Under the Tobacco Control Act, every individual who owns or operates any “establishment” in the U.S. that is in the business of manufacturing, preparing or processing a “tobacco product” must register with the Food and Drug Administration (FDA) by Dec. 31 each year.
The FDA’s Deeming Rule has been in effect since August and established the government agency’s authority over vapor products, which are now considered to be regulated tobacco products. As such, manufacturers of these vapor products must also register with the FDA by the end of the year.
During registration vapor product companies, which include both hardware and e-liquid businesses, must “submit to FDA a detailed list of all products that are being manufactured, prepared, compounded, or processed for commercial distribution, along with copies of consumer information, all product labeling, and a representative sampling of advertisements,” according to The National Law Review.
The FDA encourages electronic submissions through the FDA Unified Registration and Listing Systems (FURLS). Companies can also file their establishment registrations “manually by filling out a Form FDA 3741 and mailing all of the necessary materials to CTP’s Document Control Center, or by packaging the files electronically using FDA’s eSubmitter software and submitting that package through the CTP Portal,” The National Law Review also reports.
Domestic manufacturers of finished tobacco products must register their facilities, and this includes vape shops that mix e-liquid in-house.
Those tobacco products produced that are not registered by the Dec. 31 deadline will be deemed “misbranded”, and through enforcement actions manufacturers could face fines, seizures or injunctions.
For more detailed information and links to forms and additional resources see “FDA’s Establishment Registration and Product Listing Deadline is Fast Approaching – Are You Prepared?”, an article that appeared in The National Law Review.