Cissus quadrangularis extract

About

What it is and where it shows up.

Cissus quadrangularis (family Vitaceae) is a succulent climbing plant native to tropical Asia and Africa whose stem extract is used as a botanical nutraceutical ingredient. It contains phytosterols (including 3-ketosteroids), flavonoids, stilbenes, ascorbic acid, and quercetin, and is traditionally used to support bone health, weight management, and metabolic function.

Safety summary

The regulatory and scientific consensus.

A 90-day rat subchronic toxicity study (CQR-300 extract) found no adverse effects up to 2,500 mg/kg bw/day — the highest dose tested — and mutagenicity assays revealed no genotoxicity. A 2017 systematic review and meta-analysis of nine RCTs (1,108 patients) found the extract generally safe and well-tolerated across conditions including bone pain and metabolic syndrome. Documented hypoglycemic activity warrants caution in individuals on antidiabetic medications, and product labels uniformly recommend physician consultation for pregnant or lactating women; no formal ADI has been established by any major regulatory body.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Restricted	Cissus quadrangularis is not assigned an E-number and is not listed as an approved novel food in the EU Novel Food Catalogue (Regulation (EU) 2015/2283). Concentrated extracts would require novel food authorisation before placement on the EU market if there is no demonstrated history of significant consumption in the EU prior to May 1997. No EFSA safety opinion specific to this extract has been published as of the research date.source
FDA (Food and Drug Administration) (United States)	Restricted	Legally marketed as a botanical dietary supplement under DSHEA (21 USC 321(ff)); no GRAS notification or food-additive approval found in FDA's GRAS Notice Inventory or 21 CFR Parts 182/184 for use in conventional foods. Product labels recommend up to 800 mg/day. USDA classifies the plant as an edible vegetable, but this does not confer food-additive status for concentrated extracts.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Permissible as a botanical/plant extract ingredient in health supplements and nutraceuticals under FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 and the FSSAI Nutraceuticals Compendium (2021). Long-standing traditional (Ayurvedic) use supports inclusion; specific health claims require prior approval from the Food Authority.source

Who should approach with care

Whose guidance would steer them away.

Pregnancy — Commercial product labels and standard botanical supplement guidance recommend physician consultation before use during pregnancy due to insufficient safety data in pregnant humans.

Lactation — Commercial product labels explicitly advise pregnant or lactating women to consult a physician before use, reflecting a lack of controlled safety data in this population.

Diabetes — Cissus quadrangularis extract demonstrates documented hypoglycemic activity via modulation of gluconeogenesis and carbohydrate-metabolizing enzymes; concurrent use with antidiabetic medications may produce additive blood-glucose-lowering effects requiring dose monitoring.

Infants — No safety data exist for infants and the extract is formulated exclusively for adults (18–50 years per NIH DSLD labelling); use in infants is contraindicated.

Children — Clinical trials have been conducted exclusively in adult populations; safety and appropriate dosing in children have not been established by any regulatory or clinical authority.

Research citations

The sources behind this verdict.

1PubMed. Anti-hyperglycemic effects of Cissus quadrangularis extract via regulation of gluconeogenesis in type 2 diabetic db/db mice, 2024. pubmed.ncbi.nlm.nih.gov
2other. Cissus Quadrangularis Extract — NIH Dietary Supplement Label Database, 2021. dsld.od.nih.gov
3PubMed. The Use of a Stem and Leaf Aqueous Extract of Cissus quadrangularis (CQR-300) to Reduce Body Fat and Other Components of Metabolic Syndrome in Overweight Participants, 2019. pmc.ncbi.nlm.nih.gov
4PubMed. Efficacy and Safety of Cissus quadrangularis L. in Clinical Use: A Systematic Review and Meta-analysis of Randomized Controlled Trials, 2017. pubmed.ncbi.nlm.nih.gov
5PubMed. A review and evaluation of the efficacy and safety of Cissus quadrangularis extracts, 2012. pubmed.ncbi.nlm.nih.gov
6PubMed. Safety assessment of Cissus quadrangularis extract (CQR-300): subchronic toxicity and mutagenicity studies, 2011.

Independently researched6 citations