Maine Natural Health, Inc.

CLOSEOUT LETTER Maine Natural Health, Inc. MARCS-CMS 525870 — October 01, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United Parcel Service Product: Dietary Supplements Recipient: Recipient Name Patricia Leighton Recipient Title CEO Maine Natural Health, Inc. 825 Atlantic Hwy Warren , ME 04864-4617 United States Issuing Office: Division of Human and Animal Food Operations East I (HAFE1) 158-15 Liberty Avenue Jamaica , NY 11433 United States Dear Ms. Leighton: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 525870, issued on December 19, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this 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/ CDR Catherine Beer Director, Compliance Branch Office of Human and Animal Food Operations East Division 1 Content current as of: 10/04/2019 Regulated Product(s) Dietary Supplements