[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-best-chinese-medicines-llc-738556-10232026":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":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},22010,"best-chinese-medicines-llc-738556-10232026","Warning Letter","Best Chinese Medicines LLC",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs","2026-10-27","2026-10-23","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbest-chinese-medicines-llc-738556-10232026","738556","Drugs","VIA ELECTRONIC MAIL READ\u002FDELIVERY RECEIPT REQUESTED","Gretchen Synclaire","\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>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv>Gretchen Synclaire\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv>Director\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Best Chinese Medicines LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>102 Shawnee Dr\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Lake Kiowa\u003C\u002Fspan>, \u003Cspan>TX\u003C\u002Fspan> \u003Cspan>76240\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:support@bestchinesemedicines.com\"> support@bestchinesemedicines.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>October 23, 2026\u003C\u002Fp>\u003Cp>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>Reference Number: 738556\u003C\u002Fp>\u003Cp>To Gretchen Synclaire:\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, https:\u002F\u002Fbestchinesemedicines.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\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during a review of your website https:\u002F\u002Fbestchinesemedicines.com in September 2026. Based on our review, “Dissolve Mass Stasis Breaker,” “Gynostemma Leaf (Penta) Jiao Gu Lan,” “Wenxin Keli,” “Lianhua Qingwen Capsules,” and “Duhuo Jisheng Wan” 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>This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.\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, “Dissolve Mass Stasis Breaker,” “Gynostemma Leaf (Penta) Jiao Gu Lan,” “Wenxin Keli,” “Lianhua Qingwen Capsules,” and “Duhuo Jisheng Wan” 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>Dissolve Mass Stasis Breaker\u003C\u002Fu>\u003Cbr>On the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fdissolve-mass-stasis-breaker-liquid-extract-tincture\u002F:\u003C\u002Fp>\u003Cul>\u003Cli>“Dissolve Mass (Stasis Breaker) helps dissipate nodules, palpable masses, and tumors by strongly invigorate [sic] the circulation of blood, qi, & lymph.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Gynostemma Leaf (Penta) Jiao Gu Lan\u003C\u002Fu>\u003Cbr>On the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fjiao-gu-lan-liquid-extract-tincture\u002F:\u003C\u002Fp>\u003Cul>\u003Cli>“Lowers LDL cholesterol, raises HDL cholesterol”\u003C\u002Fli>\u003Cli>“Controls blood pressure”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>On your blog post “How to Reduce Hypertension (Blood Pressure) with Chinese Medicine” on your website https:\u002F\u002Fbestchinesemedicines.com\u002Fblog\u002Fhow-to-reduce-blood-pressure-with-chinese-medicine\u002F, where you direct consumers to your “Gynostemma Leaf (Penta) Jiao Gu Lan” webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fjiao-gu-lan-liquid-extract-tincture\u002F:\u003C\u002Fp>\u003Cul>\u003Cli>“Chinese Herbal Medicine for Hypertension (High Blood Pressure)\u003Cbr>Chinese herbal medicine has no shortage of high blood pressure formulas. . . . Jiaogulan is an adaptogenic herb that is used to restore healthy blood pressure, manage blood sugar, reduce ‘bad’ cholesterol, and slow the signs of aging.(Examine.com). Along with improving heart health, Jiaogulan also reduces stress and soothes the mind.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Wenxin Keli\u003C\u002Fu>\u003Cbr>On the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fwenxin-keli-by-buchang\u002F:\u003C\u002Fp>\u003Cul>\u003Cli>“Wenxin Keli for arrhythmias, restless heart palpitations, shortness of breath and fatigue, dizziness and palpitations, chest pain and oppression, ventricular contractions, atrial premature beats and other cardiovascular disease.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Lianhua Qingwen Capsules\u003C\u002Fu>\u003Cbr>On the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Flianhua-qingwen-capsules\u002F:\u003C\u002Fp>\u003Cul>\u003Cli>“Lianhua Qingwen has become a popular treatment for symptoms related to Covid-19.”\u003C\u002Fli>\u003Cli>“Lianhua Qingwen gained widespread popularity because it became known as a convenient, easy-to-use herbal formula often kept on hand during cold and flu season and periods of increased respiratory concerns.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cu>Duhuo Jisheng Wan\u003C\u002Fu>\u003Cbr>On the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fduhuo-jisheng-wan-solitary-hermit-min-kang\u002F:\u003C\u002Fp>\u003Cul>\u003Cli>“Take Du Huo Ji Sheng Wan if you experience the following symptoms:\u003Cbr>• Lower back pain\u003Cbr>• joint pain\u003Cbr>• rheumatoid arthritis\u003Cbr>• pain accompanied with numbness\u003Cbr>• weakness, and\u002For stiffness”\u003C\u002Fli>\u003Cli>“This is a popular formula for those suffering from:\u003Cbr>• Diabetic Neuropathy\u003Cbr>• Osteoarthritis”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>“Dissolve Mass Stasis Breaker,” “Gynostemma Leaf (Penta) Jiao Gu Lan,” “Wenxin Keli,” “Lianhua Qingwen Capsules,” and “Duhuo Jisheng Wan” 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 future and sustained compliance so that these violations and any others do not occur.\u003C\u002Fp>\u003Cp>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 “738556” in the subject line of the email.\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>cc:\u003Cbr>Gretchen Synclaire\u003Cbr>Econic Ventures Corporation\u003Cbr>102 Shawnee Dr,\u003Cbr>Lake Kiowa, TX 76240\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\nRecipient Name\n\nGretchen Synclaire\n\nRecipient Title\n\nDirector\n\nBest Chinese Medicines LLC\n\n102 Shawnee Dr\n\nLake Kiowa, TX 76240\n\nUnited States\n\nsupport@bestchinesemedicines.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nOctober 23, 2026\nWARNING LETTER\nReference Number: 738556\nTo Gretchen Synclaire:\nThis warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https:\u002F\u002Fbestchinesemedicines.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\u002Fbestchinesemedicines.com in September 2026. Based on our review, “Dissolve Mass Stasis Breaker,” “Gynostemma Leaf (Penta) Jiao Gu Lan,” “Wenxin Keli,” “Lianhua Qingwen Capsules,” and “Duhuo Jisheng Wan” 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, “Dissolve Mass Stasis Breaker,” “Gynostemma Leaf (Penta) Jiao Gu Lan,” “Wenxin Keli,” “Lianhua Qingwen Capsules,” and “Duhuo Jisheng Wan” 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:\nDissolve Mass Stasis Breaker\nOn the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fdissolve-mass-stasis-breaker-liquid-extract-tincture\u002F:\n“Dissolve Mass (Stasis Breaker) helps dissipate nodules, palpable masses, and tumors by strongly invigorate [sic] the circulation of blood, qi, & lymph.”\nGynostemma Leaf (Penta) Jiao Gu Lan\nOn the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fjiao-gu-lan-liquid-extract-tincture\u002F:\n“Lowers LDL cholesterol, raises HDL cholesterol”\n“Controls blood pressure”\nOn your blog post “How to Reduce Hypertension (Blood Pressure) with Chinese Medicine” on your website https:\u002F\u002Fbestchinesemedicines.com\u002Fblog\u002Fhow-to-reduce-blood-pressure-with-chinese-medicine\u002F, where you direct consumers to your “Gynostemma Leaf (Penta) Jiao Gu Lan” webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fjiao-gu-lan-liquid-extract-tincture\u002F:\n“Chinese Herbal Medicine for Hypertension (High Blood Pressure)\nChinese herbal medicine has no shortage of high blood pressure formulas. . . . Jiaogulan is an adaptogenic herb that is used to restore healthy blood pressure, manage blood sugar, reduce ‘bad’ cholesterol, and slow the signs of aging.(Examine.com). Along with improving heart health, Jiaogulan also reduces stress and soothes the mind.”\nWenxin Keli\nOn the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fwenxin-keli-by-buchang\u002F:\n“Wenxin Keli for arrhythmias, restless heart palpitations, shortness of breath and fatigue, dizziness and palpitations, chest pain and oppression, ventricular contractions, atrial premature beats and other cardiovascular disease.”\nLianhua Qingwen Capsules\nOn the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Flianhua-qingwen-capsules\u002F:\n“Lianhua Qingwen has become a popular treatment for symptoms related to Covid-19.”\n“Lianhua Qingwen gained widespread popularity because it became known as a convenient, easy-to-use herbal formula often kept on hand during cold and flu season and periods of increased respiratory concerns.”\nDuhuo Jisheng Wan\nOn the webpage https:\u002F\u002Fbestchinesemedicines.com\u002Fproducts\u002Fduhuo-jisheng-wan-solitary-hermit-min-kang\u002F:\n“Take Du Huo Ji Sheng Wan if you experience the following symptoms:\n• Lower back pain\n• joint pain\n• rheumatoid arthritis\n• pain accompanied with numbness\n• weakness, and\u002For stiffness”\n“This is a popular formula for those suffering from:\n• Diabetic Neuropathy\n• Osteoarthritis”\n“Dissolve Mass Stasis Breaker,” “Gynostemma Leaf (Penta) Jiao Gu Lan,” “Wenxin Keli,” “Lianhua Qingwen Capsules,” and “Duhuo Jisheng Wan” 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 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 “738556” 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\ncc:\nGretchen Synclaire\nEconic Ventures Corporation\n102 Shawnee Dr,\nLake Kiowa, TX 76240","2026-11-03T01:02:32.738+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-10-27T04:00:00Z\">10\u002F27\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-23T04:00:00Z\">10\u002F23\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbest-chinese-medicines-llc-738556-10232026\">Best Chinese Medicines LLC\u003C\u002Fa>","","2026-11-03T01:02:17.615107+00:00","2026-11-03T01:02:32.929962+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-11-02T02:00:49.695+00:00","2026-11-02T02:00:37.227+00:00","2026-11-02T02:00:44.301+00:00","2026-11-03T04:01:24.375+00:00","2026-09-07T05:17:28.839+00:00","2026-11-02T02:00:52.698+00:00","2026-11-03T01:03:13.194+00:00"]