By Chris Mellides
The Food and Drug Administration (FDA) issued its revised guidance on Dec. 9 advising all tobacco manufacturers, including those makers of vapor products, that they will now have until June 30, 2017 to register their products.
The initial revised guidance was issued in July and preceded the FDA’s Deeming Rule, which as of Aug. 8 established the government agency’s authority over vapor products.
Under section 905 of the Tobacco Control Act, every individual who owns or operates any establishment in the United States that is in the business of manufacturing, preparing or processing a tobacco product, must register with the FDA by Dec. 31 each year.
Domestic manufacturers of finished tobacco products must register their facilities as well, and this includes vape shops that mix e-liquid in-house.
During registration, all vapor product companies 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.
This will mark 2017 as being the first year that e-liquid manufacturers and makers of vapor hardware would also have to comply. Failure to do so would deem those unregistered products as being misbranded, and through enforcement actions, manufacturers could face fines, seizures or injunctions.
In the new revision to the guidance, newly regulated tobacco products manufactured in the U.S. that were released before Aug. 8 will not endure the enforcement of the submission deadline so long as establishment registration and product listing submissions are received by the FDA on or before June 30, 2017.
Those companies that began manufacturing after the effective date of the FDA’s Deeming Rule must register and list immediately.
The FDA is currently accepting submissions and encourages companies to register and list their products online using the FDA Unified Registration and Listing Systems (FURLS) in advance of the new compliance date.