Category: U.S. FDA

U.S. FDA Shifts Deadline for PMTA to Sept. 9

Tobacco and vapor companies have an extra four months to file their premarket tobacco applications (PMTAs) for newly deemed tobacco products with the Food and Drug Administration (FDA) following a U.S. court ruling.
On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020.
However, the coronavirus pandemic has drastically impaired the FDA’s ability to adhere to this timeline. As a result of the pandemic and these exceptional and unforeseen circumstances, the agency requested on March 30 a 120-day extension of the May 12 deadline. This request has now been granted.
The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by the FDA on an application during that time.
Following the Covid-19 outbreak, the agency received numerous inquiries from the tobacco industry expressing concern they would be unable to complete premarket applications by the original May 12 deadline due to disruptions at all stages of preparation, including preventions or disruptions to in-person laboratory work and clinical studies or necessary foreign travel, or from the shuttering of manufacturing facilities abroad.
In a statement, the FDA said it believes the public health is better protected by not having these firms compromise their employees’ health or take actions that would risk spreading Covid-19 to others by trying to meet the previous May 12 deadline. In the more than a dozen requests for an extension that the FDA received, this public health concern was mentioned repeatedly.
Another consideration, according to the agency, was that a number of the FDA’s Center for Tobacco Products (CTP) personnel have been deployed to work on Covid-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications. Many of those deployed are among the staff that had been playing a critical role as CTP prepared for this deadline.
“Ultimately, a Sept. 9 deadline will better serve the public health by allowing manufacturers to prepare for, and the agency to conduct, the thorough scientific review of these products that is required under law and vital to our mission of protecting Americans while reducing or eliminating physical contact during this critical period,” the FDA wrote in its statement.
“Importantly, this new deadline does not detract from our efforts to prioritize enforcement of certain e-cigarette products currently on the market. Although the FDA’s in-person compliance checks and vape shop inspections are currently on hold due to the pandemic, review of previous inspections continues, and we continue to monitor the online marketplace and will take action as appropriate.
“Accordingly, the January 2020 enforcement priorities guidance, which independently prioritizes earlier enforcement against certain e-cigarette products that are widely used by youth, remains in effect regardless of whether an application is submitted, although we intend to update it for products for which the Sept. 9 date now applies.”
May 8, 2020
U.S. Fourth Circuit Denies PMTA Appeal

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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
Fontem U.S. Submits PMTAs for Myblu

Imperial Brands subsidiary Fontem US has submitted Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the continued marketing of a wide range of its Myblu electronic vapor products.
Fontem US’s Blu products play a fundamental role in the company’s goal of providing adult smokers with options that are potentially less harmful than combustible tobacco products. The PMTA submissions include data from a comprehensive range of laboratory and clinical scientific studies, including product analyses, behavioral data, nonclinical health risk information, and information on the impact to both users and non-users of tobacco products.
Fontem US believes the evidence provided shows that Blu electronic vaping products could play a role in the protection of the public health, in line with the guidance issued by FDA.
“We agree that the electronic vaping industry should be held to the highest product and marketing standards while providing adult smokers with alternative products that could serve the interest of the public health,” said Antoine Blonde, president of Fontem US.
“Fontem US looks forward to working with the FDA as the agency develops and enforces an evidence-based regulatory policy.”
April 29, 2020
U.S. FDA Sends 10 Warning Letters for Targeting Youth
Today, the U.S. Food and Drug Administration (FDA) issued 10 warning letters to retailers and manufacturers who sell, manufacture and/or import unauthorized electronic nicotine delivery system (ENDS) products targeted to youth or likely to promote use by youth.
The warning letters were sent to establishments marketing unauthorized products, such as a backpack and sweatshirt designed with stealth pockets to hold and conceal an e-cigarette, ENDS products that resemble smartwatches, or devices appearing as children’s toys such as a portable video game system or fidget spinner.
Warning letters were also issued to companies marketing e-liquids that imitate packaging for food products that often are marketed and appeal to youth, such as candy, or feature cartoon characters like SpongeBob SquarePants.
“The FDA is focused on manufacturers and retailers that make and sell ENDS products that are targeted to youth and increase their appeal. The public should really be outraged by these products. The FDA is especially disturbed by some of these new products being marketed to children and teens by promoting the ease with which they can be used to conceal product use, which appeals to kids because it allows them to conceal tobacco product use from parents, teachers, law enforcement or other adults,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “Even in the midst of the COVID-19 pandemic, we have not lost our focus on protecting youth against the dangers of e-cigarettes and will do everything we can to take action. These warning letters should send a clear message to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace. If you’re marketing or selling these products to youth, the FDA will not tolerate it.”
The following retailers and/or manufacturers or importers received a warning letter:
Vaprwear Gear, LLC (manufacturer, online retailer)
Vapewear, LLC (manufacturer, online retailer)
Wizman Limited (manufacturer, online retailer)
EightCig, LLC (online retailer)
Ejuicepack, LLC (online retailer)
Vape Royalty, LLC (online retailer)
VapeCentric, Inc. (online retailer)
Dukhan Store (online retailer)
VapeSourcing (online retailer)
Shenzhen Uwell Technology Co., Ltd. d/b/a DTD Distribution Inc. (importer, retailer)
The FDA has also issued warning letters to 73 brick-and-mortar retailers for selling unauthorized flavored, cartridge-based ENDS products. This follows 22 warning letters that FDA issued last month for similar violations to online and brick-and-mortar retailers and manufacturers across the country. These warning letters are part of a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.
April 27, 2020
FDA Warns CBD Companies Over Illegal Claims

The U.S. Food and Drug Administration has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug and Cosmetic Act. This action is part of the FDA’s efforts to pursue companies that illegally market CBD products with claims that they can treat medical conditions, including opioid addiction or as an alternative to opioids.
“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy.
“CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”
The two warning letters were issued to Biota Biosciences of Washington state and Homero Corp DBA Natures CBD Oil Distribution of New Hampshire.
April 24, 2020
RAI Files 2 New PMTAs for Vuse Products

Reynolds American Inc. (RAI) has submitted two new premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA). RAI is seeking marketing orders for its Vuse Vibe and Vuse Ciro vapor products, which would allow these products to remain on the market after the FDA’s deadline for PMTAs for electronic nicotine-delivery systems.
The applications include a range of scientific studies for Vuse Vibe and Vuse Ciro using well-known methodologies, including the comparative assessment of cigarettes and associated health risks. Though the PMTAs themselves are considered commercially proprietary and are thus confidential, the data and information submitted to the FDA include the results of product analyses, nonclinical health risk information and human health and population information, including the impact to both users and nonusers of tobacco products.
According to RAI, the results of these studies demonstrate that the continued marketing of the Vuse Vibe and Vuse Ciro products is appropriate for the protection of the public health. The FDA s expected to extend the PMTA deadline to from May 12 to Sept. 9.
“I am incredibly proud of our diverse team of scientists, researchers and regulatory experts, who have worked tirelessly together to complete these applications well ahead of the FDA’s May deadline for ENDS products,” noted Reynolds’ executive vice president and head of scientific and regulatory affairs, James Figlar.
The PMTAs for Vuse Vibe and Vuse Ciro are the second and third complete grouped PMTA applications submitted by Reynolds to the FDA for review, following the initial PMTA applications for Vuse Solo submitted in October 2019.
April 21, 2020
U.S. FDA Shifts its Covid-19 Stance on Vaping

Courtesy: US FDA
The U.S. Food and Drug Administration modified its stance on Covid-19 and vaping, saying it has an unknown effect on the risk of the new coronavirus, while warning that smoking can create worse outcomes, according to Bloomberg News.
“E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of Covid-19 is not known,” the agency said Wednesday in an emailed response to a question from Bloomberg News.
The agency had said late last month that vapers and smokers with underlying health conditions might be at higher risk from complications.
Its description of cigarettes’ risks also differed from its earlier statements. “Cigarette smoking causes heart and lung diseases, suppresses the immune system, and increases the risk of respiratory infections,” FDA spokeswoman Alison Hunt said. “People who smoke cigarettes may be at increased risk from Covid-19, and may have worse outcomes from Covid-19.”
The new statement comes as the disease afflicts young people in some countries at rates that are surprising, given initial data out of China, and some health experts speculate as to whether vaping could play a role, the article states.
‘Especially Serious’
Other U.S. agencies have issued mixed warnings on both smoking and vaping. Nora Volkow, director of the National Institute on Drug Abuse, wrote a recent blog post warning that the coronavirus “could be an especially serious threat to those who smoke tobacco or marijuana or who vape.”
The coronavirus presents a new challenge for the tobacco industry, which for years has faced lawsuits and higher taxes due to links between smoking and higher rates of lung disease. E-cigarette maker Juul Labs Inc. was already under fire for allegedly marketing its product to teenagers, and an amended complaint filed in San Francisco district court this month includes claims that vapers suffer a greater risk of more serious coronavirus complications.
Before the outbreak of the coronavirus, the vaping industry had drawn scrutiny and restrictions from federal and state governments amid a series of deaths and illnesses that were linked to faulty cannabis products.
Michael R. Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. He is the majority owner of Bloomberg LP, the parent company of Bloomberg News.
April 20, 2020
Opinion: Four-Month FDA Extension Not Sufficient

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Consumers are staying home and spending less as COVID-19 and social distancing mandates sweep across the globe. The extreme, necessary steps to control the spread of the virus have already taken an economic toll, and there certainly will be a long-term impact on individual businesses and workers. One industry, in particular, will likely fail without swift federal action: e-cigarettes, according to Michelle Minton with the Competitive Enterprise Institute.
Cigarettes may prove “pandemic-proof.” Since they are often sold at outlets deemed “essential” under the current lockdown, cigarettes continue to be available and big tobacco companies have so far remained financially unscathed. But the same is not true for their lower-risk competitors. Vape shops, which sell vapor products, like e-cigarettes, have not been universally recognized as essential businesses, so they have been forced to close.
To maximize ways to fight the virus, many states have pressed pause on certain rules and regulations (leading many to wonder if they were #NeverNeeded in the first place.) For example, Vermont Governor Phil Scott signed an order lifting the state ban on home alcohol delivery. This was a pragmatic move, as Reason’s Guy Bentley aptly put it. Vermont lawmakers understand that people still want to imbibe, and at-home delivery discourages unnecessary booze runs.
Yet that pragmatism hasn’t been extended to e-cigarettes, and Governor Scott’s online e-cigarette sales ban enacted last year remains in place. As a result, some adults now find themselves cut off from the products they rely on to stay smoke-free. Without swift federal action, they may be cut off permanently as vape shops go belly up, and many people will revert to smoking.
The last year has already been difficult for those who sell and enjoy vapor products. Even as the evidence that e-cigarettes are relatively harmless for adults and highly effective for smoking cessation has become clearer, calls to ban or restrict e-cigarettes have only grown louder. Groups that oppose nicotine use, no matter how safe, ramped up attacks, spending millions to promote the idea that e-cigarettes are no different than cigarettes and to foment panic over the non-existent “epidemic” of youth vaping.
Last summer, as scores of mostly young people fell ill with a mysterious lung ailment, anti-tobacco groups (with the aid of the CDC and news media) convinced people e-cigarettes were to blame, obfuscating the fact that the injuries were caused by black market THC vaping products, contaminated with vitamin E acetate (an oil that cannot be mixed into nicotine-containing e-cigarettes).
By exploiting fear and confusion, e-cigarette opponents amassed support among the public and lawmakers for restrictions on e-cigarettes. Cities and states instituted onerous new rules, including banning all e-cigarette sales (but not traditional cigarettes), prohibiting flavored e-cigarettes, restricting sales to in-person transactions, and criminalizing possession of certain e-cigarettes.
Some members of Congress tried to make these rules national, holding several hearings antagonistic toward vaping and considering a number of bills. Rep. Frank Pallone’s (D-NJ) bill, which bans all flavors except “tobacco,” prohibits online and mail-order sales and raises the national tobacco purchasing age limit to 21 (which it already is), passed the House. If enacted, it would make e-cigarettes less attractive, harder to get, and more expensive—leading some to label the bill a “win for cigarettes.”
E-cigarette supporters battled threats to products they believe saved their lives. But unless federal regulators take immediate action there will be no industry left to save: By May 12, 2020 all vapor products must either submit a pre-market tobacco application (PMTA) to the Food and Drug Administration (FDA) for approval or exit the market. Filing a PMTA is an expensive and time-consuming task, which the FDA admitted would Eliminate 99 percent of the e-cigarette market. COVID-19 disruption could make that figure nearer to 100 percent.
Last week, the FDA submitted a request to delay the PMTA deadline by four months, but even if granted, this would merely push the inevitable end of the e-cigarette industry to September 2020. The FDA should go further: Make the process, which vapor industry experts estimate takes over 1,700 hours and millions of dollars, quicker and cheaper for small companies. Although Health and Human Services Secretary Alex Azar announced plans in January to create a “streamlined” avenue for small businesses, that has yet to materialize.
In the meantime, anti-nicotine advocates are still trying to spread misinformation, slip state-wide vaping bans around the normal legislative process, and, ludicrously, link COVID-19 deaths to e-cigarette use—for which there is zero evidence. Worse, some have even encouraged countries to reject critically needed medical equipment like ventilators if donated by Big Tobacco.
The outbreak of COVID-19 should elevate the value of harm reduction—the idea that you can’t entirely stop people from engaging in risky behavior, but you can reduce harm by encouraging them to do so in the least risky way possible. E-cigarettes are the best way we know so far to reduce the harms related to nicotine use. They are vastly safer than smoking and more popular than most other forms of tobacco cessation. Lawmakers should do everything in their power to keep e-cigarettes a viable option for smoking cessation.
April 9, 2020
U.S. FDA to Announce Sept. 9 PMTA Deadline

While not yet official, the deadline for submitting premarket tobacco product authorizations (PMTA) to the U.S. Food and Drug Administration (FDA) is one step closer to being delayed from May 12, 2020 to Sept. 9, 2020 due to the Covid-19 pandemic.
Judge Paul Grimm of the U.S. District Court for the District of Maryland issued an “indicative ruling” granting the FDA’s request to delay the deadline by 120 days.
The ruling is not yet final, however, due to procedural issues that are expected to be resolved expeditiously. Due to appeals filed by several organizations, including the Vapor Technology Association and the FDA itself, Grimm no longer has the authority to modify his original ruling which moved the deadline to May 2020. That power now lies with the U.S. Court of Appeals for the Fourth Circuit.
For the ruling to become valid, the Fourth Circuit must remand the case back to Grimm’s court where Grimm says he would modify the order to allow the FDA to delay the change. The FDA will then need to update its regulations to move the PMTA date to Sept. 9, 2020.
April 4, 2020
U.S. FDA Asks District Court for PMTA Extension

The US Food and Drug Administration (FDA) has submitted a letter to the U.S. District Court for the District of Maryland asking Judge Grimm to extend the May 12, 2020 court-ordered PMTA deadline by 120-days to September 9, 2020 “in light of the global outbreak of respiratory illness caused by a new coronavirus.”
The FDA explained in its submission that “the global coronavirus outbreak poses unforeseen challenges and has made the May 12 deadline a public health risk to those who cannot comply with the deadline through telework.” In addition, FDA explained that telework also will complicate and delay FDA’s review of applications, according to a release by the Vapor Technology Association (VTA).
In deciding to request a 120-day extension, the FDA noted that it had received requests from numerous trade associations and companies, including consultants involved in the PMTA process, for extensions “between 8 weeks and 180 days, with the majority of requests for 180 days.” The VTA was one of those entities that submitted a request to FDA and did so on March 20, 2020 outlining the basis and necessity for deadline extensions for large manufacturers and small manufacturers.
At this point in time, no one can predict the length and severity of the COVID-19 commercial shutdown. The FDA explicitly recognized this point in the Second Declaration of Director the FDA’s Center for Tobacco Products (CTP) Mitch Zeller which accompanied the letter to the Court.
In his Declaration, Zeller stated that “it is not clear at this point what the precise impact of the COVID-19 outbreak will be on the scope of FDA’s ability to complete application reviews within the 12-month period of time once applications are filed.”
That is precisely why VTA requested a new deadline of November 2020 (or at least 180 days from business resumption) for large manufacturers, and a new deadline of February 2021 (or at least 270 days from business resumption) for small manufacturers, according to the VTA statement. “To that end, VTA explained that ‘the question of whether these deadline changes are sufficient or ultimately realistic can and must be re-evaluated in the coming months as more information comes to light about the length and severity of the commercial shutdown due to COVID-19.’”
In its letter to the District Court, FDA notes that the plaintiffs (American Academy of Pediatrics, et al.) will not oppose the FDA’s request, though the plaintiffs have requested the opportunity to “express their misgivings about the extension on the record.” In order to rule, Judge Grimm still will have to have the case remanded to him by the Fourth Circuit and then he would need to make his decision on whether or not to grant the FDA’s request.
However, given the strong case made by the FDA, the obvious insurmountable obstacles created by the coronavirus, and the apparent lack of opposition by the plaintiffs, a ruling extending the deadline is reasonably likely though still not certain.
March 31, 2020