[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-warrior-labz-sarms-655280-06122023":3,"fda-latest-sync-dates":30},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":28,"updated_at":29},2050,"warrior-labz-sarms-655280-06122023","Warning Letter","Warrior Labz SARMS",null,"Center for Drug Evaluation and Research | CDER","Unapproved New Drugs\u002FMisbranded","2023-06-20","2023-06-12","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fwarrior-labz-sarms-655280-06122023","655280","Drugs","Via Email","Jeremy Brown","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Jeremy Brown\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Warrior Labz SARMS\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1319 Sawyer Avenue\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Simi Valley\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">93065\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:sales@warriorlabzsarms.com\"> sales@warriorlabzsarms.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:Jeremy@warriorlabzsarms.com\"> Jeremy@warriorlabzsarms.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research | CDER\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>June 12, 2023\u003C\u002Fp>\n\n\u003Cp>Warrior Labz SARMS\u003Cbr>\n5737 Kannan Road, Unit 215\u003Cbr>\nAgoura Hills, CA 91301 \u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>RE: 655280\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Brown:\u003C\u002Fp>\n\n\u003Cp>This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwarriorlabzsarms.com\u002F in May 2023 and has observed that you take orders there for products marketed on your firm’s website as selective androgen receptor modulators (SARMs) including “RAD-140 Testolone,” “MK-677 Ibutamoren,” “MK-2866 Ostarine,” and “LGD-4033 Ligandrol.” We observed that you also take orders on your website for “19-Nor Andro,” “4-Andro,” “BPC-157” (injectable and nasal spray), “TB-500” (injectable and nasal spray), “Viagra-Max Sildenafil,” and “Cialis-Max Tadalafil.” We also have reviewed your Instagram social media website at the Internet address https:\u002F\u002Fwww.instagram.com\u002Fwarrior_labz_sarms\u002F?hl=en, which directs consumers to your website https:\u002F\u002Fwarriorlabzsarms.com\u002F to purchase your products. As described below, your before-named products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 301(d).\u003C\u002Fp>\n\n\u003Cp>FDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke. Likewise, FDA has safety concerns about your unapproved new drugs intended for injectable\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> and intranasal\u003Csup>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> routes of administration.\u003C\u002Fp>\n\n\u003Cp>Despite statements on your product labeling marketing your products for “research purpose only” and “not for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended to prevent, treat, or cure disease conditions and\u002For affect the structure or function of the body. Examples of claims observed on your website and social media website that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following:\u003C\u002Fp>\n\n\u003Cp>From your website https:\u002F\u002Fwarriorlabzsarms.com\u002F:\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>RAD-140 Testolone\u003C\u002Fstrong>\u003Cbr>\n“RAD-140 \u002F TESTOLONE\u003Cbr>\nSARM for Muscle Growth and Size\u003Cbr>\nReduces Fat and Increases Muscle Mass\u003Cbr>\nRapid Muscle Recovery\u003Cbr>\nCarries the benefits of Testosterone injections without all the risks\u003Cbr>\nReduced androgenic effects on the prostate to cut the risk of growth of Prostate Cancer.\u003Cbr>\nProduces High Stamina and Energy Levels\u003Cbr>\nIncreased Libido and Sexual Performance . . .\u003Cbr>\nCYCLE LENGTH – 12 Weeks is best for optimal results.\u003Cbr>\nDOSAGE – 1ML AM”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>MK-677 Ibutamoren\u003C\u002Fstrong>\u003Cbr>\n“MK- 677 – IBUTAMOREN \u002F NUTROBOL\u003Cbr>\nIncreased Production of GH and IGF-1\u003Cbr>\nPromotes muscle growth\u003Cbr>\nIncreases bone density\u003Cbr>\nHas anti-again [sic] properties\u003Cbr>\nTreats deficiency in Growth Hormone\u003Cbr>\nBeneficial in preventing muscle wasting . . .\u003Cbr>\nDOSAGE – 1ML ABOUT 2-3 HOURS BEFORE BED OR 1ST THING IN THE AM”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>MK-2866 Ostarine\u003C\u002Fstrong>\u003Cbr>\n“OSTARINE \u002F MK-2866\u003Cbr>\nIncreases muscle mass, growth, and strength\u003Cbr>\nJoint healing capabilities\u003Cbr>\nHelps maintain Muscle Mass when calorie deficit\u003Cbr>\nImproves and protects Heart Health\u003Cbr>\nBuilds endurance\u003Cbr>\nAccelerates healing . . .\u003Cbr>\nCYCLE LENGTH – 12 Weeks is best for optimal results.\u003Cbr>\nDOSAGE – 1ML AM”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>LGD-4033 Ligandrol\u003C\u002Fstrong>\u003Cbr>\n“LGD-4033 \u002F LIGANDROL\u003Cbr>\nIncreased Strength\u003Cbr>\nIncreased Lean Muscle Mass\u003Cbr>\nFaster Muscle Recovery\u003Cbr>\nHelps maintain your hard-earned gains\u003Cbr>\nDeveloped to prevent muscle wasting\u003Cbr>\nTreats Osteoporosis . . .\u003Cbr>\nCYCLE LENGTH – 12 Weeks is best for optimal results.\u003Cbr>\nDOSAGE – 1ML AM”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>19-Nor Andro\u003C\u002Fstrong>\u003Cbr>\n“19 NOR ANDRO . . .\u003Cbr>\nEXTREME LEAN MUSCLE GROWTH\u003Cbr>\nSERIOUS STRENGTH GAINS\u003Cbr>\nPREVENTS MUSCLE FATIGUE\u003Cbr>\nFASTER RECOVERY FROM SORENESS”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>4-Andro\u003C\u002Fstrong>\u003Cbr>\n“4-ANDRO . . .\u003Cbr>\nEXTREME LEAN MUSCLE GROWTH\u003Cbr>\nINCREASES IGF-1 AND GH SECRETION\u003Cbr>\nPREVENTS MUSCLE FATIGUE\u003Cbr>\nRECOVER FROM SORENESS”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>BPC-157\u003C\u002Fstrong>\u003Cbr>\n“BPC 157 has been shown to protect organs and aids in the prevention of gastric ulcers. BPC-157 acts systemically in the digestive tract to combat leaky gut, IBS, gastrointestinal cramps, and Crohn’s disease. This peptide has been known to exhibit analgesic characteristics. Research has shown its ability to help skin burns heal at a faster rate by increasing blood flow to damaged tissues. BPC-157 significantly accelerates reticulin and collagen formation as well as angiogenesis together with stimulation of macrophages and fibroblasts infiltration representing a potential therapeutic tool in wound healing management. . . .\u003C\u002Fp>\n\n\u003Cp>Doses can range from 1 mg to 20 mg per week by SQ or IM injections divided into 2-3 injections per week. It is then lowered after the first 1-2 weeks to a maintenance dose approximately 1\u002F2 of the original weekly dose and administered once a week thereafter.”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>TB-500\u003C\u002Fstrong>\u003Cbr>\n“TB-500 5MG VIAL . . . In animal models, Thymosin Beta-4 has been shown to improve blood vessel growth, regulate wound healing, decrease inflammation, and reduce oxidative damage in the heart and central nervous system. Thymosin-beta-4 has a role in protection, tissue repair, regeneration, and remodeling of injured or damaged tissues. It is also of active interest in anti-aging research. . . .\u003C\u002Fp>\n\n\u003Cp>Doses can range from 1 mg to 20 mg per week by SQ or IM injections divided into 2-3 injections per week. It is then lowered after the first 1-2 weeks to a maintenance dose approximately 1\u002F2 of the original weekly dose and administered once a week thereafter.”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Viagra-Max Sildenafil\u003C\u002Fstrong>\u003Cbr>\n“Viagra-Max \u002F Sildenafil is usually taken only when needed, generally 30 minutes to 1 hour before desired sexual activity. You may take it up to 4 hours before sexual activity. Do not take Viagra more than once per day. Shake the oral suspension (liquid) before usage [sic]”\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Cialis-Max Tadalafil\u003C\u002Fstrong>\u003Cbr>\n“Cialis can be taken once a day. If your doctor recommends using Cialis every day, you should take the drug at about the same time each day. You don’t need to take Cialis before sexual activity unless your doctor says to use the drug only as needed.”\u003C\u002Fp>\n\n\u003Cp>From your webpage https:\u002F\u002Fwarriorlabzsarms.com\u002Ftestimonials\u002F:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>From a testimonial by John R. – “For almost 4 weeks now I have been using MK-677, RAD-140 and LGD-4033, The Warrior Mass Stack, and I feel amazing. My strength is up and I am putting on muscle size and my sleep at night from the MK-677 is awesome. I feel like a Warrior !!!”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>From your Instagram website https:\u002F\u002Fwww.instagram.com\u002Fwarrior_labz_sarms\u002F?hl=en:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>From a July 6, 2022 post – “Warrior Labz is proud to offer you a Six Pack !!! Yes...A Strong 6 Pack of any 6 Individual Sarms, Peptides, Pro Hormones, Male Enhancement for only $299 Delivered anywhere USA !!! . . . Stacks are Higher and additional Bottles may be purchased @ $50 each also. Payment via: Zelle, Cash App, Venmo, Apple Pay and Pay Pal - Friends and Family. Call or Text . . . www.warriorlabzsarms.com”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cstrong>Unapproved New Drugs\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Your “RAD-140 Testolone,” “MK-677 Ibutamoren,” “MK-2866 Ostarine,” “LGD-4033 Ligandrol,” “19-Nor Andro,” “4-Andro,” “BPC-157,” “TB-500,” “Viagra-Max Sildenafil,” and “Cialis-Max Tadalafil” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\u003C\u002Fp>\n\n\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them.\u003Cbr>\n\u003Cbr>\nFailure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\u003C\u002Fp>\n\n\u003Cp>Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\n\n\u003Cp>Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>CAPT Tina Smith\u003Cbr>\nActing Director\u003Cbr>\nOffice of Unapproved Drugs and Labeling Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\nFood and Drug Administration\u003C\u002Fp>\n\n\u003Cp>______________________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> Injectable drug products can pose a serious risk of harm to users because they are delivered directly into the bloodstream and 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.\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> Intranasal drug products may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation, where they may exert undesirable systemic effects such as increased heart rate or elevated blood pressure. If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur.\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nJeremy Brown\n\nWarrior Labz SARMS\n\n1319 Sawyer Avenue\n\nSimi Valley, CA 93065\n\nUnited States\n\nsales@warriorlabzsarms.com\n\nJeremy@warriorlabzsarms.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nJune 12, 2023\n\nWarrior Labz SARMS\n\n5737 Kannan Road, Unit 215\n\nAgoura Hills, CA 91301\n\nRE: 655280\n\nDear Mr. Brown:\n\nThis letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwarriorlabzsarms.com\u002F in May 2023 and has observed that you take orders there for products marketed on your firm’s website as selective androgen receptor modulators (SARMs) including “RAD-140 Testolone,” “MK-677 Ibutamoren,” “MK-2866 Ostarine,” and “LGD-4033 Ligandrol.” We observed that you also take orders on your website for “19-Nor Andro,” “4-Andro,” “BPC-157” (injectable and nasal spray), “TB-500” (injectable and nasal spray), “Viagra-Max Sildenafil,” and “Cialis-Max Tadalafil.” We also have reviewed your Instagram social media website at the Internet address https:\u002F\u002Fwww.instagram.com\u002Fwarrior_labz_sarms\u002F?hl=en, which directs consumers to your website https:\u002F\u002Fwarriorlabzsarms.com\u002F to purchase your products. As described below, your before-named products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 301(d).\n\nFDA has safety concerns about products that contain SARMs. Life-threatening reactions, including liver toxicity, have occurred in people taking products containing SARMs. SARMs also have the potential to increase the risk of heart attack and stroke. Likewise, FDA has safety concerns about your unapproved new drugs intended for injectable1 and intranasal2 routes of administration.\n\nDespite statements on your product labeling marketing your products for “research purpose only” and “not for human consumption,” evidence obtained from your website establishes that your products are intended to be drugs for human use. Your products are drugs as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because they are intended to prevent, treat, or cure disease conditions and\u002For affect the structure or function of the body. Examples of claims observed on your website and social media website that establish the intended use of your products as drugs intended for human use include, but may not be limited to, the following:\n\nFrom your website https:\u002F\u002Fwarriorlabzsarms.com\u002F:\n\nRAD-140 Testolone\n\n“RAD-140 \u002F TESTOLONE\n\nSARM for Muscle Growth and Size\n\nReduces Fat and Increases Muscle Mass\n\nRapid Muscle Recovery\n\nCarries the benefits of Testosterone injections without all the risks\n\nReduced androgenic effects on the prostate to cut the risk of growth of Prostate Cancer.\n\nProduces High Stamina and Energy Levels\n\nIncreased Libido and Sexual Performance . . .\n\nCYCLE LENGTH – 12 Weeks is best for optimal results.\n\nDOSAGE – 1ML AM”\n\nMK-677 Ibutamoren\n\n“MK- 677 – IBUTAMOREN \u002F NUTROBOL\n\nIncreased Production of GH and IGF-1\n\nPromotes muscle growth\n\nIncreases bone density\n\nHas anti-again [sic] properties\n\nTreats deficiency in Growth Hormone\n\nBeneficial in preventing muscle wasting . . .\n\nDOSAGE – 1ML ABOUT 2-3 HOURS BEFORE BED OR 1ST THING IN THE AM”\n\nMK-2866 Ostarine\n\n“OSTARINE \u002F MK-2866\n\nIncreases muscle mass, growth, and strength\n\nJoint healing capabilities\n\nHelps maintain Muscle Mass when calorie deficit\n\nImproves and protects Heart Health\n\nBuilds endurance\n\nAccelerates healing . . .\n\nCYCLE LENGTH – 12 Weeks is best for optimal results.\n\nDOSAGE – 1ML AM”\n\nLGD-4033 Ligandrol\n\n“LGD-4033 \u002F LIGANDROL\n\nIncreased Strength\n\nIncreased Lean Muscle Mass\n\nFaster Muscle Recovery\n\nHelps maintain your hard-earned gains\n\nDeveloped to prevent muscle wasting\n\nTreats Osteoporosis . . .\n\nCYCLE LENGTH – 12 Weeks is best for optimal results.\n\nDOSAGE – 1ML AM”\n\n19-Nor Andro\n\n“19 NOR ANDRO . . .\n\nEXTREME LEAN MUSCLE GROWTH\n\nSERIOUS STRENGTH GAINS\n\nPREVENTS MUSCLE FATIGUE\n\nFASTER RECOVERY FROM SORENESS”\n\n4-Andro\n\n“4-ANDRO . . .\n\nEXTREME LEAN MUSCLE GROWTH\n\nINCREASES IGF-1 AND GH SECRETION\n\nPREVENTS MUSCLE FATIGUE\n\nRECOVER FROM SORENESS”\n\nBPC-157\n\n“BPC 157 has been shown to protect organs and aids in the prevention of gastric ulcers. BPC-157 acts systemically in the digestive tract to combat leaky gut, IBS, gastrointestinal cramps, and Crohn’s disease. This peptide has been known to exhibit analgesic characteristics. Research has shown its ability to help skin burns heal at a faster rate by increasing blood flow to damaged tissues. BPC-157 significantly accelerates reticulin and collagen formation as well as angiogenesis together with stimulation of macrophages and fibroblasts infiltration representing a potential therapeutic tool in wound healing management. . . .\n\nDoses can range from 1 mg to 20 mg per week by SQ or IM injections divided into 2-3 injections per week. It is then lowered after the first 1-2 weeks to a maintenance dose approximately 1\u002F2 of the original weekly dose and administered once a week thereafter.”\n\nTB-500\n\n“TB-500 5MG VIAL . . . In animal models, Thymosin Beta-4 has been shown to improve blood vessel growth, regulate wound healing, decrease inflammation, and reduce oxidative damage in the heart and central nervous system. Thymosin-beta-4 has a role in protection, tissue repair, regeneration, and remodeling of injured or damaged tissues. It is also of active interest in anti-aging research. . . .\n\nDoses can range from 1 mg to 20 mg per week by SQ or IM injections divided into 2-3 injections per week. It is then lowered after the first 1-2 weeks to a maintenance dose approximately 1\u002F2 of the original weekly dose and administered once a week thereafter.”\n\nViagra-Max Sildenafil\n\n“Viagra-Max \u002F Sildenafil is usually taken only when needed, generally 30 minutes to 1 hour before desired sexual activity. You may take it up to 4 hours before sexual activity. Do not take Viagra more than once per day. Shake the oral suspension (liquid) before usage [sic]”\n\nCialis-Max Tadalafil\n\n“Cialis can be taken once a day. If your doctor recommends using Cialis every day, you should take the drug at about the same time each day. You don’t need to take Cialis before sexual activity unless your doctor says to use the drug only as needed.”\n\nFrom your webpage https:\u002F\u002Fwarriorlabzsarms.com\u002Ftestimonials\u002F:\n\nFrom a testimonial by John R. – “For almost 4 weeks now I have been using MK-677, RAD-140 and LGD-4033, The Warrior Mass Stack, and I feel amazing. My strength is up and I am putting on muscle size and my sleep at night from the MK-677 is awesome. I feel like a Warrior !!!”\n\nFrom your Instagram website https:\u002F\u002Fwww.instagram.com\u002Fwarrior_labz_sarms\u002F?hl=en:\n\nFrom a July 6, 2022 post – “Warrior Labz is proud to offer you a Six Pack !!! Yes...A Strong 6 Pack of any 6 Individual Sarms, Peptides, Pro Hormones, Male Enhancement for only $299 Delivered anywhere USA !!! . . . Stacks are Higher and additional Bottles may be purchased @ $50 each also. Payment via: Zelle, Cash App, Venmo, Apple Pay and Pay Pal - Friends and Family. Call or Text . . . www.warriorlabzsarms.com”\n\nUnapproved New Drugs\n\nYour “RAD-140 Testolone,” “MK-677 Ibutamoren,” “MK-2866 Ostarine,” “LGD-4033 Ligandrol,” “19-Nor Andro,” “4-Andro,” “BPC-157,” “TB-500,” “Viagra-Max Sildenafil,” and “Cialis-Max Tadalafil” products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\n\nConclusion\n\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\n\nThis letter notifies you of our concerns and provides you an opportunity to address them.\n\nFailure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\n\nPlease notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.\n\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nCAPT Tina Smith\n\nActing Director\n\nOffice of Unapproved Drugs and Labeling Compliance\n\nCenter for Drug Evaluation and Research\n\nFood and Drug Administration\n\n______________________________\n\n1 Injectable drug products can pose a serious risk of harm to users because they are delivered directly into the bloodstream and 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.\n\n2 Intranasal drug products may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation, where they may exert undesirable systemic effects such as increased heart rate or elevated blood pressure. If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur.","2026-08-20T01:02:50.969+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2023-06-20T13:20:00Z\">06\u002F20\u002F2023\u003C\u002Ftime>\n","\u003Ctime datetime=\"2023-06-12T04:00:00Z\">06\u002F12\u002F2023\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fwarrior-labz-sarms-655280-06122023\">Warrior Labz SARMS\u003C\u002Fa>","Unapproved New Drugs\u002FMisbranded ","","2026-08-18T06:42:29.145918+00:00","2026-08-20T02:24:56.344395+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]