About
Shilajit resin is a dark, tar-like mineral exudate found predominantly in the Himalayas and other high-altitude mountain ranges, formed over centuries by the microbial decomposition of plant matter; it is composed mainly of humic and fulvic acids (60–80%) plus diverse trace minerals. It is used traditionally in Ayurvedic medicine as an adaptogen and rejuvenator, and is sold globally as a dietary supplement.
Safety summary
Purified shilajit preparations appear generally safe at typical supplement doses, but unpurified or inadequately tested products may contain toxic heavy metals—including lead, arsenic, mercury, cadmium, and thallium—whose concentrations vary widely by geographic source and processing method. No formal Acceptable Daily Intake (ADI) has been established by any major regulatory authority, and the compositional variability of commercial products presents a population-wide quality-control risk. Pregnant women, children, and individuals with kidney or liver disease face amplified risk from potential heavy metal accumulation.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| Health Canada (Canada) | Restricted | Health Canada issued a public consumer warning and market removal order against certain Ayurvedic products including Shilajit capsules (Dabur India Ltd.) due to high heavy metal content (lead, mercury, and/or arsenic). Products containing shilajit require pre-market authorisation as Natural Health Products under the Natural Health Products Regulations.source |
| EFSA (European Food Safety Authority) (European Union) | Restricted | Classified as a Novel Food under Regulation (EU) 2015/2283. Permitted for use in food supplements without novel food authorisation based on history of use; requires novel food authorisation for any other food categories (categorised as food from material of mineral origin or food from animals). Not assigned an E-number.source |
| FDA (Food and Drug Administration) (United States) | Restricted | Not GRAS as a food additive; may be marketed as a dietary supplement under DSHEA but cannot bear disease-treatment claims. FDA has issued multiple warning letters against shilajit products making drug claims (cure/prevention of cancer, diabetes, depression, hypertension, kidney stones). No approved New Dietary Ingredient (NDI) notification confirmed.source |
| FSSAI (Food Safety and Standards Authority of India) (India) |
Who should approach with care
Research citations
- 1other. Consultation Request for Determination of Novel Food Status – Mumijo (synonyms: shilajit, asphaltum panjabinum). food.ec.europa.eu
- 2PubMed. Quantifying of Thallium in Shilajit and Its Supplements to Unveil the Potential Risk of Consumption of This Popular Traditional Medicine, 2025. pubmed.ncbi.nlm.nih.gov
- 3PubMed. 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
- 4FDA. Advisory Letter: Healthy Nutrition Group LLC – Shilajit Resin, 2018. fda.gov
- 5PubMed. Evaluation of Safety Profile of Black Shilajit after 91 Days Repeated Administration in Rats, 2013. pmc.ncbi.nlm.nih.gov
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