About
Triphala is a traditional Ayurvedic polyherbal powder composed of equal parts of three dried fruits: Emblica officinalis (Amalaki), Terminalia bellirica (Bibhitaki), and Terminalia chebula (Haritaki). It is used as a health supplement and nutraceutical for gastrointestinal support, antioxidant effects, immunomodulation, and general rejuvenation.
Safety summary
Acute and chronic toxicity studies in rats at doses up to 5000 mg/kg (acute) and 2400 mg/kg/day for 270 days found no significant toxic effects, and a human Phase I clinical trial at 2500 mg/day showed no serious adverse effects. However, Triphala inhibits key cytochrome P450 enzymes (CYP1A2, CYP3A4, CYP2C9, CYP2D6), raising concerns about pharmacokinetic herb-drug interactions. No formal Acceptable Daily Intake (ADI) has been established by any major global regulatory authority.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Triphala is permitted as a plant/botanical ingredient under Schedule II of the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. It may be used as a health supplement or nutraceutical. Health claims require prior approval from FSSAI. Minimally processed botanical powders in non-supplement food contexts are regulated separately.source |
| FDA (Food and Drug Administration) (United States) | Approved | Triphala is marketed as a dietary supplement in the US under DSHEA (1994). It is not listed as a food additive or GRAS substance; manufacturers assume full responsibility for product safety. No specific FDA approval or maximum daily intake has been established for Triphala powder.source |
| EFSA (European Food Safety Authority) (European Union) | Under_review | Triphala is not specifically evaluated or authorized as a food supplement ingredient by EFSA. Botanical food supplements in the EU are governed by national regulations in the absence of a harmonized EU-positive list. Triphala-based supplements are commercially available in several EU member states but lack a centralized EFSA opinion or authorized health claim.source |
Who should approach with care
Research citations
- 1PubMed. Safety of the Oral Triphala Recipe from Acute and Chronic Toxicity Tests in Sprague-Dawley Rats, 2022. pubmed.ncbi.nlm.nih.gov
- 2PubMed. Inhibitory effects of Triphala on CYP isoforms in vitro and its pharmacokinetic interactions with phenacetin and midazolam in rats, 2022. pmc.ncbi.nlm.nih.gov
- 3FSSAI. Food Safety and Standards (Health Supplements, Nutraceuticals…) Regulations Compendium, 2021, 2021. fssai.gov.in
- 4PubMed. Effects of Triphala on Lipid and Glucose Profiles and Anthropometric Parameters: A Systematic Review, 2021. pmc.ncbi.nlm.nih.gov
- 5PubMed. Study of the safety of oral Triphala aqueous extract on healthy volunteers, 2020. pubmed.ncbi.nlm.nih.gov
- 6PubMed. Therapeutic Uses of Triphala in Ayurvedic Medicine, 2017. pmc.ncbi.nlm.nih.gov
