FDA 致 Best Chinese Medicines LLC 警告信（编号 738556，2026 年 10 月 23 日）：五款中成药被认定为未获批新药

WARNING LETTER

Best Chinese Medicines LLC MARCS-CMS 738556 — October 23, 2026

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Product:

Drugs

Recipient:

Recipient Name

Gretchen Synclaire

Recipient Title

Director

Best Chinese Medicines LLC

102 Shawnee Dr
Lake Kiowa, TX 76240
United States

[email protected]

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 23, 2026

WARNING LETTER
Reference Number: 738556

To Gretchen Synclaire:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website, https://bestchinesemedicines.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.

FDA Review

Violations were identified and documented during a review of your website https://bestchinesemedicines.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).

This review was conducted as part of FDA’s public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.

Violations of the Federal Food, Drug, and Cosmetic Act

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.

Unapproved New Drug Violations

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/or 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:

Dissolve Mass Stasis Breaker
On the webpage https://bestchinesemedicines.com/products/dissolve-mass-stasis-breaker-liquid-extract-tincture/:

• “Dissolve Mass (Stasis Breaker) helps dissipate nodules, palpable masses, and tumors by strongly invigorate [sic] the circulation of blood, qi, & lymph.”

Gynostemma Leaf (Penta) Jiao Gu Lan
On the webpage https://bestchinesemedicines.com/products/jiao-gu-lan-liquid-extract-tincture/:

• “Lowers LDL cholesterol, raises HDL cholesterol”
• “Controls blood pressure”

On your blog post “How to Reduce Hypertension (Blood Pressure) with Chinese Medicine” on your website https://bestchinesemedicines.com/blog/how-to-reduce-blood-pressure-with-chinese-medicine/, where you direct consumers to your “Gynostemma Leaf (Penta) Jiao Gu Lan” webpage https://bestchinesemedicines.com/products/jiao-gu-lan-liquid-extract-tincture/:

• “Chinese Herbal Medicine for Hypertension (High Blood Pressure)
  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.”

Wenxin Keli
On the webpage https://bestchinesemedicines.com/products/wenxin-keli-by-buchang/:

• “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.”

Lianhua Qingwen Capsules
On the webpage https://bestchinesemedicines.com/products/lianhua-qingwen-capsules/:

• “Lianhua Qingwen has become a popular treatment for symptoms related to Covid-19.”
• “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.”

Duhuo Jisheng Wan
On the webpage https://bestchinesemedicines.com/products/duhuo-jisheng-wan-solitary-hermit-min-kang/:

• “Take Du Huo Ji Sheng Wan if you experience the following symptoms:
  • Lower back pain
  • joint pain
  • rheumatoid arthritis
  • pain accompanied with numbness
  • weakness, and/or stiffness”
• “This is a popular formula for those suffering from:
  • Diabetic Neuropathy
  • Osteoarthritis”

“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).

Conclusion

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.

Send your written response to [email protected] 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.

Please note FDA posts warning letters on www.fda.gov.

Sincerely,
/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

cc:
Gretchen Synclaire
Econic Ventures Corporation
102 Shawnee Dr,
Lake Kiowa, TX 76240