After a year of hype and endless stories about FDA’s Sept. 9, 2021 decisions that would “determine the future of vaping,” the agency punted on its obligations and left the vaping industry twisting in the wind.
The FDA issued no product authorizations, announced no exemptions for manufacturers allowing continued sales, and offered no enforcement discretion assurances for businesses whose products haven’t been denied.
The agency reaffirmed in April that it would not (and could not, based on the court order) issue a blanket exemption to the industry. Companies that have not received a specific Marketing Denial Order (MDO) or authorization for a product will technically be selling it illegally tomorrow, but the agency said it recognizes “that we are unable, as a practical matter, to take enforcement action against every illegally marketed tobacco product, and that we need to make the best use of Agency resources.”
Jim McDonald – Vaping360 – 2021-09-09.
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