About
Shilajit (also called Mumijo) is a blackish-brown resinous exudate or mineral pitch that oozes from rocks in the Himalayas and other mountain ranges, formed over centuries by the microbial decomposition of plant matter. Rich in fulvic acid, humic acid, and trace minerals, it is used traditionally in Ayurvedic medicine as an adaptogen, rasayana (rejuvenator), and dietary supplement.
Safety summary
Animal studies at typical supplemental doses (250–500 mg/day) show no significant toxicity, and inorganic anion levels at recommended doses are within safe limits; however, shilajit can contain up to 65 heavy metals (including Pb, As, Cd, Hg) that may exceed safe thresholds in some commercial products. Long-term consumption of poorly standardised supplements may lead to accumulation of toxic trace elements such as thallium in kidneys and liver. No official Acceptable Daily Intake (ADI) has been established by any major regulatory body; stringent quality control and standardisation are strongly recommended by researchers.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Restricted | Classified as a Novel Food under Regulation (EU) 2015/2283 when used in foods other than food supplements. Not novel (and therefore permitted without novel food authorisation) only when used as or in food supplements. Use in other food categories requires prior novel food authorisation.source |
| FDA (Food and Drug Administration) (United States) | Restricted | Not GRAS for use as a conventional food ingredient or food additive. Permitted only as a dietary supplement ingredient under DSHEA; FDA has issued warning/advisory letters to companies making disease treatment or prevention claims for shilajit products, citing violations of the Federal Food, Drug, and Cosmetic Act. No approved NDA or GRAS notice on record for shilajit.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Approved as a non-specified food ingredient under FSS (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017; application reference 22/Std/PA/FSSAI/2019 dated 24.10.2019. Permitted for use in health supplements and nutraceuticals; specific maximum dose or daily intake level not published in the approval record.source |
Who should approach with care
Research citations
- 1other. Consultation Request for Determination of Novel Food Status: Mumijo (Shilajit). food.ec.europa.eu
- 2FSSAI. List of product(s)/ingredient(s) applications Approved under Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 — Status as on 2nd May 2025, 2025. fssai.gov.in
- 3PubMed. Screening and quantification of inorganic anions in Shilajit and its supplements, 2025. pmc.ncbi.nlm.nih.gov
- 4PubMed. Quantifying of thallium in Shilajit and its supplements to unveil the potential risk of consumption of this popular traditional medicine, 2025. pmc.ncbi.nlm.nih.gov
- 5PubMed. Hazardous or Advantageous: Uncovering the Roles of Heavy Metals and Humic Substances in Shilajit (Phyto-mineral) with Emphasis on Heavy Metals Toxicity and Their Detoxification Mechanisms, 2024. pubmed.ncbi.nlm.nih.gov
