FDA/Deeming Regulations

16 Thoughts: FDA Proposes Regulating Cigar Factories & Other Tobacco Manufacturing Facilities

FDA has announced a proposed plan that would require all tobacco manufacturing facilities to create, follow and document a wide range of procedures ranging from cleanliness to production processes to vetting suppliers like tobacco growers. While nothing changed today, this marks a monumental step forward in how FDA could regulate the cigar industry because today’s proposed changes would mean FDA would be regulating the cigar factories directly.

FDA Head Says Agency Plans to Announce Flavored Cigar, Menthol Cigarette Bans in Fall 2023

Given previous statements from FDA, if the agency follows through with this timeline, flavored cigars and menthol cigarettes could be illegal by the end of 2024. That would assume no lawsuits challenging the proposed regulations, an almost certainty.

FDA’s Center for Tobacco Products Responds to Reagan-Udall Foundation Report, Announces Plans for New Transparency & Policy Units

After public missteps surrounding Juul, the Reagan-Udall Foundation was tasked with reviewing how FDA’s Center for Tobacco Products was doing. It issued a report in December outlining some changes, today, the agency has responded in detail about how it plans on making some of those changes.

Senators Reintroducing Bill to Exempt Premium Cigars from FDA Regulation

Sen. Marco Rubio, R-Fla., is once again introducing a bill that would exempt premium and traditional cigars from FDA regulation.

Reagan-Udall Foundation Publishes Review of FDA’s Tobacco Regulations

The Reagan-Udall Foundation’s report is critical of FDA’s leadership, transparency and inability to act quickly. While cigars are barely mentioned in the report, there are some parts of this that could impact the regulation of cigars in the future.

HHS Inspector General Critical of FDA’s Regulation of Online Tobacco Retailers

The report indicated that FDA issued warning letters to 899 online retailers from 2010-2020 but “took no enforcement actions.”

Court Blocks FDA’s Plans for Graphic Warning Labels on Cigarettes

This is the latest in a long line of rulings against American regulators who have attempted to require more aggressive warning labels on tobacco products. Even if FDA had won the case, the ruling would have had no immediate impact on cigars.

Premium Cigar Association Meets With Dr. Brian King, New FDA CTP Director

PCA’s meeting comes while the industry awaits whether FDA will still regulate “premium cigars.”

Cigar Industry, FDA Brief Court Over Potential Deregulation of Premium Cigars

Yesterday, the cigar industry and the Department of Justice submitted briefs regarding the outcome of a July 2022 ruling by a federal court in Washington, D.C. If the cigar industry is successful, “premium cigars” might be deregulated.

FDA’s Comment Period on Proposed Flavored Cigar Ban Ends Today (Update)

Manufacturers, retailers, consumers and other interested parties are invited to submit comments on the matter.