About
Tulsi (Ocimum tenuiflorum / Ocimum sanctum) is an aromatic culinary and medicinal herb of the Lamiaceae family, indigenous to the Indian subcontinent and used in Ayurvedic medicine for over 3,000 years. It is consumed as a flavouring agent in foods and herbal teas, and is used as a nutraceutical supplement for its adaptogenic, antimicrobial, anti-inflammatory, and immunomodulatory properties, with eugenol identified as its primary bioactive constituent.
Safety summary
A systematic review of 24 human clinical studies reported no significant adverse events associated with tulsi ingestion across metabolic, immune, and neurocognitive outcomes. Animal studies have indicated potential antifertility and uterotonic effects, warranting caution in pregnant and lactating women. No formal Acceptable Daily Intake (ADI) has been established by EFSA, FDA, or WHO, reflecting its status as a traditional culinary and herbal botanical rather than a regulated food additive.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Tulsi holds no E-number and is not regulated as a food additive in the EU. Available commercially as herbal tea and food supplement. Scientific literature has raised concerns about frequent species substitution with Ocimum basilicum L. in European commercial tulsi products; HPLC fingerprinting and DNA barcoding are recommended for quality authentication. No formal EFSA safety opinion or ADI has been issued specifically for tulsi.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Recognised under the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016; spices listed by the Spices Board of India, including holy basil, may be used as nutraceutical or health supplement ingredients. Specific health benefit claims require prior FSSAI approval. Products in this category are not to be used by infants and children under 5 years except under medical advice.source |
| FDA (Food and Drug Administration) (United States) | Approved | Marketed and sold in the US as a botanical dietary supplement regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994. No specific GRAS listing identified for tulsi as a conventional food additive. Products making unsupported disease or therapeutic claims have received FDA warning letters (e.g., March 2019 enforcement action referencing Holy Basil concentrate products). FDA UNII for Ocimum tenuiflorum top: 34T63W8ULS.source |
Who should approach with care
Research citations
- 1PubMed. Harnessing the Antibacterial, Anti-Diabetic and Anti-Carcinogenic Properties of Ocimum sanctum Linn (Tulsi), 2024. pmc.ncbi.nlm.nih.gov
- 2FSSAI. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 – Compendium 2021, 2021. fssai.gov.in
- 3PubMed. The Clinical Efficacy and Safety of Tulsi in Humans: A Systematic Review of the Literature, 2017. pmc.ncbi.nlm.nih.gov
- 4PubMed. Tulsi - Ocimum sanctum: A herb for all reasons, 2014. pmc.ncbi.nlm.nih.gov
- 5PubMed. Therapeutic uses of Ocimum sanctum Linn (Tulsi) with a note on eugenol and its pharmacological actions: a short review, 2005. pubmed.ncbi.nlm.nih.gov