martes, 1 de septiembre de 2020

T minus 9 days till Vaping D-Day

D.C. Diagnosis
Nicholas Florko

T minus 9 days till Vaping D-Day

Vaping companies have just nine days until they must submit formal applications to the FDA for permission to sell their products or risk being kicked off the market. It’s the most make-or-break moment in the industry’s short, chaotic history: Companies that don’t submit applications will likely be put out of business, as will companies that see their applications rejected by the FDA.

The deadline is a long time coming, and shrouded in controversy: The FDA has repeatedly offered extensions. It was even sued by tobacco control advocates in March 2018 over the issue.

A number of the top vaping companies, like JUUL Labs, Reynolds American, which makes VUSE, and Fontem, which makes blu, submitted their applications earlier this year, but small companies are asking for an extension. As I report in a new story for STAT this morning, it’s not entirely absurd to ask for the extension, given the pandemic and the demanding nature of the ask — JUUL’s application, for example, is 125,000 pages. But even just the formal extension request garnered more than 5,000 comments this past weekend, and tobacco control advocates have circulated their own petition urging the FDA to reject any extension. That petition garnered over 121,000 signatures. Read more here.

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