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# FDA Hits Juul with Warning Letter
- URL: https://www.fdaweb.com/fda-hits-juul-with-warning-letter/
- Published: 2019-09-09T12:00:00.000Z
- Updated: 2026-09-15T01:48:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144947

FDA 9/9 has issued a [Warning Letter](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktocvfSWVlMd-2BiItC5jjTVAlvUgxvwFjkcXmVFFGEk-2BrJbxcbXJB1mNeVYSW6uhvsyLHAOOI5TDjZ0Sfi4dRlkNQIVOrlDsyymnwLwFWPmqZsYBCNck5xUcf-2BCT-2BCak-2BMThJzwJd-2BtfnOov0tHy1Xw7TlpIDjNtOjkIiJn5SbfF7CgV8MiDFy2Ri-2F3vk9vzzIj7iiKNoanwNGLjTRQ93UUw2BwH1VxwXogml8gE5oiJSpbYBOkNzWxgTITKdkvexycz8-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuecVktKYfX8pHoINV-2FshDZW958Zea1ZymzRZO-2FSX1j4iJEVYyALzOFVt16fdG67PJmb-2BwmyfmSTBDCkvfrVyKu3DMuqIM1ebtzuy33UrAWfXUS0Wfw0d1iQ-2FiuVk2A-2BY50TKFgEr90cutzaPLUbdeJQb7Wxk9rgJjegOQaH96SceKl3EMQ-2BE7nLE427mtCzLriADPTsKXEmpsI-2B1Ska0VBIrsQcHRcw5nrPt-2BY7kWFrKMrSgGFsyUQvs42NI2FwAp9xXtromGgYdTlGUtcFzAzHWwBclHUAqaBmWKtwdMvUw-3D&ref=fdaweb.com) to Juul Labs over marketing unauthorized modified risk tobacco products by “engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school.” The agency also sent a [letter to the company](http://email.prnewswire.com/wf/click?upn=zySGXW1QLHU8t7wSbPI8iADmwAaKTbie2jeFmcdktocvfSWVlMd-2BiItC5jjTVAlvtERFiuHYKz6AIlqrZmmn-2B17IDe94aeOxJg12fPiJOHNB7HNNnrrshVUNDGbFR21zRfErwkfgXO5MM1zaYcD2-2F6yCFnGAjYLmD0iadYU4nJsmtXLSSTPEHwi9FVs-2BtseN38iD58OYjlZcGyWUzaAySA-3D-3D%5FnE9rxSXA5G4kxsTVkgv43tTJnmhvULg8vMtvbdZHwXEle6c6tqdvw12Z3skft0RuecVktKYfX8pHoINV-2FshDZW958Zea1ZymzRZO-2FSX1j4iJEVYyALzOFVt16fdG67PJmb-2BwmyfmSTBDCkvfrVyKu3DMuqIM1ebtzuy33UrAWfXUS0Wfw0d1iQ-2FiuVk2A-2BY50TKFgEr90cutzaPLUbdeJYhNSbyxqqy2o7Lb7pZf89JyFtpjppnUUjmo6WACHuDJ80er0NianDlf25kmlCakLjo8ugMWmWBzH4ezYhxu16op4YVzuuis7M7E6hFWEPbzTkd5TjZR3qa4kqn8yN6jxRNyPWWQp8K2wxjk5efdDFs-3D&ref=fdaweb.com) requesting more information about several issues raised in a recent Congressional hearing about Juul’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers.

The letters follow stepped up criticism from Capitol Hill on the agency’s enforcement effortsto curb vaping by under-aged users. On 9/6, Senator **Richard Durbin** (D-IL) wrote FDA acting commissioner **Ned Sharpless** urging him to take immediate and decisive action to curb the e-cigarette and vaping epidemic that threatens young adults and children in the U.S. or resign ([see story). ](https://www.fdaweb.com/login.php?sa=v&aid=D5144943&cate=&stid=%241%24BL%2F.0u4.%24Pd.nky8woorv5OfRB%2FwzV0)

“Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs-marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth?ref=fdaweb.com) says. “Juul has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth.”