Niche Pharmaceuticals, Inc

RESPONSE LETTER Niche Pharmaceuticals, Inc July 08, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Company: Niche Pharmaceuticals, Inc 580 Commerce St. Ste. 100 Southlake , TX 76092-9156 United States 817-421 -2777 Recipient: Dana Lewis Compliance Officer United States Dear Ms. Lewis, This letter is a follow-up to our discussion regarding the Warning Letter received by Niche Pharmaceuticals, Inc. on July 19, 2018. Case 553911. Pursuant to the Agency's request Niche Pharmaceuticals, Inc. has reformulated its product Mag-Tab SR to remove yellow dye #10 from the formulation. The caplet now contains " (b)(4) white" which is approved for dietary supplements as a colorant. As allowed by the CFSAN, all existing yellow caplets were sold by about April 1, 2019. All current inventory and sales are now yellow dye free and are white coated caplets. Further to the Warning Letter, we edited our website shortly after receiving the letter to remove the few items cited as drug claims in the Metabolic section as well as a few testimonials. As such we are requesting the FDA to update their action with a follow-up letter stating that Niche Pharmaceuticals, Inc. is "in compliance" with the stated Warning Letter demands. Sincerely, /S/ Stephen F. Brandon Sr. - CEO Niche Pharmaceuticals, Inc. Content current as of: 08/15/2019 Regulated Product(s) Dietary Supplements Food & Beverages