martes, 8 de septiembre de 2020

Small vape makers seek extension on a looming FDA application deadline

Small vape makers seek extension on a looming FDA application deadline

Morning Rounds

Shraddha Chakradhar

Vape makers reach crucial FDA application deadline

Today is a high-stress day for vape makers: If they don’t submit formal marketing applications to the FDA by tomorrow, or if their paperwork doesn’t pass muster, they’ll likely be put out of business. The documentation isn’t something you can just slap together: It’s supposed to include data on the manufacturing process, the chemical ingredient list, and the potential for misuse by minors. Juul’s, for instance, runs over 125,000 pages (take that, Tolstoy!). After repeated deadline extensions and lawsuits, the agency seems unlikely to give in to a petition from companies asking for yet more time. But the FDA has indicated that it will give those who’ve submitted “deficient” applications by Sept. 9 an extra 90 days to make corrections.

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