Court Tells FDA to Make a Decision Regarding Substantial Equivalence Extension This Week or Risk Trial
The U.S. Food & Drug Administration (FDA) will have until this Friday to grant an extension for the upcoming substantial equivalence deadline, set for May…
Micallef Launching PredX, Trade Exchange for FDA Predicate Blends
In a world of strict FDA regulation of cigars, there will likely be some process where companies trade or sell the rights to FDA-approved blends…
FDA Announces Proposed Record-Keeping Rules for Substantial Equivalence
Yesterday, the U.S. Food & Drug Administration (FDA) published proposed rules for the process of applying for agency approval of e-cigarettes and vaping products. Almost…
CRA Gives FDA Three Options for the Future of Cigar Regulation
The Cigar Rights of America (CRA), representing roughly 100 companies that are involved with the production of premium cigars, has filed its comments to the…
Six Companies File Joint Comments Seeking Premium Cigar Exemption from FDA
Six of the world’s largest cigar companies have filed joint comments regarding the FDA’s regulation of premium cigars, advocating that the agency is not able…
FDA Extends Comment Period for Revised Substantial Equivalence Process to July 17
The U.S. Food & Drug Administration (FDA) has announced a 30-day extension to its current request for comments on how it should revise its substantial…
FDA Plans Updated Substantial Equivalence Process for Tobacco Products
One of the many complaints cigar companies have with the FDA and the agency’s regulations on tobacco products is a lack of clarity. Nowhere is…
