The Regulatory Distinction: Food vs. Supplement
In the United States, and in many other countries, the classification of a product as a "food" or a "dietary supplement" is not based on its natural origin but on its intended use, form, and labeling. Conventional foods are consumed primarily for taste, aroma, and nutritive value as part of a regular diet. In contrast, dietary supplements are intended to supplement the diet and are typically sold in forms not resembling traditional foods, such as capsules, powders, or liquids. This regulatory framework is critical for understanding why shilajit, despite being a naturally derived substance, falls squarely into the supplement category.
How the FDA Classifies Health Products
Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the U.S. Food and Drug Administration (FDA) treats dietary supplements differently than conventional foods and pharmaceuticals.
- FDA Approval: The FDA does not approve dietary supplements for safety and effectiveness before they are marketed and sold to the public. The responsibility lies with the manufacturer to ensure their product's safety and labeling accuracy.
- Intended Use: The intended use, as determined by the product's labeling and marketing, is a primary factor. Supplements are marketed to 'supplement' the diet, often with claims related to nutrient content or effects on the body's structure and function.
- Labeling: Products are required to carry a "Supplement Facts" panel, not a "Nutrition Facts" panel, distinguishing them from conventional foods.
Why Shilajit Is a Supplement, Not a Food
Shilajit is marketed and consumed primarily as a supplement for its purported health benefits, not for its taste or as a staple part of a meal. While historically used in Ayurvedic tradition, its modern commercial application is in supplement form, typically as a resin, powder, or capsule. The intended purpose is to enhance health, vitality, or address specific conditions, aligning with the definition of a supplement. Even when mixed into beverages like milk or tea, it is used for its medicinal or 'tonic' properties rather than being a core food ingredient.
The Importance of Purity and Regulation for Shilajit
Since the FDA does not pre-approve supplements, purity and quality control are significant concerns for shilajit. Raw or unprocessed shilajit, which oozes from rocks in its natural state, can be contaminated with harmful substances, posing a significant health risk.
Potential Contaminants in Unpurified Shilajit
Raw shilajit is a natural mineral pitch that can harbor a number of dangerous contaminants that are inappropriate for human consumption.
- Heavy Metals: Unpurified shilajit can contain toxic heavy metals such as arsenic, lead, mercury, and cadmium. These can cause heavy metal poisoning, with one study finding that some supplements had higher levels of thallium than the raw material.
- Microbial Organisms: Contamination with viruses, bacteria, and fungi is a risk with unprocessed shilajit.
- Other Impurities: Dirt and other organic debris are common in raw forms.
Comparison of Food vs. Supplement Classification
| Feature | Conventional Food | Dietary Supplement (Shilajit) |
|---|---|---|
| Primary Purpose | Consumed for taste, aroma, and nutritive value. | Taken to supplement the diet and enhance health. |
| Packaging Label | Must display a "Nutrition Facts" panel. | Must display a "Supplement Facts" panel. |
| Regulatory Pathway | Regulated by FDA for safety, manufacturing, and labeling. | Manufacturer responsible for safety and compliance; no pre-market FDA approval required. |
| Form of Consumption | Part of meals or snacks in traditional forms. | Often in non-traditional forms like capsules, powders, or resins. |
| Risk Factor | Generally safe for consumption as a category. | Can pose risks if not properly purified and tested. |
How to Ensure You're Buying a Safe Shilajit Product
Because of the lack of pre-market FDA approval, consumers must exercise due diligence to ensure they are purchasing a safe and purified product.
- Seek Third-Party Testing: Look for products with a third-party certification seal from organizations like NSF Certified Sport or USP. These certifications indicate independent lab testing for contaminants.
- Request a Certificate of Analysis (COA): Reputable manufacturers should provide a COA confirming the product's purity and potency.
- Avoid Raw or Unprocessed Forms: Never consume raw, unprocessed shilajit due to the high risk of heavy metal and microbial contamination. Ensure the product is labeled as purified.
- Consult a Healthcare Provider: It is wise to consult a healthcare provider, especially if you have existing health conditions or take other medications, to determine if shilajit is right for you.
Conclusion: Clarifying Shilajit's Role
While derived from natural sources and revered in traditional medicine, shilajit is not considered a food. Instead, its modern commercial incarnation is a dietary supplement, subject to a different set of regulations and consumer precautions. The key distinction lies in its intended use—supplementing the diet for health rather than providing conventional nutrition. Because it is not FDA-approved, the burden of ensuring a safe, pure product rests with both the manufacturer and the consumer, who must seek evidence of third-party testing to mitigate health risks associated with heavy metal and microbial contamination. Informed choice is the most important ingredient when adding shilajit to a wellness routine.
Evaluation of safety profile of black shilajit after 91 days repeated administration in rats - PMC
