FDA Releases Updated Guidance For Cigar Warning Statements

Following the July 2018 announcement that a federal judge had delayed the cigar and pipe tobacco warning statements, now the U.S. Food and Drug Administration (FDA) has released updated guidance stating that due to the court order issued in Cigar Association of America et. al on July 5, 2018, the FDA will comply and will not be enforcing the warning statement requirements for cigars and pipe tobacco until 60 days after the final disposition of the Plaintiff’s appeal. The FDA also revealed that it will not be enforcing the labeling requirements under sections 903(a)(2) for cigars and pipe tobacco while the injunction remains in effect.

Many manufacturers have begun including warning statements on many of their products and advertising. It is unclear if manufacturers will continue to do this until the matter is completely settled or if those warning statements will be removed from future packaging and advertising. The FDA’s guidance states that, “Cigar and pipe tobacco firms, however, may add the warnings and make these labeling changes while the injunction remains in effect. The compliance policy in this guidance supersedes the compliance dates included in any other guidance issued prior to this guidance.”

Warning statements on tobacco products has been a hot topic in 2018. As part of the FDA’s deeming rules, there was a compliance deadline of Aug. 10, 2018 that would have required one of six pre-approved warning statements be included on cigar packaging and advertisements and a nicotine warning for pipe tobacco products. The ongoing lawsuit waged between cigar industry and the FDA, however, challenged the warning statement requirement, calling it unconstitutional since it allegedly infringes on a company’s First Amendment-granted commercial free speech and that the requirement was burdensome. Companies had to submit a plan and get approval from the FDA before running the warning statements on products.

You can read the full updated guidance document from the FDA by clicking here. To read more about the warning statement requirements by clicking here.