Is Shilajit Legal?

By Rhyss | Updated on June 28, 2023
Facts checked by editors at Shilajit Resin
Table of Contents

For the past couple of years, Shilajit has been all the rage among health fanatics. After all, this Himalayan herbomineral drug promises so many benefits that everyone wants to add it to their daily supplement. Amongst many of Shilajit’s advantages, a few of them are increased testosterone, anti-inflammatory property, and improved body immunity & memory.

But many of you are already aware of the fact that you can’t just consume any drug or herb, even if it is labeled ‘from the Himalayas.’ First and foremost we oughta know if the black gunk you bought from your local store or an online store is legal in the first place or not.

Is Shilajit legal?

Yes, the medicinal herb is legal in many countries throughout the world. Those of you, who live in the US might be curious if it is approved by the FDA (U.S. Food and Drug Administration); well, the answer is yes or no.

As of 2023, Shilajit’s legal status is: Not currently recognized as safe by FDA. But wait, that’s just the tip of the iceberg. It is very important to know that Shilajit is also one of those supplements that are not regulated by the FDA.

FDA Stance on Shilajit (Dietary Supplement)

“Dietary supplements are not regulated like drugs in the United States, meaning the Food and Drug Administration (FDA) does not approve them for safety and effectiveness before products are marketed. When possible, choose a supplement tested by a trusted third party, such as USP, ConsumerLabs, or NSF.  However, even if supplements are third-party tested, that doesn’t mean they are necessarily safe for all or effective in general. Therefore, it is important to talk to your healthcare provider about any supplements you plan to take and check in about potential interactions with other supplements or medications.”

From the above statement alone, we can safely say Shilajit is legal. FDA has clearly stated that it periodically tests all the dietary supplements that are on the market and considering Shilajit has been on the market for some time now, sure FDA has deemed it legal, albeit indirectly.

FDA once sent a notice to a couple of Shilajit’s vendor

Back in 2017, the U.S. Food and Drug Company sent letters to two different companies,, asking them to review everything they have claimed their Shilajit product does.

FDA warning against Illegal products
FDA warned a few vendors who had claimed Shilajit has so and so benefits without evidence.

The letter read,


“Various claims and statements made on your website and/or in other labeling establish that these products are drugs as defined in 21 U.S.C. § 321(g)(1)(B) because they are intended for the treatment, cure, mitigation, or prevention of disease. For example, your website recommends or suggests the use of Shilajit Resin, NutriHoney, and Bulk Shilajit to treat or prevent cancer, diabetes, depression, high blood pressure and kidney stones. As explained further below, the introduction of these products into interstate commerce for such uses violates the Federal Food, Drug, and Cosmetic Act.”

The whole point of this letter was to show you that although FDA has clearly established boundaries in regard to monitoring a natural substance like Shilajit, they will definitely interfere if there are any illegal practitioners. So guys you can relax on this and not worry about its legality.

Shilajit is proven Safe to Use

Despite being not regulated by FDA, you need not worry about its safety. A lot of studies have evidently concluded that Shilajit is safe for everyone, be it a person with hypertension, or diabetes, or a woman who is breastfeeding or pregnant.

Furthermore, not only is it safe to use by everyone, but it also gives a varied amount of benefits to just about everyone, even your pet dogs or cats. Thus, if you are looking to incorporate Shilajit into your diet then do it with ease. We at PureShilajitResin strive to provide you with all the answers to your concerns in regards to this miracle herbomineral.

About Author:

Rhyss is an accomplished author and respected authority in the realm of Shilajit, showcasing a profound dedication to natural remedies and ancient healing practices. With vast experience and expertise, Rhyss has penned numerous articles and informative pieces on Shilajit, encompassing its rich history, diverse applications, and scientific foundations. Known for their ability to present complex information in a clear and accessible manner, Rhyss's writings have garnered widespread acclaim among a diverse readership. His comprehensive understanding of Shilajit serves as an invaluable resource, enlightening readers about its remarkable benefits, cultural significance, and fostering an appreciation for this extraordinary substance.