FDA Stakeholder Update - September 13, 2019

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being.

FDA Announcements Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products The Trump Administration announced that as part of its ongoing work to tackle the epidemic of youth e-cigarette use, the FDA intends to finalize a compliance policy in the coming weeks that would prioritize the agency’s enforcement of the premarket authorization requirements for non-tobacco-flavored e-cigarettes, including mint and menthol, clearing the market of unauthorized, non-tobacco-flavored e-cigarette products. The FDA plans to share more on the specific details of the plan and its implementation soon. [9/11/2019] FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth The FDA 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. [09/09/2019] FDA Announces Cooperative Agreement to Implement Produce Safety Rule The FDA announced the award of a cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to provide critical information and resources to help state and territorial regulatory agencies plan and help carry out implementation of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule. [09/09/2019]

Meetings - Request for Comment FDA Public Hearing: Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile The FDA is announcing a public hearing to obtain input on the use of fecal microbiota for transplantation (FMT) to treat Clostridium difficile infection not responsive to standard therapies. FDA will consider scientific data and other information from the public hearing as we continue to consider ways to support the development of FMT to treat C. Date: 11/04/2019 Time: 9:00AM ET - 4:00PM ET Docket Number: FDA-2019-N-3631 Electronic comments must be submitted on or before January 21, 2020.

Consumer Update Vaping Illnesses: Consumers can Help Protect Themselves by Avoiding Tetrahydrocannabinol (THC)-Containing Vaping Products Consumers are likely aware of the recent reports of respiratory illnesses — including some resulting in deaths – following the use of vaping products. The FDA remains deeply concerned about these incidents and is working closely with the U.S. Centers for Disease Control and Prevention (CDC), as well as state and local public health partners to investigate them as quickly as possible. While the work by federal and state health officials to identify more information about the products used, where they were obtained and what substances they contain is ongoing, the FDA is providing consumers with some information to help protect themselves. [09/06/2019]