The US FDA: PMTA

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Recent Developments

April 2024: Shenzhen Yibo Technology

FDA issued marketing denial orders (MDOs) to Yibo Tech for 65 disposable e-cigarettes marketed as “MNGO Disposable Stick”. Based on scientific review, FDA specifically determined that Yibo’s applications (PMTAs)

– did not provide adequate evidence on product stability, manufacturing and product design features

– did not sufficiently demonstrate that the flavored e-cigarettes (relative to tobacco-flavored ones) could offer an added benefit to smokers that would outweigh the associated risks to youth.

More interestingly, FDA stated that the MDOs also include several “Clear” flavor products that were described as flavorless or unflavored. However, the data indicated that these products contained flavor enhancers known to impart a menthol or mint flavor. Based on the entirety of evidence, FDA determined that these products have a characterizing flavor. Recall that following the California flavor ban, tobacco companies launched “non-menthol” cigarettes with added synthetic cooling agents that activate the cold/menthol receptors (i.e. resulting in cooling sensations). For further information: Tobacco Research. US FDA’s statement implies that these products are most likely to be treated as “having a characterizing flavor”; or, in other words, a countrywide menthol (flavor) ban is likely to be defined in a way to include these products (i.e. a definition based on “sensation” rather than “ingredients”).

February 2024: Fontem US (Imperial Brands)

FDA issues marketing denial orders (MDOs) to Imperial Brands’ Fontem US for four blu disposable and one myblu e-cigarette products. The denied products include (1.2%) menthol myblu pod and (2.4%) menthol, mint, vanilla and cherry flavored blu disposable e-cigarettes.

According to the FDA’s statement:

– Fontem’s application lacked sufficient evidence regarding Harmful & Potentially Harmful Compounds (HPHCs) in the aerosol for one product and battery safety data for several products

– Fontem didn’t present sufficient data demonstrating that the new products have a potential to benefit adult smokers, in terms of complete switching or significant cigarette use reduction, that would outweigh the risk to youth. According to the 2023 National Youth Tobacco Survey, among youth who currently used e-cigarettes, 6% reported using blu e-cigarettes.

As a result of the MDOs, Fontem must remove these products from the market and must not market/distribute them in the US. However, Fontem may submit new applications for the products that are subject to these MDOs.

January 2024: US FDA – PMTA Status Report

The US FDA now expects to complete the review of pending PMTAs (for the new tobacco products that were on the market as of August 8, 2016) by June 30, 2024 while noting that

– several of the remaining applications present complex scientific issues that require careful review and consideration

– it continues the reviews in light of recent judicial decisions, including the DC Circuit’s unanimous decision in the Fontem v. US FDA case (upholding the denial of flavored vapes, but rejecting the denial of unflavored vapes)

– delays are partly caused by the manufacturers that made amendments to their PMTAs following several legal decisions (last amendment being filed as late as in December 2023).

The Agency could not meet the original deadline to complete the reviews by September 9, 2021 (i.e. one year after the PMTA submission deadline for the non-pre-existing tobacco products) due to the extremely large number of PMTAs filed by manufacturers. The US FDA is now under court order to file regular status reports on the review of pending PMTAs. The Agency expects to take action on 94% of the applications by March 31, 2024 and file another status report by April 22, 2024.

January 2024: FDA issues a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick – Classic e-cigarette. This product is a closed-system, disposable, tobacco-flavored e-cigarette device. Bidi Vapor may submit a new application to the US FDA addressing the scientific deficiencies.

Since June 2022, Kaival Brands, the US distributor of all products manufactured by Bidi Vapor, has in place an international licensing agreement with Philip Morris International for the development and distribution of its e-cigarettes (known as the Bidi Stick) outside the US.

January 2024: FDA issues marketing denial orders (MDOs) to Shenzhen IVPS Technology’s 22 SMOK e-cigarette products1. The denied products include devices, pods, atomizers and cartridges which are part of an open system e-cigarette (marketed without an e-liquid). After reviewing the company’s PMTAs, FDA determined that

– the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health

– the applicant failed to provide sufficient data to characterize constituent delivery, product stability and product abuse liability

– SMOK products have the potential to be used with any tobacco-flavored and non-tobacco flavored e-liquid on the market (as the denied SMOK e-cigarette products are not sold with an e-liquid and users instead add their separately purchased e-liquid into the device).

Following FDA’s MDOs, Shenzhen IVPS Tech filed an appeal with the New Orleans, Louisiana-based US Court of Appeals for the Fifth Circuit while stating that

– they invested more than $30Mn in PMTA preparation and their PMTAs totaled well over 600,000 pages

– they conducted harmful and potentially harmful constituent (HPHC) aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing and clinical pharmacokinetic studies (to test the products’ potential abuse liability profiles).

The US Court of Appeals for the Fifth Circuit recently vacated two other MDOs issued by the US FDA in 2021 to e-liquid manufacturers. See below for further details.

January 2024: FDA issues marketing denial orders (MDOs) to Shenzhen Youme Tech for two Suorin e-cigarette products (device and empty/refillable cartridge) and to Imperial Brand’s Fontem US LLC for their blu PLUS+ e-cigarette products (battery and 7 pre-filled e-liquids of tobacco and menthol flavors as well as additional variants currently not marketed in the US)2.

Suorin applications are denied as

– consumers are able to fill the empty Suorin cartridges with an e-liquid purchased separately

– they lacked sufficient evidence regarding abuse liability (i.e. risk of a tobacco product to promote continued use and the development of addiction and dependence).

Fontem applications are denied as, among other deficiencies, they don’t include

– sufficient ingredient information, HPHC yield quantities and abuse liability information

– sufficient evidence demonstrating that the flavored products have a potential to benefit adult smokers that would outweigh the risk to youth. 

Since 2020, FDA has received applications for more than 26Mn products and has made decisions on 99% of these applications. To date, FDA has authorized 23 tobacco-flavored e-cigarette products. 

January 2024: Reversing an earlier decision (July 2022), the New Orleans-based 5th US Circuit Court of Appeals ordered the US FDA to reconsider the marketing denial orders (MDOs) issued to two makers of flavored liquid for e-cigarettes (Triton Distribution and Vapetasia LLC)3. The court concluded that the Agency acted arbitrarily & capriciously (in issuing MDOs without reviewing the marketing plans) and also violated the fair notice doctrine.

The Court decided that the US FDA:

– has not been clear on the (relative) importance of marketing plans that restrict youth access versus scientific studies that demonstrate product benefits for adult smokers

– has not offered fair notice to conduct long-term studies on the specific flavored products.

To continue to market their flavored e-liquids, Triton and Vapetasia submitted PMTAs – which were rejected by the US FDA on the basis of failure to demonstrate that the benefit to adult smokers would outweigh the risks to youth.

October 2023: The FDA issued marketing denial orders (MDOs) to BAT for six flavored e-cigarette products under its Vuse Alto brand after determining that the applications lacked sufficient evidence to demonstrate that marketing of the products would be appropriate for the protection of the public health (i.e. added benefit for smokers relative to the known risks to youth). The denied products include three menthol-flavored and three mixed berry-flavored pods, with each flavor being offered in three nicotine strengths. US FDA requests BAT to stop marketing these products in the US in order not to risk facing FDA enforcement action. However, BAT may submit new applications for the products that are subject to these MDOs. Moreover, we expect BAT to win a temporary stay order from Appeals Court, pending the court review of the US FDA decision.

Vuse is now the most commonly sold e-cigarette brand in the USA, with Vuse Alto being its most popular sub-brand. Vuse Vibe and Vuse Ciro devices and the accompanying tobacco-flavored cartridges are approved for marketing by the FDA. Applications for six tobacco-flavored Vuse Alto products remain under the FDA review.

BAT generated 60% of the global Vuse revenue in the US in H1 2023 and menthol variants account for ~75% of Vuse consumables (i.e. ~45% of global Vuse revenue is associated to the menthol variants sold in the US).

July 2023: Juul Labs submitted PMTA to the US FDA for JUUL24. The submission includes JUUL2 device, tobacco-flavored pods (18 mg/mL) and information on novel, data-driven technologies to restrict underage access. JUUL2 System was initially launched in the UK in 2021. FDA issued Marketing Denial Orders (MDO) for the currently-marketed JUUL System in June 2022 (- for further details, see the “High-profile cases: JUUL” section below).

High-profile cases: JUUL

On June 23, 2022, FDA issued a Marketing Denial Orders (MDO) to Juul Labs5,6:

– On June 24, a federal appeals court granted a temporary stay to Juul [to keep its e-cigarettes on the market], pending the court review of the US FDA decision. The court cautioned that the stay “should not be construed as a ruling on the merits”

– On July 5, the FDA temporarily suspended the marketing denial order for JUUL as it determined that there are scientific issues unique to the JUUL application warranting additional review

– On Sept 20, Juul sued FDA over the agency’s refusal to disclose documents supporting its order to take Juul’s e-cigarettes off the shelves in the US market. Juul accused the FDA of violating the Freedom of Information Act.

High-profile cases: Others

FDA issued MDO to Imperial Brands/Fontem’s myblu portfolio in April 2022. The Agency also denied marketing to BAT and JT’s menthol vapes. On July 10, 2023, the FDA issued MDO for Imperial’s myblu menthol (2.4%) product7

Litigation

Some FDA decisions are successfully challenged at court, creating uncertainty

– JUUL, Vuse and Logic won temporary stay orders from Appeals Court, pending the court review of the US FDA decision.

– In Aug 2022, the Eleventh Circuit Court vacated the MDOs of six smaller e-cigarette companies, forcing the FDA to conduct new reviews.

– In May 2023, the FDA Commissioner stated that the Agency is drained by the tobacco lawsuits: more than 40 lawsuits initiated by the e-cigarette companies [whose marketing applications were denied] are ongoing. He also hinted that the FDA would soon discuss [PMTA] enforcement with the DOJ.

Background Information

A Pre-market Tobacco Product Application (PMTA) is submitted to obtain FDA marketing order. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health8.

The FDA requested all new (i.e. non-pre-existing) tobacco products, that was on the market as of Aug 8, 2016, to submit a PMTA by Sept 9, 2020 as required by the Court:

– Products on the market as of Feb 15, 2007 are considered pre-existing tobacco products (and a pre-existing product does not require an application)

– A new tobacco product, that was not on the market as of Aug 8, 2016, is required to submit a PMTA and receive authorization before marketing the product

The FDA accepted 6.7Mn products for review, almost all of which are for e-cigarettes. In May 2022, FDA issued its first PMTA Status Report:

– Decision issued on 99+% of the applications

– Decision on all remaining applications to be taken by June 30, 2023 (later postponed to the end of 2023)

– Prioritized review for the brands with the largest Share of Market

So far, in the e-cigarette category, FDA granted 23 [PMT] marketing orders to three companies9:

– BAT/Reynolds: Vuse (9 products)  

– Japan Tobacco: Logic (8 products)

– NJOY (6 products)

Outside the e-cigarette category, the FDA has – so far – granted 22 [PMT] marketing orders to

– Swedish Match: General Snus portfolio (8 products; first ever PMTA in Nov 2015)

– PMI: IQOS heated tobacco portfolio (8 products; April 2019, Dec 2020, Jan 2022)

– 22nd Century: VLN cigarettes (2 products; Dec 2019)

– Altria: Verve portfolio (4 products; chewable, but non-dissolvable nicotine pills; Oct 2021).

References:

  1. https://www.fda.gov/tobacco-products/ctp-newsroom/fda-denies-marketing-smok-e-cigarette-products ↩︎
  2. https://www.fda.gov/tobacco-products/ctp-newsroom/fda-denies-marketing-suorin-and-blu-plus-e-cigarette-products ↩︎
  3. E-Cigarette Liquid Makers Win Review of FDA Product Block (bloomberglaw.com) ↩︎
  4. https://www.juullabs.com/next-generation-platform-pmta ↩︎
  5. https://nytimes.com/2022/06/24/health/juul-ecigarettes-ban.html ↩︎
  6. https://axios.com/2022/09/20/juul-sues-fda ↩︎
  7. https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-products-marketing-orders ↩︎
  8. https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications ↩︎
  9. https://www.fda.gov/tobacco-products/premarket-tobacco-product-applications/premarket-tobacco-product-marketing-granted-orders ↩︎

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