Safety data of VENETRON®

Longstanding safety record

・VENETRON® is manufactured and sold by Tokiwa Phytochemical Co., Ltd. for over 20 years. During the period no adverse effect was ever reported.



Self-affirmed GRAS

・VENETRON® has acquired “self-affirmed GRAS”

※Self-affirmed GRAS (Generally Recognized as Safe)



Scientifically acquired safety data

In vivo studies

VENETRON® does not induce neither CYP3A nor P-glycoprotein in drug-drug interaction study

(Ref.: Apocynum venetum extract does not induce CYP3A and P-glycoprotein in rats. Biological and Pharmaceutical Bulletin, 27(10), 1649-1652 (2004))


・VENETRON® is non-genotoxic


・Acute and subchronic toxicity studies indicated that VENETRON® has high safety margin

(Ref.: Safety and Toxicological Evaluation of VENETRON® – A Botanical Health Product-. Japanese Pharmacology & Therapeutics., 46, 127-135 (2018))


eeeeLD50 ≧ 2000 mg/kg/bw – Equivalent to 1200 mg VENETRON®  per day for a 60 kg person.


eeeeNOAEL ≧ 250 mg/kg per day – Equivalent to 150 mg VENETRON®  per day for a 60 kg person.


eeee※Recommended dosage of VENETRON® is 50 mg/day


Clinical studies

No adverse effect was observed from 6 clinical trials conducted in Japan, United States of America, and Canada. 

(Ref.: Safety Study of Apocynum venetum L. Extract in Healthy Adults. Journal of Nutritional Food, 12(3), 1-9 (2009); The Stress Reducing Effect of γ-Aminobutyric Acid and Apocynum venetum Leaf Extract on Changes in Concentration of Salivary Chromogranin A. Japanese Journal of Physiological Anthropology 14(3), 151-155 (2009); The Improvement of Sleep by Oral Intake of GABA and Apocynum venetum Leaf Extract. Journal of Nutritional Science and Vitaminology 61(2), 182-187 (2015); Effect of an Apocynum venetum leaf extract (VENETRON®) on sleep quality and psychological stress improvement: A randomized, double-blind, placebo-controlled, crossover study. Japanese Pharmacology & Therapeutics, 46, 117-126 (2018))


eeeeEg. No adverse event was observed in a clinical trial conducted over 12-weeks period (50 mg/day for 8 weeks, followed by 150 mg/day for 4 weeks)



More safety data coming soon. STAY TUNED.

VENETRON® has acquired “self-affirmed GRAS” certification, and is applying for “GRAS” certification.

※self-affirmed GRAS (Generally Recognized as Safe)・・・

A type of GRAS that is acquired by manufacturer through convening the formation of a panel of experts to assess the safety of their particular ingredient along with standard established by FDA.

For detail, see FDA’s web site.