The new U.S. administration has frozen all new and pending rules introduced in the last days of the Trump administration. Included in the freeze are the new finalized rules for premarket tobacco product applications (PMTA) and substantial equivalence (SE) that were announced on Jan. 19, the last full day of the Trump administration. What this means for the nicotine business is unclear. It does not change the rules concerning the Sept. 9 deadline to submit a PMTA to be eligible to stay on the market for year. Because the rule was not formally published in the Federal Register by the U.S. FDA before the end of Trump’s presidency, the Biden administration could move forward with the rule as is, make changes to the rule or scrap the rules entirely. An note on the Federal Register website reads,” The Food and Drug Administration withdrew this document while it was on public inspection. It will remain on public inspection until the close of business on January 27, 2021. A copy of the withdrawal request is available at the Office of the Federal Register.”
ARTICLE LINK: PMTA Included in White House Rules Freeze
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