[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-jjlbro-729873-06172026":3,"fda-latest-sync-dates":29},{"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":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":27,"updated_at":28},84,"jjlbro-729873-06172026","Warning Letter","JJLBRO",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FMisbranded","2026-06-23","2026-06-17","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjjlbro-729873-06172026","729873","Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","\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 ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\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>\u003C\u002Fdd>\n                    \n            \u003Cdd>JJLBRO\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">Romvy E-Ticaret Limited Sirketi\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"address-line2\">Oba Başaranlar Sk. No: 16\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"postal-code\">07400\u003C\u002Fspan> \u002F\u003Cspan class=\"administrative-area\">Antalya\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Turkey\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:eroxoninmed@gmail.com\"> eroxoninmed@gmail.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>June 17, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">Reference Number: 729873\u003C\u002Fp>\u003Cp>To JJLBRO and Romvy E-Ticaret Limited Sirketi:\u003C\u002Fp>\u003Cp>This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during a review of your website https:\u002F\u002Fjjlbro.com\u002F in May 2026. We also reviewed your Amazon storefront in May 2026.\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> Based on our review, “Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>\u003Cspan style=\"font-family:"Arial",sans-serif;\">This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>Unapproved New Drug Violations\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>Based on a review of your website, “Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:\u003C\u002Fp>\u003Cp>\u003Cu>Men’s Foreskin Repair Gel\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmens-extra-power-foreskin-repair-enhancement-gel?variant=41998671478878:\u003C\u002Fp>\u003Cul>\u003Cli>“DOUBLE LINE CARE, DIRECT HIT PHIMOSIS”\u003C\u002Fli>\u003Cli>“ABSORPTION OF INTERNAL ADHESIONS”\u003C\u002Fli>\u003Cli>“TO PROMOTE THE VITALITY OF PRIVATE CELLS FROM THE CONGENITAL PHIMOSIS”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Size’Up Chrono Erect\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmens-size-up-chrono-erect-enlargement-cream-extra-power-massage-gel-oil-for-huge-thickness-strength-and-prolonged-performance?variant=41998765916254:\u003C\u002Fp>\u003Cul>\u003Cli>“Proven Size Enhancement: Clinically . . . shown to help promote blood flow and stimulate cell growth, leading to visible results in size enhancement with consistent use.”\u003C\u002Fli>\u003Cli>“Prolonged Performance: Men’s Size Up Chrono Erect Enlargement Cream supports prolonged performance by stimulating circulation and energy flow, improving stamina and endurance.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Penile Health Cream\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmale-performance-med3000-enhancement-gel?variant=41998765850718:\u003C\u002Fp>\u003Cul>\u003Cli>“BOOST MUSCLE STRENGTH”\u003C\u002Fli>\u003Cli>“ENHANCES LIBIDO AND PLEASURE”\u003C\u002Fli>\u003Cli>“INCREASE ENERGY AND STAMINA”\u003C\u002Fli>\u003Cli>“IMPROVE MALE REPRODUCTIVE HEALTH”\u003C\u002Fli>\u003Cli>“Naturally Boosts Energy, Libido, Fertility, Mood, and Hormonal Balance.”\u003C\u002Fli>\u003Cli>“Enhances intimacy, Improves Blood Flow, and Elevates Performance.”\u003C\u002Fli>\u003Cli>“Believed to Support Brain Health, Soothe Pain, and Reinforce Masculinity.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Men’s External Delayed Spray\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmens-best-external-delay-enhancement-spray:\u003C\u002Fp>\u003Cul>\u003Cli>“Prolonged Performance: Allows for extended enjoyment and satisfaction”\u003C\u002Fli>\u003Cli>“Quick-Acting Formula: Starts working within minutes for immediate results, so you’re always prepared.”\u003C\u002Fli>\u003Cli>“PREMATURE EJACULATION MAKES MEN MISERABLE”\u003C\u002Fli>\u003Cli>“MAY STIMULATE CAVERNOUS BODIES, REPRODUCTIVE GLANDS, NERVOUS SYSTEM IT MAKES IT PLAY A NORMAL FUNCTION, NOT ONLY TO HELP WITH OVERTIME, BUT ALSO TO HELP THE ERECTION FUNCTION”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Men’s Penis XXL Care Cream\u003C\u002Fu>\u003C\u002Fp>\u003Cp>On the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmen-s-care-ultra-enlargement-cream-jjlbro-huge-xxl-extra-strength-growth-cream-for-mens-size-power-xxl-care?variant=41998751563870:\u003C\u002Fp>\u003Cul>\u003Cli>“SEXUAL EXCITEMENT”\u003C\u002Fli>\u003Cli>“LAST LONGER”\u003C\u002Fli>\u003Cli>“LARGER SIZE”\u003C\u002Fli>\u003Cli>“HUGE”\u003C\u002Fli>\u003Cli>“Proven Size Enhancement: Clinically . . . shown to help promote blood flow and stimulate cell growth, leading to visible results in size enhancement with consistent use”\u003C\u002Fli>\u003Cli>“Prolonged Performance . . . by stimulating circulation and energy flow, improving stamina and endurance”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>“Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 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, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure sustained compliance so that these violations and any others do not occur.\u003Cbr>Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729873” in the subject line of the email.\u003C\u002Fp>\u003Cp>If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\u003C\u002Fp>\u003Cp>Please note FDA posts warning letters on www.fda.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Tina Smith, M.S.\u003Cbr>Captain, U.S. Public Health Service\u003Cbr>Director\u003Cbr>Office of Unapproved Drugs and Labeling Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\u003Cp>__________________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> https:\u002F\u002Fwww.amazon.com\u002Fs?i=merchant-items&me=A327E0NFTQVK94&marketplaceID=ATVPDKIKX0DER&qid=1778778461&xpid=ogniWslo1h6zF&ref=sr_pg_1\u003C\u002Fp>\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 ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nProduct:\n\nDrugs\n\nRecipient:\n\nJJLBRO\n\nRomvy E-Ticaret Limited Sirketi\n\nOba Başaranlar Sk. No: 16\n\n07400 \u002FAntalya\n\nTurkey\n\neroxoninmed@gmail.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nJune 17, 2026\nWARNING LETTER\nReference Number: 729873\nTo JJLBRO and Romvy E-Ticaret Limited Sirketi:\nThis warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\nFDA Review\nViolations were identified and documented during a review of your website https:\u002F\u002Fjjlbro.com\u002F in May 2026. We also reviewed your Amazon storefront in May 2026.1 Based on our review, “Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nThis review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.\nViolations of the Federal Food, Drug, and Cosmetic Act\nThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.\nUnapproved New Drug Violations\nBased on a review of your website, “Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:\nMen’s Foreskin Repair Gel\nOn the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmens-extra-power-foreskin-repair-enhancement-gel?variant=41998671478878:\n“DOUBLE LINE CARE, DIRECT HIT PHIMOSIS”\n“ABSORPTION OF INTERNAL ADHESIONS”\n“TO PROMOTE THE VITALITY OF PRIVATE CELLS FROM THE CONGENITAL PHIMOSIS”\nSize’Up Chrono Erect\nOn the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmens-size-up-chrono-erect-enlargement-cream-extra-power-massage-gel-oil-for-huge-thickness-strength-and-prolonged-performance?variant=41998765916254:\n“Proven Size Enhancement: Clinically . . . shown to help promote blood flow and stimulate cell growth, leading to visible results in size enhancement with consistent use.”\n“Prolonged Performance: Men’s Size Up Chrono Erect Enlargement Cream supports prolonged performance by stimulating circulation and energy flow, improving stamina and endurance.”\nPenile Health Cream\nOn the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmale-performance-med3000-enhancement-gel?variant=41998765850718:\n“BOOST MUSCLE STRENGTH”\n“ENHANCES LIBIDO AND PLEASURE”\n“INCREASE ENERGY AND STAMINA”\n“IMPROVE MALE REPRODUCTIVE HEALTH”\n“Naturally Boosts Energy, Libido, Fertility, Mood, and Hormonal Balance.”\n“Enhances intimacy, Improves Blood Flow, and Elevates Performance.”\n“Believed to Support Brain Health, Soothe Pain, and Reinforce Masculinity.”\nMen’s External Delayed Spray\nOn the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmens-best-external-delay-enhancement-spray:\n“Prolonged Performance: Allows for extended enjoyment and satisfaction”\n“Quick-Acting Formula: Starts working within minutes for immediate results, so you’re always prepared.”\n“PREMATURE EJACULATION MAKES MEN MISERABLE”\n“MAY STIMULATE CAVERNOUS BODIES, REPRODUCTIVE GLANDS, NERVOUS SYSTEM IT MAKES IT PLAY A NORMAL FUNCTION, NOT ONLY TO HELP WITH OVERTIME, BUT ALSO TO HELP THE ERECTION FUNCTION”\nMen’s Penis XXL Care Cream\nOn the webpage https:\u002F\u002Fjjlbro.com\u002Fproducts\u002Fmen-s-care-ultra-enlargement-cream-jjlbro-huge-xxl-extra-strength-growth-cream-for-mens-size-power-xxl-care?variant=41998751563870:\n“SEXUAL EXCITEMENT”\n“LAST LONGER”\n“LARGER SIZE”\n“HUGE”\n“Proven Size Enhancement: Clinically . . . shown to help promote blood flow and stimulate cell growth, leading to visible results in size enhancement with consistent use”\n“Prolonged Performance . . . by stimulating circulation and energy flow, improving stamina and endurance”\n“Men’s Foreskin Repair Gel,” “Size’Up Chrono Erect,” “Penile Health Cream,” “Men’s External Delayed Spray,” and “Men’s Penis XXL Care Cream” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 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, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nConclusion\nAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure sustained compliance so that these violations and any others do not occur.\nSend your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729873” in the subject line of the email.\nIf you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\nPlease note FDA posts warning letters on www.fda.gov.\nSincerely,\n\u002FS\u002F\nTina Smith, M.S.\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs and Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration\n__________________________\n1 https:\u002F\u002Fwww.amazon.com\u002Fs?i=merchant-items&me=A327E0NFTQVK94&marketplaceID=ATVPDKIKX0DER&qid=1778778461&xpid=ogniWslo1h6zF&ref=sr_pg_1","2026-08-19T04:33:45.056+00:00",[22,23,24,9,25,26,26,26],"\u003Ctime datetime=\"2026-06-23T04:00:00Z\">06\u002F23\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-06-17T04:00:00Z\">06\u002F17\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fjjlbro-729873-06172026\">JJLBRO\u003C\u002Fa>","Unapproved New Drugs\u002FMisbranded \u003Cbr \u002F>\r\n","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"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"]