Next Week Promises Major Milestone in FDA’s Regulation of Tobacco Products

The Food and Drug Administration is under a court ordered deadline to issue market approval decisions for e-cigarettes, candy flavored cigars and other novel tobacco products that have recently entered the U.S. marketplace. The FDA’s decision next week will mark the agency’s first foray into providing meaningful regulation of e-cigarette products. Youth initiation and addiction to e-cigarettes has been a major public health problem, and FDA is under close scrutiny regarding how it will implement its regulatory authority to protect kids from e-cigarette products. By law, the FDA can only approve new tobacco products if allowing these products in the market will “improve public health.”

Currently, FDA is reviewing over six million unique product applications, including a range of flavoring and ingredient combinations, it received as part of its regulatory obligation to review and approve all new tobacco products entering the U.S. market.

While FDA is not expected to reach a decision in on all six million product applications that it has received, the agency has committed to issuing decisions on those products that account for the largest share of the e-cigarette market including Juul, Vuse, Puffbar, Blu and NJoy.

The ATS will closely monitor the FDA’s pending decision and will continue to push the agency to issue effective regulation to protect Americans, particularly youth, from the harms of tobacco use and nicotine addiction.