FDA Files Complaints Against Four E-Cigarette Product Manufacturers
In an attempt to strongly regulate the e-cigarettes and vapes industry, the U.S. Food and Drug Administration (FDA) filed civil money penalty (https://www.fda.gov/news-events/press-announcements/fda-files-civil-money-penalty-complaints-against-four-e-cigarette-product-manufacturers) (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquid products without authorization. The action marks the first time FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic Act’s (https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act) premarket review requirements for new tobacco products.
FDA filed CMP complaints against four manufacturers (https://www.fda.gov/news-events/press-announcements/fda-files-civil-money-penalty-complaints-against-four-e-cigarette-product-manufacturers) in early 2023:
- BAM Group, LLC, doing business as VapEscape
- Great American Vapes, LLC
- The Vapor Corner, Inc.
- 13 Vapor Co., LLC
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” Brian King, PhD, MPH, director of FDA’s center for tobacco products, said (https://www.fda.gov/news-events/press-announcements/fda-files-civil-money-penalty-complaints-against-four-e-cigarette-product-manufacturers). “We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.”
FDA said (https://www.fda.gov/news-events/press-announcements/fda-files-civil-money-penalty-complaints-against-four-e-cigarette-product-manufacturers) it filed the complaints because the companies were making and selling their e-liquids without marketing authorization. The companies were previously warned (https://www.fda.gov/news-events/press-announcements/fda-files-civil-money-penalty-complaints-against-four-e-cigarette-product-manufacturers) that they were in violation of premarket requirements for tobacco products and failure to correct could lead to enforcement action.
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