Cigar Makers and FDA Meet About Rules

Attorneys representing U.S. cigar makers met with the Food and Drug Administration (FDA) to present arguments as to whether part or all of FDA’s deeming regulations should be thrown out or modified, reports Halfwheel.

The two-hour meeting, which took place via a videoconference, primarily concerned the substantial equivalence process, is part of the ongoing Cigar Association of America et al. v. United States Food and Drug Administration et al. case.

In previous rulings, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia removed the requirements for warning labels on premium cigars, while siding with the FDA on other issues.

On the subject of extending the Sept. 9 submission date once again, the FDA said that it would not request a further extension while Department of Justice attorney Garrett Cole noted that if an extension did occur, it would be a two-month extension.