In response to the complaints, the companies must now either pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing by an Administrative Law Judge.[2] The companies risk a default order imposing the full penalty amount—statutorily set at $19,192 for a single violation relating to tobacco products—if no action is taken within 30 days of receiving the complaint.[3]

FDA’s press release also stated that this is “the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the [Federal Food, Drug, and Cosmetic Act (FFDCA)] premarket review requirements for new tobacco products.”[4] It should be noted that this is not the first groundbreaking action FDA has taken against small vape shops within the last year. As reported on this blog on October 25, 2022, FDA filed permanent injunctions against six small vape shops for alleged premarket review violations.[5] FDA had noted at the time that “these cases represent the first time FDA has initiated injunction proceedings to enforce the [Federal Food, Drug, and Cosmetic Act (FFDCA)] premarket review requirements for new tobacco products.”[6]