U.S. Food and Drug Administration - Tobacco Reporter

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

Robert Califf Confirmed as FDA Commissioner

The U.S. Senate on Feb. 15 narrowly confirmed Robert Califf as commissioner of the 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.

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 15, 2022

FDA Nominee Faces Stiff Senate Opposition

U.S. President Joe Biden’s nominee to lead the Food and Drug Administration is facing stiff opposition in the Senate.

According to an article in The New York Times, abortion foes are urging Republican lawmakers to reject Robert Califf, who previously led the agency during the final year of the Obama administration. Meanwhile, key Democrats are withholding support over Califf’s opioid policies and industry ties.

At least five Democrats are publicly opposing his nomination, so Califf needs at least five Republicans to support him in the evenly divided Senate, where Vice President Kamala Harris has a tie-breaking vote.

The FDA commissioner role has been subject to Senate confirmation since 1988, unlike the director of the Centers for Disease Control and Prevention, who is a presidential appointee. The nominee tends to be subject to sharp questioning, but observers say the decision has never been so wrapped up in national politics unrelated to the nominee’s qualifications.

With no confirmed leader, Janet Woodcock, the interim commissioner, can serve while the nomination is pending. If Califf’s nomination is voted down, she could lead the agency for 210 more days, according to the Government Accountability Office.

February 7, 2022

Court Stays Bidi Vapor Marketing Denial Order

The U.S. Court of Appeals for the Eleventh Circuit has stayed the marketing denial order (MDO) issued by the U.S. Food and Drug Administration to Bidi Vapor in September 2021.

The Feb. 1, 2022, ruling allows Bidi Vapor and Kaival Brands to market and sell all of its Bidi Stick electronic nicotine-delivery systems (ENDS), including its tobacco, menthol and flavored products, while Bidi Vapor continues with its merits lawsuit compelling the FDA to place Bidi Vapor’s premarket tobacco product application (PMTA) for the flavored ENDS back under scientific review.

With the judicial stay decision going in favor of Bidi Vapor, the company expects many distribution partners to reestablish their previous sales volumes, with potentially new distribution chains added as well.

“We expect this judicial stay will result in a rebounding of Bidi Stick sales,” said Niraj Patel, president and CEO of both Kaival Brands and Bidi Vapor, in a statement. “Many wholesale and retail partners had discontinued or slowed purchases of the Bidi Stick until we heard back from the courts on the likelihood of our merits case succeeding. This is what our wholesale and retail partners have been waiting for.”

“We believe that Bidi Vapor has developed substantial, robust and reliable scientific evidence through, among other things, surveys, behavioral studies and clinical trials establishing support that the product is appropriate for the protection of the public health,” Patel said. “Following on FDA’s initial administrative stay of the MDO, we believe that this recent judicial stay is a good indication that the court finds some merit in Bidi Vapor’s arguments and puts Bidi Vapor’s PMTA one step closer to being properly and fully evaluated by FDA. We are extremely pleased with the court’s decision on this judicial stay order and continue to expect to be successful on the merits case as well.”

“The company believes that this decision signals a new milestone in the path toward providing adult smokers 21 and older with a viable alternative to combustible cigarettes. Distributors, wholesalers, retailers and adult consumers are all anxious to see positive outcomes not just for Bidi Vapor, but for the vaping industry as a whole. We believe in science-based regulation of ENDS and hope the courts will require FDA to adhere to the law as it reviews Bidi Vapor’s PMTAs,” Patel said.

February 3, 2022

FDA Webinar on Pending Product Standards

The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a live webinar, titled “FDA’s Rulemaking Process and Upcoming Tobacco Product Standards,” on Feb. 10 from 2 p.m. to 3 p.m. Eastern Time.

The webinar will address the FDA’s planned tobacco product standards to prohibit menthol as a characterizing flavor in cigarettes and to prohibit characterizing nontobacco flavors in cigars; the FDA’s rulemaking process and how stakeholders can submit comments on proposed rules; and available cessation resources and tools.

The webinar will feature a presentation from the FDA’s Office of Minority Health and Health Equity, the CTP’s Office of Health Communication and Education, and the CTP’s Office of Regulations. There will also be a question-and-answer session.

The FDA will respond only to questions submitted by Feb. 4. To submit a question, please register for the webinar and complete the appropriate field on the registration form.

The FDA stresses this webinar is not intended to communicate contents of the proposed rules or details about the timeline for their release.

The webinar is live and free of charge, but prior registration is required by Feb. 9.

February 1, 2022

FDA Looking for New CTP Director

The U.S. Food and Drug Administration is now accepting applications for the position of director of the Center for Tobacco Products (CTP). The current director, Mitch Zeller, plans to retire in April.

The CTP director is responsible for planning, managing, directing and coordinating major tobacco program objectives to implement the Tobacco Control Act and related regulations.

This senior-level FDA position advises the FDA commissioner, senior FDA officials and others on all matters involving tobacco product regulation that have an impact on policy development and execution and long-range program goals. The director develops and executes the strategies for compliance outreach, enforcement, regulations and guidance formulation, science-based application review and other product regulation activities.

The individual selected for this position will represent the agency and establish/maintain relationships in meetings and conferences with top level FDA and Health and Human Services officials, national industry representatives, members of Congress, and counterparts from federal, state, local and foreign governments.

Candidates must complete their applications by 11:59 p.m. on Feb. 25, 2022.

January 29, 2022

FDA Urged to Act on Remaining Applications

Several anti-tobacco groups have sent a letter to the U.S. Food and Drug Administration urging the agency to act on the outstanding premarket tobacco product applications (PMTAs) and pushing for the denial of all flavored e-cigarette products.

It’s been more than four months since the FDA was supposed to decide which e-cigarette products can remain on the market, but the agency still hasn’t completed some of the reviews, including some of the bestselling e-cigarettes.

“We write to urge the U.S. Food and Drug Administration (FDA) to expedite decisions on the premarket tobacco product applications (PMTAs) still pending before the agency involving the flavored e-cigarette products, including those with menthol flavoring and, based on the best available scientific evidence, deny the pending applications for all nontobacco flavored e-cigarettes in order to protect the nation’s young people from the health harms of these products,” the letter said.

The letter was signed by the American Academy of Pediatrics, the American Heart Association and the Campaign for Tobacco-Free Kids, among others.

“Every day that FDA delays action, more of our kids remain at risk,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “While the FDA has ruled on applications from a lot of small companies, it hasn’t ruled on the applications from the large companies whose products are being used by a majority of kids.”

American Vaping Association President Gregory Conley pointed to data showing that youth vaping has been declining. According to the Centers for Disease Control and Prevention (CDC), use of e-cigarettes went down among middle school and high school students from 2019 to 2020.

But even with the drop, the CDC said it “estimated that more than 2 million U.S. middle [school] and high school students reported currently using e-cigarettes in 2021.”

January 20, 2022

Tag: U.S. Food and Drug Administration