BotableBook a call
FDA Warning Letter Explorer
Drugs · Letter issue date: Oct 23, 2026

Best Chinese Medicines LLC

7 extracted findings

FDA source excerpt, selected passage

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).

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
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).
02
“Dissolve Mass (Stasis Breaker) helps dissipate nodules, palpable masses, and tumors by strongly invigorate [sic] the circulation of blood, qi, & lymph.”
03
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).
04
“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.”
05
“Lianhua Qingwen has become a popular treatment for symptoms related to Covid-19.”
06
“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”
07
“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.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 201.128

Explore Botable’s work in Pharmaceuticals and Document control operations.

Keep exploring

Find related letters →Browse your letters
For regulated teams

Put this kind of reading to
work on your own records.

Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.

Book a call ↗Read the case studies

FDA Warning Letter Alerts

Share this view

Send the same filters, search and view to a colleague.

LinkedIn Email

You choose what to post or send. Sharing a link does not change access to this site.