Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, September 9, 2019
FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth
Agency sends additional letter requesting more information on several issues, including outreach and marketing practices, as part of ongoing investigation
Today, the U.S. Food and Drug Administration issued a warning letter to JUUL Labs Inc. for 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 expressing concern, and requesting more information, about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, including those targeted at students, tribes, health insurers and employers. These letters are the latest in a series of actions the agency has taken as part of its continued commitment to providing strong oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS) and the latest development in the FDA’s ongoing investigation related to JUUL.
“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...