Shudh Shilajit Extract

About

What it is and where it shows up.

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

The regulatory and scientific consensus.

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

What food-safety regulators have decided.

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

Whose guidance would steer them away.

Pregnancy — No clinical safety data exist for pregnant women, and potential heavy metal contamination (Pb, Hg, Cd) in unregulated products poses a risk to foetal development; FSSAI nutraceutical labelling guidelines recommend products not be used by pregnant or lactating women unless under medical advice.

Lactation — Absence of safety data during lactation and risk of transfer of heavy metals or trace contaminants through breast milk warrants medical guidance before use.

Infants — FSSAI health supplement regulations explicitly state that nutraceutical/supplement products of this class are not to be used by infants and children under 5 years of age.

Children — FSSAI nutraceutical regulations advise against use of non-standard supplement ingredients in children under 5; heavy metal content risk is disproportionate for developing systems.

Kidney Disease — Studies on thallium content in shilajit supplements note that long-term consumption may lead to accumulation of thallium in kidneys, posing heightened risk to individuals with pre-existing kidney disease.

Research citations

The sources behind this verdict.

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

Independently researched8 citations