Warning letter · FDA Warning Letters, Historical Archive

ActiveHerb Technology, Inc: FDA Warning Letter 574615 (May 15, 2019)

Agency action: May 15, 2019Record ID: fda_warning_-3697ec19ff01a009
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What happened

Original notice title

ActiveHerb Technology, Inc MARCS-CMS 574615, May 15, 2019

From the archived source record

Based on a subsequent review of your product labeling, including labeling collected during the inspection as well as your website at the internet address www.activeherb.com , we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Unapproved New Drugs Following the September 2018 inspection, FDA reviewed labeling collected during the inspection, including product labels and a product catalog. LiverVive may protect the liver from damage and enhance the immune function of the body for the clearance of viruses that are harmful to normal liver function. Vertigo Headache” Product Catalog: “This formula is used for the TCM syndrome that includes vertigo, nausea, frequent headaches, and epilepsy” “Related concerns: Epilepsy . . . Headache” Nasopass (Bi Yan Pian) Product webpage: “It is commonly recommended herbal remedy in China for relieving symptoms such as nasal congestion, and stuffy nose with phlegm” “Related concerns . . . Withdrawal Support” “[T]he applications of this formula have expanded to include many disorders . . . [including] irregular heartbeat and mental disturbance . . . .” Product catalog: “used . . . to calm . . . anxiety, help insomnia, palpitations” “This herbal remedy may also be used in some cases of schizophrenia, epilepsy, bipolar disorder, and drug withdrawal . . . .” “Related Concerns: Anxiety . . . In another trial, 52 patients with the same condition were treated with Du Huo Ji Sheng Wan for 2 to 3 months, 35 showed significant improvement” Product catalog: “a Chinese herbal remedy . . . to alleviate pains . . . used for rheumatic arthritis, rheumatoid arthritis, rheumatic back pain, sciatica, etc” Cardiovigor (Fu Fang Dan Shen Pian) Product webpage: “relieves pain” “has antiplatelet action” Product catalog: “used in China to alleviate heart-related pain like angina pectoris, palpitations, shortness of breath” “Related concerns: Angina . . . palpitation” Kudzu Relaxe (Ge Gen Tang Pian) Product webpage: “Effective for cluster headaches” “Related topics . . .

What the official notice says to do

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Status and source details

Status recorded in the archive
Historical warning letter; closeout not established by annual index
Source checked
Jul 16, 2026
Record revision
932a1bfc8578

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
Si Ni San, yet another building formula of LiverVive, showed anti-liver injury effects; Hepatitis Remedies; Related topics . . . Vertigo Headache; Related concerns: Epilepsy . . . Vertigo . . . Headache; Related Concerns: Anxiety . . . Epilepsy . . . Withdrawal; Related concerns: Angina . . . palpitation; Related topics . . . Cold & Flu Remedies . . . headache; Related concerns . . . Cold & Flu Remedies . . . Headache; Related concerns . . . Asthma Remedies . . . Cough & Phlegm; Related Concerns: Kidney Stone; Related concerns . . . Hepatitis Remedies; Platycodi Grandiflori; Platycodon; Radix Ginseng; Herbal Dietary Supplement
Company
ActiveHerb Technology, Inc
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.