U.S. Food and Drug Administration - Tobacco Reporter

FDA Ignored Evidence in ‘Deeming’ Premium Cigars

The U.S. Food and Drug Administration ignored evidence about health risks in considering premium cigars to be subject to same law as cigarettes, a federal judge ruled on July 5, reports Reuters.

The litigation focuses on the 2016 Deeming Rule, in which the agency identified a wide range of tobacco products, including premium cigars, to be subject to its regulatory authority along with cigarettes under the Family Smoking Prevention and Tobacco Control Act.

The FDA rule requires cigar makers to register their products annually, provide ingredient lists for each product and submit products for laboratory testing—procedures the premium cigar industry considers impractical for its handmade, “artisan” products.

The Premium Cigar Association and Cigar Rights of America challenged the Deeming Rule, arguing that, unlike cigarettes and e-cigarettes, premium cigars do not appeal to young people and are not associated with addiction. They cited studies showing that young people are unlikely to use premium cigars, that users of premium cigars are unlikely to smoke them frequently and that infrequent cigar use is not associated with increased mortality.

U.S. District Judge Amit Mehta in Washington DC agreed that the FDA had not adequately considered the studies cited by the plaintiffs, instead asserting that there was “no evidence” that premium cigars were less harmful.

“Where, as here, an agency speaks in absolute terms that there is no evidence, it acts arbitrarily and capriciously when there is in fact pertinent record evidence and the agency ignores or overlooks it,” the judge wrote.

Judge Mehta asked the FDA and the industry groups to submit briefs on whether he should vacate the FDA’s decision or simply remand the matter back to the agency.

July 6, 2022

It’s Official: FDA Denies Juul Market Access

Today, the U.S. Food and Drug Administration confirmed what many had already been anticipating: Juul Labs must remove all currently marketed Juul products from the U.S. market.

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

These marketing denial orders (MDO) pertain only to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products.

After reviewing the company’s premarket tobacco product applications, the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data—including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods—that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.

The FDA says that, to date, it has not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the Juul products.

“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device,” the agency wrote in a statement.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

June 23, 2022

Zeller: CTP Tenure ‘Incredibly Rewarding’

Mitch Zeller, the outgoing director of the U.S. Food and Drug Administration Center for Tobacco Products (CTP), described his tenure at the center as “incredible rewarding.” “I’ve had the opportunity to work with the best, hardest working people in the world and we’ve gotten a lot done, so my time here has been a joy,” he said in an interview published on the FDA website ahead of his retirement from public service in April.

Zeller joined the CTP as director in March 2013. During his tenure, the center grew from 426 people to more than 1,110. The CTP, said Zeller, also published multiple foundational rules and took action on just over 99 percent of marketing applications for 6.7 million products.

Asked about the remaining challenges for the CTP, Zeller cited the importance of taking action on the remaining marketing applications, but noted that the center and the agency are “more than up to the task.” He also stressed the importance of evidence-based policies.

“We must be faithful to our responsibility that whatever decision we make on any of them is firmly grounded in the science, whether we’re issuing a marketing authorization or a marketing denial order,” said Zeller.

Asked what advice he would give to the next CTP director, Zeller said he would encourage him or her to ask questions. “You’ll be working with extraordinarily talented people in the Commissioner’s Office and throughout the agency as well as the Department of Health and Human Services,” he said. “A lot of new insights and good thinking can come from people hearing a question that hadn’t occurred to them.

On the future of tobacco regulation, the outgoing CTP director said the opportunity over the next three to five years is for the center to continue the process of building the institution. “CTP remains the “baby” center in terms of how long it’s been around compared to the other FDA centers,” he said.

“In light of that, one of the things that I think I can safely predict is that more and more of those critically important foundational regulations will be proposed and finalized. With each one that comes, CTP will become that much more mature and stood up as a center like its sister centers that have been around for many, many decades.”

April 20, 2022

FDA to Provide PMTA Updates Every Three Months

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.

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 approved some products from Vuse and Logic, while denying applications for Blu’s Myblu products.

The decision was expected by the vaping industry. Speaking during Keller and Heckman (K&H) annual E-Vapor and Tobacco Law Symposium Feb. 2–3, K&H Partner Azim Chowdhury 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.

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 Tobacco Reporter’s sister publication 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 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 17, 2022

FDA Denies Market Access to Myblu

The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to Fontem US 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.

According to a notice published on the FDA’s website, the currently marketed products receiving MDOs include Myblu Device Kit, Myblu Intense Tobacco Chill 2.5% and Myblu Intense Tobacco Chill 4.0%.

In reviewing premarket applications for tobacco products, the FDA evaluates the risks and benefits of those products to the population as a whole, including users and nonusers of the tobacco product, and considers, among other things, the likelihood that those who do not currently use tobacco products will start using those tobacco products.

Based on the information 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 FDA. 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, the agency said.

Tobacco products subject to an MDO may not be offered for sale, distributed or marketed in the U.S.

April 8, 2022

Michele Mital to lead FDA CTP

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will name Michele Mital, the current deputy director of the CTP, as acting director when Mitch Zeller retires in April, reports Vaping360.

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.

Mital joined the FDA in 1996 and has held various positions in the agency, including in the Office of Legislation. Since the CTP was formed in 2009, Mital has worked there in various capacities. She was named deputy director in 2018.

The FDA is still looking for a permanent director.

March 31, 2022

Health Groups Urge FDA Action on Top Vape Brands

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

Reduced-Exposure Claim for IQOS 3

The U.S. Food and Drug Administration has issued a modified-risk granted order authorizing Philip Morris Products to market the IQOS 3 system holder and charger with the following reduced-exposure information:

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.
This reduced-exposure information is the same as the information previously authorized by FDA in July 2020 for an earlier version of the device.

Today’s action follows the FDA’s review of a new modified-risk tobacco product (MRTP) application submitted by the company for the IQOS 3 system holder and charger. This MRTP application primarily cross-referenced the supplemental premarket tobacco product application for this device, which was authorized for legal sale and distribution in the United States in December 2020, as well as the MRTP application for the previous version of the device.

The IQOS 3 device is similar in design to the previous version (with mainly aesthetic changes), uses the same tobacco source, and the company requested to use the same exposure reduction claim as authorized for the previous version of the device. Given these similarities, FDA largely relied on its past evaluations of the IQOS 3 device and previous version of the device in determining that the IQOS 3 device meets the authorization criteria to be marketed as an MRTP.

Headquartered in Switzerland, Philip Morris is currently banned from importing the product into the United States following an adverse ruling in a patent dispute with BAT’s Reynolds American subsidiary.

In an interview with Bloomberg, PMI CEO Jack Olczak said the company plans to manufacture IQOS in the U.S. to get around the import ban.

March 11, 2022

First FDA Warning for Vapor Hardware

The U.S. Food and Drug Administration posted its first warning letter for vaping hardware products on Tuesday. The letter was issued on Feb. 14.

“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 agency wrote in its letter.

On Feb. 5, 2021, the FDA sent Sigelei a “refuse to accept” letter regarding its premarket tobacco product application (PMTA) for six 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 warned.

The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. Thus far, the agency has 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,” the manufacturer said. “It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too. 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.

February 23, 2022

Graphic Health Warnings Postponed Again

The U.S. Food and Drug Administration has postponed the effective date of its “Required Warnings for Cigarette Packages and Advertisements” final rule to April 9, 2023, following a Feb. 10, 2022, ruling by the U.S. District Court for the Eastern District of Texas.

The move marks at least the fifth delay for graphic warning health warnings in the United States when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022, and July 13, 2022.

The FDA released its final rule requiring new graphic warnings for cigarettes in March 2020. The rule calls for labels that feature some of the lesser known health risks of smoking, such as diabetes. The graphic warnings 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.

In April and May 2020, cigarette manufacturers and retailers sued the FDA, arguing that the graphic warning requirements amount to governmental anti-smoking advocacy because the government has never forced makers of a legal product to use their own advertising to spread an emotionally charged message urging adults not to use their products.

In a more recent challenge, tobacco companies argued that the deadline was too onerous due to the impact of the Covid-19 pandemic. They also pointed to the risk that they would lose their investments in new packaging if the graphic health warning requirement were to be thrown out in court.

In March 2021, the Texas District Court granted a motion by the plaintiffs to postpone the effective date of the final rule to April 14, 2022. The move was followed by additional postponements.

This is the FDA’s second attempt to enact graphic health warnings under the 2009 Family Smoking Prevention and Tobacco Control Act. The first rule was struck down by the federal court in the District of Columbia as a violation of the First Amendment.

Pursuant to the Feb. 10, 2022, court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. The FDA encourages entities to submit cigarette plans as soon as possible, and in any event by June 10, 2022.

February 16, 2022

Tag: U.S. Food and Drug Administration