The U.S. Food & Drug Administration (FDA) has extended the comment period for three Advanced Notice of Proposed Rulemakings (ANPRM), including the one regarding whether the agency should reevaluate its regulations on premium cigars.
All three of the recent ANPRMs regarding FDA’s regulation of tobacco were extended for 30 days.
- Premium Cigar — July 25 (Originally June 25)
- Flavored Tobacco — July 19 (Originally June 19)
- Maximum Nicotine Levels — July 14 (Originally June 14)
The ANPRM for premium cigars covers a variety of issues, including asking for a definition of premium cigar, whether premium cigars have different health impacts from non-premium cigars and whether premium cigars have different use patterns from non-premium cigars.
Manufacturers—including some of the world’s largest tobacco companies—have petitioned FDA to extend the comment period, citing the complexity of the questions being asked and the type of data the agency is seeking in comments.
Last week, 33 members of Congress sent a letter to the White House Office of Management and Budget (OMB)—which oversees some of FDA’s actions—urging it to extend the comment deadline to September and delay the warning label requirements.
Today’s announcement has no effect on the warning label requirements which are set to begin Aug. 10.