- Delivery Method:
- VIA UPS and Electronic Mail
- Reference #:
Dear Brendan McDermott:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions included in your responses dated June 19, 2019 and June 23, 2019, in response to our Warning Letter dated June 7, 2019. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding the Instagram account of Pandora Blue (https://www.instagram.com/pandora.blue), the Facebook account of Pandora Blue (https://www.facebook.com/pandorablueee), and the Twitter account of Pandora Blue (https://twitter.com/pandora_pblive), containing social media posts with labeling and/or advertising for e-liquid products on behalf of Solace Vapor, as well as the website https://solacevapor.com, the Instagram account of Solace Vapor (https://www.instagram.com/solacevapor), and the Facebook account of Solace Vapor(https://www.facebook.com/solacevapor).
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
Attn: Azim Chowdhury