Shilajit Supplier for the United States
Bulk Supply & Private-Label Compliance for the US Dietary Supplement Market
Navigating 21 CFR 111 cGMP adherence, FSVP qualified importer requirements, FDA Prior Notice, and California Proposition 65 verification.
Regional Statutory Pillars
Specific customs clearance requirements and laboratory documentation provided for this destination market.
FSVP Importer Qualification Support
US importers must maintain a Foreign Supplier Verification Program (FSVP) under 21 CFR 1 Subpart L. Shilergy provides batch-traceable hazard analyses, third-party laboratory verification, and supplier audit documentation.
California Proposition 65 Heavy Metal Thresholds
California requires stringent Safe Harbor limits (Lead < 0.5 mcg/day, Arsenic < 10 mcg/day). Our batches are quantified by ICP-MS with limits of detection at 0.001 ppm to substantiate compliance.
Labeling Review & Claims Guidance
FDA regulates dietary supplement labeling under 21 CFR 101. We advise clients against impermissible disease claims ("treats arthritis", "cures insomnia") and ensure compliant structure/function language with required disclaimer boxes.
Customs Harmonized Tariff & Prior Notice
Expedited clearance support using compliant HTS classifications (3004.90 / 1302.19) and seamless FDA Prior Notice generation prior to sea or air cargo dispatch.
Testing Standard for Commercial Dispatch
Verified ICP-MS heavy metals, microbiological absence, and HPLC fulvic acid identification included with every shipment.
Analytical Certificate of Analysis (COA) Specification
Each commercial export batch is tested against this standardized testing panel before quarantine release. Commercial partners receive full unredacted lab documents upon NDA completion.
| Analytical Parameter | Methodology / Standard | Contract Specification Limit | Observed Batch Result | Batch Conformance |
|---|---|---|---|---|
| Lead (Pb) | ICP-MS (EPA 6020B) | < 0.5 ppm (Prop 65 / USP) | < 0.012 ppm | Meets Specification |
| Arsenic (Inorganic As) | ICP-MS (EPA 6020B) | < 1.0 ppm | < 0.010 ppm | Meets Specification |
| Cadmium (Cd) | ICP-MS (EPA 6020B) | < 0.3 ppm | < 0.005 ppm | Meets Specification |
| Mercury (Hg) | Cold Vapor AA / ICP-MS | < 0.1 ppm | < 0.001 ppm (ND) | Meets Specification |
| Fulvic Acid Content | HPLC-UV / Lamar / AOAC modified | > 50.0% w/w | 58.4% w/w | Meets Specification |
| Humic Acid Complex | Gravimetric Precipitation | 12.0% - 20.0% w/w | 16.2% w/w | Meets Specification |
| Total Aerobic Microbial Count | USP <2021> | < 1,000 CFU/g | < 10 CFU/g | Meets Specification |
| Yeast & Mould Count | USP <2021> | < 100 CFU/g | < 10 CFU/g | Meets Specification |
| E. Coli, Salmonella, S. aureus | USP <2022> | Absent in 10g | Absent | Meets Specification |
| Multiresidue Pesticide Screen | GC-MS/MS & LC-MS/MS (>450 compounds) | Below EU MRL & USP <561> | Not Detected (< LOQ) | Meets Specification |
Frequently Asked Questions
Is Shilajit "FDA Approved"?
The FDA does not issue pre-market "approvals" for dietary supplements or their ingredients. Instead, facilities must adhere to cGMP (21 CFR 111), and importers must comply with FSVP. Shilergy provides verified partner facility documentation and testing evidence required for importer records.
What packaging formats are most common for the US market?
30g dark violet and amber glass jars with tamper-evident induction seals, packed inside rigid slide boxes or folding cartons with batch-specific QR codes.