# FDA WARNING_LETTER - JUUL Labs, Inc. - September 28, 2018

Source: https://www.globalkeysolutions.net/records/warning_letter/juul-labs-inc/61e8f844-b2ff-4872-887c-b52adbcb2053

> FDA WARNING_LETTER for JUUL Labs, Inc. on September 28, 2018. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: JUUL Labs, Inc.
- Inspection Date: 2018-09-28
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/ann-simoneau/155ef03c-6b60-4063-b35d-75522fa67d2b)
- [Jerry Masoudi](https://www.globalkeysolutions.net/people/jerry-masoudi/49571cce-3df7-40e5-9ae2-59e119d5adad)

Company: https://www.globalkeysolutions.net/companies/juul-labs-inc/c1960bc1-3abe-4e40-9418-f1d68aff017a

Office: https://www.globalkeysolutions.net/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374