Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Reset IV, LLC dba Reset IV9501 Hillwood Drive, Suite 200Las Vegas,NV89134United Statescustomercare@resetiv.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Reset IV:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://resetiv.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.1As described below, your claims concerning compounded semaglutide and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The following claims concerning compounded semaglutide and tirzepatide products appear on your website:“Semaglutide (the same ingredient in Wegovy & Ozempic)”“Tirzepatide (the same ingredient in Zepbound & Mounjaro)”Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2For the reasons discussed above, your compounded semaglutide and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are 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 operations comply with all requirements of federal law, including FDA regulations.You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded drugs that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_______________________1The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

Delivery Method:Via EmailReference #:320-25-106Product:DrugsRecipient:Mr. Veerappan SubramanianOwner, Chairman, & CEOSomerset Therapeutics Private Limited300 Franklin Square DriveSomerset,NJ08873United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-106September 4, 2025Dear Mr. Subramanian:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Somerset Therapeutics Private Limited, FEI 3003821988, located at 54/1 Budihal (Boodihal) Village, Nelamangala, Bengaluru, Karnataka, India, from February 10 to 21, 2025.This Warning Letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).The inspection also revealed that Somerset Therapeutics Private Limited failed to submit(b)(4)Field Alert Report (FAR) to FDA as required by section 505(k) of the FD&C Act 21 U.S.C. 355(k), 21 CFR 314.81(b)(1) (NDA),(b)(4).We reviewed your March 14, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).You failed to conduct adequate investigations. Investigations lacked data supporting the assigned root cause(s), were not adequately expanded to include all potentially affected drug products, or were not formally documented in your deviation system. Specifically:A. Your firm did not adequately investigate extensive contamination in a September 2024 media fill failure on the(b)(4)filling line. Notably, the contamination was visible to the human eye coming off the line before incubation.Your investigation identified the cause of the media fill failure as a breach in the(b)(4)tank(b)(4)tubing and indicated that the contamination may have occurred due to operator activities.Your investigation also identified your ampoule filling line as having a similar equipment configuration to the(b)(4)filling line and indicated that the ampoule filling line is susceptible to the same failure mode. The investigation noted, “Over the past 2 years, no tubing damage was ever observed in the product pathway which can be readily detected in the form of leakage. Hence, a very low risk is anticipated for previously filled and completed product batches.” You did not sufficiently address the detectability of this defect or the possibility of a similar event going undetected on the ampoule filling line. You also did not adequately address contamination risks posed by vessel changeovers, nor ensure timely elimination of the use of unnecessary tubing to connect(b)(4)to(b)(4)vessels.We also note that your(b)(4)filling line was used to fill(b)(4)sterilized drug products. Regarding the(b)(4)batches of(b)(4)sterilized drug products produced since the previous successful media fill on May 29, 2024, your investigation stated that there was “… [no] impact and no action required” and that the(b)(4)sterilization cycles were “… validated using an overkill approach.” However, you failed to adequately consider the potential for high levels of contamination and the susceptibility of the isolated spore-forming organism (Bacillus cereus) to the sterilization process.B. You failed to adequately investigate out-of-specification (OOS) results for “any individual unspecified impurity” during related compound analysis of(b)(4)injection validation batches and an(b)(4)solution commercial batch. You identified the unspecified impurity in these drug products to be associated with an individual active pharmaceutical ingredient (API) lot used to manufacture the drug products, which exhibited a different impurity profile during the drug product shelf life when compared to exhibit batches. The investigation lacked adequate information on the root cause of the API impurity, and you did not ensure a timely response to assess the risks to other finished product batches potentially affected by the API from this supplier.C. You failed to review electronic data from(b)(4)air samplers used for environmental monitoring and ensure a timely and appropriate investigation of numerous aborted air sampler events. During the inspection, we identified at least 16 aborted air samples collected over(b)(4)in February 2025, within the(b)(4)areas and corridors. The review of aborted air sampler data was limited by its unacceptable data retention capability of only 115 entries.Your response is inadequate. You state that the “(b)(4)” of the(b)(4)organisms used to validate your(b)(4)sterilization cycle is greater than the “(b)(4)” of theB. cereusorganisms identified in the contaminated media. AlthoughB. cereusis typically known to exhibit less(b)(4)than(b)(4),B. cereusis also known to have a relatively wide range of(b)(4), with some strains exhibiting significant(b)(4).1Your response did not indicate plans to evaluate the susceptibility of specific contaminating organisms found in media used to simulate drug products and drug products prior to sterilization against your(b)(4)sterilization process in the future.You note in your response, “…(b)(4)of the(b)(4)vessels, their tubing, the manifold, and(b)(4)tubing had already been decontaminated and(b)(4). The(b)(4)vessel (ID# PDN/(b)(4)/1264) and the(b)(4)tank (ID# PDN/(b)(4)/574) which had been used to fill the(b)(4)of vials had not yet been decontaminated and(b)(4).” You failed to adequately maintain the equipment, thereby limiting your ability to ensure investigation and determination of the true root cause of the failure.Your response acknowledges a significant adverse trend ofB. cereuscontamination in your facility at the time of the media fill failure and that the route of contamination may involve employee changing rooms. Notably, you also indicate that(b)(4)airborne microbial monitoring is conducted in change rooms “For Information” only. Your response does not propose a systemic review and CAPA to address your environmental monitoring program.Your response provides an extended investigation into the impurities in the(b)(4)drug products. While you collaborated with your API supplier to identify the impurities and establish new specifications, adequate CAPA activities were completed only after the inspection identified the deficiency. Your response fails to include provisions for improving ongoing lifecycle oversight of suppliers.We acknowledge your statement that your(b)(4)air samplers are now compliant with applicable data control requirements and that you evaluated the available electronic data. However, the investigation into the aborted air samples was severely limited because of irretrievable data, resulting in an uncertain assessment of the acceptability of the environment for many marketed batches.In response to this letter, provide:A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.A further investigation into the(b)(4)media fill failure that examines all potential contributing causes and includes CAPA to address them.An independent, comprehensive assessment of microbiological contamination risk for all distributed drug products and batches remaining within expiry that were manufactured on the(b)(4)and ampoule lines using(b)(4)tubing for(b)(4)assemblies on(b)(4)tanks.Your program to assess(b)(4)of spore-forming microorganisms identified in product bioburden and the manufacturing environment for(b)(4)sterilized drug products.A comprehensive, independent review of your personnel and environmental monitoring programs, including but not limited to a plan to fully remediate these programs. For example, describe changes to procedures, practices, and testing equipment that will ensure meaningful ongoing data is collected to promptly detect and respond to emerging risks in your classified areas. Provide a timeline for implementation of your remediated program, including a summary of the steps you will be undertaking to ensure CAPA effectiveness.An evaluation of the source of the(b)(4)API impurity, including CAPA that address the need to develop full impurity profiles for your supplier’s APIs.A comprehensive assessment of your air samplers and how you will ensure data will be retained and reviewed. Also provide an update on your impact assessment relating to the lost data.A comprehensive, independent assessment of electronic and paper-based documentation systems in manufacturing and laboratory operations, to identify insufficient documentation practices. Include a detailed CAPA plan to remediate data review practices and to ensure attributable, legible, complete, original, accurate, contemporaneous records.A comprehensive, independent assessment and CAPA plan for computer-system security and integrity. Include a report identifying design and control vulnerabilities and the appropriate remediations for each of your laboratory and manufacturing computer systems.Clarify whether you will continue to use(b)(4)suppliers of(b)(4)API, and what standards will be required of these suppliers, including but not limited to, impurities.2. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).On February 11, 2025, we observed that tape was being used to secure(b)(4)to the interior ceiling of the(b)(4)filling line ISO 5 (Grade A) space. This tape was detached in multiple locations during the aseptic manufacture of(b)(4)injection, USP(b)(4)mg/mL ((b)(4)mL), batch(b)(4). Your decision to use tape in a critical area to overcome a cleanroom deficiency raises significant concerns about your oversight of the adequacy of your facilities for aseptic processing. The detached tape may disrupt airflow within the ISO 5 space, is insanitary, cannot be cleaned, and has an adhesive side that can collect particulate contaminants. You subsequently performed airflow (smoke) studies within the ISO 5 space in an effort to assess the effect of the detached tape on airflows. You also performed surface sampling of the exposed adhesive side of the detached tape, which was intended to detect any microbiological contamination.Your response is inadequate. You reported that multiple personnel, working in and around the(b)(4)filling line on February 1-2 and 6-7, 2025, did not notice any abnormalities. You therefore estimated that the tape detachment started between February 7 and 11, 2025. Your personnel reportedly did not observe detached tape while working in the area in the days preceding the FDA inspection. However, you did not conclusively show that the equipment was suitable for the aseptic manufacture of sterile drugs before FDA observed this deficiency during the inspection. Your response also did not include an investigation explaining why multiple segments of the tape became detached. You did not establish that(b)(4)injection, USP(b)(4)mg/mL ((b)(4)mL), batch(b)(4), was the only product manufactured under these conditions. The subsequent smoke studies and use of(b)(4)plates to perform microbiological sampling do not justify the existence of insanitary surfaces over exposed sterile drugs on an aseptic processing line.In response to this letter, provide:Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.An amended investigation into the detached tape issue that evaluates all drug products and batches manufactured under this adverse condition, identifies the root cause(s), and includes your CAPA to address the root cause(s).3. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).We observed multiple significant risks to product sterility during your aseptic manufacturing operations.InterventionsSome interventions were not adequately designed to prevent the risk of contamination. For example, operators use(b)(4)Restricted Access Barrier System ((b)(4)RABS)(b)(4)on the(b)(4)line to transfer materials to and from the ISO 5 area. You identify these interventions in the ISO 5 area as “(b)(4)” interventions, despite personnel(b)(4)the ISO 5 area with their hands and arms to perform various activities. Poor aseptic behaviors associated with the use of similar(b)(4)RABS(b)(4)on the(b)(4)line were previously discussed in the October 6, 2022, regulatory meeting between your firm and FDA.Material TransfersMaterial transfers were also deficient. For example, FDA observed that one of the(b)(4)RABS(b)(4)was being(b)(4)for extended periods of time to facilitate the transfer of sterilized stopper bags to the ISO 5 area on the(b)(4)filling line.Airflow StudiesAirflow studies did not allow for adequate identification and evaluation of aseptic processing hazards. For example, a video recording of the airflow study performed on the(b)(4)line did not include the removal of vials between the(b)(4)vial(b)(4)and the filling machine. There was significant activity in the area where the operator was performing this manual intervention.Additionally, the video of an airflow study performed for the(b)(4)adjustment did not allow for adequate analysis of potential hazard(s) posed by the intervention. The study did not sufficiently visualize smoke in the vicinity of the intervention.Your response is inadequate. You do not commit to sufficient review of aseptic processing line design, including the hazards posed by use of the(b)(4)RABS(b)(4)(e.g., the(b)(4)) to perform interventions.Although you supplied a third-party report indicating that the videos were adequate, the report does not address the sufficiency of airflow visualization at the point of these interventions. You also state, “During(b)(4)intervention within the filling zone (between the sensors) in(b)(4)Line, all the containers (i.e., bottles/vials) exposed from start of filling zone until stoppering zone are rejected….” However, you do not adequately address the hazard posed to empty vials on the filling line immediately adjacent to the filling zone, where airflow was interrupted during the intervention.We acknowledge your commitment to revise the stopper bag addition procedure to require(b)(4)the barrier system(b)(4)bag sanitizations. You further commit to modifying the(b)(4)design and incorporating the use of an(b)(4)to transfer sterilized stopper bags into the(b)(4). However, the modifications to equipment and processes are insufficient to fully address the manual hazards associated with your process design. You also do not adequately address the conditions under which, and maximum length of time, barrier system(b)(4).In response to this letter, provide:Comprehensive risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including an independent assessment that includes but is not limited to:o All human interactions within the ISO 5 areao Equipment placement and ergonomicso Air quality in the ISO 5 area and the surrounding roomo Facility layouto Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations)o Maximum in-process hold times and batch processing timesA detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control.Your plan to reevaluate interventions performed in airflow studies and media fills, to ensure that they appropriately reflect those taking place during commercial manufacturing operations (e.g., specific activities, duration).Your plan to conduct new airflow studies, by or with the assistance of one or more qualified independent third parties. Your plan should include a qualified independent third-party assessment of the airflow studies.Your plan to provide training for relevant personnel on the conduct and interpretation of airflow studies, to be conducted by one or more qualified third parties.Field Alert Reporting ViolationsThe NDA/ANDA Field Alert reporting requirements in 21 CFR 314.81(b)(1)(ii), effective since May 23, 1985, require holders of NDAs and ANDAs to submit information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, to the appropriate FDA district office within three working days of receipt by the applicant. The intent of the 21 CFR 314.81(b)(1) regulation is to establish an early warning system so that significant problems are brought to the FDA’s attention by applicant holders in order to prevent potential safety hazards from drug products already in distribution and also to prevent potential safety hazards with drug products manufactured in the future. FARs must be submitted for confirmed and unconfirmed problems meeting the definition of the regulation within three working days of becoming aware of the problem.From this inspection, in addition to the aforementioned CGMP violations, your firm is in violation of the Field Alert reporting requirements set forth in 21 CFR 314.81(b)(1)(ii). FARs related to a September 2024 aseptic processing simulation (media fill) failure were not provided to FDA within three working days. Specifically, you identified visually cloudy vials among the filled vials around September 30, 2024. No FAR was submitted until after the close of this inspection.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your drug products.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Somerset Therapeutics Private Limited, located at Budihal (Boodihal) Village, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days2. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3003821988 and ATTN: Jason Chancey and Vilmary Negrón Rodríguez.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research___________________________1(b)(4)2Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Product:DrugsRecipient:David A. RicksChief Executive OfficerEli Lilly and CompanyLilly Corporate CenterIndianapolis,IN46285United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesRE: NDA 217806ZEPBOUND® (tirzepatide) Injection, for subcutaneous useMA 824WARNING LETTERDear David A. Ricks:The U.S. Food and Drug Administration (FDA) has reviewed a promotional communication, a direct-to-consumer online video (video) of an interview featuring representatives from Eli Lilly and Company (Eli Lilly) and a corresponding reporter asking questions regarding ZEPBOUND® (tirzepatide) injection, for subcutaneous use (Zepbound) posted on the website okcfox.com1. The video features Dr. Clare Lee2, Associate Vice President of Medical Affairs for Eli Lilly and Company (Eli Lilly) and Rhonda Pacheco3, Group Vice President of Diabetes and Obesity for Eli Lilly. The video starts with the disclaimer that “this segment is sponsored by Eli Lilly and Company.” The video originally appeared on Fox25’s “Living Oklahoma” website on July 11, 2025. FDA has determined that the video is false or misleading. Thus, the video misbrands Zepbound and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(3)(i); (e)(5). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i). These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Zepbound, which is a drug with multiple serious, potentially life-threatening risks, including a boxed warning for the risk of thyroid C-cell tumors.BackgroundBelow are the indication and summary of the most serious and most common risks associated with the use of Zepbound4. According to the INDICATIONS AND USAGE section of the Zepbound FDA-approved prescribing information (PI) (in pertinent part):ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity:to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.Limitations of Use:ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.The PI for Zepbound contains a boxed warning regarding the risk of thyroid C-cell tumors. Zepbound is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Zepbound is also contraindicated in patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide. In addition, the PI for Zepbound includes warnings and precautions regarding severe gastrointestinal adverse reactions, acute kidney injury, acute gallbladder disease, acute pancreatitis, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes mellitus, suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation. The most common adverse reactions observed with Zepbound were nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.Prior CommunicationsFDA notes that advisory comments dated May 3, 2024, to Eli Lilly addressed draft promotional communications for Zepbound with certain similarities to the video addressed in this letter. In these advisory comments, FDA recommended revising draft promotional communications regarding gastrointestinal adverse reactions associated with Zepbound, or otherwise misrepresenting important risk information. Additionally, FDA notes that our advisory comments dated November 6, 2024, included recommendations to revise draft promotional communications to avoid omitting information regarding the limitations of use of Zepbound. FDA also recommended revising draft promotional communications to avoid omitting information regarding the risks of hypoglycemia and depression associated with Zepbound, thus creating a misleading impression about the safety and approved use of the drug.False or Misleading Risk PresentationPrescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk. The determination of whether a promotional communication is misleading includes, among other things, not onlyrepresentations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.The video, which features a reporter introducing Dr. Lee and Ms. Pacheco as representatives from Eli Lilly, contains claims and representations about obesity and the benefits of Zepbound but fails to communicate any risk information. For example, Dr. Lee talks about obesity and how adults with obesity should “look out for FDA-approved safe and authentic medicines if they are already on treatment for obesity and to avoid those unapproved ones. . . .” The reporter then asks Ms. Pacheco (in pertinent part), “. . . what are people’s options to access safe and effective obesity medicines” and Ms. Pacheco responds making claims such as (in pertinent part), “We at Lilly are providing options. One of the options for treatment is Zepbound, which is now available at LillyDirect which is our self-pay pharmacy solution. This provides an option to patients to get access to safe and effective authentic medicine. . . .” The video, however, entirely omits risk information. By omitting the risks associated with Zepbound, the video fails to provide material information about the consequences that may result from the use of Zepbound and creates a misleading impression about the drug’s safety. This omission is especially concerning from a public health perspective given the boxed warning and serious risks associated with Zepbound.Omission of Material FactsThe video is misleading because it fails to provide material information regarding Zepbound’s limitations of use. Specifically, the INDICATIONS AND USAGE section of the PI states the following (underlined emphasis added):ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity:to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.Limitations of Use:ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.By failing to disclose the limitations of use associated with Zepbound, the video creates a misleading suggestion about the FDA-approved indication and use for Zepbound.Failure to Submit Under Form FDA-2253FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A copy of the video was not submitted to OPDP under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).Conclusion and Requested ActionFor the reasons discussed above, the video misbrands Zepbound within the meaning of the FD&C Act and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(5). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i).This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for Zepbound that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Zepbound.If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Zepbound; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.Please direct your response to the undersigned at theFood and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266.A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 824 in addition to the NDA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to the OPDP RPM at CDER-OPDP-RPM@fda.hhs.gov.Sincerely,{See appended electronic signature page}George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and Research--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------CARTER M BEACH09/09/2025 05:09:22 PMOn behalf of George Tidmarsh, M.D., Ph.D_____________________________1This video is available on the internet at https://okcfox.com/features/living-oklahoma/experts-share-tips-onfinding-safe-authentic-obesity-meds-amid-rising-online-scams (last accessed September 8, 2025).2Dr. Clare Lee is Associate Vice President of Global Medical Affairs for Eli Lilly and Company (LLY). https://www.linkedin.com/in/clarejlee/.3Rhonda Pacheco is Group Vice President of US Cardiometabolic Health for Eli Lilly and Company. https://www.linkedin.com/in/rhonda-janice-pacheco-1176666/.4This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication cited in this letter.Promotional Material

Product:DrugsRecipient:David A. RicksChief Executive OfficerEli Lilly and CompanyLilly Corporate CenterIndianapolis,IN46285United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesRE: NDA 217806 and 215866ZEPBOUND® (tirzepatide) injection, for subcutaneous useMOUNJARO® (tirzepatide) injection, for subcutaneous useMA 974 and 832WARNING LETTERDear David A. Ricks:The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer video (video), titled “An Oprah Special: Shame, Blame, and the Weight Loss Revolution,” regarding ZEPBOUND® (tirzepatide) injection, for subcutaneous use (Zepbound) and MOUNJARO® (tirzepatide) injection, for subcutaneous use (Mounjaro). The video features Dr. W. Scott Butsch1and Dr. Amanda Velazquez2, paid consultants (representatives) who “receive research funding from companies making GLP-13drugs.”4The video also features Rhonda Pacheco,5Group Vice President of Diabetes and Obesity for Eli Lilly and Company (Eli Lilly). The video originally appeared on ABC as a Primetime Oprah Special on March 18, 2024 and can also be accessed through ABC’s website.6The video subsequently appeared on Hulu on March 19, 2024. FDA has determined that the video is false or misleading. Thus, the video misbrands Zepbound and Mounjaro within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative. 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(5); (e)(7)(viii). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i). These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety of Zepbound and Mounjaro, which are drugs with multiple serious, potentially lifethreatening risks, including a boxed warning for the risk of thyroid C-cell tumors. Obesity and excessive weight and type 2 diabetes mellitus are significant public health concerns that affect vulnerable populations (e.g., children) and millions of adults in the United States and are associated with numerous co-morbidities. Consumers and patients who seek medical treatment for managing obesity and excessive weight or their type 2 diabetes mellitus should receive truthful and non-misleading information regarding the serious risks associated with the use of a weight management prescription drug product, such as Zepbound, and with the use of a type 2 diabetes prescription drug product, such as Mounjaro.BackgroundBelow are the indication and summary of the most serious and most common risks associated with the use of Zepbound and Mounjaro.7According to the INDICATIONS AND USAGE section of the respective FDA-approved prescribing information (PI)8,9(in pertinent part):ZEPBOUND® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:30 kg/m2or greater (obesity) or27 kg/m2or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease).Limitations of Use:ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.The safety and efficacy of ZEPBOUND in combination with other products intended for weight management, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.ZEPBOUND has not been studied in patients with a history of pancreatitis.The PI for Zepbound contains a boxed warning regarding the risk of thyroid C-cell tumors. Zepbound is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Zepbound is also contraindicated in patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide. In addition, the PI for Zepbound includes warnings and precautions regarding severe gastrointestinal disease, acute kidney injury, acute gallbladder disease, acute pancreatitis, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes mellitus, and suicidal behavior and ideation. The most common adverse reactions observed with Zepbound were nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.MOUNJARO ® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use:MOUNJARO has not been studied in patients with a history of pancreatitis.MOUNJARO is not indicated for use in patients with type 1 diabetes mellitus.The PI for Mounjaro contains a boxed warning regarding the risk of thyroid C-cell tumors. Mounjaro is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Mounjaro is also contraindicated in patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Mounjaro. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with Mounjaro. In addition, the PI for Mounjaro includes warnings and precautions regarding pancreatitis, hypoglycemia with concomitant use of insulin secretagogues or insulin, hypersensitivity reactions, acute kidney injury, severe gastrointestinal disease, diabetic retinopathy complications in patients with a history of diabetic retinopathy, and acute gallbladder disease. The most common adverse reactions observed with Mounjaro were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.Prior CommunicationsFDA notes that advisory comments dated June 13, 2022 and June 21, 2022, to Eli Lilly addressed draft promotional presentations for Mounjaro with certain similarities to the video in this letter. In these advisory comments, FDA recommended revising draft promotional communications to avoid minimizing the risk of gastrointestinal adverse reactions associated with Mounjaro, or otherwise misrepresenting important risk information.10We are concerned that Eli Lilly is promoting Zepbound and Mounjaro in a manner that fails to present the serious risks of these drug products in a truthful and non-misleading manner despite FDA’s prior comments.False or Misleading Risk PresentationPrescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk. The determination of whether a promotional communication is misleading includes, among other things, not only representations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.The video is a 42-minute special program, hosted by Oprah Winfrey, concerning the “new drugs sparking... a weight loss revolution...that have captured the world’s attention”11due to “so-called miracle medications like Ozempic, Wegovy, Mounjaro, and Zepbound.” The video features testimonials from those who struggle with obesity and excessive weight, including those who have used these drug products to help lose weight. The video also prominently features two paid consultants of Eli Lilly, Drs. Butsch and Velazquez,12who are asked about their experiences with treating patients who are obese or have excess weight, and the use of these medications. The Eli Lilly Group Vice President of Diabetes and Obesity, Rhonda Pacheco, is also featured at the end of the video to discuss access to their drug products, Zepbound and Mounjaro. At approximately 12 minutes and 30 seconds into the video, Ms. Winfrey introduces Dr. Butsch using a pre-recorded cut-away where he provides information to the audience about the complexity of obesity as a medical condition. Ms. Winfrey then introduces Dr. Velazquez at approximately 16 minutes and 40 seconds using another prerecorded cut-away with the preface that they will now ask “how these medications actually work.” Dr. Velazquez describes in the cut-away how the “newer agents like GLP-1s” are a “new era for the treatment of obesity.” Dr. Velazquez continues by describing how our naturally occurring GLP-1 hormone works in the body and how drugs, like Zepbound and Mounjaro, are “essentially copying what our normal GLP-1 hormone does in our body, but doing it a little bit better.” Throughout the remainder of the cut-away, Dr. Velazquez provides more details about the clinical and metabolic processes associated with GLP-1s and how the medications, compared to previous obesity and excessive weight treatments, have achieved “double the amount of weight loss.” Ms. Winfrey then continues the conversation with both Drs. Butsch and Velazquez on-stage about the benefits of the medications, and then concludes this segment of the video (20:05) by asking “Both of you are consultants to the drug companies, what does that mean?” Dr. Velazquez answers that “…they are looking for our expert opinion to be able to deliver high quality care to patients” and Dr. Butsch further states “I’ve been involved with some of these companies in developing education programs and modules for medical students and medical trainees to learn more about the disease of obesity. I’m also running clinical trials with future medications.”The video includes numerous representations about the benefits of Zepbound and Mounjaro made by representatives of Eli Lilly, but omits important risk information and otherwise minimizes the risks of these drug products. We note that the video includes a segment on “the side effects” of GLP-1s, generally (beginning at 33:35 and ending at 37:47). However, this segment begins with a description from a non-Eli Lilly affiliated health care provider about how patients should be weighing the risks and benefits of taking any GLP-1 drug and, as explained below, concludes after several misleading omissions and statements are made by representatives of Eli Lilly about the risks of Zepbound and Mounjaro.13First, the video omits an important concept from the boxed warning for both drugs; specifically the contraindication in patients with a personal or family history of MEN 2 due to the risk of thyroid c-cell tumors. While Dr. Velazquez does provide a limited discussion of the thyroid risk to “anybody [who] has a history specifically of medullary thyroid cancer,” the risk to patients with a history of MEN 2 is omitted. The boxed warning in the Zepbound and Mounjaro PIs states the following (in pertinent part; bolded emphasis original, underlined emphasis added):ZEPBOUND[andMOUNJARO] is contraindicated in patientswith a personal or family history of MTCorin patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) . . . . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND[andMOUNJARO] and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).Additionally, several warnings and precautions associated with Zepbound and Mounjaro are also completely omitted from the video. Specifically, serious risks pertaining to severe gastrointestinal disease, acute kidney injury, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes mellitus, and suicidal behavior and ideation, which are described in the“What are the possible side effects of ZEPBOUND?”section of the Medication Guide, are omitted from the video. Furthermore, similar warnings and precautions for Mounjaro, as described in the“What are the possible side effects of MOUNJARO?”section of the Medication Guide, are also omitted from the video.These omissions are further exacerbated by statements made by Dr. Velazquez in the video that misleadingly minimize and downplay the drugs’ boxed warning, contraindications, warnings and precautions and other common adverse events. For example, when Ms. Winfrey asks about “serious health effects down the road” from treatment with GLP-1 medications, like Zepbound and Mounjaro (36:56), Dr. Velazquez responds (emphasis added):“There’s been a lot of hype around like pancreatitis, gallbladder complications, concerns for thyroid cancer. This has reallynot been shown in human studiesthat this is a downstream complication,and that really the risk is less than 1%.” (37:00)“If anybody has ahistory specifically of MTC... is very, very rare. So if they do have that, we are not prescribing that medication. So, we have to be able to keep up with knowing the data, and recognizing that it’srare, but it’s thereand we have to always screen.” (37:19)These statements by Dr. Velazquez misleadingly minimize the serious risks of Zepbound and Mounjaro, including the boxed warning. A boxed warning is ordinarily used to highlight for prescribers when there is an adverse reaction so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug. We note that the Agency has informed Lilly to conduct a MTC registry-based case series study of at least 15 years duration to systemically monitor the annual incidence of MTC in the United States and to identify any increase related to the introduction of tirzepatide into the marketplace. While we acknowledge that current data is insufficient to establish or exclude a causal relationship between MTC and Zepbound and Mounjaro, it is misleading to describe this risk as such because there is a boxed warning across the entire GLP-1 pharmacological class.These statements are also concerning because they misleadingly minimize the serious risks associated with Zepbound and Mounjaro by suggesting that a patient does not need to be worried about the potential for developing “pancreatitis,” “gallbladder complications,” and “thyroid cancer” from treatment with Zepbound and Mounjaro. Specifically, the statements that “there’s been a lot of hype” about the risks and they are “rare, but…there” are especially egregious, given the nature of the risks to patients from GLP-1 treatment, including pancreatitis, which has led to serious complications. According to the WARNINGS AND PRECAUTIONS, Acute Pancreatitis, section of the Zepbound and Mounjaro PIs, “acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists or tirzepatide.” Moreover, “gallbladder complications,” such as acute gallbladder disease, were observed in patients treated with Zepbound and Mounjaro, and is a warning and precaution across the entire GLP-1 pharmacologic class, since GLP-1 drug treatment has led to hospitalization and cholecystectomy (gallbladder removal) in some patients.Additional statements made in the video, with respect to the common adverse reactions for Zepbound and Mounjaro, are similarly misleading since they suggest that Zepbound and Mounjaro are safer because the adverse events are less common and less severe than have been demonstrated. For example, when asked to respond to the concerns of a guest patient that experienced side effects from using GLP-1s and subsequently had to discontinue treatment, the following conversation occurs (emphasis added):Ms. Winfrey: (after speaking to the guest patient “Rolanda” about her need to discontinue treatment with a GLP-1 medication due to side effects, such as becoming “very nauseous” and vomiting blood) “So Dr. Velazquez, what do you want to say about that?” (36:37)Dr. Velazquez: “Yeah, I think that it’s about education of the side effects. It’s about effective management of the side effects.” (36:42)Ms. Winfrey: “But they do have side effects?” (36:46)Dr. Velazquez: “I think that they’ve gotten overhyped. Medicines have side effects, but the important part is that they’re mild to moderate in the research studies.” (36:48)Dr. Butsch: “Yeah.” while nodding affirmatively in response to Dr. Velazquez (36:53)These statements further compound the misleading minimization of the risks for both Zepbound and Mounjaro, (particularly the common adverse events), by suggesting such risks are “overhyped.” The use of phrases such as “a lot of hype” and “overhyped” when referring to risk information misleadingly undermines the risk’s importance and severity.14These statements also minimize the risks by describing them as “mild to moderate,” when this has not been demonstrated. Similar to the guest patient who was the subject of the above conversation, a number of patients taking GLP-1s, such as Zepbound and Mounjaro, experienced adverse events, of which some were so severe that patients discontinued use of the drug. For example, according to the WARNINGS AND PRECAUTIONS section of the Zepbound and Mounjaro PIs, “Use of ZEPBOUND [and MOUNJARO] has been associated with gastrointestinal reactions, sometimes severe.” In addition, according to the ADVERSE REACTIONS section of the Zepbound PI (in pertinent part):In ZEPBOUND clinical trials, gastrointestinal adverse reactions occurred more frequently among patients receiving ZEPBOUND (5 mg 56%, 10 mg 56%, 15 mg 56%) than placebo (30%). More patients receiving ZEPBOUND 5 mg (1.9%), ZEPBOUND 10 mg (3.3%), and ZEPBOUND 15 mg (4.3%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.5%).. . . .Across both trials, 4.8%, 6.3%, and 6.7% of patients treated with 5 mg, 10 mg, and 15 mg of ZEPBOUND, respectively, permanently discontinued treatment as a result of adverse reactions compared to 3.4% of patients treated with placebo.Similarly, according to the ADVERSE REACTIONS section of the Mounjaro PI (in pertinent part, emphasis added):In the pool of placebo-controlled trials, gastrointestinal adverse reactions occurred more frequently among patients receiving MOUNJARO than placebo (placebo 20.4%, MOUNJARO 5mg 37.1%, MOUNJARO 10 mg 39.6%, MOUNJARO 15 mg 43.6%. More patients receiving MOUNJARO 5 mg (3.0%), MOUNJARO 10 mg (5.4%), and MOUNJARO 15 mg (6.6%) discontinued treatment due to gastrointestinal adverse reactions than patients receiving placebo (0.4%).Moreover, the statement that “medicines have side effects,” coupled with the statement that GLP-1 side effects are “mild to moderate,” further downplays the serious nature of the risks associated with GLP-1s, like Zepbound and Mounjaro, by suggesting that because drugsgenerallyhave side effects, that the individual risks of GLP-1s are no more than other drugs and are therefore of little concern. There are several additional common adverse reactions, some of which were severe in nature (e.g., hypoglycemia), that were also observed with both Zepbound and Mounjaro; but, as noted above, were omitted entirely from the video. Therefore, it is misleading to represent that the side effects of GLP-1s, like Zepbound and Mounjaro, are “mild to moderate.”The video not only omits several serious and significant risks, it also understates the safety profile of these drugs. By essentially suggesting that safety or tolerability issues have been “overhyped,” and by implying that these products are not associated with the serious and significant risks outlined above, the video grossly misrepresents the safety profile of Zepbound and Mounjaro. This implication is false or misleading and raises significant public health and safety concerns.Finally, the video is also misleading because it fails to present information related to side effects and contraindications for Zepbound and Mounjaro with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Zepbound and Mounjaro. As noted, the video contains numerous representations and suggestions about the benefits of Zepbound and Mounjaro, while the risk information is relegated to the end of the video and briefly discussed. Of the 42-minute video, only four minutes in total are devoted to the important shared risks associated with GLP-1s, like Zepbound and Mounjaro. Additionally, the video does not provide any signal to alert the viewer where they may be able to find additional risk information about the drugs. The overall effect of disclosing risk information in this limited manner undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of Zepbound and Mounjaro.Failure to Submit Under Form FDA-2253FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A copy of the video was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).Conclusion and Requested ActionFor the reasons described above, the video misbrands Zepbound and Mounjaro and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(5). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i).This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for Zepbound and Mounjaro that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Zepbound and Mounjaro.If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Zepbound and Mounjaro; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.Please direct your response to theFood and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266. A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 974 and MA 832 in addition to the NDA numbers in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to CDEROPDP-RPM@fda.hhs.gov.Sincerely,{See appended electronic signature page}George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and Research--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------CARTER M BEACH09/09/2025 05:18:14 PMOn behalf of George Tidmarsh, M.D., Ph.D________________________________1Dr. W. Scott Butsch is a health care provider who serves as the Director of Obesity Medicine in the Bariatric and Metabolic Institute at Cleveland Clinic. Dr. Butsch has financial and consultancy connections to Eli Lilly. Based on currently available data, from 2017-2023, the Centers for Medicare and Medicaid Services Open Payments Data website reports that Dr. Butsch has received(b)(4)in consulting fees, grants, and other payments from Eli Lilly (https://openpaymentsdata.cms.gov/physician/1050529).2Dr. Amanda Velazquez is a health care provider who serves as an Assistant Professor of Medicine and Surgery and the Director of Obesity Medicine at the Center for Weight Management and Metabolic Health at Cedars-Sinai Medical Center. Dr. Velazquez has financial and consultancy connections to Eli Lilly. Based on currently available data, from 2019-2023, the Centers for Medicare and Medicaid Services Open Payments Data website reports that Dr. Velazquez has received(b)(4)in consulting fees, grants, and other payments from Eli Lilly (https://openpaymentsdata.cms.gov/physician/439627).3GLP-1 = Glucagon-like Peptide-14At approximately 20 minutes and 46 seconds, the video includes the following prominent on-screen text: “Dr. Butsch and Dr. Velazquez consult for and receive research funding from companies making GLP-1 drugs.”5Rhonda Pacheco is Group Vice President of Diabetes and Obesity for Eli Lilly and Company (LLY). https://investor.lilly.com/news-releases/news-release-details/zepboundtm-tirzepatide-now-available-uspharmacies-adults-living6This video is available on the internet at https://abc.com/shows/an-oprah-special-shame-blame-and-theweight-loss-revolution/episode-guide/season-01/01-an-oprah-special-shame-blame-and-the-weight-lossrevolution (last accessed date September 8, 2025)7This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication(s) cited in this letter.8The version of the Zepbound PI referred to in this letter is dated March 2024.9The version of the Mounjaro PI referred to in this letter is dated July 2023.10FDA notes that additional advisory comments have also been sent in May and November 2024 to Lilly regarding Zepbound with same/similar concerns.11The entirety of this video is focused on weight loss and weight loss products, specifically GLP-1s. While diabetes is briefly mentioned, the majority of the program focuses on weight loss. Mounjaro is not FDA approved for weight loss.12Seesuprafootnotes 1, 2, and 3.13We note that shortly after the segment on side effects, Ms. Pacheco was introduced (38:19) as Group Vice President for Eli Lilly. Although Ms. Pacheco appeared to be present during the filming of the side effects segment video, Ms. Pacheco made no additions to the limited risk information provided or corrections to the misleading representations made by the previous representatives of Eli Lilly.14While these and other statements made by Dr. Velazquez may be a reflection of their experience as a health care provider treating patients with GLP-1s, like Zepbound and Mounjaro, their personal experience does not support the representation in a promotional communication regarding the benefits of these drugs that the serious risks associated with Zepbound and Mounjaro have received “a lot of hype” or have been “overhyped.”Promotional Material

Product:DrugsRecipient:David A. RicksChief Executive OfficerEli Lilly and CompanyLilly Corporate CenterIndianapolis,IN46285United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesRE: NDA 217806ZEPBOUND® (tirzepatide) injection, for subcutaneous useMA 831WARNING LETTERDear David A. Ricks:The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, a direct-to-consumer online video (video) of an interview featuring representatives from Eli Lilly and Company (Eli Lilly) and a corresponding reporter asking questions regarding ZEPBOUND® (tirzepatide) injection, for subcutaneous use (Zepbound) posted on the website dayton247now.com.1The video features Dr. Clare Lee2, Associate Vice President of Medical Affairs for Eli Lilly and Company (Eli Lilly) and Rhonda Pacheco3, Group Vice President of Diabetes and Obesity for Eli Lilly. The video originally appeared on Dayton247 Now’s “Your Day” website on July 9, 2025. FDA has determined that the video is false or misleading. Thus, the video misbrands Zepbound and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(3)(i); (e)(5). In addition, these materials were not submitted at the timeof initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i). These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the safety and effectiveness of Zepbound, which is a drug with multiple serious, potentially life-threatening risks, including a boxed warning for the risk of thyroid C-cell tumors.BackgroundBelow are the indication and summary of the most serious and most common risks associated with the use of Zepbound4. According to the INDICATIONS AND USAGE section of the Zepbound FDA-approved prescribing information (PI) (in pertinent part):ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity:to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.Limitations of Use:ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.The PI for Zepbound contains a boxed warning regarding the risk of thyroid C-cell tumors. Zepbound is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Zepbound is also contraindicated in patients with a known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with tirzepatide. In addition, the PI for Zepbound includes warnings and precautions regarding severe gastrointestinal adverse reactions, acute kidney injury, acute gallbladder disease, acute pancreatitis, hypersensitivity reactions, hypoglycemia, diabetic retinopathy complications in patients with type 2 diabetes mellitus, suicidal behavior and ideation, and pulmonary aspiration during general anesthesia or deep sedation. The most common adverse reactions observed with Zepbound were nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.Prior CommunicationsFDA notes that advisory comments dated May 3, 2024, to Eli Lilly addressed draft promotional communications for Zepbound with certain similarities to the video addressed in this letter. In these advisory comments, FDA recommended revising draft promotional communications regarding gastrointestinal adverse reactions associated with Zepbound, or otherwise misrepresenting important risk information. Additionally, FDA notes that our advisory comments dated November 6, 2024, included recommendations to revise draft promotional communications to avoid omitting information regarding the limitations of use of Zepbound. FDA also recommended revising draft promotional communications to avoid omitting information regarding the risks of hypoglycemia and depression associated with Zepbound, thus creating a misleading impression about the safety and approved use of the drug.False or Misleading Risk PresentationPrescription drug advertisements and labeling (promotional communications) misbrand a drug if they are false or misleading with respect to risk. The determination of whether a promotional communication is misleading includes, among other things, not onlyrepresentations made or suggested in the promotional communication, but also the extent to which the promotional communication fails to reveal facts material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the promotional communication.The video, which features a reporter introducing Dr. Lee and Ms. Pacheco as representatives from Eli Lilly, contains claims and representations about obesity and the benefits of Zepbound but fails to communicateanyrisk information. For example, Dr. Lee talks about obesity and how “if pharmacotherapy is indicated, . . . make sure they have access to the FDA-approved, authentic and safe medicines . . . . ” The reporter then asks Ms. Pacheco (in pertinent part), “what are the options for people who want to access the safe and effective obesity medicines?” Ms. Pacheco responds making claims such as (in pertinent part), “We at Lilly are providing options. We know different patients have different needs and we have access to Zepbound on Lilly Direct. You can go to Lilly Direct, it’s our self-pay option. . . . This is the option for patients living with obesity that have a way to get that access to that safe and authentic medication . . . . ” The video, however, entirely omits risk information. By omitting the risks associated with Zepbound, the video fails to provide material information about the consequences that may result from the use of Zepbound and creates a misleading impression about the drug’s safety. This omission is especially concerning from a public health perspective given the boxed warning and serious risks associated with Zepbound.Omission of Material FactsThe video is misleading because it fails to provide material information regarding Zepbound’s limitations of use. Specifically, the INDICATIONS AND USAGE section of the PI states the following (underlined emphasis added):ZEPBOUND® is indicated in combination with a reduced-calorie diet and increased physical activity:to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.Limitations of Use:ZEPBOUND contains tirzepatide. Coadministration with other tirzepatide containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.By failing to disclose the limitations of use associated with Zepbound, the video creates a misleading suggestion about the FDA-approved indication and use for Zepbound.Failure to Submit Under Form FDA-2253FDA regulations require any labeling or advertising devised for promotion of the drug product to be submitted at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A copy of the video was not submitted to FDA under cover of Form FDA-2253 at the time of initial publication as required by 21 CFR 314.81(b)(3)(i).Conclusion and Requested ActionFor the reasons discussed above, the video misbrands Zepbound and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 21 U.S.C. 352(a), (n); 321(n); 331(a). See 21 CFR 202.1 (e)(5). In addition, these materials were not submitted at the time of initial dissemination or publication as required by 21 CFR 314.81(b)(3)(i).This letter notifies you of our concerns and provides you with an opportunity to address them. You should take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all other promotional communications (with the 2253 submission date) for Zepbound that contain representations such as those described above, and explaining your plan for discontinuation of such communications, or for ceasing distribution of Zepbound.If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.Additionally, we request that your submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter. The corrective communication(s) should be disseminated to the audience(s) that received the promotional communication(s) identified in the opening paragraph of this letter. We recommend that corrective communication(s) include a description of the promotional communication(s) identified in this letter, which misbrand Zepbound; include a summary of the concern(s) described in this letter; and provide information to correct each of these concern(s). Corrective communication(s) should be free of promotional claims and presentations. To the extent possible, corrective communication(s) should be distributed using the same media, and generally for the same duration of time and with the same frequency as the promotional communication(s) identified in the opening paragraph of this letter.The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.Please direct your response to theFood and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266.A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 831 in addition to the NDA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Questions related to the submission of your response letter should be emailed to CDER-OPDP-RPM@fda.hhs.gov.Sincerely,{See appended electronic signature page}George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and Research--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------CARTER M BEACH09/09/2025 05:09:35 PMOn behalf of George Tidmarsh, M.D., Ph.D___________________________1This video is available on the internet at https://dayton247now.com/news/local/experts-discuss-obesitymedications-and-warn-against-online-scams# (last accessed September 8, 2025).2Dr. Clare Lee is Associate Vice President of Global Medical Affairs for Eli Lilly and Company (LLY). https://www.linkedin.com/in/clarejlee/.3Rhonda Pacheco is Group Vice President of US Cardiometabolic Health for Eli Lilly and Company. https://www.linkedin.com/in/rhonda-janice-pacheco-1176666/.4This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional communication cited in this letter.Promotional Material

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:EvoLife Wellness777 Glades Rd, Ste 100Boca Raton,FL33434United Statesinfo@evolifewellness.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025EvoLife Wellness:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://evolifewellness.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.1As described below, your claims concerning compounded semaglutide and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The following claims concerning compounded semaglutide and tirzepatide products appear on your website:“FDA-Approved”“Clinically Proven: Semaglutide is FDA-approved for chronic weight management….”Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2For the reasons discussed above, your compounded semaglutide and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are 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 operations comply with all requirements of federal law, including FDA regulations.You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded drugs that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration________________________1The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:eDrugstore5801 S. McClintock Drive, Suite 107Tempe,AZ85283United Statessupport@eDrugstore.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025eDrugstore:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://www.edrugstore.com in August 2025 and has observed that your website offers various compounded drug products, including tirzepatide.1As described below, your claims concerning compounded tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The following claims concerning compounded tirzepatide products appear on your website:“FDA-Approved Active”“eDrugstore guarantees that all Tirzepatide medications are genuine, FDA-approved formulations for maximum efficacy and safety.”“Tirzepatide (Zepbound)….”Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2For the reasons discussed above, your compounded tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are 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 operations comply with all requirements of federal law, including FDA regulations.You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded drugs that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_________________________1The tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

行政相对人名称汕头市×××化妆品有限公司行政相对人类别法人及非法人组织行政相对人代码_1(统一社会信用代码)×××法定代表人×××法定代表人证件类型身份证法定代表人证件号码×××行政处罚决定书文号粤药监妆罚〔2025〕4001号违法行为类型未按照化妆品生产质量管理规范的要求组织生产化妆品。违法事实2025年5月22日至23日，广东省药监监督管理局在开展化妆品监督检查中，发现当事人存在关键项目1项不符合规定、其他重点项目3项不符合规定、一般项目5项不符合规定，判定为“生产质量管理体系存在严重缺陷”。当事人生产“XXX控油清爽洗发乳”(批号：20250326)733支（含检验用1支，留样2支），2025年6月7日，当事人将34支作为样品免费发样给客户，剩余696支已主动封存在成品仓库，按单价3元/支计算，货值金额2190元，违法所得0元。当事人生产“XXX柔顺去屑洗发水”(批号：20250506)1995支（含检验用1支，留样3支），销售给XX医疗器械有限公司1991支，单价3元/支，货值金额5973元，违法所得5973元。上述两批次产品货值金额共8163元，违法所得5973元。处罚依据1.《中华人民共和国行政处罚法》第二十八条第一款 2.《化妆品监督管理条例》第六十条第三项处罚类别没收违法所得、没收非法财物、罚款处罚内容对当事人作出以下行政处罚：1.没收违法所得人民币5973元；2.没收违法生产经营的化妆品“XXX控油清爽洗发乳”(批号：20250326)696支；3.处罚款人民币20000元。以上罚没款共计人民币25973元。罚款金额（万元）2.00没收违法所得、没收非法财物的金额（万元）0.5973处罚决定日期2025年9月8日处罚有效期3个月处罚机关广东省药品监督管理局处罚机关统一社会信用代码11440000MB2D034421数据来源单位广东省药品监督管理局数据来源单位统一社会信用代码11440000MB2D034421

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Nuvo Life Health Inc. dba Nuvo Life Health2222 Santa Monica Blvd, Unit 105Santa Monica,CA90404United Statesinfo@nuvolifehealth.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERSeptember 9, 2025Nuvo Life Health:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://nuvolifehealth.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide.1As described below, your claims concerning compounded semaglutide and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)].Under section 502(a) of the FDCA [21 U.S.C. § 352(a)] a drug is misbranded if its labeling is false or misleading in any particular. Furthermore, under section 502(bb) of the FDCA [21 U.S.C. § 352(bb)], a compounded drug is misbranded if its advertising or promotion is false or misleading in any particular.The following claims concerning compounded semaglutide and tirzepatide products appear on your website:• “Semaglutide Injection (similar to Ozempic and Wegovy)”• “Tirzepatide (similar to Mounjaro)”Compounded drug products are not FDA-approved. Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)]. The claims identified in this letter put you on notice of our concerns but do not represent an exhaustive list of misbranding violations.2For the reasons discussed above, your compounded semaglutide and tirzepatide products are misbranded drugs under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)], introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]. Please be advised, the receipt in interstate commerce of misbranded drugs, and the delivery or proffered delivery thereof, is also a violation of section 301(c) of the FDCA [21 U.S.C. § 331(c)].As previously stated, the violations cited in this letter are 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 operations comply with all requirements of federal law, including FDA regulations.You should take immediate action to address any violations (including, for example, ceasing and desisting from using the language cited above that misbrands the product). Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (CDER)’s Office of Compliance describing the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.If you are not located in the U.S., please note that products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded drugs that cannot be legally sold to consumers in the U.S.All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/s/George Tidmarsh, M.D., Ph.D.DirectorCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration1The semaglutide and tirzepatide products offered on your website are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.2Overstatements of efficacy or minimization of risk are of particular concern and may constitute misbranding.

按照《关于加强药品经营企业歇业管理有关问题的通知》（皖食药监市〔2008〕180号）规定，同意下列企业在《药品经营许可证》有效期内歇业。    企业歇业期间，不得开展药品经营活动。如企业在许可证有效期内恢复经营，须向省局提交恢复经营申请及恢复经营专项审计报告和企业严格执行《药品经营质量管理规范》的承诺，经同意后发还《药品经营许可证》正副本。企业名称法定代表人/负责人许可证编号许可证有有效期至经营地址仓库地址经营范围安徽臻迹医药科技有限公司张卫国/张卫国皖AA551a003272029.10.29安徽省亳州市亳州芜湖现代产业园圆通电商创业园20栋C102安徽省亳州市亳州高新区酒城大道1055号9#综合仓库二楼中区中成药、化学药（原料药及制剂）中药饮片、生物制品（上述经营范围含冷藏药品）***               安徽省药品监督管理局2025年9月15日