The Food and Drug Administration (FDA) has withdrawn a rule to take effect in December that sets criteria for refusing to accept tobacco product applications for regulatory review, the agency said.

“On August 8, the FDA issued a direct final rule (with a companion proposed rule) describing when the agency would refuse to accept a tobacco product application,” the agency said. “Due to some significant comments received during the 30-day comment period, the FDA is withdrawing the direct final rule. The FDA will consider the comments received and will proceed with the proposed rule, which was issued concurrently with the final rule, through the usual rulemaking procedures.”
Grounds for automatic rejection included applications submitted in a language other than English and that do not state what type of submission. Comments were accepted until 24 Oct and the withdrawn rule was to have gone into effect on 21 Dec.