Tag: FDA

Juul Labs Submits PMTA for Juul system

Photo: Juul
Juul Labs has submitted a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) for the company’s Juul system, an electronic nicotine delivery system (ENDS) product. The company’s submission includes comprehensive scientific evidence for the Juul device and Juul pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5.0 percent and 3.0 percent, as well as information on its data-driven measures to address underage use of its products.
With its PMTA submission, Juul Labs has provided a scientific foundation for the FDA to evaluate whether these products are “appropriate for the protection of the public health” with respect to the risks and benefits to the population as a whole. The application includes detailed scientific data from over 110 studies totaling more than 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.
As part of the PMTA process, Juul Labs has built a comprehensive research program focused on examining the public health impact of the Juul system. This includes research addressing the harm reduction potential of the product, including its ability to convert adult smokers from combustible cigarettes. This research is supplemented with information on the controlled design and repeatable manufacturing processes associated with the Juul system, as well as data-driven measures to limit unintended consequences to the overall population, including initiation among nonusers.
“In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” said Juul Labs CEO K.C. Crosthwaite.
“Juul Labs has committed all necessary resources to deliver the best possible PMTA based on rigorous scientific research and data-driven measures to address underage use,” said Joe Murillo, chief regulatory officer at Juul Labs. “We respect the PMTA process and believe it is the right forum to determine the role ENDS products can play in transitioning and completely switching adult smokers from combustible cigarettes to potentially less harmful alternative products while combating underage use.”
Late last year, the company, under Crosthwaite’s leadership, committed to resetting the vapor category and seeking to work cooperatively with regulators, legislators, attorneys general, public health officials, and other stakeholders to combat underage use and transition adult smokers from combustible cigarettes. As part of that process, the company reduced its product portfolio, halted television, print, and digital product advertising, built up its science and evidence-based capabilities, and supported the U.S. Administration’s final flavor policy for ENDS products, while taking a methodical approach to its global presence.
Juul Labs has built up its science and evidence-based capabilities and will use its research and data to explore additional pathways in other countries. The company will continue to share its research with regulators and the public health community globally through peer-reviewed journals, conferences, and one-on-one meetings.
July 31, 2020
Cigar Makers and FDA Meet About Rules

Photo: Tobacco Reporter archive
Attorneys representing U.S. cigar makers met with the Food and Drug Administration (FDA) to present arguments as to whether part or all of FDA’s deeming regulations should be thrown out or modified, reports Halfwheel.
The two-hour meeting, which took place via a videoconference, primarily concerned the substantial equivalence process, is part of the ongoing Cigar Association of America et al. v. United States Food and Drug Administration et al. case.
In previous rulings, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia removed the requirements for warning labels on premium cigars, while siding with the FDA on other issues.
On the subject of extending the Sept. 9 submission date once again, the FDA said that it would not request a further extension while Department of Justice attorney Garrett Cole noted that if an extension did occur, it would be a two-month extension.
July 23, 2020
Ten Companies Told to Remove Their Products

Photo: Jhvephotos | Dreamstime.com
The U.S. Food and Drug Administration (FDA) has issued warning letters notifying 10 companies, including Cool Clouds Distribution (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.
These new actions are part of the FDA’s ongoing, aggressive effort to act against illegally marketed tobacco products amid the public health crisis of youth e-cigarette use in America. The agency is particularly concerned about the appeal of flavored, disposable e-cigarettes to youth and continues to monitor all available data.
“The FDA continues to prioritize enforcement against e-cigarette products, specifically those most appealing and accessible to youth,” said FDA Commissioner Stephen M. Hahn. “We are concerned about the popularity of these products among youth and want to make clear to all tobacco product manufacturers and retailers that, even during the ongoing pandemic, the FDA is keeping a close watch on the marketplace and will hold companies accountable.”
“Despite suspending in-person inspection activities—such as retail compliance checks and vape shop inspections—due to the COVID-19 pandemic, our enforcement against unauthorized e-cigarette products has endured,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These warning letters are the result of ongoing internet monitoring for violations of tobacco laws and regulations.”
Three firms are receiving warning letters for illegally marketing disposable e-cigarettes—Puff Bar, HQD Tech USA and Myle Vape. The FDA’s review of the companies’ websites revealed that each firm is selling or distributing unauthorized tobacco products that were first introduced or modified after Aug. 8, 2016—the effective date of the deeming rule that extended the FDA’s authority to all tobacco products.
Any new tobacco product not in compliance with the premarket requirements of the Federal Food, Drug and Cosmetic (FD&C) Act is adulterated and misbranded and may not be marketed without FDA authorization. Puff Bar and HQD Tech USA were also cited for an additional violation for marketing their products as modified risk tobacco products without an FDA order in effect that permits such marketing.
Additionally, FDA issued seven other warning letters to the following firms: Eleaf USA, Vape Deal, Majestic Vapor, E Cigarette Empire, Ohm City Vapes, Breazy and Hina Singh Enterprises (doing business as Just Eliquids Distro), who sell or distribute unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
These firms were cited for marketing unauthorized e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as Cinnamon Toast Crunch cereal, Twinkies, Cherry Coke and popcorn, or feature cartoon characters.
The FDA has requested responses from each firm within 15 working days detailing how each company intends to address the agency’s concerns, including the dates on which each firm discontinued the sale and/or distribution of these tobacco products, and its plans for maintaining compliance. Failure to correct violations may result in further action such as a civil money penalty complaint, seizure or injunction. In addition, misbranded or adulterated products imported into the U.S. are subject to detention and refusal of admission.
The FDA’s actions during the COVID-19 pandemic also include a recent warning letter to e-liquid manufacturer StemStix for violations of the FD&C Act, including marketing new tobacco products without authorization, marketing tobacco products with false and misleading advertising and marketing unauthorized modified risk tobacco products.
Additionally, last month the agency issued letters to seven tobacco product manufacturers requesting information to help the FDA examine whether certain tobacco products were first marketed after the deeming rule’s effective date and therefore not subject to FDA’s policy on deferred enforcement of the premarket requirements for certain deemed products. Over the past four months, the agency has also refused admission into the U.S. of at least 74 entries of disposable ENDS products for violations of the Act.
July 20, 2020
FDA Orders Retailers to Stop Selling 13 Products
Photo: Jhvephotos | Dreamstime.com
The U.S. Food and Drug Administration (FDA) on July 16 ordered retailers to cease selling 13 tobacco products that received nonsubstantially equivalent orders. These 13 products, which are deemed “misbranded and adulterated” by the FDA, include:
Camel Sticks Mint, Viceroy Flex, Camel Strips Mint and Camel Orbs Mint from R.J. Reynolds Tobacco Co.
Skoal Smooth Mint Tobacco Stick, Skoal Rich Tobacco Stick, Skoal Mint Tobacco Stick and Skoal Original Tobacco Stick from U.S. Smokeless Tobacco Co.
Union Full Flavor 100’s Box, Union Gold 100’s Box, Union Platinum 100’s Box, Union Menthol 100’s Box and Union Menthol Gold 100’s Box from Heritage Tobacco.
The FDA added that any retail with remaining inventory should work with the product manufacturer or supplier to discuss options for disposing of the products.
In response to the FDA announcement, R.J. Reynolds said that the FDA order has no impact on the company as the three brands listed have not been sold since 2013. R.J. Reynolds spokeswoman Kaelan Hollon said July 16, “We received the FDA’s orders earlier this year. Given these products have not been commercially sold in several years, these orders will have no commercial impact.”
July 17, 2020
FDA Grants IQOS Exposure Claim
Photo: PMI
The U.S. Food and Drug Administration (FDA) on July 7 issued exposure modification orders to Philip Morris Products’ (PMP) IQOS heat-not-burn device system (holder and charger) and three Marlboro Heatstick variants.
The FDA previously authorized the marketing of IQOS without modified risk information in April 2019 via the premarket tobacco application pathway.
In its most recent ruling. the FDA determined that IQOS does not currently meet the standard for marketing with reduced-risk claims but can be marketed with a reduced-exposure claim.
Specifically, the FDA is allowing the company to claim:
The IQOS system heats tobacco but does not burn it.
This significantly reduces the production of harmful and potentially harmful chemicals.
Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.
“Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.
“Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.”
In its announcement, the FDA stressed that is marketing authorization doesn’t mean the reviewed products are safe or “FDA approved.”
The FDA’s marketing order requires PMP to conduct post-market surveillance and studies to determine the impact of these orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.
These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use.
“The FDA’s decision is a historic public health milestone,” said Andre Calantzopoulos, CEO of Philip Morris International. “Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.”
“The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.”
“We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product,” said Billy Gifford, CEO of Philip Morris USA’s parent company, Altria Group, which will be marketing the product in the U.S. “This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS and this decision is an important step for adult smokers.”
In a note to investors, Morgan Stanley described the FDA’s order as a positive development because it provides greater flexibility for IQOS to be marketed as relatively less harmful than cigarettes.
“The inability to make relative lower harm claims is a constraint to broader IQOS adoption in the U.S.,” wrote Morgan Stanley analyst Pamela Kaufman.
“Over time, PM can continue to submit additional information towards a full MRTP approval. The modified exposure designation combined with pending PMTA approval for IQOS 3 should accelerate MO’s [Altria’s] U.S. expansion strategy for IQOS. The FDA’s recognition of IQOS’s benefits relative to cigarettes may also enhance IQOS’ perception with international health agencies, helping its growth prospects,” Kaufman said.
Anti-smoking activists were less enthusiastic. In a joint statement, the Campaign for Tobacco-Free Kids, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Truth Initiative, said the FDA marketing order would put consumers at risk.
“With today’s action, the FDA has created a real danger that kids and adults will falsely believe IQOS has been proven to present a lower health risk and that kids will be exposed to marketing that portrays IQOS, a highly addictive tobacco product, as an appealing, cool alternative to cigarettes, in much the same way as e-cigarettes,” the anti-tobacco groups wrote in their statement.
IQOS is the first tobacco product to receive exposure modification orders and the second to be authorized as a modified risk tobacco product. In October 2019, the FDA authorized Swedish Match U.S. division’s amended MRTP applications for eight varieties of General Snus, giving the company the right to market the product as a less harmful alternative to cigarettes.
July 8, 2020
Court Upholds FDA Authority Over Vaping

Photo: Michal Kalasek | Dreamstime.com
The 5th U.S. Circuit Court of Appeals has upheld the U.S. Food and Drug Administration (FDA)’s authority to regulate e-cigarettes as tobacco products, reports Reuters.
A unanimous panel ruled Thursday that Congress’ decision to delegate vaping regulation to the FDA was constitutional under the non-delegation doctrine because Congress had articulated an “intelligible principle” in delegating authority to determine what qualified as a tobacco product to the FDA.
The 5th Circuit’s ruling is the latest rejection of a series of legal challenges from the vapor industry.
June 29, 2020
Marketing Authorization Requested for Leap

Photo: Timothy Donahue
E-Alternative Solutions (EAS) has submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the marketing and sale of its portfolio of Leap and Leap Go vapor products.
“We are pleased to take this important step in demonstrating our commitment to the vapor industry, retailers and adult smokers seeking an alternative to combustible cigarette smoking with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS.
“At EAS, we have always held ourselves to high standards, from supplying adult consumers with products they can trust to consistently following ethical marketing practices. We are confident in the strong merits of our PMTAs and want to thank our compliance and research teams for developing and delivering thorough submissions.”
According to EAS, the PMTAs plays support the proposition that Leap and Leap Go vapor products are appropriate for the protection of public health. “The collective 75,000-plus-page PMTA submissions for Leap and Leap Go are the result of months of hard work and investigation that included an assessment of the stability of the products over time, toxicological formula reviews, toxicology testing, an assessment of abuse liability, label comprehension studies and behavioral studies,” the company wrote in a statement.
In addition, EAS undertook an extensive review of available literature on vapor products related to health effects, behavioral factors and toxicological end points. Further, an exacting risk assessment was conducted across many areas of potential risk for Leap and Leap Go products.
“Our PMTA submissions provide a robust analysis of the Leap and Leap Go products that will enable [the] FDA to conclude these products are appropriate for the protection of public health,” said Chris Howard, vice president, general counsel and chief compliance officer at EAS. “The PMTA process sets a high bar and holds companies accountable, ensuring vapor product manufacturers follow the rules and act in good faith. Looking ahead, a robust collaboration with [the] FDA will help build a strong future for both the vapor industry and adult consumers.”
June 17, 2020
Health Labels Planned for October 2021

Image: FDA
The U.S. Food and Drug Administration (FDA) has set Oct. 16, 2021, as the new effective date for graphic health warning labels for combustible cigarettes.
The FDA signed off March 18 on a new set of 11 graphic warning labels for traditional cigarettes that are toned down considerably from its first attempt in 2012, which was abandoned after an industry legal challenge.
The new set of warnings contains images of diseased lungs, a man experiencing erectile dysfunction, a man with surgical stitches from heart or lung surgery and a child with an oxygen mask. But there is no smoke coming out of a tracheal hole, no cadaver and no photo of a man who appears deathly ill, as the FDA proposed.
The labels must cover the top 50 percent of the front and rear panels of packages, as well as at least 20 percent of the top of advertisements. The messages must be randomly and equally displayed and distributed on cigarette packages and rotated quarterly in cigarette advertisements.
The warnings were mandated by a federal judge for cigarette packaging and marketing. The ruling does not affect other tobacco products, such as electronic cigarettes.
Initially, the agency set a deadline for June 18, 2021. However, on April 3, Philip Morris USA, R.J. Reynolds Tobacco Co., ITG Brands and Liggett Group filed a joint motion requesting a preliminary injunction on implementing the labels and a ruling to prohibit enforcement. The manufacturers insist that the labels violate the First Amendment of the U.S. Constitution, which guarantees free speech.
On May 8, the FDA and the manufacturers filed a joint motion to extend the deadline by 120 days. The manufacturers said the pandemic has complicated their ability to meet the June 18, 2021, deadline.
Despite the postponement of the deadline, the FDA urged manufacturers to submit plans for compliance as soon as possible.
“Early submission will facilitate timely FDA review of plans prior to the effective date of the required warnings, encourage dialogue with entities regarding any implementation concerns, and provide time to consider proposals by entities in a timely manner,” the FDA said.
May 29, 2020
FDA Wants to Delay Graphic Warnings

The U.S. Food and Drug Administration (FDA) has asked a federal judge in Texas to delay the effective date of a rule requiring graphic health warnings on cigarette packages due to the outbreak of Covid-19, reports Reuters.
The FDA and tobacco companies that are suing the agency have asked the court to delay the effective date from June 18, 2021, to Oct. 16, 2021.
May 7, 2020
U.S. Fourth Circuit Denies PMTA Appeal

The Fourth Circuit on Monday dismissed an appeal from various vaping groups challenging a compliance deadline for vapor products. The decision states that January directives from the U.S. Food and Drug Administration (FDA) have rendered the appeal moot.
In a per curiam opinion, the appellate judges held that guidance issued by the FDA in January moots the vape groups’ appeal because that guidance supersedes older directives from August 2017 at issue in the appeal and leaves “no possible meaningful relief” that the court could grant, according to law360.com.
“Any ruling by this court as to the procedural or substantive reasonableness of the August 2017 guidance would amount to nothing more than an advisory opinion,” the court said.
The appeal stems from a Maryland district court ruling that ordered the agency to set a May 2020 deadline for premarket tobacco product applications (PMTA) on smokeless tobacco products. The FDA, along with various health and anti-vaping groups, had argued that the January guidance restricting the sale of flavored, cartridge-based vapes rendered moot the vape groups’ appeal.
“Because the enforcement timetable for e-cigarettes set out in the January 2020 guidance is independent of the district court’s order, an order by this court reversing the district court would have no effect on FDA’s enforcement of the statute and regulations against e-cigarette manufacturers,” the agency had previously said.
But the vape groups disagreed, saying the January guidance was enacted without proper notice-and-comment procedures, according to the opinion.
While the court said it can’t offer the vape groups relief in this case, the panel added in a footnote that the groups can challenge the January guidance in a separate action in federal court. The panel also ruled that a Maryland district court did not abuse its discretion in denying cigar industry groups’ motion to intervene, saying those groups did not intervene in a timely manner.
Counsel for the cigar and vape groups and a representative of the FDA did not immediately respond to requests for comment Monday.
Last month, a Maryland federal judge said that in light of the coronavirus pandemic, he would grant a 120-day extension to the May 12 deadline for e-cigarette PMTAs, which have proceeded slowly since the FDA first determined vapes should be regulated like tobacco products. The new deadline is Sept. 9, 2020.
The FDA had previously asked the Fourth Circuit for approval for the lower court to extend the May deadline, saying it would not affect the merits of the appeal brought by the industry groups. The FDA said many of the laboratories and research organizations conducting the clinical trials for the regulatory applications have shut down or otherwise halted in-person testing in light of the COVID-19 pandemic.
Public health groups previously sought to accelerate the FDA’s regulation of vaping products under the Tobacco Control Act, citing vaping-related lung injuries that sickened thousands of people and left nearly 70 dead in 2019. In July 2019, a Maryland district judge effectively allowed the FDA to set the May 2020 deadline, prompting the vape groups to claim the decision was an arbitrary overextension of both the FDA and the court’s authority.
The vape groups had also argued that the May deadline left too little time for manufacturers to file complete applications. Cigar industry groups that filed joint briefs on appeal argued that the district court’s order on deadlines unfairly ensnared cigar and pipe tobacco manufacturers as well.
May 5, 2020