The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first time FDA authorized the marketing of such a product under the premarket tobacco product application pathway.

As we discussed in a previous LawFlash, under the premarket tobacco product application (PMTA) pathway, to market a new or modified tobacco product—including an electronic nicotine delivery system (ENDS)—an applicant must submit a PMTA to the Food and Drug Administration (FDA) providing information on the product sufficient to allow FDA to determine that an order authorizing the product’s market introduction is “appropriate for the protection of the public health.”

THE PMTA STANDARD

To make a determination on whether market introduction is appropriate for the protection of public health, FDA considers the risks and benefits to the population as a whole, including whether the tobacco product will

• increase or decrease the likelihood that existing users of tobacco products will stop using such products; and
• increase or decrease the likelihood that those who do not use tobacco products will start using such products.

This includes a review of available data on the likelihood of use of the product by young people.

RJR VAPOR PRODUCTS MEET THE STANDARD

In a press release announcing the approval, FDA noted that the RJR Vapor products were found to meet the PMTA standard, in key part because study participants who used only the authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols when compared to users of combusted cigarettes. A toxicological assessment also found that the RJR Vapor products’ aerosols are significantly less toxic than combusted cigarettes.

The RJR products’ authorization includes strict marketing restrictions, including on digital, radio, and television advertising. RJR Vapor will also be subject to ongoing reporting requirements.

KEY TAKEAWAYS

As it currently stands, the PMTA process presents a significant barrier to market entry for ENDS and casts a long shadow on the industry’s long-term prospects for viability. However, new entrants on the market may be able to model their applications on RJR Vapor’s successful approach.

FDA reported in September that it received thousands of submissions representing more than 6.5 million products by the PMTA deadline of Sept. 9, 2020. The vast majority of those applications were for ENDS products.

Products for which applications were submitted by the deadline could generally remain on the market for up to a year from the date of the application pending FDA review. FDA reports that it has taken action on more than 98% of the applications submitted by the deadline, including the issuance of more than one million Marketing Denial Orders for flavored ENDS products that failed to meet the PMTA standard. It is unclear how FDA intends to focus its enforcement resources with currently marketed ENDS.

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