Duncan's Botanical Products, Inc.

CLOSEOUT LETTER Duncan's Botanical Products, Inc. MARCS-CMS 519077 — October 11, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UPS Product: Dietary Supplements Recipient: Recipient Name Brent W. Duncan Recipient Title Owner and President Duncan's Botanical Products, Inc. 1231 E. Smithville Road Bloomington , IN 47401 United States Issuing Office: Center for Food Safety and Nutrition 550 W. Jackson Blvd. Suite 1500 Chicago , IL 60661 United States (312) 353-5863 Dear Mr. Duncan, The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (2017-DET-06, dated May 8, 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/ Byron Ho, DVM Compliance Officer Office of Human and Animal Food Division East 6 Content current as of: 10/21/2019 Regulated Product(s) Dietary Supplements