Regulatory & Compliance

We manufacture nicotine-free functional food pouches and support compliant market entry with documentation and transparent ingredient status.

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Documentation Pack

Specifications, COA, MSDS, production flow and shipping documents for every order.

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Claim-Safe Positioning

We help frame functional positioning as structure/function statements and avoid disease claims.

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Nicotine-Free Status

No nicotine or tobacco inputs; suitable for channels that exclude nicotine products.

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Import Requirements

Market-by-market input on ingredient status and labeling; buyers confirm final rules with local counsel.

Certifications & Registrations

Verified credentials of our manufacturing facility. Click any certificate to view the full document.

US FDA cGMP Compliance Certificate (21 CFR Part 111)

US FDA cGMP Compliance Certificate (21 CFR Part 111)

Issued by Technical Standards Institute (TSI)

Certificate No.: TGM/CN48/1231208

Third-party assessment · Manufacture, blending, filling & packaging of food / dietary supplements in oral pouch formats · Valid to 11 May 2029

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US FDA Food Facility Registration

US FDA Food Facility Registration

Registration per Bioterrorism Act 2002 · Registrar Foods (US Agent)

FDA Food Facility Registration No.: 17237614552 · UFI (DUNS): 778540571

Effective 05 Oct 2026 · Expires 31 Dec 2028

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China Food Production License (SC) — Special Dietary Foods

China Food Production License (SC) — Special Dietary Foods

Issued by Hunan Provincial Administration for Market Regulation

License No.: SC13043011210578 · Unified Social Credit Code: 91430112MAE4RE896G

Category: Special dietary food · Legal representative: Chen Qiuyang · Issued 06 Feb 2026 · Valid to 05 Feb 2031

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Documents available with orders

📄Commercial Invoice & Packing List
📄Certificate of Origin
📄Bill of Lading / AWB
📄Batch Certificate of Analysis
📄Product Specification Sheet
📄MSDS where applicable
📄Factory license & quality-system certificates

Regulatory status of functional ingredients, caffeine limits and permitted claims vary by country and change over time. Sonvi Bio provides factual product information and documentation support; final compliance and registration are the buyer's responsibility, and we recommend local regulatory counsel. Our statements have not been evaluated by the FDA and our products are not intended to diagnose, treat, cure or prevent any disease.

FDA establishment registration and third-party cGMP assessment documents are shown for verification only. FDA registration does not imply FDA approval or endorsement, and certificates remain the property of their issuing bodies.