Brand New Energy, LLC

CLOSEOUT LETTER Brand New Energy, LLC June 27, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Brand New Energy, LLC United States Issuing Office: United States 5001 Campus Drive College Park, MD 20740 June 27, 2018 Mr. Darren Housholder Brand New Energy, LLC 3424 West Magnolia Boulevard Burbank, CA 91505 Dear Mr. Housholder: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 447545, issued April 24, 2015. 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 Acting Branch Chief Dietary Supplements and Labeling Assessment Branch Division of Enforcement Office of Compliance Center for Food Safety and Applied Nutrition Content current as of: 07/17/2018