Shilajit in Thailand: Is It Legal? Thai FDA Status, Risks, and Market Reality

In recent years, Shilajit has gained global popularity as a dietary supplement, particularly in markets such as the United States and India. However, companies looking to introduce Shilajit into Thailand face a very different regulatory landscape.

This article provides a clear, technical answer to a common question:
Can Shilajit be legally sold or registered in Thailand?

Short Answer: No

As of today:

Shilajit is not approved in Thailand
It is not registrable as a dietary supplement
It is not recognized under Thai traditional medicine
There are no approved products on the market
Products currently sold online are non-compliant

Thai FDA Position on Shilajit

The Thai Food and Drug Administration (TFDA) regulates food supplements under a structured framework based on:

Approved ingredient lists
Recognized herbal substances
Safety and quality standards

Shilajit does not fit into any of these categories.

1. Not a Recognized Food Ingredient

Shilajit is:

A mineral-organic exudate (often referred to as “mineral pitch”)
Highly variable in composition
Not included in Thai FDA positive lists

This creates a fundamental issue: There is no clear regulatory classification pathway

2. Not Accepted as a Herbal Product

Thailand recognizes Thai traditional medicine, not Ayurvedic substances by default.

Shilajit is widely used in Ayurveda (India)
It is not included in the Thai Herbal Pharmacopoeia

Result: It cannot be registered as a traditional or herbal product in Thailand

Shilajit as Novel Food? In Theory Yes — In Practice No

One might argue that Shilajit could be submitted as a novel food.

However, this route is not viable in practice.

Why?

A novel food submission would require:

Full toxicological profile
Standardized composition
Reproducible manufacturing process
Comprehensive safety data

Shilajit typically fails on all critical points:

Highly variable composition
Difficult to standardize
Frequent contamination concerns (heavy metals such as lead, arsenic, mercury)

Conclusion: A novel food safety assessment would very likely fail

Contamination Risk: A Major Regulatory Barrier

One of the main reasons regulators reject Shilajit is safety risk.

Typical issues include:

Heavy metals exceeding permissible limits
Environmental contamination
Lack of pharmaceutical-grade purification

Thai FDA applies strict limits on:

Lead (Pb)
Arsenic (As)
Mercury (Hg)
Cadmium (Cd)

Shilajit, by nature, is considered a high-risk raw material

Market Reality in Thailand

Despite the regulatory situation, Shilajit products can still be found:

On e-commerce platforms
Through social media sellers
Via informal import channels

These products are:

Not registered
Not approved
Not compliant with Thai law

In simple terms: They are illegal

Why You See Shilajit Online Anyway

This is a classic case of:

Weak enforcement in digital channels
Cross-border e-commerce leakage
Mislabeling or deliberate misclassification

However, this does not change the regulatory status.

Illegally sold ≠ legally accepted

Can It Be Made Compliant?

At present, there are only theoretical options:

1. Reformulation

Extracting and isolating specific compounds (e.g. fulvic acid)
→ but this becomes a different product, not Shilajit

2. Cosmetic Route

Inclusion as a cosmetic ingredient
→ highly questionable and still risky

3. Exclude Thailand

Launch in markets where Shilajit is accepted
→ most realistic strategy

Conclusion

Shilajit is a clear example of a product that is:

Popular globally
Commercially attractive
Regulatorily blocked in Thailand