In an update to the case of the American Association of Pediatrics versus the U.S. Food & Drug Administration, district court judge Paul Grimm has ruled that the FDA must set a deadline of 10 months to begin enforcing pre-market tobacco applications. The PMTA process is still not completely prepared, as HPHC guidance has still not been issued.
Grimm’s order reads, in part:
- The FDA shall require that, for new tobacco products on the market as of the August 8, 2016 effective date of the Deeming Rule (“New Products”), applications for marketing order must be filed within 10 months of the date of this memorandum Opinion and Order;
- New Products for which applications have not been filed within this period shall be subject to FDA enforcement actions, in the FDA’s discretion.
- New Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application;
- The FDA shall have the ability to exempt New Products from filing requirements for good cause on a case-by-case basis.
With HPHC (Harmful and Potentially Harmful Constituents) guidance not yet having been provided, however, it will be impossible for manufacturers to comply with such a short deadline.
The ruling can be read in full here. (H/T to Mindy Wuenschell and North Guide Solutions for the link and the full document.)
John Castle is a contributing writer and news contributor for VAPE News Magazine. Contact him at firstname.lastname@example.org.
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