What’s Happening in Tobacco? Q1 2023

Delivery

This report comes in PPT.

Regulatory updates

Only a few e-vapour products authorised to be sold in the US market

The US Food and Drug Administration announced in March 2023 that over 99% of the nearly 26 million applications submitted from e-vapour product manufacturers had been revised and the agency had only authorised 23 tobacco flavoured e-vapour products and devices. The agency issued refuse to accept letters, refuse to file letters or marketing denial orders for all e-vapour products not authorised.

In accordance with the new federal law passed in April 2022, around 25 million e-vapour tobacco products and nearly one million e-vapour non-tobacco nicotine products were reviewed by the FDA since September 2020.

The FDA denies authorisation to Reynolds’ Vuse Solo menthol e-vapour products

In March 2023, the FDA issued a marketing denial order for two Reynolds’ Vuse Solo menthol e-vapour products. According to the agency, the Vuse Solo menthol refills do not meet the agency’s “appropriate for the protection of public health” standard because menthol e-cigarettes “have a known and substantial risk with regard to youth appeal, uptake and use”. The FDA has issued marketing denial orders for millions of flavoured e-liquids and pre-filled devices since the agency started the review of all e-vapour products existing in the US market in 2020.