US
Retailers have 30 days to sell off products that are not similar to FDA-approved products, according to new draft guidance issued by the US Food and Drug Administration (FDA) on February 28, 2019, on its enforcement policy for tobacco products.
The draft guidance "Enforcement Policy for Certain Marketed Tobacco Products” explains FDA’s enforcement policy for manufacturers, importers, or distributors of certain marketed tobacco products that receive a not substantially equivalent (NSE) order and explains the sell-off time allowed, as well as the enforcement policy for retailers with such products in their inventory. These certain marketed tobacco products include “provisional” tobacco products (those that were first introduced or delivered for introduction into interstate commerce after February 15, 2007, and prior to March 22, 2011, and for which a substantial equivalence report was submitted no later than March 22, 2011) and to new tobacco products created by modifying the quantity of a provisional tobacco product in a pending substantial equivalence report.
“When final, this new draft guidance will explain to regulated industry, including manufacturers and retailers, the FDA’s current thinking regarding its enforcement policy for certain marketed tobacco products for which the agency issues an order finding the product doesn’t meet the public health standards under the law,” said FDA Commissioner, Scott Gottlieb.
Retailers may receive a letter to stop selling NSE products (the products are not similar to already legally marketed products), meaning retailers cannot sell those products until they are cleared by the FDA.
Per the new draft guidance, FDA does not intend to take enforcement action against a manufacturer, importer, or distributor of a product that has received an NSE order for at least 30 calendar days from the date of the NSE order. FDA also does not intend to take enforcement action against a retailer for at least 30 calendar days from the date the NSE order is posted on FDA’s Misbranded and Adulterated NSE Tobacco Products webpage. FDA encourages retailers to contact their supplier or manufacturer to discuss possible options for the misbranded and adulterated product that they may have in their inventory.
The new draft guidance also notes that should FDA receive a request for a supervisory review of an NSE order from the applicant within 30 calendar days from the issue date of the NSE order, FDA does not intend to take enforcement action against the manufacturer, importer, or distributor based on the order until the agency makes a decision on the request. If the appeal results in FDA affirming the NSE order, the agency does not intend to take enforcement action for at least 30 calendar days from the date of FDA’s decision on the appeal.
The FDA is seeking comments on the guidance and will issue a final guidance once all comments have been collected.