CLOSEOUT LETTER

Mind, Body & Coal LLC MARCS-CMS 593774 — December 21, 2020

Product:: Dietary Supplements

Recipient:: Recipient Name

Lisa Smith; Recipient Title

CEO; Mind, Body & Coal LLC; 2920 Bayshore Vista Drive
Tampa, FL 33611
United States

Issuing Office:: Center for Food Safety and Applied Nutrition (CFSAN); United States

Dear Mrs. Smith:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #593774, issued 07/23/20. Based on our evaluation, it appears you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
Carrie Lawlor
/S/
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition

Cc:
Jessica S. West | Shumaker
Attorney at Law
Bank of America Plaza, Suite 2800
101 East Kennedy Boulevard | Tampa, FL 33602