FDA In Brief: FDA advances enforcement policy for certain marketed tobacco products that receive a not substantially equivalent order
February 28, 2019
“Our commitment to the effective and appropriate regulatory oversight of tobacco products, and our efforts to protect kids and significantly reduce tobacco-related disease and death, includes developing new guidance and regulations that help industry comply with the law. Improving and enhancing industry’s ability to comply with federal tobacco laws and regulations, and making sure our regulatory process is efficient and effective, is an important part of our public health mission and our comprehensive plan on nicotine and tobacco regulation,” said FDA Commissioner Scott Gottlieb, M.D. “When final, this new draft guidance will explain to regulated industry, including manufacturers and retailers, the FDA’s current thinking regarding its enforcement policy for certain marketed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. We understand that such a change in the marketing status for a product may require companies to take a series of steps to implement its complete market withdrawal, and the process could take time to fully implement. With that in mind, the agency’s new policy would include a revised short sell-off period for retailers before the FDA intends to take action to ensure the products are no longer being sold. We understand that in some cases this time is needed to withdraw the product from the market. But industry should make certain that these products are removed from the market as quickly as possible. We don’t believe any company should need more than the time periods described in this draft guidance to accomplish this goal. We take the removal of these products seriously and intend to take enforcement action against any company that doesn’t take the necessary steps to comply.”
Today, the U.S. Food and Drug Administration issued a draft guidance, “Enforcement Policy for Certain Marketed Tobacco Products,” which, when final, will explain the agency’s current thinking regarding its enforcement policy for manufacturers, importers and distributors of certain marketed tobacco products that receive a not substantially equivalent (NSE) order and will explain 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 Feb. 15, 2007 and prior to March 22, 2011, and for which a substantial equivalence report was submitted no later than March 22, 2011) and new tobacco products created by modifying the quantity of a provisional tobacco product in a pending substantial equivalence report.
The Federal Food, Drug, and Cosmetic Act permits a provisional tobacco product to remain on the market pending the FDA’s review of the substantial equivalence report for that product. Under the new draft guidance, the FDA would 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. The agency also would not intend to take enforcement action against a retailer for at least 30 calendar days from the date the NSE order is posted on the FDA’s Misbranded and Adulterated NSE Tobacco Products webpage. The 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 the 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, the agency would 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 the FDA affirming the NSE order, the agency would not intend to take enforcement action for at least 30 calendar days from the date of the agency’s decision on the appeal.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.