[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-natuzem-737558-10262026":3,"fda-latest-sync-dates":28},{"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":26,"updated_at":27},22100,"natuzem-737558-10262026","Warning Letter","Natuzem",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FMisbranded","2026-11-03","2026-10-26","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fnatuzem-737558-10262026","737558","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>\n  \u003Cdl>\n\n              \u003Cdt>Delivery Method:\u003C\u002Fdt> \n        \u003Cdd>VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt>Product:\u003C\u002Fdt> \n        \u003Cdd>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>\n  \u003Cdiv>\n    \u003Cdl>\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>Natuzem\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>201 General Guadalupe Victoria\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>20000\u003C\u002Fspan> \u003Cspan>Aguascalientes AGS\u003C\u002Fspan>, \u003Cspan>Méx.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Mexico\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:natuzemags@gmail.com\"> natuzemags@gmail.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:natuzem@natuzem.com\"> natuzem@natuzem.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv>\n    \u003Cdl>\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>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>\u003Cspan>October 26, 2026\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fspan>\u003Cbr>\u003Cspan>Reference Number: 737558\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>To Natuzem:\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https:\u002F\u002Fnatuzem.com, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>Violations were identified and documented during a review of your website https:\u002F\u002Fnatuzem.com\u002F in September 2026. Based on our review, “Testitón Extra Strong vials,” “Reumofan Plus,” and “Artrifan King” 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\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>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>\u003Cspan>\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>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\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cspan>\u003Cstrong>Unapproved New Drug Violations\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>\u003Cspan>Based on a review of your website, “Testitón Extra Strong vials,” “Reumofan Plus,” and “Artrifan King” 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\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>\u003Cu>Testitón Extra Strong vials\u003C\u002Fu>\u003C\u002Fspan>\u003Cbr>\u003Cspan>On the webpage https:\u002F\u002Fnatuzem.com\u002Fen\u002Fproducts\u002Famp-testiton-extra-fuerte-c-10-de-15-ml-herbomex:\u003C\u002Fspan>\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cspan>“Reduces premature ejaculation.”\u003C\u002Fspan>\u003C\u002Fli>\u003Cli>\u003Cspan>“It helps blood circulation, improving erection.”\u003C\u002Fspan>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cspan>\u003Cu>Reumofan Plus\u003C\u002Fu>\u003C\u002Fspan>\u003Cbr>\u003Cspan>On the webpage https:\u002F\u002Fnatuzem.com\u002Fen\u002Fproducts\u002Freumofan?keyword=reumofan:\u003C\u002Fspan>\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cspan>“Reumofan is used to treat arthritis . . . osteoarthritis, osteoporosis, bone cancer.”\u003C\u002Fspan>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cspan>\u003Cu>Artrifan King\u003C\u002Fu>\u003C\u002Fspan>\u003Cbr>\u003Cspan>On the webpage https:\u002F\u002Fnatuzem.com\u002Fen\u002Fproducts\u002Fartrifan-king:\u003C\u002Fspan>\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cspan>“[S]upports cartilage regeneration, improves mobility, and provides additional protection against serious diseases such as bone cancer.”\u003C\u002Fspan>\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cspan>“Testitón Extra Strong vials,” “Reumofan Plus,” and “Artrifan King” 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\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>We also observed that your website https:\u002F\u002Fnatuzem.com\u002F offers “RMSOL Gracian,” “Kuka Flex Forte,” and “Reuma King” for sale to consumers in the United States. Previous FDA lab analyses of products similarly named to “Reumofan Plus,”\u003C\u002Fspan>\u003Cem>\u003Cspan>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> “Artrifan King,”\u003C\u002Fspan>\u003Cem>\u003Cspan>\u003Cstrong>\u003Csup>2\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> “RMSOL Gracian,”\u003C\u002Fspan>\u003Cem>\u003Cspan>\u003Cstrong>\u003Csup>3\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> “Kuka Flex Forte,”\u003C\u002Fspan>\u003Cem>\u003Cspan>\u003Cstrong>\u003Csup>4\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> and “Reuma King”\u003C\u002Fspan>\u003Cem>\u003Cspan>\u003Cstrong>\u003Csup>5\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> sold on your website revealed these products contained undeclared drug ingredients. While the Agency has not sampled and tested these product variations from your inventory to date, this letter expresses our serious concern about the safety of these products. We emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>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. 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. Identify your response with reference number “737558” in the subject line of the email.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>Please note FDA posts warning letters on www.fda.gov.\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>Sincerely,\u003C\u002Fspan>\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>\u003Cspan>Tina Smith, M.S.\u003C\u002Fspan>\u003Cbr>\u003Cspan>Captain, U.S. Public Health Service\u003C\u002Fspan>\u003Cbr>\u003Cspan>Director\u003C\u002Fspan>\u003Cbr>\u003Cspan>Office of Unapproved Drugs and Labeling Compliance\u003C\u002Fspan>\u003Cbr>\u003Cspan>Office of Compliance\u003C\u002Fspan>\u003Cbr>\u003Cspan>Center for Drug Evaluation and Research\u003C\u002Fspan>\u003Cbr>\u003Cspan>U.S. Food and Drug Administration\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cspan>________________________\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cspan>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud\u002Fquestions-and-answers-reumofan-plus-and-reumofan-plus-premium\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cspan>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud\u002Fartrifan-king-may-be-harmful-due-hidden-drug-ingredients\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cspan>\u003Cstrong>3\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud\u002Frmsol-gracian-contains-hidden-drug-ingredient\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cspan>\u003Cstrong>4\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud\u002Fkuka-flex-forte-contains-hidden-drug-ingredient\u003C\u002Fspan>\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cspan>\u003Cstrong>5\u003C\u002Fstrong>\u003C\u002Fspan>\u003C\u002Fem>\u003Cspan> https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud-notifications\u002Freuma-king-may-be-harmful-due-hidden-drug-ingredients\u003C\u002Fspan>\u003C\u002Fp>\n\n\n\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED\n\nProduct:\n\nDrugs\n\nRecipient:\n\nNatuzem\n\n201 General Guadalupe Victoria\n\n20000 Aguascalientes AGS, Méx.\n\nMexico\n\nnatuzemags@gmail.com\n\nnatuzem@natuzem.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nOctober 26, 2026\nWARNING LETTER\nReference Number: 737558\nTo Natuzem:\nThis warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https:\u002F\u002Fnatuzem.com, and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them 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 any 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\u002Fnatuzem.com\u002F in September 2026. Based on our review, “Testitón Extra Strong vials,” “Reumofan Plus,” and “Artrifan King” 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, “Testitón Extra Strong vials,” “Reumofan Plus,” and “Artrifan King” 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:\nTestitón Extra Strong vials\nOn the webpage https:\u002F\u002Fnatuzem.com\u002Fen\u002Fproducts\u002Famp-testiton-extra-fuerte-c-10-de-15-ml-herbomex:\n“Reduces premature ejaculation.”\n“It helps blood circulation, improving erection.”\nReumofan Plus\nOn the webpage https:\u002F\u002Fnatuzem.com\u002Fen\u002Fproducts\u002Freumofan?keyword=reumofan:\n“Reumofan is used to treat arthritis . . . osteoarthritis, osteoporosis, bone cancer.”\nArtrifan King\nOn the webpage https:\u002F\u002Fnatuzem.com\u002Fen\u002Fproducts\u002Fartrifan-king:\n“[S]upports cartilage regeneration, improves mobility, and provides additional protection against serious diseases such as bone cancer.”\n“Testitón Extra Strong vials,” “Reumofan Plus,” and “Artrifan King” 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).\nWe also observed that your website https:\u002F\u002Fnatuzem.com\u002F offers “RMSOL Gracian,” “Kuka Flex Forte,” and “Reuma King” for sale to consumers in the United States. Previous FDA lab analyses of products similarly named to “Reumofan Plus,”1 “Artrifan King,”2 “RMSOL Gracian,”3 “Kuka Flex Forte,”4 and “Reuma King”5 sold on your website revealed these products contained undeclared drug ingredients. While the Agency has not sampled and tested these product variations from your inventory to date, this letter expresses our serious concern about the safety of these products. We emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.\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 future and 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. 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. Identify your response with reference number “737558” in the subject line of the email.\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.fda.gov\u002Fdrugs\u002Fmedication-health-fraud\u002Fquestions-and-answers-reumofan-plus-and-reumofan-plus-premium\n2 https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud\u002Fartrifan-king-may-be-harmful-due-hidden-drug-ingredients\n3 https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud\u002Frmsol-gracian-contains-hidden-drug-ingredient\n4 https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud\u002Fkuka-flex-forte-contains-hidden-drug-ingredient\n5 https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fmedication-health-fraud-notifications\u002Freuma-king-may-be-harmful-due-hidden-drug-ingredients","2026-11-10T01:03:04.926+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2026-11-03T05:00:00Z\">11\u002F03\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-26T04:00:00Z\">10\u002F26\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fnatuzem-737558-10262026\">Natuzem\u003C\u002Fa>","","2026-11-10T01:02:16.121874+00:00","2026-11-10T01:03:05.09341+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"event_backfill":33,"pma":34,"warning_letter":35},"2026-11-09T02:00:35.105+00:00","2026-11-09T02:00:29.052+00:00","2026-11-09T02:00:32.696+00:00","2026-11-12T04:02:32.647+00:00","2026-09-07T05:17:28.839+00:00","2026-11-09T02:00:36.308+00:00","2026-11-10T01:03:48.189+00:00"]