The Mineral Store, Inc./Elemental Research, Inc.

CLOSEOUT LETTER The Mineral Store, Inc./Elemental Research, Inc. MARCS-CMS 609178 — January 28, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Ms. Anette Hasalone and Mr. Jason Brunson The Mineral Store, Inc./Elemental Research, Inc. 4353 East Poleline Avenue Post Falls , ID 83854 United States Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN) United States Mr. Jason Brunson The Mineral Store, Inc. 315 North 400 West, Suite B Fillmore, UT 84631 Dear Mr. Brunson and Ms. Hasalone: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 609178, issued October 9, 2020. 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, /S/ Carrie Lawlor Branch Chief Dietary Supplements and Labeling Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Food and Drug Administration Content current as of: 02/02/2021 Regulated Product(s) Dietary Supplements