FDA Issues Enforcement Guidance on Unauthorized E-Cigarette Products

The Food and Drug Administration issued enforcement guidance targeting unauthorized electronic nicotine delivery systems. The guidance directs enforcement against products that bypassed the required Pre-Market Tobacco Product Application process. 3 percent of e-cigarette sales. The products are described as originating primarily from the People’s Republic of China.

The Trump administration announced that Operation Red Mist confiscated more than 18 million unauthorized units. The estimated retail value of those units exceeded $175 million. One seizure of 3 million units was valued at $76 million. 3 million vape devices and cartridges along with more than 100 weapons in a single week.

Congress allocated $200 million to the FDA last year for enforcement of illicit Chinese vapes. The House Oversight Committee has asked the FDA how the funding is being used and how quickly enforcement is increasing. The guidance calls for coordination between the FDA, the Department of Homeland Security, and Customs and Border Protection.

Officials said the agencies will share intelligence on shipping manifests and known manufacturers to stop products at ports of entry.