Is Shilajit Safe? What the FDA Has, and Hasn't, Said

Short answer: purified shilajit has a good safety record in human trials of up to 90 days. When we searched in October 2026, we found no FDA warning or recall that names shilajit specifically. The FDA has warned that some Ayurvedic products contain lead, mercury and arsenic, and Health Canada named one shilajit capsule product in a 2005 heavy-metal advisory. The risk is contamination of poorly purified product, not shilajit itself.

What the FDA has actually said

Search "FDA shilajit warning" and you might expect a recall notice. There isn't one that names shilajit. What the FDA has published is broader, and it matters more than a single headline would.

The agency's consumer warning on Ayurvedic products says some of them contain heavy metals such as lead, mercury and arsenic, and that these products "typically are not labeled" to contain them. The warning followed the FDA's own analysis of one product, Rheumacare, after a consumer was found with extremely elevated blood lead levels. That product also contained strychnine.

Two other lines from the same page are worth reading closely:

• "There are no FDA-approved ayurvedic products."
• Ayurvedic products "marketed to prevent, treat, diagnose or cure any disease are illegally marketed in the U.S."

That second line is a useful filter. A shilajit seller promising to treat low testosterone, diabetes or anything else with a diagnosis is breaking the rules, and a seller willing to break that rule tells you something about the rest of the operation.

The one regulator that named shilajit

In 2005, Health Canada warned consumers not to use a list of Ayurvedic products found to contain high levels of lead, mercury or arsenic. One of them was a shilajit capsule product. Several brands on that list had also turned up in a 2004 study in JAMA, which bought Ayurvedic remedies in Boston-area stores and found about one in five contained potentially harmful levels of heavy metals.

A follow-up study in 2008 bought 193 products online, made in the United States and India, and again found about one in five contained detectable lead, mercury or arsenic. US-made products were no cleaner than Indian ones.

None of this says shilajit is dangerous. It says that unpurified or carelessly made products in this category have a long record of contamination, which is the thing to buy around.

Why heavy metals show up in shilajit at all

Shilajit forms in high-altitude rock, and it carries some of whatever was in that rock. Lead, arsenic, mercury and cadmium are part of the geology, so raw material can contain them by nature.

Purification is the processing step that removes them: the resin is dissolved, filtered to take out rock particles and insoluble matter, and dried back into a standardized extract, a step covered in more detail in How to Tell If Shilajit Is Real or Fake. The human trials people cite were all run on purified material. Raw resin sold as-is is the version the contamination studies keep turning up.

Does the FDA approve shilajit supplements?

No, and it doesn't approve any dietary supplement. Under US law, the FDA does not review supplements for safety or effectiveness before they go on sale. The manufacturer is responsible for that, and the FDA steps in after a product is on the market if it finds a problem.

What the FDA does set is the manufacturing rule, 21 CFR Part 111. It requires supplement makers to set specifications for identity, purity, strength and limits on contaminants, to keep batch records, and to investigate complaints.

So two phrases on a label deserve suspicion:

• "FDA approved." For a supplement, this is false.
• "FDA registered facility." Registration means the FDA knows the facility exists. It is not an inspection result or an approval.

What a California Prop 65 warning means

Some supplements carry a "WARNING" label under California's Proposition 65. The law requires a warning when a product could expose someone to a listed chemical, and lead is on the list. The threshold for lead is very low, so a warning can appear on products with trace amounts that would pass most other standards.

A Prop 65 warning is not a finding that a product is unsafe. It also doesn't mean the absence of one proves a product is clean. Treat it as one data point.

How to choose a safer shilajit

Five things to look for on the label and the listing:

1. "Purified" shilajit extract, not just "pure" or "Himalayan."
2. The milligrams of extract per serving, not a raw-material equivalent. The trials used 250 to 500 mg a day.
3. A fulvic acid percentage, which shows the extract was standardized. Around 15 to 20% is the honest range; why higher numbers aren't better.
4. Manufacturing under 21 CFR Part 111 and a lot number on the bottle, so a batch can be traced and recalled.
5. No disease claims. A seller promising to cure anything is already ignoring US rules.

Our gummies are made in a facility certified under 21 CFR Part 111, and every bottle carries a lot number.

Who should not take shilajit

Skip it, or ask a doctor first, if you are pregnant or breastfeeding, under 18, taking prescription medication, or managing kidney disease or another chronic condition. There is a published case report of a serious complication in a pregnant woman taking unpurified shilajit. The full list, with the reported side effects, is in Shilajit Gummies Side Effects.

Questions people actually ask

Has the FDA banned shilajit?

No. Shilajit is legally sold in the US as a dietary supplement. When we searched in October 2026, we found no FDA ban, recall or warning that names shilajit.

Is there an FDA warning about shilajit and heavy metals?

Not one that names shilajit. The FDA has warned about heavy metals in Ayurvedic products in general. Health Canada's 2005 advisory did name a shilajit capsule product among products with high lead, mercury or arsenic.

Is shilajit dangerous?

Purified shilajit produced no safety signal in trials of 250 to 500 mg a day for up to 90 days. The danger in this category is contamination in raw or poorly purified products.

Is shilajit FDA approved?

No supplement is FDA approved. The FDA regulates how supplements are made and labeled, and acts after products reach the market.

Is it safe to take shilajit every day?

Daily use is how it was studied, for up to 90 days. There is no trial data beyond that. If you plan to take it longer, mention it to your doctor.

Can shilajit hurt your kidneys?

Heavy metals in contaminated products can, which is why purification matters. Anyone with existing kidney disease should not take shilajit without medical advice.

Sources

• US Food and Drug Administration. FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug products. fda.gov
• Health Canada. Health Canada warns consumers not to use certain Ayurvedic medicinal products. 2005. canada.ca
• Saper RB, et al. Heavy metal content of Ayurvedic herbal medicine products. JAMA. 2004. PubMed 15598918
• Saper RB, et al. Lead, mercury, and arsenic in US- and Indian-manufactured Ayurvedic medicines sold via the Internet. JAMA. 2008. PubMed 18728265
• US Food and Drug Administration. Dietary supplements. fda.gov
• Current Good Manufacturing Practice for dietary supplements, 21 CFR Part 111. ecfr.gov
• California Office of Environmental Health Hazard Assessment. Proposition 65 warnings. p65warnings.ca.gov
• Stohs SJ. Safety and efficacy of shilajit (mumie, moomiyo). Phytother Res. 2014. PubMed 23733436
• Stavropoulos K, et al. Pseudohyperaldosteronism due to mumijo consumption during pregnancy: a licorice-like syndrome. Gynecol Endocrinol. 2018. PubMed 29933704

This article is general information, not medical advice. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.