U.S. Food and Drug Administration - Tobacco Reporter

Altria Submits PMTA for ‘On! Plus’ Pouches

Altria Group has submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration for its “On! Plus” oral nicotine pouch products. The PMTAs were submitted by Altria’s wholly owned subsidiary Helix Innovations.

On! Plus is a spit-free, oral tobacco-derived nicotine (TDN) pouch product made from a proprietary “soft-feel” material to provide a more comfortable product experience. The On! Plus pouch is designed for adults who dip and adult dual users (i.e., adults who smoke and dip).

According to Altria, On! Plus pouches are seamless and larger than the leading U.S. TDN brands. Similar to the currently marketed On! products, On! Plus packaging features a compartment to responsibly dispose of used product. Helix submitted PMTAs for three distinct On! Plus varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.

“Helix’s submission of the On! Plus applications underscores Altria’s commitment to addressing consumers’ evolving preferences through innovation in potentially reduced risk products. We firmly believe that On! Plus is a transformative product that will meaningfully contribute to Helix’s growth in the U.S. market, upon timely FDA authorization,” said Nick MacPhee, managing director and general manager of Helix in a statement.

“We’ve long believed in the value of a robust marketplace of authorized smoke-free products for adult tobacco consumers. We believe that these PMTAs demonstrate that responsibly marketed On! Plus pouches can provide a compelling alternative in the marketplace,” said Paige Magness, senior vice president of regulatory affairs, Altria Client Services.

Upon authorization, Altria expects the products to be distributed by Altria Group Distribution Co.

Helix currently sells On! nicotine pouches in the U.S. In the first quarter of 2024, On! shipment volume grew 32 percent versus the prior year and the brand achieved a 7.1 percent retail share of the total U.S. oral tobacco category.

Altria entered the U.S. oral nicotine products market in 2019 after signing a deal with Burger Söhne to acquire an 80 percent ownership stake in some companies that commercialized On! Products, according to The Wall Street Journal. In December 2020 and April 2021, Altria subsidiaries concluded transactions to buy the remaining 20 percent stake of the global on! business for about $250 million.

Altria’s PMTA announcement comes after Philip Morris International’s Swedish Match North America unit suspended nationwide sales on its U.S. website as local officials in Washington, D.C., investigate whether the company is in compliance with the district’s ban on the sale of flavored products.

June 27, 2024

FDA Authorizes NJOY Menthol Products

The U.S. Food and Drug Administration today authorized four NJOY products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY, an Altria subsidiary, for two pods for its Ace closed e-cigarette device, which was authorized in April of 2022, and two disposable e-cigarettes—NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 2.4%.

The two authorized ACE pods are the NJOY ACE Pod Menthol 2.4% and the NJOY ACE Pod Menthol 5%. All four of the newly authorized products are pre-filled and non-refillable.

The decision is significant because it is the first non-tobacco flavored vapor product to be authorized by the FDA. In his TPL Review, Office of Science Director Matthew Farrelly said that NJOY had “demonstrated the potential for these new products to benefit adults who smoke [combustible cigarettes] as compared to those who continue to use [combustible cigarettes] exclusively,” and that the company had “also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization.” Farrelly also highlighted data from a longitudinal cohort study that NJOY submitted with its application, which pointed to “robust absolute switching rates” as well as a higher rate of complete switching than tobacco-flavored NJOY DAILY ENDS.

The FDA noted, however, that applications are reviewed on a case-by-case basis, and that this authorization of menthol products does not apply to any other menthol-flavored vaping products.

“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome,” said CTP Director Brian King in the agency’s press release. “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”

Altria welcomed the authorizations. “With the addition of NJOY menthol e-vapor products, we are now uniquely positioned with an FDA-authorized portfolio to support adult smokers in their transition to smoke-free alternatives. We believe these marketing orders are a testament to the quality of the NJOY products and the strength of evidence supporting the authorizations of the NJOY menthol e-vapor products,” said NJOY President and CEO Shannon Leistra in a statement.

“We believe that, for tobacco harm reduction to succeed, adult smokers must have access to a robust marketplace of FDA-authorized smoke-free alternatives,” said Paige Magness, senior vice president, regulatory affairs of Altria Client Services. “FDA authorization of NJOY menthol e-vapor products provides adult smokers and vapers with regulated alternatives to the illicit flavored disposable e-vapor products on the market today. We believe the NJOY menthol marketing orders are a positive outcome for public health.”

The FDA previously authorized the NJOY Ace and three of its tobacco-flavored pods on April 27, 2022. In March of 2023, Altria acquired NJOY for $2.75 billion cash. The acquisition was completed on June 1, 2023. However, the transaction terms included $500 million in additional cash payments contingent upon the product approvals received today, which would bring Altria’s total spend to $3.25 billion.

June 21, 2024

Warnings Over Liquids in Medicine Bottles

The U.S. Food and Drug Administration has warned six online retailers for selling unauthorized e-liquid products from the Bad Drip brand that imitate prescription drug bottles. The retailers were also warned for selling unauthorized flavored, disposable e-cigarettes, including those under the brand names Funky Republic and HQD.

“It boggles the mind that someone thought it was a good idea to package a tobacco product to look like a prescription drug bottle,” said FDA Center for Tobacco Products Director Brian King in a statement. “There’s no place for this gratuitous and blatantly dangerous packaging, and FDA is committed to taking action against the illegal sale of these products.”

In addition to selling e-liquids that imitate prescription drug bottles, each of these retailers was warned for selling unauthorized disposable e-cigarettes that appeal to youth—including flavors such as apple watermelon and mint.

According to the 2023 National Youth Tobacco Survey, among U.S. middle and high school students who used e-cigarettes, 89.4 percent reported using flavored products and 60.7 percent reported using disposable products.

June 14, 2024

Juul Ban Reversal Welcomed

The potential return of Juul to U.S. store shelves would represent a win for consumers and tobacco harm reduction, according to the Consumer Choice Center (CCC).

On June 6, the U.S. Food and Drug Administration rescinded its 2022 marketing denial order. While the move is neither an authorization nor a denial, it places the company’s premarket tobacco product application back into scientific review, meaning it could potentially be authorized at some point.

“This is a step in the right direction for consumers who want more nicotine alternatives to combustible tobacco,” said CCC U.S. Policy Analyst Elizabeth Hicks.

The FDA said in its June 6 statement that it had “conducted additional substantive review of the applications in a number of disciplines, including toxicology, engineering, social science and clinical pharmacology” and that their change of course is based on a “review of information provided by the applicant” plus new case law based on court decisions involving MDOs for e-cigarette products.

“With over 26 million applications submitted to the FDA, less than 10 e-cigarette devices have been approved by the agency. Vaping is 95 percent less harmful than smoking combustible tobacco, and the FDA has an opportunity to help drastically improve public health by allowing consumers a choice when it comes to alternatives to combustible cigarettes,” said Hicks.

The FDA decision opens the door for Juul to return to the market in the future and allow U.S. consumers the same choice as those in the U.K. and Canada.

“We hope the FDA provides a clear and transparent pathway for Juul Labs and the thousands of other companies who submitted product applications to finally gain authorization to offer their products to consumers in a regulated market,” concluded Hicks.

June 10, 2024

FDA Updates Vaping Products ‘Red List’

The U.S. Food and Drug Administration has updated its import alert, which includes a “red list” of vapor products that may be detained “without physical examination,” the agency announced.

The alert authorizes U.S. Customs and Border Protection to detain new tobacco products that do not have the required marketing authorization under the Federal Food, Drug and Cosmetic Act, which gives the FDA the authority to regulate all tobacco products.

The list of products now includes Chinese manufacturers and distributors as well as U.S. importers and distributors.

The FDA announced last week that it is taking stronger enforcement actions against unauthorized e-cigarettes. The agency is seeking civil money penalties (CMP) against nine brick-and-mortar retailers and one online retailer for selling unauthorized Elf Bar brand vaping products. The FDA is seeking a penalty of more than $20,000 from each retailer.

“In order to remove a firm’s product from the red list, information should be provided to the agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation,” the FDA wrote. “The purpose of this is so that the agency will have confidence that future shipments/entries will be in compliance with the Federal Food, Drug and Cosmetic Act.”

June 4, 2024

Retailers Fined for Selling Elf Bar

The U.S. Food and Drug Administration is seeking civil money penalties (CMPs) from nine brick-and-mortar retailers and one online retailer for selling Elf Bar products.

The FDA previously issued warning letters to these retailers for selling unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

The agency is now seeking a CMP of $20,678 from each retailer.

“The $20,678 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including February and April of this year,” the FDA stated.

The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.

May 31, 2024

Agencies Urged to Remove Unauthorized Products

Seventy-eight U.S. public health and other organizations urged the U.S. Food and Drug Administration, the U.S. Department of Justice and the U.S. Customs and Border Protection to utilize all the enforcement tools at their disposal to clear the market of unauthorized e-cigarette products, including flavored products.

To date, the FDA has authorized the sale of only 23 tobacco-flavored e-cigarette products.

“This means that virtually the entire e-cigarette market consists of unauthorized, illegal products, including a wide variety of flavored products—largely disposables—that FDA has found to be highly appealing to youth,” the groups wrote in a letter addressed to all three agencies.

“This is a wholesale failure to enforce the Family Smoking Prevention and Tobacco Control Act by FDA and other government enforcement agencies. There must be an intensified and coordinated, multi-agency federal effort to enforce the law against these illegal products in an effective and equitable manner.”

The groups urged the adoption of several concrete changes in tobacco enforcement policies and activities, including more frequent use of enforcement tools, such as civil monetary penalties; and prioritization of efforts to stop illegal importation of unauthorized products.

“The failure to adequately enforce the law against unauthorized products has real, and significant public health consequences. We urge FDA, DOJ and CBP to respond with an ‘all hands on deck’ strategy that will use all enforcement tools at their disposal to protect the public health, and particularly the health of our young people, from the flood of illegal, unauthorized e-cigarettes,” the letter writers concluded.

May 23, 2024

Verbeten to lead CTP Compliance Office

John Verbeten will be the new director of the U.S. Food and Drug Administration Center for Tobacco Products’ Office of Compliance and Enforcement, effective June 16.

Verbeten has more than 20 years of experience leading field operations, compliance and enforcement, and national-level program management. In his latest role within Office of Import Operations, Verbeten served as the principal advisor to the Office of Regulatory Affairs’ (ORA) leadership on import operations and enforcement activities, and oversaw the FDA’s field import operations, which includes a staff of more than 700 people.

He also provided leadership in the development, implementation and evaluation of new laws, regulations and policies related to ORA’s global and national programs and activities.

Most recently, he led the agency’s development of a memorandum of understanding between the FDA and U.S. Postal Service (USPS), which established a framework that provides a basis for the development of bilateral data exchange and provides the FDA access to the USPS advanced electronic data for imported mail shipments.

May 13, 2024

MRTP Renewal Application Filed

The U.S. Food and Drug Administration on May 9 filed for scientific review modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products for the following IQOS products:

IQOS 2.4 System Holder and Charger
IQOS 3.0 System Holder and Charger
Marlboro Amber HeatSticks (formerly named Marlboro HeatSticks)
Marlboro Green Menthol HeatSticks (formerly named Marlboro Smooth Menthol HeatSticks)
Marlboro Blue Menthol HeatSticks (formerly named Marlboro Fresh Menthol HeatSticks)

In 2020 and 2022, the FDA issued modified risk granted orders for products. These orders are valid for a fixed time period. To continue marketing the MRTPs after the authorized term, the company submitted MRTP renewal applications to FDA.

Starting May 10, 2024, people may submit public comments on these applications on regulations.gov to docket FDA-2021-N-0408 for the IQOS 3.0 device and docket FDA-2017-D-3001 for the IQOS 2.4 device and the Marlboro HeatSticks products.

The FDA will post application documents, including amendments; given that the documents will need to be redacted for any confidential information, they will be posted on the Center for Tobacco Products’ website on a rolling basis.

Once all materials for these MRTP applications, including amendments, have been made publicly available, FDA will announce a closing date for the comment period. The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last application materials.

May 10, 2024

FDA Updates Authorized Products Database

The U.S. Food and Drug Administration has uploaded the first update to its recently created Searchable Tobacco Products Database, which provides an overview of tobacco products and vapor products that may be legally marketed in the United States.

Due to timing factors associated with the initial launch, the products included in this update cover a longer time period (January through mid-April 2024) than will typically be included in the future. The agency intends to update the database every month.

The current database updates include the addition of several tobacco products that were issued a substantial equivalence or exempt order, a number of tobacco products that were determined to be preexisting tobacco products through voluntary submissions, and links to redacted and 508-compliant order letters, decision summaries and other documents for various authorized products that were already in the database.

The database is available here.

May 6, 2024

Tag: U.S. Food and Drug Administration