FDA grants first PMTA authorization for electronic cigarettes | Morgan lewis

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The United States Food and Drug Administration recently issued an order authorizing RJ Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These approvals mark the first time that the FDA has cleared such a product for sale under the pre-market tobacco product application pathway.

As we discussed in a previous LawFlash, as part of the pre-market tobacco product application (PMTA) procedure, 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 sufficient product information to enable the FDA to determine that an order authorizing the marketing of the product is “appropriate for the protection of public health.”

THE PMTA STANDARD

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

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

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

RJR STEAM PRODUCTS MEET THE STANDARD

In a press release announcing the approval, the FDA noted that RJR Vapor products met the PMTA standard, in large part because study participants who only used approved products were exposed to fewer harmful and potentially harmful (HPHC) constituents in aerosols. compared to users of burnt cigarettes. A toxicological evaluation also revealed that the aerosols of RJR Vapor products are significantly less toxic than burnt cigarettes.

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

KEY POINTS TO REMEMBER

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

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

Products for which applications were submitted before the deadline could generally remain on the market for up to one year from the date of the application pending FDA review. The FDA reports that it has taken action on more than 98% of claims submitted before the deadline, including issuing over a million denial-of-market orders for flavored ENDS products that were not responding to the PMTA standard. It is not known how the FDA intends to focus its enforcement resources on currently marketed ENDS.

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