For international food and beverage companies eyeing the lucrative U.S. market, FDA compliance isn't just a regulatory hurdle—it's your gateway to success. With over $1.5 trillion in annual food sales, the United States represents an enormous opportunity, but only for companies that can navigate its complex regulatory landscape with confidence.
The FDA's jurisdiction covers approximately 80% of the U.S. food supply, and non-compliance can result in product detention, import refusal, costly recalls, and significant damage to your brand reputation. Whether you're a established global brand or an emerging food producer, understanding and implementing these five critical steps will help you enter and thrive in the American market.
Step 1: Register Your Facility and Understand FDA Jurisdiction
Before your first product crosses U.S. borders, you must complete the fundamental requirement of FDA registration—a step that many international companies underestimate in its importance and complexity.
What You Need to Do:
Every foreign facility that manufactures, processes, packs, or holds food for consumption in the United States must register with the FDA using the Food Facility Registration Module. This isn't a one-time formality; registrations must be renewed biennially during even-numbered years between October 1 and December 31.
Your registration must include detailed information about your facility, including the types of food products you handle, your business structure, and a U.S. agent who will serve as your communication point with the FDA. This agent must be physically present in the United States and available for FDA contact during normal business hours.
Critical Considerations:
Understanding which facilities require registration is nuanced. If you operate multiple facilities in your supply chain, each one that handles food for U.S. consumption needs separate registration. Additionally, any significant changes to your operations—such as adding new product lines or changing ownership—require registration updates within 60 days.
The registration process also determines your Foreign Supplier Verification Program (FSVP) obligations and affects how your shipments are processed at U.S. ports of entry. A single error in your registration can cascade into shipment delays and increased FDA scrutiny.
Step 2: Master the Food Safety Modernization Act (FSMA) Requirements
The Food Safety Modernization Act represents the most significant overhaul of U.S. food safety laws in over 70 years, fundamentally shifting the FDA's approach from responding to contamination to preventing it. For international companies, FSMA compliance is non-negotiable and far-reaching.
Core FSMA Components for International Companies:
The Preventive Controls for Human Food rule requires you to implement a comprehensive food safety system. This means developing a written food safety plan that includes hazard analysis, preventive controls, monitoring procedures, corrective actions, and verification activities. Your plan must be prepared by a Preventive Controls Qualified Individual (PCQI)—someone who has successfully completed accredited training.
Your preventive controls must address potential hazards at points where they can be controlled, including biological hazards like Salmonella and Listeria, chemical hazards such as allergens and toxins, and physical hazards like glass or metal contamination. These controls must be validated scientifically and monitored regularly.
Supply Chain Verification:
If you're importing food into the United States, you're likely subject to the Foreign Supplier Verification Program (FSVP). This regulation makes importers responsible for verifying that their foreign suppliers produce food in compliance with U.S. safety standards. As a foreign supplier, you should expect your U.S. importers to conduct supplier verification activities, which may include audits of your facility, sampling and testing of your products, and review of your food safety records.
The Sanitary Transportation rule also affects how your products must be handled during shipment, requiring proper temperature controls, adequate cleaning of transport vehicles, and protection from contamination during transit.
Step 3: Perfect Your Labeling and Nutritional Compliance
FDA labeling requirements are exhaustively detailed and strictly enforced. Even minor labeling errors can result in your products being deemed misbranded, leading to import refusal or costly relabeling operations.
Mandatory Label Elements:
Every food label must include specific information in a precise format: the statement of identity (what the product is), net quantity of contents, nutrition facts panel, ingredient list in descending order of predominance by weight, and the name and address of the manufacturer, packer, or distributor.
The Nutrition Facts label must follow the FDA's updated format, which emphasizes certain nutrients like added sugars and vitamin D. Serving sizes must align with FDA's Reference Amounts Customarily Consumed (RACC), and all nutritional values must be calculated accurately using approved methods.
Allergen Declarations:
The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires clear disclosure of major food allergens. The eight major allergens—milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans—must be declared in plain language. Sesame was added as the ninth major allergen effective January 1, 2023.
Health Claims and Label Statements:
Be extremely cautious with any health-related claims on your packaging. The FDA distinguishes between authorized health claims, qualified health claims, nutrient content claims, and structure/function claims, each with specific requirements and pre-approval processes. Unauthorized claims can result in your product being considered misbranded or even an unapproved drug.
Country of origin labeling, ingredient sourcing claims like "organic" or "non-GMO," and any quality or grade designations must meet specific regulatory standards and may require certification from appropriate authorities.
Step 4: Implement Robust Food Safety and HACCP Systems
While not all food products require a formal Hazard Analysis and Critical Control Points (HACCP) plan, implementing these principles demonstrates your commitment to food safety and prepares you for FDA inspections.
HACCP Fundamentals:
For products that do require HACCP—including juice, seafood, and certain other categories—you must implement all seven principles: conduct hazard analysis, determine critical control points, establish critical limits, implement monitoring procedures, establish corrective actions, implement verification procedures, and maintain detailed recordkeeping.
Even for products not requiring formal HACCP, adopting these principles as part of your preventive controls significantly strengthens your food safety program and provides a systematic framework that FDA inspectors recognize and respect.
Documentation and Recordkeeping:
The FDA operates under the principle that "if it isn't documented, it didn't happen." Your facility must maintain comprehensive records including production records, temperature logs, cleaning and sanitation records, employee training documentation, supplier verification records, and all testing results.
These records must be available for FDA inspection and typically must be retained for at least two years. Electronic records are acceptable but must meet specific requirements for security, validation, and protection against alteration.
Employee Training:
All personnel involved in food production must receive appropriate training in food safety principles relevant to their duties. Training records must document the topics covered, the date of training, and the trainer's qualifications. Refresher training should be conducted regularly, particularly when processes change or after any food safety incidents.
Step 5: Navigate Import Procedures and Prior Notice Requirements
Successfully importing food into the United States requires precise execution of FDA's Prior Notice system and coordination with U.S. Customs and Border Protection (CBP).
Prior Notice Requirements:
Before your food shipment arrives at a U.S. port of entry, you or your importer must submit Prior Notice to the FDA through the Prior Notice System Interface (PNSI). This electronic submission must include detailed information about the product, the shipper, the importer, the anticipated arrival information, and the intended recipient.
The timing of your Prior Notice submission is critical and varies by mode of transportation: no more than 15 calendar days before arrival and no less than 2 hours before arrival for food arriving by water, 4 hours for air, 2 hours for rail, or 2 hours for road. Inadequate or incorrect Prior Notice can result in your shipment being refused entry.
FDA Examination and Testing:
The FDA uses a risk-based approach to determine which imported food shipments to examine or test. Factors influencing this decision include your compliance history, the nature of your product, current food safety concerns, and intelligence about potential hazards.
If your shipment is selected for examination, it will be held at the port of entry. Physical examination may involve opening containers, visual inspection, and sample collection for laboratory analysis. During this time, your product cannot be distributed and remains under FDA and CBP control.
Import Alerts and Detention:
The FDA maintains a system of Import Alerts that automatically detain shipments from facilities known to have produced violative products. If your facility is placed on an Import Alert, all future shipments may be detained without physical examination until you can provide evidence that the problem has been corrected.
Responding to detention requires submitting evidence that your product complies with U.S. regulations. This might include laboratory test results, certificates of analysis, or documentation of corrective actions taken at your facility. The costs of storage during detention, sample collection, laboratory testing, and potential product destruction are borne by the importer or foreign shipper.
Building a Positive FDA History:
Establishing a track record of compliance is invaluable. The FDA's Voluntary Qualified Importer Program (VQIP) offers expedited review and entry for importers who demonstrate consistently high standards of food safety. While achieving VQIP eligibility requires significant documentation and a clean compliance record, the reduced examination rates and faster clearance times provide substantial competitive advantages.
Putting It All Together: Your Compliance Strategy
FDA compliance isn't a one-time achievement but an ongoing commitment that must be woven into every aspect of your operations. The companies that succeed in the U.S. market are those that view compliance not as a burden but as a competitive advantage—a demonstration of quality and reliability that builds consumer trust and opens doors to major retail partnerships.
Start by conducting a comprehensive gap analysis comparing your current operations against these five critical steps. Identify areas where you need to strengthen procedures, update documentation, or implement new controls. Consider engaging qualified consultants or legal advisors who specialize in FDA regulations, particularly for complex issues like FSMA compliance or FSVP implementation.
Invest in training for your team, ensuring that everyone from production workers to senior management understands their role in maintaining compliance. Build relationships with your U.S. importers and agents, as they are your partners in navigating the regulatory landscape.
Finally, stay informed about regulatory changes. The FDA regularly updates guidance documents, issues new rules, and modifies enforcement priorities. Subscribing to FDA news updates, participating in industry associations, and maintaining communication with regulatory experts will help you stay ahead of changes that could affect your business.
The U.S. market rewards companies that demonstrate excellence in food safety and regulatory compliance. By mastering these five critical steps, you're not just avoiding penalties—you're building a foundation for long-term success in one of the world's most important food markets.