Shilajit P.E.fulvic Acid

The trade divides between raw resin, which is the crude sun-dried exudate and carries a variable and often high mineral and insoluble load, and purified extract, which has been water extracted and filtered. Purified extract is graded on fulvic acid at 20, 50 and 70 percent, and sometimes on combined fulvic plus humic acid, which produces a much higher nominal figure for the same material and should be read carefully. Dibenzo-alpha-pyrone content is declared on a minority of specifications and is the more selective marker where it appears.

Physical grades are a free-flowing spray-dried powder milled to pass 80 mesh, a granulated grade for sachets and capsules, and a soft resin sold in jars for direct consumer use. Heavy metal content is the defining quality issue for this ingredient rather than assay, because the geological origin brings lead, arsenic and mercury into the raw material, so purified grades are differentiated in practice by their tested heavy metal levels and by whether the producer applies a dedicated removal step.

In the United States shilajit is sold as a dietary ingredient under the Dietary Supplement Health and Education Act. It is not GRAS-listed and has no food additive regulation, so its use is confined in practice to supplements rather than conventional foods, and firms rely on documented marketing history or on a new dietary ingredient notification. The FDA has issued warning letters to firms making disease claims for shilajit products, and the agency has also acted on imported material found to contain heavy metals above acceptable levels, so import testing is a practical regulatory reality for this ingredient rather than an optional check.

In the European Union shilajit has no E number, being a nutritional ingredient and not an additive. Its principal barrier is the novel food rules: shilajit does not have a demonstrated history of significant consumption in the Union before May 1997, so placing it on the EU market as a food or food supplement requires novel food authorisation, and it is not currently authorised. Several member states have taken enforcement action against unauthorised shilajit supplements on that basis. Lead, arsenic, mercury and cadmium in food supplements are subject to the EU maximum levels for contaminants, which is the other limit that applies to the material. No Codex commodity standard or JECFA specification covers shilajit.