FDA Compliance, SHILAJ Integrity

The main takeaways:

✅ The FDA does not approve dietary supplements before they go to market. 

✅ Supplements are regulated as food, not as drugs, under the Dietary Supplement Health and Education Act (DSHEA).

✅ FDA requires all supplement labels to include a disclaimer if any structure/function claims are made.

✅ Claims cannot state that a supplement treats, cures, or prevents disease.

✅ Manufacturing must follow FDA’s Good Manufacturing Practices (GMPs) to ensure quality and safety.

✅ The FDA can inspect facilities, issue warnings, and remove unsafe products from the market.

✅ At SHILAJ, all products are made in FDA-compliant, GMP-certified U.S. facilities and undergo third-party testing.

What the FDA Has to Do With Supplements Like SHILAJ

If you’ve ever read the back of a supplement bottle—including SHILAJ—you’ve likely come across this statement:

"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."

We get it—on first glance, it might sound alarming. But it’s not. This is a standard disclaimer required by the FDA for all dietary supplements that mention how they may support the body (like energy, immunity, or stress relief).

So what does the FDA actually do when it comes to supplements like ours?  

Understanding the FDA’s Role

The U.S. Food and Drug Administration (FDA) oversees industries that impact public health—like food, medicine, and supplements. For dietary supplements, including SHILAJ, the FDA does not “approve” products before they hit the market (unlike pharmaceutical drugs). But that doesn’t mean supplements are unregulated.

Instead, the FDA sets rules for:

  • Labeling: Claims must follow clear guidelines (you’ll never see us saying SHILAJ cures anything). 

  • Manufacturing: Facilities must follow Good Manufacturing Practices (GMP)—a standard SHILAJ proudly meets. 

  • Safety Monitoring: The FDA has the power to inspect, recall, or remove unsafe products. 

Drugs vs. Supplements: Why the Distinction Matters 

Pharmaceutical drugs are designed to treat or cure medical conditions, and require years of clinical trials and FDA pre-approval. 

Supplements—like SHILAJ—are meant to support your body's natural processes, not replace medical treatment. That’s why we talk about things like energy, stress balance, or vitality—without making exaggerated health claims. 

So What Can SHILAJ Say? 

Under the Dietary Supplement Health and Education Act (DSHEA), brands can discuss how ingredients may support the structure or function of the body. At SHILAJ, we’re always careful and responsible with our wording. 

We won’t claim our products cure fatigue, but we can say that Shilajit—backed by research—may support healthy energy metabolism, hormonal balance, and overall vitality. That’s the difference. 

How SHILAJ Ensures Safety and Transparency 

We go above and beyond the FDA’s baseline requirements by adhering to what we call The Audrey Standard—a commitment to: 

✅ GMP-compliant U.S. Manufacturing 
 ✅ Third-Party Testing for Purity & Potency 
 ✅ Traceable Sourcing of Ingredients 
 ✅ No Proprietary Blends—Full Transparency Always 

You deserve to know exactly what you're putting in your body. That’s why our “Supplement Facts” panel is honest, detailed, and never hides behind vague blends or gimmicks. 

Be a Smart Supplement User 

Here’s how you can make informed choices, whether you're using SHILAJ or any other supplement:

  1. Read the Label 
     Understand what’s inside and stick to the suggested use. 

  1. Look for Third-Party Testing 
     It’s a signal of trust. SHILAJ products are tested for quality at multiple stages. 

  1. Watch for Red Flags 
     Any supplement that promises to “cure” or “treat” anything should raise questions. 

  1. Talk to Your Healthcare Provider 
     Before starting any supplement, especially if you’re on medications or managing a health condition. 

In Short

The FDA doesn’t “approve” supplements—but it does oversee their manufacturing, labeling, and safety. SHILAJ meets and exceeds these standards, because integrity is non-negotiable. No shortcuts. No hype. Just honest, effective supplements from nature, backed by science.