FDA Premarket Tobacco Product Application (PMTA) Pathway
Under FDA’s premarket tobacco product application (PMTA) pathway, manufacturers or importers of tobacco products must demonstrate to the U.S. Food and Drug Administration (FDA) that the marketing of a new tobacco product would be appropriate for the protection of the public health (APPH). See Section 910(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA). This statutory threshold standard requires that FDA consider the risks and benefits of the product to the population as a whole, including users and non-users of tobacco products. The Agency’s risk-benefit analysis includes evaluating the impact of the product, both the likelihood that existing users will stop using such products and the likelihood that non-users, particularly youth and vulnerable populations, will start using such products. In its evaluation of whether a product is appropriate for the protection of the public health, the Agency reviews a product’s components, ingredients, additives, constituents, health risks, the manufacturing process, and the product’s packaging and labeling. If FDA concludes that the benefits outweigh the risks, it may authorize the product for marketing, which the Agency notes is different from the approvals that it issues for drugs or medical device products. Under the provisions of Section 910 of the FD&C Act, an issuance of a marketing granted order allows the introduction into interstate commerce of the tobacco products.
As of March 24, 2022, FDA announced that it has now taken action on approximately 99% of the almost 6.7 million electronic nicotine delivery system (ENDS) products submitted for premarket authorization. As previously reported, the vast majority of these applications for non-tobacco flavored ENDS have either been refused filing or have been denied. As to its next order of business, FDA has signaled that it will be issuing decisions on applications for popular ENDS products, noting that these products have the potential to substantially impact public health, positive or negative, given their large market share.
FDA Issues Marketing Granted Orders to Logic Technology Development LLC
On March 24, 2022, FDA authorized several tobacco-flavored electronic nicotine delivery system (ENDS) products from Logic Technology Development LLC (Logic), including various e-cigarette devices and tobacco-flavored cartridges/capsules. The Agency noted that several other products from Logic were issued marketing denial orders and must be removed from the market or be subject to enforcement action. Further, additional PMTAs remain under review (e.g., menthol products).
Last October, FDA issued its first authorization for an e-cigarette device and tobacco-flavored cartridges produced by the R.J. Reynolds Vapor Company under the brand name Vuse. The Agency notes that its authorization for the sale of such products (e.g., Logic or Vuse ENDS products that received marketing granted orders) does not mean that these products are safe, nor are they considered “FDA approved.” Instead, FDA has concluded after its review that the likely benefit for adult smokers who use such products and significantly reduce their cigarette use outweighs the risk to youth. The company must follow post-market requirements to reduce youth access and youth exposure to their marketing.
Logic PMTAs
The Agency issued premarket tobacco product marketing granted orders[1] for the following Logic products:
- Logic Vapeleaf Regular Cartridge/Capsule Package – a blister pack of 5 capsules
- Logic Vapeleaf Cartridge/Capsule Package – a closed e-liquid cartridge containing an atomizer and U-plugs on either end of the cartridge
- Logic Vapeleaf Tobacco Vapor System – a closed e-cigarette device
- Logic Pro Tobacco e-Liquid Package – a tobacco flavored closed e-liquid product
- Logic Pro Capsule Tank System – a closed e-cigarette device
- Log Pro Capsule Tank System – a closed e-cigarette system battery unit/USB charger
- Logic Power Tobacco e-Liquid Package – a closed e-liquid cartridge containing tobacco flavored e-liquid
- Logic Power Rechargeable Kit – a closed e-cigarette with battery unit/USB charger
The Vapeleaf sub-brand products are electronic cigarette products, while the Logic Pro sub-brand products are rechargeable ENDS devices with a traditional screw-in atomizer supplement.
In its decision summaries[2] and order letters, FDA has noted that in making the APPH assessment for noncombustible tobacco products such as ENDS products, the Agency weighs the negative public health impact (i.e., youth initiation and use of the product) against the potential positive public health impact (i.e., decrease of adult traditional combustible cigarette users). The Agency explained that Logic’s products were authorized only after the Agency concluded that Logic had demonstrated that the products were appropriate for the protection of public health. FDA based its conclusions on the following:
- Data demonstrating that the marketing of Logic products may help addicted smokers transition from combustible cigarette use. Specifically, current smokers were more likely to decrease their use of traditional combustible cigarettes, from an average of 13–16 cigarettes per day (Day 1) to 1–2 cigarettes per day (by Day 59).
- Data showing that, in comparison to traditional combustible cigarettes, ENDS products produced fewer or lower levels of toxins (e.g., carbon monoxide).
- Data demonstrating that non-smokers, particularly youth, were unlikely to start using ENDs products. However, FDA noted that Logic is still subject to strict post-marketing requirements and must comply with the applicable statutory or regulatory requirements to minimize the potential for youth access and exposure. In addition, Logic is still subject to the Agency’s enforcement discretion (i.e., if Logic fails to comply with any applicable requirements or if there is a notable increase in the number of non-smokers who begin to use the authorized products, the Agency may suspend or withdraw the marketing order).
- Logic’s PMTA marketing materials indicated that to decrease the potential for youth use of its products, Logic (1) eliminated all social media accounts as of September 28, 2020; (2) does not pay social media or other influencers to market or promote Logic’s products; (3) does not employ social media bots to market products; (4) only uses models over the age of 30 in its marketing materials; (5) does not use characterizing words that appeal to youth (e.g., sweet, fruity, candy, juicy, etc.); (6) does not use cartoon imagery or images of foods marketed to youth; (7) requires adult consumers to confirm that they are current tobacco or vapor users; and (8) requires mandatory age verification when purchasing Logic products.
- Microbial stability data supporting the stability of the products over 12 months.
The Agency highlighted that the risk for the use of tobacco-flavored ENDS products by youth is lower than for flavored ENDS products. Accordingly, a PMTA applicant has a higher burden to establish that the product meets the APPH standard. Notably, the above products which have received a marketing granted order are tobacco-flavored ENDS products.
As regulated tobacco products, Logic’s authorized ENDS products are subject to the requirements of the FD&C Act, which include submission of annual registrations, ingredient and product listing requirements, reporting of harmful and potentially harmful constituents, packaging, labeling, and advertisement requirements. Should any information submitted in the PMTAs (e.g., marketing and advertising of products) change and have an effect (e.g., expanding opportunities to reach youth), those changes may, in turn, affect FDA’s APPH analysis of the products and the marketing granted order.
FDA Issues Marketing Denial Orders to Fontem US, LLC
On April 8, 2022, the Agency issued marketing denial orders (MDOs) to Fontem US, LLC (Fontem) for several of the company’s ENDS products under the ‘myblu’ brand. In reviewing Fontem’s PMTAs, FDA determined that the applications lacked sufficient evidence to show that permitting the marketing of the myblu products would meet the Agency’s APPH standard.
The Agency has noted that it is not typical practice to disclose whether a company has submitted a PMTA or its intent to commercially market a new product that has never been marketed. However, FDA has indicated that the Fontem products listed below are confirmed by the manufacturer to currently be on the U.S. commercial market. In addition, the products subject to the April 8, 2022 MDOs are listed on the publicly available ‘Deemed New Tobacco Product Applications Lists,’ which indicate products for which PMTAs were timely submitted by September 9, 2021. The following Fontem ENDs products are subject to an MDO:[3]
- 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%
FDA has also indicated that it issued several MDOs for Fontem products that were not on the publicly available Deemed New Tobacco Product Applications Lists; thus, FDA cannot release those product names. Tobacco products subject to an MDO (or negative action regarding its PMTA submission such as a Refuse to Accept or Refuse to File) may not be offered for sale, distributed, or marketed in the U.S., and if already on the market, they must be removed.
Notably, the Agency has noted in its announcement of Fontem’s MDOs, that its “highest enforcement priorities are ENDS products for which no application is pending, including, for example, those with an MDO or those for which no application [has been]… submitted.”
[1] See Logic Technology Development LLC’s marketing granted orders; available at: https://www.fda.gov/media/157143/download.
[2] See FDA’s decision summaries for Logic Technology Development LLC’s marketing granted orders; available at: https://www.fda.gov/media/157144/download.
[3] See FDA, Center for Tobacco Products April 8, 2022 press release re the Agency’s issuance of marketing denial orders to Fontem US, LLC for several of the company’s ENDS products; available at: https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-denial-orders-fontem-us-myblu-products?utm_campaign=ctp-pmta&utm_content=CTPStatement&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms.