FDA Authorizes Marketing of Tobacco- and Menthol-Flavored JUUL E-Cigarette Products
FDA will monitor compliance with robust restrictions to limit youth exposure to marketing & will act appropriately if company fails to comply with requirements
Today, the U.S. Food and Drug Administration authorized the marketing of five JUUL e-cigarette products through the premarket tobacco product application (PMTA) pathway – the JUUL device, Virginia Tobacco flavor JUULpods (3% and 5% nicotine concentration) and Menthol flavor JUULpods (3% and 5% nicotine concentration).
Following an extensive scientific review, the FDA determined that evidence provided by the company – including new information the company submitted in response to a deficiency letter from the FDA – demonstrates that these specific products meet the legal standard set by the 2009 Family Smoking Prevention and Tobacco Control Act to market new tobacco products in the United States. This standard requires FDA to consider the risks and benefits to the U.S. population as a whole – including the benefits to adults who currently smoke cigarettes and completely switch to a potentially less harmful product or significantly reduce their cigarette use – that is sufficient to outweigh the risks of the product, including to any youth and adults who are not current users of tobacco products. Regarding these specific products, the applicant submitted robust data—including a two-year longitudinal cohort study—demonstrating high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavored JUUL products.
While today’s actions permit these specific e-cigarette products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they “FDA approved.” There is no safe tobacco product. Those who do not currently use tobacco products should not start. Youth should never use tobacco products.
Related Information
- JUUL Labs: Order Letter, Decision Summary, Environmental Assessment and Finding of No Significant Impact
- FDA has now authorized 39 e-cigarette products; these are the only e-cigarette products that currently may be lawfully marketed and sold in the U.S.