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FDA & PGA Compliance Screening

Every product entering the United States is subject to review by up to 16 Partner Government Agencies beyond CBP itself. A single missed requirement — an FDA prior notice, a TTB COLA number, an APHIS phytosanitary certificate — results in a hold at the port, storage fees, and delays that cascade through your supply chain. Our engine screens against all 16 agencies automatically, flags every requirement, and generates the PGA filing records before your entry is transmitted.

All 16 Partner Government Agencies

Food, Health & Safety

FDA — Food, drugs, medical devices, cosmetics, dietary supplements, radiation-emitting products. Prior notice required for all food articles (21 CFR 1.279). Facility registration under Bioterrorism Act. FSVP importer verification. FSIS — Meat, poultry, processed egg products (USDA jurisdiction, not FDA). CPSC — Consumer product safety, children’s products, household chemicals, textiles flammability. DEA — Schedule I-V controlled substances, List I/II chemicals, narcotic raw materials.

Environment, Agriculture & Wildlife

EPA — TSCA chemicals, pesticides (FIFRA), motor vehicle emissions, ozone-depleting substances, hazardous waste. APHIS — Live animals, plants, seeds, soil, wood packaging (ISPM-15), veterinary biologics. FWS — CITES species, wildlife products, exotic leather, Lacey Act, Endangered Species Act. NMFS — Seafood, marine mammals (MMPA), Seafood Import Monitoring Program (SIMP).

Alcohol, Firearms & Energy

TTB — Alcohol (wine, spirits, beer, cider), tobacco products. Importer permit + Certificate of Label Approval (COLA) required. ATF — Firearms, ammunition, explosives, destructive devices. Import permit required. DOE — Energy efficiency standards for appliances, lighting, HVAC equipment, motors. PHMSA — Hazardous materials transportation, DOT packaging standards.

Communications & Transportation

FCC — Radio frequency devices, telecommunications equipment, intentional and unintentional radiators. Equipment authorization required. NHTSA — Motor vehicles, tires, child restraints, motorcycle helmets. FMVSS compliance required. HS-7 declaration form. All 16 agencies are checked simultaneously on every product. If none apply, you get a clean screening result. If any apply, you get the specific requirements, CFR references, and filing records — all before the entry is transmitted.

How It Works

1

Product Data Ingested

Submit your product description, HTS code, ingredients (for food/cosmetics), material composition, intended use, and country of origin. The engine also accepts commercial invoices, product labels, or Safety Data Sheets (SDS). Multimodal input means you can photograph a product label and our AI extracts the relevant PGA data fields.

2

All 16 Agencies Screened

Your product is evaluated against the jurisdiction and requirements of every PGA simultaneously: FDA (food, drugs, devices, cosmetics), TTB (alcohol, tobacco), APHIS (animals, plants), EPA (chemicals, pesticides, vehicles), CPSC (consumer safety), NHTSA (motor vehicles), FWS (wildlife), FCC (electronics), FSIS (meat/poultry), NMFS (seafood), DOE (energy efficiency), ATF (firearms/explosives), PHMSA (hazmat), and DEA (controlled substances).

3

Requirements Flagged

For each applicable agency, the engine generates the specific compliance requirements: FDA prior notice with anticipated arrival data, TTB COLA number verification, APHIS phytosanitary certificate requirements, EPA TSCA certification language, CPSC product safety documentation. Each requirement includes the CFR reference and filing deadline.

4

PGA Records Filed

OI and PG records are generated in CATAIR format and attached to your customs entry. FDA prior notice is submitted through the Prior Notice System Interface (PNSI). When your entry transmits to CBP ACE, all PGA data travels with it — no separate filings, no missed agencies, no holds at the port.

Key Benefits

Zero Missed Agencies

The most common cause of CBP holds is a missed PGA requirement — an importer files the customs entry but forgets that their product triggers FDA, CPSC, or EPA review. Our engine checks all 16 agencies on every product, every time. If an agency applies, you know before filing.

APHIS Agricultural Screening

Wood packaging (ISPM-15), live plants, seeds, soil, animal products, and any biological material triggers APHIS review. The engine checks for required phytosanitary certificates, veterinary health certificates, and import permits. Lacey Act declarations for plant products are generated automatically.

TTB Alcohol & Tobacco

Importing wine, spirits, beer, or tobacco requires a TTB importer permit and, for most alcohol, a Certificate of Label Approval (COLA). The engine verifies that your COLA number is valid and matches the product being imported. Missing a COLA means your shipment sits at the port until TTB clears it.

EPA Chemical Compliance

TSCA (Toxic Substances Control Act) certification is required for chemical substances and mixtures. The engine determines whether your product requires positive or negative TSCA certification, checks for Significant New Use Rules (SNUR), and generates the appropriate certification language for your entry.

CPSC Consumer Product Safety

Children's products, textiles, electronics, and household goods must comply with CPSC standards. The engine checks for required testing (ASTM F963 for toys, 16 CFR 1610 for textiles), General Certificate of Conformity (GCC) requirements, and children's product certificate (CPC) obligations.

NMFS & FWS Wildlife/Seafood

Seafood imports require NMFS documentation and may trigger the Seafood Import Monitoring Program (SIMP). Wildlife products — from leather goods to exotic wood — trigger FWS review under CITES, Lacey Act, and the Endangered Species Act. The engine flags both and generates the required declarations.

Never miss a PGA requirement again

Screen your products against all 16 agencies before they ship. Catch compliance issues at origin, not at the port of entry where they become expensive holds.

Goldmex International, LLC · 2345 Michael Faraday Dr, Ste 8, San Diego, CA 92154

Licensed US Customs Broker \· Customs Intelligence Technology