By Emma Rumney LONDON, March 13 (Reuters) - The U.S. Food and Drug Administration this week granted a licence for sale for one more vape brand, but only in tobacco flavour, according to a public list
US FDA Authorises Glas Tobacco Vape, Maintains Strict Policy on Flavours
FDA Vape Authorisation and Flavour Policy Overview
By Emma Rumney
LONDON, March 13 (Reuters) - The U.S. Food and Drug Administration this week granted a licence for sale for one more vape brand, but only in tobacco flavour, according to a public list of licensed products.
The move highlights ongoing caution in the tobacco regulator's approach to flavoured vapes, despite guidance earlier this week that could open the door for more to go on sale.
Current Status of Vape Product Authorisations
The FDA, which must greenlight new nicotine products before they can be legally sold in the U.S., the world's largest market for smoking alternatives, has been criticised for the slow pace of authorisations.
Some applications have been open for over five years, and only 41 vape products are permitted to be sold as of this week, all of which are tobacco or menthol flavoured.
Glas Vape Authorisation Details
An updated version of the agency's list of authorised vapes dated March 12 adds a device and associated vape pod made by Glas, a small U.S. vape maker that uses technology to age-gate its devices. Only Glas' tobacco flavour was added to the list.
Glas founder Sean Greenbaum said he remained confident the company's menthol and other flavours would also be allowed to market, adding its pending applications aligned with standards outlined by the FDA in new guidance issued on Monday.
FDA's New Guidance on Flavoured Vapes
Policy Changes and Industry Response
NEW GUIDANCE
In the guidance, the agency tweaked its strict approach to flavoured vapes, a shift that follows intensifying tobacco industry lobbying and political pressure to allow more products to market.
Burden of Proof for Flavoured Vapes
The agency said it would continue to require a heavy burden of evidence of benefits to smokers for vape flavours that also have strong appeal to youth, such as fruit or candy flavours.
A lower burden of proof would be required for flavours with less known youth appeal, like coffee or spices.
Reactions from Advocacy Groups and Experts
Yolonda Richardson, president of the Campaign for Tobacco Free Kids, criticised the FDA for opening the door to more flavoured products that could addict young people, who may switch to whatever flavour is readily available.
But Mitch Zeller, a former director of the FDA's Center for Tobacco Products, said the move could help smokers and crowd out a booming market for unregulated e-cigarettes.
"There's a need to get more authorised flavoured products on the market," he said, adding however the agency would have to respond quickly if a new flavour takes off among young people.
(Reporting by Emma Rumney; Editing by Jan Harvey)
