Shilajit has surged in popularity across social media and online marketplaces—but so have counterfeits: resins cut with fillers, spiked with synthetics, or contaminated with heavy metals. If you sell a product labeled “shilajit” that isn’t what you claim, you’re not just risking bad reviews—you’re inviting regulatory enforcement and civil liability. This guide for HealingLaw.com explains the U.S. legal framework, where sellers go wrong, and practical steps to reduce risk—without turning this into a chemistry lesson.
What “Fake” Means in Legal Terms
In consumer slang, “fake” means “not real.” In law, the terms are more specific. Under the Federal Food, Drug, and Cosmetic Act (FDCA), a supplement can be misbranded (its labeling or advertising is false or misleading) or adulterated (contaminated or failing to meet identity/purity specs). Introducing a misbranded or adulterated product into interstate commerce violates 21 U.S.C. § 331 and can trigger civil and criminal penalties. Dietary supplements also follow DSHEA rules on what counts as a supplement, and must avoid drug-like claims unless approved by the FDA.
The Federal Baseline: Labeling, Advertising, and cGMP
Two pillars do most of the legal heavy lifting for shilajit sellers:
- Labeling & claims. You may not market a supplement as diagnosing, treating, curing, or preventing disease without drug approval. Even “structure–function” claims (e.g., “supports energy”) must be truthful, not misleading, and substantiated, and they require the standard FDA disclaimer. The FTC separately polices advertising and expects “competent and reliable scientific evidence.” See the FTC’s Health Products Compliance Guidance for what that actually means in practice.
- Manufacturing quality (cGMP). Supplements must be manufactured under 21 CFR Part 111. For a complex material like shilajit, cGMPs require identity, purity, strength, and composition specifications; batch records; and appropriate testing by qualified personnel. Skipping identity or heavy-metal testing is a fast track to warning letters, seizures, or injunctions.
A third area to watch is new dietary ingredients (NDIs). If your ingredient wasn’t marketed in supplements before Oct. 15, 1994—or if your processing method creates a significantly different ingredient—an NDI notification may be required before marketing. FDA’s overview of the process is here: FDA: NDI Notification Process.
State-Level Landmines: UDAP and Proposition 65
Even if you satisfy federal rules, state laws add risk. Every state has an unfair and deceptive acts and practices (UDAP) statute authorizing enforcement for deceptive labeling or advertising. California’s Proposition 65 is especially important for shilajit because heavy metals like lead, arsenic, cadmium, and mercury are listed chemicals. If exposure exceeds safe-harbor levels and you don’t provide a clear warning, you can face civil penalties and private “enforcer” suits—even if you didn’t intend to mislead anyone.
Civil Exposure: Product Liability and Warranty Claims
If consumers are harmed by contaminated or misrepresented shilajit, expect product liability lawsuits—often brought under strict liability (defect), negligence, and breach of warranty theories. Plaintiffs don’t need to prove intent to deceive; they need to show the product was defective or unreasonably dangerous and caused injury. That’s why even small supplement brands should think like manufacturers when it comes to testing, documentation, and recall readiness. Reproducible identity testing, batch-matched Certificates of Analysis (COAs), and supplier audits are not window dressing—they’re legal lifelines.
Where Sellers Go Wrong (and How to Do Better)
- Inflated claims. Promising testosterone boosts or disease treatment without robust evidence invites FTC/FDA scrutiny. Scrub listings, social posts, and influencer copy to align with the FTC guidance and include the FDA’s structure–function disclaimer where appropriate.
- No identity testing. Shilajit is a complex natural mixture. Under 21 CFR Part 111, you’re expected to verify identity and purity. If you can’t prove what’s in the jar, you’re already out of compliance.
- Ignoring heavy metals. For California sales, evaluate Proposition 65 exposure and determine whether a warning is required. Proactively manage contaminants to avoid downstream litigation. See OEHHA’s Prop 65 portal.
- Poor documentation. Maintain master manufacturing records, COAs, and supplier qualifications. These records shorten investigations and help mitigate penalties or civil exposure.
Helpful Consumer-Focused Resources (Non-Promotional)
Educated buyers make safer markets. For plain-language checklists that mirror what regulators and plaintiffs look for—identity, purity, and honest claims—see these consumer guides from American Grit (useful to sellers when designing compliant labeling and QC workflows):
- How to Spot Fake or Adulterated Shilajit Before You Buy — practical red flags, COA basics, and batch verification tips.
- Himalayan Shilajit vs. American Fulvic Acid: What’s the Real Difference? — helps clarify truthful identity and sourcing statements.
- The Missing Mineral: Fulvic Acid Explained — consumer-focused overview to align marketing with substantiated benefits.
Action Checklist for Sellers
- Verify identity and purity with validated methods; keep batch-matched COAs and supplier audits on file (21 CFR Part 111).
- Align every claim (product page, label, ads, social, influencer scripts) with the FTC Health Products Compliance Guidance and include required FDA disclaimers.
- Assess Proposition 65 exposure for California sales and use compliant warnings if thresholds are exceeded (OEHHA).
- Evaluate NDI status if you use novel processing or additives (