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FDA Files Statement of Issues

October 31, 2023 By Matthew Tabacco
FDA Updates

Today, the Food and Drug Administration filed a number of documents in their appeal of Judge Mehta’s decision, including a Statement of Issues to be Raised. The Statement of Issues to be Raised did not offer new insights into the substantive arguments FDA intends to make, and no date has been set for FDA to file substantive arguments supporting their decision to appeal.

These filings do, of course, indicate that the FDA intends to continue their pursuit of an appeal of Judge Mehta’s August 9th decision, which exempted premium cigars from the FDA’s regulation. This is a battle that the industry has been fighting for quite some time. To be clear, this is also a separate issue to the on-going efforts by the FDA to ban flavored tobacco products, that motion is still currently active and has not been decided on.

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