marijuana vaping products was the cause e-cigarette or vaping product use-associated lung injury (EVALI) more than a year ago, many media outlets continue to falsely blame nicotine vaping products for the lung illness that was first identified in 2019.
Credit: drphil.com
On his Friday episode of the show Dr. Phil, American TV personality Phillip Calvin McGraw, also known as Dr. Phil, wrongly blamed the EVALI lung illness outbreak on vaping nicotine products. Speaking to a guest who stated she only used nicotine vaping products, McGraw said he “was puzzled” by the guest’s understanding that vaping, while not entirely safe, is safer than smoking combustible cigarettes.
“Ventilators, hospitals, deaths … there is lots of news out there on this,” McGraw said. “This isn’t a matter of opinion, it’s a matter of science.” The host then went on to use several news reports wrongly blaming nicotine for EVALI to support his statements. According to Nielsen data, the average daily audience of the Dr. Phil Show is 2.9 million viewers.
Reports of serious illnesses and deaths related to vaping began mounting in summer 2019. By mid-February 2020, the CDC reported more than 2,800 cases of lung injuries requiring hospitalization across all 50 states, and 68 deaths. After nearly six months of falsely claiming nicotine vaping products were the cause of the outbreak, the CDC finally admitted that the cause was illicit THC vaping products and not nicotine vaping products.
By July of 2020, the CDC said that states no longer needed to track lung-related injuries caused by marijuana-based vapor products, partly because cases have dropped. The CDC said it stopped requiring states to report the numbers in February of 2020 after it pinpointed vitamin E acetate as the culprit in THC vaping products that were making people sick, but didn’t make the public announcement until nearly five months later.
McGraw holds a doctorate in clinical psychology, though he ceased renewing his license to practice psychology in 2006, according to Wikipedia. The CDC and U.S. Food and Drug Administration (FDA) now strongly recommend that people avoid use of “e-cigarettes or vaping products containing THC, especially from the illicit market.”
The UK and EU have a different view on e-cigarettes and whether or not combustible tobacco smokers should make the switch. More and more smokers began transitioning over to vapor products after the Public Health England stated that vaping is 95 percent safer than smoking cigarettes. Experts have pointed out that EVALI cases are almost exclusive to the United States and haven’t made a blip on the radar globally. In the UK, there are approx. 3.6 million e-cigarette users with virtually no EVALI cases reported during the media coverage period in 2019 and early 2020.
There were also little to no cases of EVALI in Canada and Mexico, the closest foreign neighbors to the US. “EVALI was largely the result of an unregulated illicit THC vape market in the United States which didn’t follow safe production standards” says Allan Rewak, executive director of Canada-based Vaping Industry Trade Association (VITA) in Nov. of 2020. “Canada’s nicotine vape market was on the final path toward federal regulation at the time, which prevented EVALI from occurring in any significant way north of the border.”
The use of EVALI to spread fear on nicotine vaping in Mexico and in Latin America was particularly crude, dishonest and more intense than in other places, according to Roberto Sussman, senior researcher and lecturer at the National University of Mexico and founder and director of Pro-Vapeo. .
“Up to this day, all officials of the health ministry in Mexico are still blam[ing] nicotine vaping,” says Sussman. “And when you try to engage them, they say, ‘No, no, no. That’s it. Full stop. End of discussion.’ That’s it.” Since EVALI has now been found to be caused by illegal THC vape pens, not nicotine-based e-cigarettes, Sussman says “no one has told Latin America.”
In late 2020, Mexico’s president signed legislation prohibiting the importation, manufacture and distribution of all noncombustible products tobacco (vaping) products, including heat-not-burn products. “Their justification was that we need to protect Mexican youth from EVALI. Given the proximity of the U.S., this epidemic can come to Mexico any time,” says Sussman. “Pure fear-mongering and they’ve refused all debate.”
Brad Jemmett, a former long-time smoker and now general manager for SnowPlus – an innovation based vape company – suggests that the core of what drove the negative media was a localized, US issue.
“Globally, we don’t really see EVALI cases like there were in the US, because EVALI was linked to illicit marijuana vapes, and most specifically the addition of Vitamin E acetate as a thickening agent. Our products on the other hand, are developed and tested to the highest degree, and designed specifically for adult smokers looking to transition out of smoking,” he said. “At SnowPlus, we never have and never will use Vitamin E acetate in any of our products. Through innovation, we’ve aimed to simulate the smoking ritual with vape technology, to provide a less harmful alternative compared to smoking cigarettes.”
