BioDrive, Inc.

WARNING LETTER BioDrive, Inc. MARCS-CMS 731846 — August 24, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Recipient: Recipient Name Cory A. Henderson Recipient Title CEO BioDrive, Inc. 325 Hudson Street, 4th Floor New York , NY 10013 United States (b)(6), (b)(7)(C) Issuing Office: Human Foods Program United States August 24, 2026 WARNING LETTER CMS #731846 Dear Mr. Henderson: This letter concerns your Evolv GLP-1 Biomimetic dietary supplement. Your product labeling identifies Saccharomyces cerevisiae S288C EV-1 Peptide as a dietary ingredient. As explained further below, introducing or delivering this product for introduction into interstate commerce violates the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. Adulterated Dietary Supplements The labeling of your Evolv GLP-1 Biomimetic dietary supplement declares “ Saccharomyces cerevisiae S288C EV-1 Peptide” (hereinafter “EV1-Peptide”) as a dietary ingredient. EV1-Peptide is a “dietary ingredient” under section 201(ff)(1)(F) of the Act [21 U.S.C. § 321(ff)(1)(F)]. EV1-Peptide is also a “new dietary ingredient” under section 413(d) of the Act [21 U.S.C. § 350b(d)] because, to the best of FDA’s knowledge, there is no information demonstrating that EV1-Peptide was marketed as a dietary ingredient in the United States before October 15, 1994. A dietary supplement is adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. § 342(f)(1)(B)] if it contains a new dietary ingredient for which there is inadequate information to provide a reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Based on our evaluation of the relevant safety evidence, there is inadequate information to provide reasonable assurance that EV1-Peptide does not present a significant or unreasonable risk of illness or injury. Therefore, your Evolv GLP-1 Biomimetic containing the EV1-Peptide is adulterated under section 402(f)(1)(B) of the Act. The introduction of the adulterated dietary supplement into interstate commerce is prohibited under section 301(a) of the Act [21 U.S.C. § 331(a)]. Moreover, available information on the use of EV1-Peptide in products raises serious safety concerns. You submitted two new dietary ingredient notifications (NDINs) to FDA in which we determined there was inadequate information to conclude that a dietary supplement containing EV1-Peptide would reasonably be expected to be safe. Specifically, FDA identified safety concerns due to potential toxicity, which raised concerns for adverse clinical consequences. You proceeded to market Evolv GLP-1 Biomimetic despite FDA’s objections due to safety concerns. 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 with 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 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Your written reply should be directed to Jamie M. Bumpas, Compliance Officer, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835, or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #713846 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov. Sincerely, /S/ Maria S. Knirk, JD, MBA Director, Office of Enforcement Office of Compliance and Enforcement Human Foods Program Content current as of: 09/22/2026 Regulated Product(s) Dietary Supplements