

#### [17] www24hreupbiz-700358-04232025 | issued 04/23/2025 | www.24hreup.biz | SUBJ: Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
WARNING LETTER This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet addresses www.24hreup.biz and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)]. As discussed below, FDA has observed that www.24hreup.biz introduces into interstate commerce unapproved and misbranded semaglutide drug products. There are inherent risks to consumers who purchase unapproved and misbranded drug products. [B90] [B91] Accordingly, FDA requests that www.24hreup.biz cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm. Unapproved New Drugs: Certain products offered for sale by www.24hreup.biz are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. [B100] [B98] [B97] On www.24hreup.biz in the “Weight Management” and “Injectable” categories of your website, you offer semaglutide marketed as “Ozempic 0.5mg” packaged as “Оземпик 1,34 мг/мл,” “Ozempic 1mg” packaged as “Оземпик 1,34 мг/мл,” and “Rybelsus Semaglutide 14mg” packaged as “1 blister card of 10 tablets.” While there are FDA-approved versions of Ozempic and Rybelsus on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Ozempic 0.5mg,” “Ozempic 1mg,” and “Rybelsus Semaglutide 14mg” offered by www.24hreup.biz. [B165] [B161] FDA-approved semaglutide tablets marketed under the brand name Rybelsus are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. [B246] [B162] [B116] Misbranded Drugs: [B101] [B108] [B143] [B144] FDA has observed that www.24hreup.biz offers “Ozempic 0.5mg,” “Ozempic 1mg,” and “Rybelsus Semaglutide 14mg” for sale without a prescription. Because these drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use. [B142] [B133] By offering these drugs for sale to U.S. consumers, www.24hreup.biz is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. [B240] By offering “Ozempic 0.5mg,” “Ozempic 1mg,” and “Rybelsus Semaglutide 14mg” without requiring a prescription, www.24hreup.biz jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. [B134] Additionally, “Ozempic 0.5mg” and “Ozempic 1mg” offered by www.24hreup.biz are intended for injection, which heightens the public health concern associated with these products and may further contribute to the potential for patient harm. [B131] FDA is sending this warning letter to www.24hreup.biz because of the inherent risks to consumers who purchase unapproved and misbranded drugs. [B96] [B94] [B93] We advise you to review your websites (including www.24hreup.com which forwards to www.24hreup.biz), product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the FD&C Act. [B103] [B104] [B125] [B102] [B83] [B99] [B81] [B95] [B117] [B223] Acting Director, Office of Drug Security, Integrity, and Response Office of Compliance Center for Drug Evaluation and Research Content current as of: 06/17/2025 Regulated Product(s)

#### [18] wwwpeacefulmedscom-703470-05052025 | issued 05/05/2025 | www.peacefulmeds.com | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
WARNING LETTER This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.peacefulmeds.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)]. As discussed below, FDA has observed that www.peacefulmeds.com introduces into interstate commerce unapproved and misbranded opioid and benzodiazepine drug products. [B257] [B256] Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co‐use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial, but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co‐used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines. The easy availability of benzodiazepines via the Internet poses additional significant risks to U.S. consumers. FDA has also observed that www.peacefulmeds.com introduces into interstate commerce misbranded injectable semaglutide drug products. [B131] [B110] [B90] [B91] Accordingly, FDA requests that www.peacefulmeds.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. [B185] Unapproved New Drugs: Evidence obtained from your website establishes that certain products offered for sale by www.peacefulmeds.com are drugs intended for human use. Examples of claims that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs for human use include the following: Your description of tramadol marketed as “TRAMADOL” and “Tramadol 100 mg Tabletas” includes: “it [sic] is an opioid analgesic (pain reliever) which works by blocking transmission of pain signals to the brain to lower pain perception.” Your description of diazepam marketed as “VALIUM” and “Valium Diazepam 10 mg 50 comprimidos” includes: “It is commonly used to treat a range of conditions, including anxiety, seizures, alcohol withdrawal syndrome, benzodiazepine withdrawal syndrome, muscle spasms, insomnia, and restless legs syndrome.” These products are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. [B109] [B100] [B98] [B97] For example, www.peacefulmeds.com offers tramadol, an opioid, marketed as “TRAMADOL” and “Tramadol 100 mg Tabletas.” While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “TRAMADOL” and “Tramadol 100 mg Tabletas” offered by www.peacefulmeds.com. FDA-approved tramadol is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is only available pursuant to a prescription from a licensed practitioner. FDA-approved tramadol bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning for tramadol addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when tramadol is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death. As another example, www.peacefulmeds.com offers diazepam, a benzodiazepine, marketed as “VALIUM” and “Valium Diazepam 10 mg 50 comprimidos.” While there are FDA-approved versions of valium on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “VALIUM” and “Valium Diazepam 10 mg 50 comprimidos” offered by www.peacefulmeds.com. FDA-approved diazepam is indicated for the management of anxiety disorders or for the short‐term relief of the symptoms of anxiety, symptomatic relief of certain symptoms associated with acute alcohol withdrawal, and as an adjunct for the relief of certain skeletal muscle spasms and convulsive disorders. It is only available pursuant to a prescription from a licensed practitioner. FDA-approved diazepam also bears a boxed warning indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning for diazepam address risks including abuse, misuse, addiction, dependence, and withdrawal reactions. In addition, when diazepam is taken in conjunction with opioids, use may result in coma or death. Misbranded Drugs: [B101] [B108] [B214] [B213] Because the aforementioned opioid and benzodiazepine drug products are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for the intended use. [B255] [B254] By offering these drugs for sale to U.S. consumers, www.peacefulmeds.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. Furthermore, evidence obtained from your website establishes that www.peacefulmeds.com offers prescription drugs for sale without a prescription. In addition to the aforementioned opioid and benzodiazepine drug products, FDA has observed that www.peacefulmeds.com offers semaglutide drug products without requiring a prescription: Your description of semaglutide marketed as “2 Pens Ozempic 1mg,” “Ozempic 0.25 mg,” “Ozempic 0.5 mg,” and “Ozempic 1 mg” includes: “Ozempic is a brand-name injectable drug pen used to further develop glucose levels in grown-ups (explicitly type 2 diabetics).” “…Ozempic likewise lessens the gamble of major cardiovascular occasions, for example, strokes, coronary episodes, or even passing.” “…Ozempic has become progressively well known for its weight reduction capacities.” Ozempic is the brand name of an FDA-approved drug for the treatment of type 2 diabetes mellitus and established cardiovascular disease that is only available by prescription. Using the brand name of the drug product Ozempic indicates that this product is intended to treat type 2 diabetes mellitus and established cardiovascular disease. The FDA-approved product Ozempic has been approved for marketing by FDA and is limited by a new drug application to use under the supervision of a practitioner licensed to administer such drugs. Therefore, Ozempic is a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. § 353(b)(1)(A)). [B248] By offering the aforementioned drugs without requiring a prescription, www.peacefulmeds.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. [B134] FDA is sending this warning letter to www.peacefulmeds.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. [B96] [B94] [B93] [B132] [B103] [B104] [B125] [B102] [B83] [B99] [B81] [B95] [B117] [B223] Acting Director, Office of Drug Security, Integrity, and Response Office of Compliance Center for Drug Evaluation and Research Content current as of: 06/24/2025 Regulated Product(s)

#### [19] wwwbuynetmedscom-706335-06122025 | issued 06/12/2025 | www.buynetmeds.com | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet
WARNING LETTER This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.buynetmeds.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)]. [B110] [B90] [B91] FDA has observed that www.buynetmeds.com introduces into interstate commerce unapproved and misbranded opioid drug products. [B257] [B256] FDA has also observed that www.buynetmeds.com introduces into interstate commerce unapproved and misbranded semaglutide drug products, including injectable versions. [B131] Accordingly, FDA requests that www.buynetmeds.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. [B185] Unapproved New Drugs: Certain products offered for sale by www.buynetmeds.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. [B109] [B100] [B98] [B97] On www.buynetmeds.com you offer for sale tapentadol, an opioid, marketed as: Asmanol 100mg Asmanol 100 Aspadol 50mg | TapentadoI Aspadol® 50 Aspadol 75mg Aspadol® 75 Aspadol 100mg Aspadol® Tab Etadol 100mg ETADOL 100 Noosanta 100mg Noosanta 100 Rin Tapenta 50mg Rin-Tapenta™-50 Tapaday 50MG | Tapentadol TAPADAY 50 Tapaday 100mg | Tapentadol TAPADAY 100 Tapaday O 100mg Tapaday-O-100 Tapal 100mg Tablets | Tapentadol Tapal 100 Tapal-ER 100mg Tapedac 100mg Tapenax ER 50 Tablet Tapfree ER™ 100 TAPFREE ER 100MG Tapidol 50mg | Tapentadol Tapidol-50mg TAPIDOL 100MG Tapidol-100 Tapsmart 100 mg Tapsmart-100 Topcynta 50mg TOPCYNTA 50 Topcynta 100MG TOPCYNTA 100 Tprexadol 100mg | Tapentadol Tprexadol™-100 Tydol 50mg | Tapentadol Tydol™ 50 Tydol 100mg Tydol™ 100 Typendol 100mg Yenta 100mg Yenta-100 Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes claims from each product’s description. Examples are listed below: “Asmanol 100mg (Tapentadol) is an opioid analgesic class medicine that is used to treat moderate to severe acute postoperative pain.” “Aspadol 50mg (Tapentadol) pill helps to relieve moderate to severe pain such as toothache, headache, or in conditions that affect joints and muscles.” “Etadol 100mg is a brand name for Tapentadol, a centrally acting analgesic that relieves pain in the brain and spinal cord.” “Noosanta 100 mg Tablet is an adult pain reliever intended to treat moderate to severe acute pain.” “Rin Tapenta 50mg Tablet is used to treat moderate to severe acute pain.” “Tapaday 100 mg tablet is a powerful medication that can provide relief for short-term acute pain…” “Tapal-ER 100mg is a prescription medication used to treat moderate to severe pain in adults.” “Tapedac 100mg Tablets are an adult-only prescription medicine used to treat moderate to severe acute pain.” “Tapenax ER 50 Tablet’s key advantage is that it gives good pain relief for moderate to severe pain.” “The prescription medication Tapfree ER 100mg is used to treat moderate to severe acute pain in adults.” “Adults who are experiencing moderate to severe acute pain may be prescribed a drug called Tapidol 100mg.” “Tapsmart 100 mg is treat [sic] for the management of moderate to severe pain in adults.” “Tapentadol hydrochloride is the active component of the pharmaceutical drug Topcynta 50mg.” “Tprexadol 100mg is prescribed to adults to relieve moderate to severe acute pain.” “Tydol 50mg is prescribed to adults to treat moderate to severe acute pain.” “Adults use Typendol 100mg to relieve moderate to severe acute pain.” “An adult painkiller called Yenta 100 mg Tablet is intended to treat moderate to severe acute pain.” While there are FDA-approved versions of tapentadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the drug products, listed above, offered by www.buynetmeds.com. Currently, there are two tapentadol products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved tapentadol marketed under the brand name NUCYNTA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved tapentadol marketed under the brand name NUCYNTA ER is indicated for the management of severe and persistent pain, including neuropathic pain associated with diabetic peripheral neuropathy, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA-approved tapentadol products bear a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when tapentadol is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death. On www.buynetmeds.com you offer for sale semaglutide, including injectable versions, marketed as: Rybelsus 3mg Tablet Semaglutide Tablets Rybelsus® 3mg 1 blister card of 10 tablets Rybelsus 7mg Rybelsus® 7mg Semaglutida Tabletas Rybelsus 14mg Semaglutide Tablets Rybelsus® 14mg 1 blister card of 10 tablets Semaglutide 0.25 mg Injection Fitaro™ 0.25 Semaglutide 0.5 mg Injection Fitaro™ 0.5 Semaglutide 1 mg Injection Fitaro™ 1 Semaglutide 1.7 mg Injection Fitaro™ 1.7 Semaglutide 2.4 mg Injection Fitaro™ 2.4 Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes but is not limited to the following claims: “Rybelsus 3mg (semaglutide) is a type 2 diabetes medicine that acts as a glucagon-like peptide-1 (GLP-1) receptor agonist.” “Rybelsus 7mg (Semaglutide) Tablet is a type 2 diabetic medicine authorized by the FDA.” “Rybelsus 14mg (Semaglutide) Pills is a type 2 diabetic medicine authorized by the FDA.” “Semaglutide 0.5 mg injection is widely administered to people with type 2 diabetes who cannot maintain optimal glycemic control by diet and exercise alone or in combination with other antidiabetic drugs. It lowers blood sugar levels by boosting insulin secretion while lowering glucagon release.” “In addition to its function in diabetes management, semaglutide has been researched for its ability to promote weight reduction.” While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the drug products, listed above, offered by www.buynetmeds.com. [B165] FDA-approved semaglutide tablets marketed under the brand name RYBELSUS are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved semaglutide injection marketed under the brand name OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. FDA-approved semaglutide injection marketed under the brand name WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients. FDA-approved semaglutide products also bear a boxed warning, which again, is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. [B116] Misbranded Drugs: [B101] [B108] [B214] [B213] [B124] [B255] [B254] By offering these drugs for sale to U.S. consumers, www.buynetmeds.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. Additionally, FDA has observed that www.buynetmeds.com offers prescription drugs for sale without a prescription. [B248] By offering the aforementioned drugs without requiring a prescription, www.buynetmeds.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. [B134] FDA is sending this warning letter to www.buynetmeds.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. [B96] [B94] [B93] We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act. [B103] [B104] Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. [B102] [B83] [B99] [B81] [B95] [B117] [B223] Acting Director, Office of Drug Security, Integrity, and Response Office of Compliance Center for Drug Evaluation and Research Content current as of: 07/01/2025 Regulated Product(s)

#### [20] cheaptrustedpharmacycom-705501-07292025 | issued 07/29/2025 | cheaptrustedpharmacy.com | SUBJ: Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
WARNING LETTER This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.cheaptrustedpharmacy.com and has observed that your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]. FDA has observed that www.cheaptrustedpharmacy.com introduces into interstate commerce certain drugs for which the FDA-approved version is subject to a Risk Evaluation and Mitigation Strategy (REMS) 1 program, is an opioid, semaglutide, an injectable, and/or is indicated to treat serious conditions such as HIV/AIDS or cancer. [B110] [B90] [B91] [B257] [B256] Furthermore, injectable drug products can pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.cheaptrustedpharmacy.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. [B185] Unapproved New Drugs: Certain products offered for sale by www.cheaptrustedpharmacy.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. [B109] [B100] [B98] [B97] On www.cheaptrustedpharmacy.com you offer for sale lenalidomide marketed as “Evermide 10 (Lenalidomide)” and “Evermide 25 (Lenalidomide)”. Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Multiple myeloma, Lepra reaction” and categorization “Life Saving Drugs / Anti Cancer”. While there are FDA-approved versions of lenalidomide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Evermide 10 (Lenalidomide)” and “Evermide 25 (Lenalidomide)” offered by www.cheaptrustedpharmacy.com. Currently there are lenalidomide products that are FDA-approved for the U.S. market and they are only available pursuant to a prescription from a licensed practitioner. FDA-approved lenalidomide, including products marketed under the brand name REVLIMID, are indicated for the treatment of certain adult patients with multiple myeloma and myelodysplastic syndromes. Certain FDA-approved lenalidomide products are also approved for the treatment of mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. FDA-approved lenalidomide bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses the risk of embryo-fetal toxicity (including birth defects and embryo-fetal death), hematologic toxicity (neutropenia and thrombocytopenia), and venous and arterial thromboembolism (deep vein thrombosis and pulmonary embolism). On www.cheaptrustedpharmacy.com you offer for sale combination abacavir, dolutegravir, and lamivudine marketed as “Inbec (Abacavir/Dolutegravir/Lamivudine)”. Evidence obtained from your website establishing that this product is a drug intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: HIV infection” and categorization “Life Saving Drugs / HIV-Aids [sic]”. While there are FDA-approved versions of combination abacavir, dolutegravir, and lamivudine drug products on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for “Inbec (Abacavir/Dolutegravir/Lamivudine)” offered by www.cheaptrustedpharmacy.com. Currently there are two combination abacavir, dolutegravir, and lamivudine products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved combination abacavir, dolutegravir, and lamivudine marketed under the brand names TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in certain pediatric patients. FDA-approved TRIUMEQ and TRIUMEQ PD bear a boxed warning addressing the risks of serious and sometimes fatal hypersensitivity reactions and severe acute exacerbations of Hepatitis B. On www.cheaptrustedpharmacy.com you offer for sale injectable semaglutide marketed as “Semaglutide 0.5mg,” “Semaglutide 1mg,” “Semanize 4 Mg (Semaglutide),” and “Semanize 8 Mg (Semaglutide).” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Type 2 diabetes” and categorization “Diabetes Care / Diabetes Type 2”. While there are FDA-approved versions of semaglutide on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Semaglutide 0.5mg,” “Semaglutide 1mg,” “Semanize 4Mg (Semaglutide),” and “Semanize 8 Mg (Semaglutide)” offered by www.cheaptrustedpharmacy.com. [B165] FDA-approved semaglutide injection marketed under the brand name OZEMPIC is indicated as an adjunct to diet and exercise to improve glycemic control in individuals with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. FDA-approved semaglutide injection marketed under the brand name WEGOVY is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in certain adult and pediatric patients. FDA-approved semaglutide tablets marketed under the brand name RYBELSUS are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. FDA-approved semaglutide products bear a boxed warning addressing the risk of thyroid C-cell tumors. On www.cheaptrustedpharmacy.com you offer for sale tapentadol, an opioid, marketed as “Noosanta 100Mg (Tapentadol),” “Noosanta 200Mg (Tapentadol),” and “Noosanta 250mg (Tapentadol).” Evidence obtained from your website establishing that these products are drugs intended for human use (as defined in 21 CFR 201.128) includes the claim “Indication: Pain Reliever” and categorization under “Pain / Tapentadol”. While there are FDA-approved versions of tapentadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Noosanta 100Mg (Tapentadol),” “Noosanta 200Mg (Tapentadol),” and “Noosanta 250mg (Tapentadol)” offered by www.cheaptrustedpharmacy.com. Currently, there are two tapentadol products that are FDA-approved for the U.S. market and these products are only available pursuant to a prescription from a licensed practitioner. FDA-approved tapentadol marketed under the brand name NUCYNTA is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved tapentadol marketed under the brand name NUCYNTA ER is indicated for the management of severe and persistent pain, including neuropathic pain associated with diabetic peripheral neuropathy, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. FDA-approved tapentadol products bear a boxed warning addressing risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when tapentadol is taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death. Misbranded Drugs: [B101] [B108] [B214] [B213] [B124] [B255] [B254] By offering these drugs for sale to U.S. consumers, www.cheaptrustedpharmacy.com is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. FDA is sending this warning letter to www.cheaptrustedpharmacy.com because of the inherent risks to consumers who purchase misbranded and unapproved new drugs. [B96] [B94] [B93] We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded and unapproved drug products in violation of the FD&C Act. [B103] [B104] Failure to adequately address this matter may result in legal action, including, without limitation, seizure, and injunction, without further notice. [B102] [B83] [B99] [B81] [B95] [B117] [B223] Acting Director Office of Drug Security, Integrity, and Response Office of Compliance Center for Drug Evaluation and Research ___________________ 1 REMS is a drug safety program that FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Content current as of: 09/23/2025 Regulated Product(s)

#### [21] asn-labs-716459-09092025 | issued 09/09/2025 | ASN-LABS | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 ASN-LABS: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://asn-labs.com in August 2025 and has observed that your website offers various compounded drug products, including retatrutide and semaglutide. [B192] In addition, your claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the 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)]. A. [B141] [B188] [B106] [B227] [B202] [B190] [B206] B. [B193] [B197] [B189] [B194] Specific violations are described below. C. Violations of the FDCA Unapproved New Drugs & Misbranded Drugs There are no FDA-approved applications on file for your compounded retatrutide drug product. [B201] [B105] [B225] [B200] 6 introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. [B198] [B12] The following claims concerning compounded semaglutide products appear on your website: • “The same active ingredient as Wegovy and Ozempic” • “Semaglutide is the generic drug in Ozempic (injectable) and Rybelsus (oral) diabetes control medications, and Wegovy (injectable) weight loss medication.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] 7 D. [B186] In addition, your claims concerning compounded semaglutide drug products are false or misleading under sections 502(a) and 502(bb) of the 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)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B81] [B203] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B259] [B5] [B187] [B149] [B195] [B199] [B258] [B226] [B224] [B204] [B157] [B156] [B196] [B191] [B205] Content current as of: 09/16/2025 Regulated Product(s)

#### [22] all-american-wellness-715991-09092025 | issued 09/09/2025 | All American Wellness | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 All American 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://all-american-wellness.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Mounjaro’s compounded version- Tirzepatide Prescription” • “Ozempic’s compounded version- Semaglutide” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [23] amazing-meds-715506-09092025 | issued 09/09/2025 | Amazing Meds | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Amazing Meds: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://amazing-meds.com in August 2025 and has observed that your website offers various compounded drug products, including retatrutide and semaglutide. [B192] In addition, your claim concerning compounded semaglutide products is false or misleading under sections 502(a) and 502(bb) of the 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)]. A. [B141] [B188] [B106] [B227] [B202] [B190] [B206] B. [B193] [B197] [B189] [B194] Specific violations are described below. C. [B228] [B201] [B105] Furthermore, your compounded retatrutide drug products are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for its intended use. [B200] 6 The introduction or delivery for introduction into interstate commerce of this product therefore violates section 301(a) of the FDCA. [B198] [B12] The following claim regarding your compounded semaglutide products appears on your website: • “Compounded semaglutide (same as Ozempic/Wegovy)” Compounded drug products are not FDA-approved. [B111] [B112] [B11] [B127] 7 D. [B186] In addition, your claim concerning compounded semaglutide drug products is false or misleading under sections 502(a) and 502(bb) of the 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)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B81] [B203] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration These substances are also not eligible for the policy applicable to certain bulk drug substances described in the final guidance titled, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act . [B199] Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA-approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. These conditions include that the substance may be eligible for inclusion on the 503A bulks list, was nominated with adequate support for FDA to evaluate it and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluaGuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf. 1 The retatrutide and semaglutide 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. [B5] [B187] [B149] [B195] [B199] Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA-approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. These conditions include that the substance may be eligible for inclusion on the 503A bulks list, was nominated with adequate support for FDA to evaluate it and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluaGuidanceComplianceRegulatoryInformation/Guidances/UCM469120.pdf. [B204] [B157] [B156] [B196] [B191] [B205] Content current as of: 09/16/2025 Regulated Product(s)

#### [24] bioverse-inc-dba-bioverse-716508-09092025 | issued 09/09/2025 | Bioverse, Inc. dba Bioverse | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Bioverse: 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.gobioverse.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] 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. he following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “Same active ingredient as Ozempic and Wegovy” • “The same active ingredient in Mounjaro and Zepbound” • “Semaglutide, the same active ingredient in Ozempic and Wegovy, is a GLP-1 RA recognized for effective weight loss.” “Doctor-trusted ingredients, formulated with the same active ingredient as Ozempic and Wegovy” • “Weight loss specialists frequently prescribe compounded semaglutide, which contains the same active ingredient as Ozempic and Wegovy” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B92] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [25] body-good-studio-716460-09092025 | issued 09/09/2025 | Body Good Studio | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Body Good Studio: 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.bodygoodstudio.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. [B229] [B14] [B12] The following claim concerning compounded semaglutide products appears on your website: • “Compound semaglutide is made of the same active ingredients as Ozempic and Wegovy, which are GLP-1 receptor agonist [sic]….” Compounded drug products are not FDA-approved. [B111] [B112] [B11] [B127] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [26] canada-med-stop-716517-09092025 | issued 09/09/2025 | Canada Med Stop | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Canada Med Stop: 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.canadamedstop.com in August 2025 and has observed that your website offers compounded semaglutide drug products. 1 As described below, your claims concerning your compounded semaglutide 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)]. [B14] [B12] The following claims concerning compounded semaglutide products appear on your website: • “The same active ingredient in branded weight loss medications.” • “FDA-Approved Medication” • “GENERIC” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B88] [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [27] cosmo-medical-spa-dba-cosmo-med-spa-715873-09092025 | issued 09/09/2025 | Cosmo Medical Spa dba Cosmo Med Spa | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Cosmo Med Spa: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://cosmomedspa.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide. [B207] [B14] [B12] [B128] “Ozempic (semaglutide) injection (4 weeks supply)” “Ozempic (semaglutide) injection (10 weeks supply)” Compounded drug products are not FDA-approved. [B111] [B15] [B11] [B23] [B89] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration ______________________ 1 The semaglutide 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. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [28] curex-716821-09092025 | issued 09/09/2025 | Curex | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Curex: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://getcurex.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] [B74] “Clinically proven success” “Clinically proven weight loss treatments” “The same active ingredients as Ozempic or Mounjaro” “Prescription weight loss with the same active ingredients as Mounjaro & Zepbound.” “While we don’t prescribe Ozempic, Wegovy, Zepbound, or Mounjaro directly, we may prescribe treatments containing the same active ingredients.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration _______________________________ 1 The 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. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [29] dr-gaters-weight-loss-wellness-712866-09092025 | issued 09/09/2025 | Dr. Gater’s Weight Loss & Wellness | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Dr. Gater: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://drgatergetsresults.com in September 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] [B74] “FDA Approved” “Tirzepatide is the active ingredient in Mounjaro….” “Semaglutide,[ sic ] is the generic version of Ozempic/Wegovy. The generic version Semiglutide [ sic ] allows for affordability and accessibility to everyday consumers looking to attain a healthy weight.” “While the Brand Ozempic from retail pharmacies is extremely expensive, Dr. Gater has licensed pharmacies that can dispense Brand Ozempic at a much more affordable price. You can purchase Brand Ozempic through our website at a significant cost savings. All prescription medications including generic Semiglutide [ sic ] and brand Ozempic require a telemedicine visit with a medical provider prior [ sic ] a prescription being sent to our partner pharmacies.” “Compounded Semiglutide [ sic ] is the generic equivalent of the brand names and pharmacologically similar to Ozempic & Wegovy.” “Generic Ozempic” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration ___________________________ 1 The 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. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [30] ea-works-limited-liability-company-dba-trust-labs-715798-09092025 | issued 09/09/2025 | EA WORKS Limited Liability Company dba Trust Labs | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Trust Labs: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://coretrustlabs.com in August 2025 and has observed that your website offers various compounded drug products, including retatrutide, semaglutide and tirzepatide. [B192] In addition, 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)]. A. [B141] [B188] [B106] [B227] [B202] [B190] [B206] B. [B193] [B197] [B189] [B194] Specific violations are described below. C. [B228] [B201] [B105] [B225] [B200] [B170] [B198] [B12] The following claims concerning compounded semaglutide and tirzepatide products appear on your website: • “FDA approval: Semaglutide was approved by the U.S. Food and Drug Administration (FDA) in December 2017.” • “FDA approval: Tirzepatide was approved by the U.S. Food and Drug Administration (FDA) in 2022.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] 7 D. [B186] In addition, your claims concerning compounded semaglutide and tirzepatide products are false or misleading under sections 502(a) and 502(bb) of the 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)]. [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B81] [B203] [B7] [B6] Sincerely, /s/ George Tidmarsh, M.D., Ph.D. [B18] [B259] [B5] [B187] [B149] [B195] [B199] [B258] [B226] [B224] [B204] [B157] [B156] [B196] [B191] [B205] Content current as of: 09/16/2025 Regulated Product(s)

#### [31] elevate-your-wellness-llc-dba-elevated-719811-09092025 | issued 09/09/2025 | Elevate Your Wellness LLC, dba Elevated | SUBJ: Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth)
WARNING LETTER September 9, 2025 Elevated: This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website content at the internet address https://elevatedhealth.com in August 2025 and has observed that your website offers various compounded drug products, including semaglutide and tirzepatide. [B47] [B14] [B12] [B74] “Compounded GLP-1 medications are personalized versions of treatments like Semaglutide or Tirzepatide. They’re made by licensed compounding pharmacies based on a prescription from a qualified healthcare provider. They contain the same active ingredient as the branded medications, but are compounded to offer a more personalized and often more accessible option.” “Semaglutide ODT is a custom-formulated, dissolvable tablet that delivers the same active ingredient found in the leading GLP-1 weight loss medications – without the need for injections.” Compounded drug products are not FDA-approved. [B24] [B15] [B11] [B23] [B43] [B9] [B10] [B2] [B3] [B19] [B1] [B8] [B17] [B0] [B16] [B4] [B13] [B21] [B7] [B6] Sincerely, /S/ George Tidmarsh, M.D., Ph.D. [B18] Food and Drug Administration ____________________ 1 The 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. [B5] [B22] Content current as of: 09/16/2025 Regulated Product(s)

#### [32] eli-lilly-and-company-716485-09092025 | issued 09/09/2025 | Eli Lilly and Company | SUBJ: False & Misleading Claims/Misbranded
WARNING LETTER Dear 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 Butsch 1 and Dr. Amanda Velazquez 2 , paid consultants (representatives) who “receive research funding from companies making GLP-1 3 drugs.” 4 The video also features Rhonda Pacheco, 5 Group 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. 6 The video subsequently appeared on Hulu on March 19, 2024. [B274] 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). [B271] 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. Background Below are the indication and summary of the most serious and most common risks associated with the use of Zepbound and Mounjaro. 7 According 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/m 2 or greater (obesity) or 27 kg/m 2 or 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 Communications FDA 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. 10 We 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. [B273] [B269] 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” 11 due 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, 12 who 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. 13 First, 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 [and MOUNJARO] is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) . . . . Counsel patients regarding the potential risk for MTC with the use of ZEPBOUND [and MOUNJARO] 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 really not been shown in human studies that this is a downstream complication, and that really the risk is less than 1% .” (37:00) “If anybody has a history 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’s rare, but it’s there and 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. 14 These 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 drugs generally have 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. [B265] [B270] 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 Action For 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). [B271] [B83] [B268] [B1] 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. [B266] [B276] [B278] 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). [B275] [B272] [B277] [B260] Please direct your response to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 . [B267] Please refer to MA 974 and MA 832 in addition to the NDA numbers in all future correspondence relating to this particular matter. [B7] [B261] [B264] Questions related to the submission of your response letter should be emailed to CDEROPDP-RPM@fda.hhs.gov. [B263] [B262] Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------ CARTER M BEACH 09/09/2025 05:18:14 PM On behalf of George Tidmarsh, M.D., Ph.D ________________________________ 1 Dr. 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). 2 Dr. 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). 3 GLP-1 = Glucagon-like Peptide-1 4 At 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.” 5 Rhonda 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-living 6 This 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) 7 This 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. 8 The version of the Zepbound PI referred to in this letter is dated March 2024. 9 The version of the Mounjaro PI referred to in this letter is dated July 2023. 10 FDA notes that additional advisory comments have also been sent in May and November 2024 to Lilly regarding Zepbound with same/similar concerns. 11 The 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. 12 See supra footnotes 1, 2, and 3. 13 We 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. 14 While 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 Content current as of: 09/16/2025 Regulated Product(s)