Premier Manufacturing Products, LLC

WARNING LETTER Premier Manufacturing Products, LLC MARCS-CMS 678912 — July 02, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Atofil@mtdst.us Product: Drugs Recipient: Recipient Name James P. Morrissette Recipient Title CEO Premier Manufacturing Products, LLC 912 46th Lane Unit 204 Cape Coral , FL 33904 United States JPM@premiermt.com Issuing Office: Center for Drug Evaluation and Research | CDER United States WARNING LETTER July 2, 2024 Christopher Mitchell, COO IT@MTDST.US CSM@premierMT.com Deborah L. Lloyd Premier Manufacturing Products, LLC 730 NE 19th Place, Cape Coral, FL 33909 Dlloyd@atofil.us RE: 678912 Dear James Morrissette, Christopher Mitchell and Deborah Lloyd: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed labeling obtained from an inspection of your drug manufacturing facility, Atofil, LLC, from January 22 to 25, 2024, from which FDA observed that you offer numerous Tianeptine products, specifically “Tianaa Red,” “Tianaa White,” and “Tianaa Green” for sale in the United States. Based on our review, your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Unapproved New Drugs Based on our review of the product labeling obtained during the inspection, your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims from your email blast promotional material, which links back to your website https://mtbrands.com/tianaa, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following: “The Wait For Tianaa is Over . . . LET US TAKE YOU THERE . . . Tianaa is a proprietary blend of Natural Herbs and Nootropics created to deliver the unparalleled pick up, clarity, relaxation, and relief” Your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Conclusion This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Sincerely, /S/ Tina Smith, M.S. Captain, U.S Public Health Service Director Office of Unapproved Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration Content current as of: 07/02/2024 Regulated Product(s) Drugs