This is to inform all concerned stakeholders that the FDA shall be temporarily suspending the implementation of Administrative Order 2019-0007, “Revised Rules and Regulations on Electronic Nicotine And Non-Nicotine Delivery System (ENDS/ENNDS)” until further notice. The suspension is upon the recommendations of the FDA Legal Services and Support Center (LSSC) and the Office of the Solicitor General (OSG) in compliance with the issued Writ of Preliminary Injunction enjoining the Department of Health (DOH) and the Food and Drug Administration (FDA) from implementing A.O. 2019-0007.
The FDA shall place all received applications for a license to operate (LTO) and product registration (FERN) on hold until the Court issues a resolution.
For any concerns or inquiries, you can send an e-mail to the Center for Cosmetics Regulation and Research (CCRR) at [email protected]
For your information and guidance.
Attachment:-> TEMPORARY SUSPENSION ON THE IMPLEMENTATION OF ADMINISTRATIVE ORDER 2019-0007 REVISED RULES AND REGULATIONS ON ELECTRONIC NICOTINE AND NON-NICOTINE DELIVERY SYSTEM (ENDSENNDS) DATE 07 November 2019