Will your product
clear US Customs?

FSVP (Foreign Supplier Verification Program) applies to US importers of food from foreign suppliers. It requires the US importer to verify that their foreign suppliers produce food in a manner that meets US safety standards. FSMA Preventive Controls (21 CFR Part 117) applies to US domestic food manufacturers and processors. It requires a written Food Safety Plan covering hazard analysis, preventive controls, monitoring, corrective actions, and verification. Both are FSMA rules, but they apply to completely different entities. If you are bringing food into the US from overseas, you need FSVP. If you are manufacturing or processing food inside the US, you need a Preventive Controls Food Safety Plan. ClearPath is PCQI-certified and handles both pathways.

Yes — under 21 CFR Part 117, your Food Safety Plan must be prepared by, or under the oversight of, a Preventive Controls Qualified Individual (PCQI). A PCQI is someone who has successfully completed FSPCA training or has equivalent job experience. Many small food businesses do not have a PCQI on staff, which means they must either hire one or engage an external PCQI consultant. ClearPath is PCQI-certified and can serve as your qualified individual for the preparation of your Food Safety Plan, ensuring your documentation meets FDA requirements and is defensible at inspection.

All ClearPath plans are structured to meet 21 CFR Part 1 Subpart L requirements, with clear hazard analysis rationale and complete verification records designed to withstand FDA inspection.

Yes. We provide corrective action guidance for importers who have received FDA import alerts, warning letters, or refusals. This includes reviewing your existing FSVP program against FDA findings, identifying gaps, and updating your documentation to address the specific deficiencies raised. If you are facing an active import alert, we recommend contacting us immediately as timelines for response are typically short. Corrective action support is scoped individually — contact us via the client portal to discuss your situation.

For FSVP: your supplier name, address, product description, and any existing food safety certifications they hold. We guide you through a simple intake questionnaire once engaged.

All plans are delivered in editable Word format plus PDF. You own the documents outright — no lock-in or proprietary software required.

A single FSVP plan typically takes 1-2 weeks from the time we receive supplier information. Multi-supplier packages or food safety plans may take 3-4 weeks. Rush timelines are available on request.

We service clients worldwide — across the US, Europe, Asia, the Middle East, Australia, New Zealand, and beyond. Wherever you or your suppliers are located, every plan is written to US FDA requirements, because the destination market is what determines the rules. Remote delivery means there is no difference in service whether you are in Sydney, Singapore, or San Francisco.

FDA publishes detailed FSVP guidance at fda.gov. The most relevant document is the Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals, updated January 2023. Our team works directly from this guidance when developing every FSVP plan.

No — seafood importers are not subject to the standard FSVP rule. Instead, seafood is governed by 21 CFR Part 123, the Seafood HACCP rule, which is a separate and distinct compliance pathway. Seafood importers must verify that their foreign processors have and implement HACCP plans, and must maintain records of that verification. This is separate from FSVP, which applies to all other food categories.

Under 21 CFR Part 123, US seafood importers must verify that every foreign processor they import from has and implements a HACCP plan for each seafood product. This verification must be documented and records must be maintained and available for FDA inspection. Importers must also take corrective action if a foreign processor is found to be out of compliance. ClearPath provides complete Seafood HACCP importer compliance documentation covering one processor and one product category.

NOAA Fisheries permits are required for importing species managed under US fishery management plans, including most commercially significant marine species. Heavily regulated species include Atlantic tuna (covered under CCSBT and ICCAT quotas), swordfish, sharks, and certain reef fish. ClearPath provides species-specific NOAA permit guidance as part of our seafood compliance services.

Potentially yes. Certain abalone species — particularly green abalone and white abalone — are listed under the Endangered Species Act and require US Fish and Wildlife Service import permits. Southern Hemisphere abalone species such as those from South Australia and Tasmania are not ESA-listed but may still be subject to CITES documentation requirements depending on country of origin. We assess your specific species and source before advising on permit requirements.

DAFF Systems Recognition is a program under Australia's Department of Agriculture, Fisheries and Forestry that certifies Australian food exporters as meeting international food safety standards. When a supplier is DAFF-certified, it can provide evidence of compliance that may reduce the verification burden within your FSVP program — potentially streamlining the documentation required. This applies to Australian food exporters broadly, not just seafood. ClearPath assesses DAFF pathway eligibility for all Australian and New Zealand supplier engagements at no extra charge.

Yes. Live seafood — including live lobster, live crab, and live molluscs — has distinct import requirements covering animal health, aquatic invasive species risk, and state-level permits in addition to FDA Prior Notice requirements. Some live species also require APHIS or FWS permits. We advise on the full permit and compliance picture for live product lines.

The USDA Food Safety and Inspection Service (FSIS) regulates meat, poultry, and certain egg products in the US. Most other food — including packaged food, fresh produce, seafood, dietary supplements, and beverages — is regulated by the FDA. If you are importing beef, lamb, pork, chicken, turkey, or processed egg products, your compliance pathway goes through USDA FSIS rather than FDA. This means FSVP does not apply — instead you need country eligibility, approved establishment listing, and FSIS port-of-entry inspection. ClearPath provides USDA/FSIS import guidance for meat and poultry importers.

Yes. Before any meat or poultry product can be imported into the US, the exporting country must have been determined by USDA FSIS to have an equivalent food safety inspection system. The specific processing establishment must also be listed on the FSIS approved foreign establishment register. Both the country eligibility determination and individual establishment listing must be in place before your first shipment. ClearPath assesses establishment eligibility and guides the listing process for foreign meat and poultry processors.

No. Beef, lamb, pork, poultry, and egg products are regulated by the USDA Food Safety and Inspection Service (FSIS) under the Federal Meat Inspection Act — not by FDA. FSVP only applies to FDA-regulated foods. Instead, FSIS requires country eligibility, approved establishment listing, and port-of-entry inspection. Australia holds FSIS equivalence for beef and lamb. One nuance: heavily processed multi-ingredient products containing meat — such as shelf-stable sauces or soups — may fall under FDA jurisdiction depending on composition. We assess your specific product during intake.

Yes — under the Modernization of Cosmetics Regulation Act (MoCRA), which came into effect in 2022, all cosmetic manufacturing facilities must register with FDA and all cosmetic products must be listed. This applies to both domestic manufacturers and foreign facilities whose products are distributed in the US. The responsible person (the brand or importer) is required to maintain records and comply with MoCRA labeling and safety substantiation requirements. ClearPath handles both facility registration ($290) and product listing ($189 per SKU) as an add-on service for cosmetics and personal care brands entering the US market.

An NDI notification is a submission to FDA required for any dietary supplement ingredient that was not marketed in the US before October 15, 1994. The notification must demonstrate a reasonable expectation of safety for the ingredient. ClearPath provides NDI status assessments — reviewing your ingredient list to identify whether any ingredients trigger the NDI notification requirement. This is an assessment service only: ClearPath identifies the obligation and advises on next steps, but does not draft or file NDI notifications. Ingredients that require notifications are complex regulatory submissions best handled by specialist regulatory counsel, which ClearPath can refer you to.

No. Any individual or entity from any country can form a US LLC — there is no citizenship or residency requirement. You can own and operate a US LLC entirely from abroad. We handle the complete formation process remotely.

For most ClearPath clients entering the US food market, New Mexico offers the lowest ongoing cost — $50 to form, no annual report fee, and no ongoing state obligations beyond maintaining a registered agent. This makes it ideal for importers and e-commerce businesses who want a clean, low-maintenance US entity. Wyoming is the other popular option — $100 to form, $62 per year for the annual report, but with stronger privacy protections and asset protection laws that may be relevant if you plan to hold assets or IP through the entity. Both states are respected by US banks and the IRS. Year one registered agent service is included at no extra charge with our formation package, then $125 per year from year two.

To open a US business bank account as a non-resident, you will need your LLC formation documents (Articles of Organization and Operating Agreement), your EIN from the IRS, a valid passport, and in most cases a US mailing address (provided by your registered agent). ClearPath recommends Mercury or Relay for non-US residents — both are online-first business banks that are well-suited to international founders, offer no monthly fees, and integrate well with payment processors. Traditional US banks (Chase, Bank of America) generally require an in-person visit with a US address, which makes them less practical for non-residents. Wise Business is an option for international payments but has limited US domestic banking functionality.

Yes — a US registered address is required for your LLC. This is included in our formation package. Your registered agent provides a legal US address for official correspondence and state filing purposes.

LLC formation typically takes 1-3 business days for Wyoming and New Mexico — both states process filings quickly. EIN from the IRS takes an additional 1-4 weeks. Full setup including domain and email is typically complete within 2-3 weeks.

Yes. A foreign-owned US LLC can be designated as the FSVP importer for food shipments owned by its foreign parent company at the time of US entry. This is a common structure for international food businesses entering the US market, and one we help clients establish through our combined formation and FSVP services.

USDA Animal and Plant Health Inspection Service permits are required to import certain agricultural products into the US — including animal products, honey, certain fruits and vegetables, plants, and some food ingredients. The requirement depends on product type and country of origin. We identify your APHIS permit obligations and guide you through the application process.

An Importer Security Filing (ISF) must be submitted to US Customs and Border Protection at least 24 hours before your cargo is loaded onto a vessel bound for the United States. It contains 10 data elements about the shipment. Failure to file results in CBP penalties. We provide complete ISF requirement guidance and help you instruct your customs broker.

Yes, if you are making formal entry shipments valued over $2,500 or importing regulated goods. Most commercial food importers require a continuous customs bond, which covers all shipments for a 12-month period. We provide guidance on bond types, amounts, and recommended surety providers.

The Harmonized Tariff Schedule (HTS) code determines the duty rate applied to your imported goods. Incorrect classification leads to underpayment or overpayment of duties, potential CBP penalties, and delays at entry. We identify the correct HTS codes for your food products and advise on applicable duty rates and any free trade agreement treatment that may apply.

Any food imported into the United States must have FDA Prior Notice submitted before the shipment arrives at the US port of entry — typically at least two hours before arrival for road shipments and eight hours for air. Prior Notice is separate from CBP entry filing and is the importer's responsibility. We provide complete Prior Notice setup guidance as part of our compliance services.

Using a licensed US customs broker is not legally required, but it is strongly advisable for food imports. A customs broker files your CBP entry, submits the Importer Security Filing (ISF), files FDA Prior Notice, and manages any holds or inspections at the US border. Errors in these filings can result in shipment refusal, detention costs, or FDA import alerts. Foreign companies acting as Importer of Record almost always need a broker because they lack CBP system access and a surety bond. Experienced US importers with internal trade compliance staff can self-file, but for most businesses entering the US market for the first time, a licensed broker is essential. Importantly, the customs broker is a separate service from ClearPath — we handle your FDA compliance documentation, they handle the physical clearance of your shipment at the border. You need both. ClearPath can introduce you to a trusted licensed US customs broker who specializes in food imports as part of your engagement, at no additional charge.

ClearPath handles everything that happens before your shipment leaves the foreign country — writing your FSVP plan, conducting hazard analysis, registering your suppliers with FDA, reviewing your labels, and ensuring your compliance documentation is complete and audit-ready. A customs broker handles everything that happens when your shipment arrives at the US border — filing the CBP entry, submitting ISF and Prior Notice, paying duties, and managing any FDA or USDA holds. Neither replaces the other. Think of ClearPath as getting you legally ready to import, and the customs broker as physically getting your goods across the border.

The FSMA Preventive Controls for Human Food rule (21 CFR Part 117) requires all registered US food facilities to have a written Food Safety Plan prepared or reviewed by a PCQI. It applies to US food manufacturers, processors, packers, and holders. Very small businesses may qualify for modified requirements.

A PCQI (Preventive Controls Qualified Individual) must prepare or oversee your Food Safety Plan under FSMA. ClearPath's principal is PCQI-certified through the FSPCA and can serve as your PCQI for plan preparation and annual review — included in our FSMA Package.

Under 21 CFR Part 117, a compliant plan must include: a hazard analysis covering biological, chemical, and physical hazards; preventive controls; monitoring, corrective action, and verification procedures; a supply-chain program; and a recall plan. ClearPath delivers all components in FDA inspection-ready format.

FSMA requires full reanalysis at least every three years, or following a significant change in your facility, processes, or ingredients, or after a recall or food safety incident. ClearPath recommends annual review to keep the plan inspection-ready.

Foreign facilities must register with FDA but are covered by FSVP rather than FSMA Preventive Controls directly. However, US importers must verify their foreign suppliers meet FSMA-equivalent standards, so supplier-level FSMA compliance directly affects importer obligations.