JUUL Labs, Inc. – FDA Warning Letter, Sep 28, 2018

This FDA Warning Letter, dated September 9, 2019, addresses JUUL Labs, Inc. (JUUL) regarding its electronic nicotine delivery system (ENDS) products. The FDA's determination is based on testimony from a July 24-25, 2019 House Subcommittee hearing, a September 24-28, 2018 FDA inspection of JUUL's headquarters, JUUL's submissions, and its website.

The core violation is that JUUL adulterated its products under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) by marketing them as "modified risk tobacco products" without an FDA order. Evidence includes statements made directly to children in school, such as "99% safer," "much safer," "totally safe," and "a safer alternative than smoking cigarettes" than cigarettes. Additionally, a "Letter from the CEO" on JUUL's website and in an email stated the product delivers "satisfaction that they want without the combustion and the harm associated with it." These statements explicitly or implicitly represent reduced risk, reduced exposure to substances, or freedom from substances, classifying them as modified risk tobacco products under section 911(b)(2)(A)(i) and (iii) of the FD&C Act.

JUUL is required to immediately correct these violations and ensure