Category: U.S. FDA

FDA to Give 90-Day PMTA Statuses Starting April 29

The U.S. Food and Drug Administration will be required to give premarket tobacco product application (PMTA) status reports every 90 days. The first reports are due on April 29, according to a revised order from District Judge Paul Grimm for the United States District Court for the District of Maryland.
US Judge Paul Grimm
The revised order, signed on April 15, granted a motion filed by American Academy of Pediatrics (AAP) and other plaintiffs that requires the FDA to “forecast the percentages of such products for which it expects to have taken ‘action’ by June 2022 and quarterly thereafter.” Subsequent reports will also be required to state any revisions to prior estimates.
The order states that “covered applications” means all applications for newly deemed tobacco products “sold under the brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar.” Additionally, any product with a reach of 2 percent of more (vaping product brands deemed to have the greatest public health impact) in “Retail & Sales” in Nielsen’s “Total E-cig Market & Players” or “Disposable E-Cig Market & Players.” The FDA has already approved some products from Vuse and Logic. Also, the agency has denied applications for Blu’s Myblu products.
The decision was not unexpected by the vaping industry. Azim Chowdhury, a partner with Keller and Heckman LLP, speaking during the firm’s annual E-Vapor and Tobacco Law Symposium held Feb. 2–3, said the FDA had appeared to concede to the requested requirement to submit status reports on many of the remaining submissions under review, adding that the updated requirements requested by the anti-vaping groups appeared to be even broader than the original.
Azim Chowdhury
It’s been more than eight months since the 12-month continued compliance policy for products subject to timely submitted PMTAs ended, but the agency is still sitting on some 88,000 reviews, including some of the vaping products with the highest market shares as measured by Nielsen.
Requiring the FDA to provide the status reports comes with some controversy. Chowdhury says that it wouldn’t be appropriate for the protection of public health (APPH) or positive for the vaping industry if a requirement for status updates forced the regulatory agency to make PMTA decisions only to appease the anti-vaping groups or politicians.
“These status reports could be used as a tool to pressure FDA to act—i.e., deny— applications quickly,” Chowdhury told Vapor Voice. “Rather, we want FDA to review the science carefully and take the time it needs to determine whether a particular product is APPH.”
In November 2021, the anti-vaping organizations whose lawsuit brought forward the deadline for filing premarket tobacco product applications (PMTAs) asked U.S. District Judge Paul Grimm to reopen the case. The plaintiffs asked him to require the U.S. Food and Drug Administration to regularly report on the status of the applications for the 10 bestselling vapor brands according to Nielsen rankings.
April 16, 2022
30-Day Countdown for Synthetic Vape PMTAs Begins
Credit: Brian Jackson
On May 14, premarket tobacco product applications (PMTAs) are due for all non-tobacco nicotine products. The legislation enacted on March 15 makes clear that U.S. Food and Drug Administration can regulate tobacco products containing nicotine from any source, according to an FDA statement.
Additionally, no new non-tobacco nicotine, such as synthetic nicotine products, can be entered into the market beginning today, as some portions of the law take effect. Electronic nicotine-delivery system (ENDS) products must ensure compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) resulting from this law, such as:

Not selling these products to persons under 21 years of age (both in-person and online);

Not marketing these products as modified risk tobacco products without FDA’s authorization; and

Not distributing free samples of these products.

Additionally, the owners and operators of establishments engaged in the manufacture, preparation, compounding, or processing of NTN products must register with the FDA and list all these tobacco products that they manufacture, prepare, compound, or process for commercial distribution.
The May 14 PMTA is the deadline for only those using the recommended FDA’s electronic submission process. An application submitted in hard copy must be received by FDA no later than 4:00 p.m. EDT on Friday, May 13, according to the agency.
April 14, 2022
Fontem US Receives Marketing Denial Orders for Myblu
The FDA has issued marketing denial orders (MDOs) to several myblu brand products manufactured by Fontem US. Fontem Ventures, a subsidiary of Imperial Brands PLC, owns the global e-cigarette brand blu. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US.
“On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.
Credit: blu
The currently marketed products receiving MDOs include:

myblu Device Kit

myblu Intense Tobacco Chill 2.5%

myblu Intense Tobacco Chill 4.0%

myblu Intense Tobacco 2.4%

myblu Intense Tobacco 3.6%

myblu Gold Leaf 1.2%

myblu Gold Leaf 2.4%
Based on the information provided in the applications submitted by Fontem US, for these myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability, according to the agency. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.
Generally, the submission of a premarket application and intent to commercially market a new tobacco product that has never been marketed would be considered confidential commercial information (CCI) that the FDA would not disclose, according to the FDA. However, the agency determined that the named products are currently marketed based on communication with the applicant during the development of the publicly available Deemed New Tobacco Product Application List, and therefore the applicant has acknowledged the submission of these premarket applications.
“FDA is issuing MDOs for additional myblu products that do not appear on the publicly available list,” the agency stated. “FDA has publicly named only products that the FDA or the manufacturer have confirmed to be currently marketed to avoid potential CCI issues.”
April 8, 2022
Michele Mital to Serve as Acting Director of CTP
Mitch Zeller, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), will officially retire on April 8, Zeller confirmed during the 103rd annual TMA meeting this week.
Today, the FDA confirmed to Vapor Voice that Michele Mital will serve as acting director of the CTP when Zeller retires. Mital has served as the deputy director of the CTP since 2018, according to the FDA.
In this position, Mital is responsible for assuring that CTP accomplishes its public health goals and for operationalizing the Center’s vision and mission as it implements the Family Smoking Prevention and Tobacco Control Act.
MItal will have some big shoes to fill. Zeller has been working on FDA issues for more than 30 years. He began his career as a public interest attorney in 1982 at the Center for Science in the Public Interest.
The news was first reported Wednesday afternoon in a tweet by FDA Tracker and confirmed by Filter reporter Alex Norcia after speaking with FDA sources. No formal announcement has been made.
This story will be updated when more information is available.
March 31, 2022
Health Groups Urge FDA Action on Top Vape Brands

Photo: Dmytro
Health groups are urging the U.S Food and Drug Administration to make haste in addressing the remaining premarket tobacco applications (PMTA) for leading e-cigarette brands such as Juul, Blu, Vuse (Alto) and NJOY, which make up 75 percent of the U.S. market and are among the most popular with youth.
“We are grateful to see movement again by the FDA on the e-cigarette pre-market approval process under Dr. Califf’s leadership and the recognition of the risks these products pose to America’s youth while assessing the public health benefit for adult smokers,” wrote Robin Koval, president and CEO of the Truth Initiative, in a statement following the FDA’s authorization of Logic Technology Development’s tobacco-flavored e-cigarettes. Logic, however, makes up a small percentage of the U.S. e-cigarette market, with just over 1 percent according to retailer scanner data.
The Truth Initiative also expressed concern about the FDA’s failure to deny marketing applications for Logic’s menthol e-cigarettes, which remain under review. “According to the latest NYTS data, nearly 30 percent of young people who use e-cigarettes reported using a menthol flavor,” wrote Koval. “As the FDA prepares to issue a proposed rule removing menthol cigarettes from the market, we continue to urge the FDA to remove all flavored tobacco products, including menthol to protect our nation’s youth.”
Meanwhile, tobacco harm reduction advocates, took the approval of Logic, which is ultimately owned by Japan Tobacco International, as further evidence that the PMTA process favors deep-pocketed tobacco multinationals.
“It’s mildly gratifying to hear FDA say out loud the obvious and simple truth that vaping is helping Americans quit smoking,” Amanda Wheeler, president of the American Vapor Manufacturers Association told Filter. “But meanwhile in the bureaucratic shadows, they are strangling the life out of our entire innovative, entrepreneurial industry.”
“The FDA should be thoroughly embarrassed that the only vaping products with PMTAs are ones that have been rejected by adult consumers,” Greg Conley, the president of the American Vaping Association, told Filter. “If JTI did not have cigarette sales to subsidize their minimal effort offerings in next-gen products, market forces would have caused them to stop selling these products years ago.”
March 28, 2022
Vaping Industry Advocates ‘Not Surprised’ by Logic Approval

When U.S Food and Drug Administration authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S. the vapor industry wasn’t surprised. Vaping advocacy groups have long expected the FDA to approve many of the brands that had premarket tobacco product applications (PMTAs) submitted and are owned by major tobacco companies.
“Although we are not surprised to learn that Japan Tobacco Inc., brand owner of Logic, is now among the Big Tobacco companies with FDA market authorization, we certainly aren’t pleased with FDA’s consistent rejection of flavored products and will continue to apply pressure in that regard, as well as in the enforcement discretion arena – particularly for the manufacturers with products still in review that participate in our Responsible Industry Network program,” said April Meyers, CEO of the Smoke-Free Alternatives Trade Association (SFATA). “As the nation’s leading regulatory body, the agency appears to be cherry-picking what science it utilizes for decision making. That FDA cited the recent NYTS data but failed to acknowledge the steep decline in youth use while coining the low rates an “epidemic”, makes its rejection of flavored products today seem more an act of fear over what might happen than a decision based on scientific evidence. This is disappointing, at best, but again, not surprising.”
Logic, based in Teaneck, New Jersey, is a part of the JT Group of companies. JTI is a international tobacco and vaping company headquartered in Geneva, Switzerland, with operations in more than 130 countries. JTI employs over 50,000 people. In a release, Logic stated that it submitted PMTAs for its Logic Pro, Logic Power, and Vapeleaf products on August 19, 2019, well before the Sept. 9, 2020, PMTA deadline.
“We take the quality of our products extremely seriously, along with the way they are marketed and sold, and we are proud that we have received marketing orders from FDA for our Logic products to remain on retailers’ shelves,” said Corrado Mautone, president of Logic. “By receiving FDA marketing orders now, Logic can remain a reliable partner for retailers going forward.”
Amanda Wheeler, owner of Jvapes and the president of American Vapor Manufacturers, said that it is good to see that the FDA is acknowledging that vaping is safer than combustible cigarettes, but the fight for small business owners continues.
“People forget that in the story, Dr. Jekyll was a benevolent physician in a lab coat who only wanted to help people. But tomorrow morning, (FDA Commissioner) Robert Califf and (director of the FDA’s Center of Tobacco Products) Mitch Zeller will transform back into their Mr. Hyde alter-egos and resume their hellbent mission to sabotage the single-most effective smoking cessation device ever devised,” said Wheeler. “Well, the American people are watching and I for one am not going to stand by and let them get away with it. So, here’s my own announcement for today: FDA and CDC have my approval to stop deceiving the American public about the safety and efficacy of nicotine vaping.”
The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products, mostly non-tobacco flavors.
“While Logic received marketing orders for its tobacco-flavored products, it is still awaiting a determination from the FDA on its menthol products. At the FDAs discretion, products like Logic’s menthol capsules can continue to be marketed while under review,” Logic stated in the release. “Additionally, Logic received marketing denial orders (MDOs) for flavored products that are not currently on retailers’ shelves. Logic is reviewing the FDAs determination and rationale before taking further action.”
The FDA also indicated that it was moving closer to issuing decisions on other applications that account for “a large part” of the marketplace, which based on Nielsen ratings, are mostly owned by large tobacco companies.
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
March 25, 2022
FDA Issues Marketing Orders to 8 Logic Vaping Products

The U.S Food and Drug Administration today authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S.. The brands include Logic Vapeleaf, Logic Power and Logic Pro, including hardware devices. The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products. Any of those products currently on the market must be removed or FDA may take enforcement action, according to the FDA.
These products were authorized after the agency said its review of the product applications concluded, among other things, that the “likely benefit for adult smokers who significantly reduce their cigarette use (or who switch completely and experience cigarette use cessation) outweighs the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.
While today’s action permits these specific products to be sold in the U.S., it does not mean these products are safe nor are they “FDA approved.”
“Retailers should contact Logic with any questions about products in their inventory. Applications for Logic’s additional products, including menthol, remain under FDA review,” an FDA release states. “The FDA has taken action on approximately 99 percent of the nearly 6.7 million ENDS products submitted for premarket authorization, including issuing marketing denial orders for more than 1 million ENDS products.”
The agency is close to making additional decisions on applications for popular ENDS products that account for a large part of the market. The continued marketing of these products has the potential to have a substantial public health impact—either positively or negatively—as they hold an overall large market share and are used by a lot of people.
“As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” said FDA Commissioner Robert M. Califf. “We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine. The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”
Under the premarket tobacco product application (PMTA) pathway, manufacturers or importers must demonstrate to the agency, among other things, that marketing of a new tobacco product would be appropriate for the protection of the public health. That statutory standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The FDA must also consider the likely impact of the products on people’s behavior—specifically, the likelihood that existing users will stop using such products and the likelihood that those who do not use tobacco products will start using such products.
This is especially important for youth. Before a product is authorized under the PMTA pathway, the agency reviews a tobacco product’s components, ingredients, additives, constituents and health risks, as well as how the product is manufactured, packaged and labeled.
“Ensuring new tobacco products undergo premarket evaluation by the FDA is a critical part of our work to reduce tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “For the authorized products, the manufacturer demonstrated that possible benefits to adult smokers outweigh the risk of youth possibly initiating. We are making progress in our review of flavored ENDS, and we will continue to deny marketing of products where the applicant hasn’t provided enough evidence to show that the potential benefit to adult smokers outweighs the considerable risk to youth. We are committed to continuing to take the appropriate actions to protect our nation’s youth from the dangers of all tobacco products, including e-cigarettes, which remain the most commonly used tobacco product by youth in the United States.”
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
March 24, 2022
U.S. Senators Pen Letter Urging FDA to Combat Youth Use
Credit: Ekim
U.S. senators Jeanne Shaheen and Maggie Hassan joined a bipartisan group of their Senate colleagues in calling on the Food and Drug Administration to take long-overdue action to combat the youth vaping crisis, which includes steps that could remove kid-friendly, addictive e-cigarettes from the market.
The letter, which was signed by 13 additional legislators, including senators Mitt Romney and Elizabeth Warren, claims the FDA has not prioritized its review of e-cigarettes with the largest market share and “therefore greatest public health implication.” Instead, the agency has deferred its decisions on the most critical applications—including for those products that are most popular with youth—to the end, the Senators wrote to FDA Commissioner Robert Califf.
“Now that FDA is six months past the court deadline, these unreviewed products are only being permitted to stay on the market due to the agency exercising enforcement discretion. It makes no sense, and runs contrary to the Tobacco Control Act’s statutory framework, that products that have not been granted authorization are being allowed to stay on the market and attract new, young users,” the letter states.
“FDA has the authority and responsibility to halt this grace period today and restore the statutory burden of proof on manufacturers to demonstrate their product is ‘appropriate for the protection of public health’ prior to market entrance,” the Senators continued. “It is our hope and expectation that you can bring a new approach and commitment to using all of FDA’s tools and prioritizing public health to protect youth from the harms of tobacco and nicotine.”
March 23, 2022
U.S. FDA Issues First Warning Letter for Vapor Hardware
Sigelei Humvee 80 coil
The U.S. Food and Drug Administration has issued hundreds of warning letters for vaping products, typically illegal e-liquids. On Tuesday, however, the regulatory agency posted its first warning letter for vaping hardware products. The letter was issued on Feb. 14 to China-based Sigelei Vapor for two coil brands.
“Our review of the website http://sigelei.com revealed that you manufacture and offer for sale or distribution to customers in the United States ENDS [electronic nicotine-delivery system] products without a marketing authorization order including: Sigelei Humvee 80 and Sigelei 213 Fog Coil,” the warning letter states.
The letter also states that Sigelei received a “refuse to accept” letter from the FDA on February 5, 2021 in response to the company’s premarket tobacco product applications (PMTAs) for six Sigelei products. “New tobacco products that do not have the required FDA marketing authorization order in effect, including your ENDS products covered by PMTA STN PM0001221 that resulted in a Refuse to Accept determination, are adulterated and misbranded,” the agency wrote.
The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. The agency has traditionally only issued letters for e-liquids, but now hardware manufacturers have been put on notice. One manufacturer, who asked to remain anonymous to avoid FDA scrutiny, said the recent action is worrisome.
“The hardware segment has been operating almost at a near-normal, the same as before PMTAs were due. It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too,” the manufacturer said. “This is going to hurt several companies and we are going to start to see smaller businesses end their marketing in the U.S.”
The letter also suggests that the warning is for all Sigelei products and not just the rejected PMTA products. “The violations discussed in this letter do not necessarily constitute an exhaustive list,” the letter states. “You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly take any necessary actions to bring your tobacco products into compliance with the FD&C [Food, Drug & Cosmetics] Act.”
February 23, 2022
Robert Califf Confirmed, Returns as FDA Commissioner
He’s back. The U.S. Senate on Feb. 15 narrowly confirmed Robert Califf as commissioner of the U.S. Food and Drug Administration, reports The New York Times.
The vote was 50-to-46, with six Republicans crossing the aisle to support him while five senators who caucus with Democrats opposed him. One senator voted present.
Credit: Bill Clark/CQ Roll Call
A cardiologist who has served as the deputy commissioner of the FDA’s Office of Medical Products and Tobacco, as President Barack Obama’s FDA commissioner and as the head of medical strategy at Alphabet, Google’s parent company, Califf takes over the position from Janet Woodcock, the acting commissioner since President Joe Biden assumed office more than a year ago.
According to Vaping360, Califf has been generally antagonistic toward vaping as a consumer product. He was at the FDA helm in 2016 when the agency rolled out the Deeming Rule, which gave the FDA authority over e-cigarettes and other tobacco-free nicotine products.
Tellingly, the Campaign for Tobacco-Free Kids (CTFK) enthusiastically welcomed Califf’s appointment. “Dr. Califf is highly qualified and prepared on day one to address the enormous challenges facing the FDA, including the most significant decisions on tobacco in the agency’s history,” wrote CTFK President Matthew L. Myers in a statement.
Califf is expected to be sworn in this week. He faces a looming flurry of decisions, including reviews of premarket tobacco applications from leading e-cigarette companies, such as Juul Labs. He will also have to contend with litigation from vapor companies over marketing denial orders (MDOs).
After issuing MDOs to hundreds of manufacturers for hundreds of thousands flavored product, the agency has been challenged in court by more than 30 companies that claim their PMTAs were denied based on a standard that was not in place when the applications were submitted.
One of the new commissioner’s first tasks will be working with Health and Human Services Secretary Xavier Becerra to find a replacement for Center for Tobacco Products Director Mitch Zeller, who plans to retire in April.
February 16, 2022