How to Register Your Food Product with the FDA

Introduction

Getting your food product on U.S. shelves means navigating the Food and Drug Administration (FDA) registration process. While it might seem daunting at first, proper FDA registration is essential—it ensures your product is safe for consumers and complies with federal regulations. Without it, your products could face import refusal, detention, or removal from the market.

This guide walks you through the FDA registration process step by step, helping you understand the requirements and avoid common pitfalls that can delay your product launch.

1. Understand FDA Regulations

Jurisdiction of the FDA

The FDA regulates most food products sold in the United States, including:

• ✔️ Conventional foods and beverages
• ✔️ Dietary supplements
• ✔️ Food additives
• ✔️ Infant formula
• ✔️ Bottled water

Notable exceptions include meat, poultry, and certain egg products, which fall under USDA jurisdiction. Alcoholic beverages are primarily regulated by the Alcohol and Tobacco Tax and Trade Bureau.

Key Laws and Regulations to Know

Several laws govern food products in the U.S.:

• ✔️ Federal Food, Drug, and Cosmetic Act (FD&C Act)
• ✔️ Food Safety Modernization Act (FSMA)
• ✔️ Bioterrorism Act of 2002
• ✔️ Nutrition Labeling and Education Act

Understanding which regulations apply to your specific product is crucial for successful registration.

2. Determine Registration Requirements

Facility Registration Necessities

Under the Bioterrorism Act and FSMA, facilities that manufacture, process, pack, or hold food for U.S. consumption must register with the FDA. This applies to both domestic and foreign facilities.

You’ll need to register if you:

• ✔️ Manufacture or process food products
• ✔️ Pack or repack food items
• ✔️ Hold food in storage facilities prior to distribution

Certain businesses are exempt, including farms, retail food establishments, restaurants, and non-profit food establishments.

Product-Specific Registration Considerations

Different food categories have additional registration requirements:

• ✔️ Low-acid canned foods require a Food Canning Establishment number
• ✔️ Acidified foods need special processing registration
• ✔️ Infant formula requires pre-market notification
• ✔️ Dietary supplements have specific requirements for ingredients and claims

3. Prepare Necessary Documentation

Essential Business Information

Gather the following before starting registration:

• ✔️ Legal business name and address
• ✔️ Parent company information (if applicable)
• ✔️ All trade names your business operates under
• ✔️ Tax identification numbers
• ✔️ Emergency contact information
• ✔️ Previous FDA registrations (if any)

Product Description Requirements

Prepare detailed information about your products:

• ✔️ Complete ingredient lists
• ✔️ Manufacturing processes
• ✔️ Product categories and subcategories
• ✔️ Food product codes

Importance of Proper Labeling

Your product labels must comply with FDA requirements, including:

• ✔️ Product name
• ✔️ Net quantity
• ✔️ Ingredient list with allergen information
• ✔️ Nutritional facts
• ✔️ Manufacturer/distributor information
• ✔️ Country of origin

Non-compliant labeling is one of the most common reasons for registration delays and import detentions.

4. Complete Online Registration

Using the FDA Registration Portal

The FDA Food Facility Registration Module (FFRM) is accessed through the FDA Industry Systems (FIS) website. This online portal handles all food facility registrations.

Account Creation Steps for First-Time Registrants

1. ✔️ Visit the FDA Industry Systems website
2. ✔️ Create an account (requires business information and an email address)
3. ✔️ Verify your account through the confirmation email
4. ✔️ Set up multi-factor authentication for security purposes

Filling Out the Registration Form

The registration form includes several sections:

1. ✔️ Facility information (address, phone numbers, etc.)
2. ✔️ Parent company details (if applicable)
3. ✔️ Facility type and operations
4. ✔️ Product categories handled at the facility
5. ✔️ Contact information for the facility and U.S. agent (required for foreign facilities)
6. ✔️ Certification statement

After submitting, you’ll receive a registration number. Keep this number accessible as you’ll need it for future interactions with the FDA.

5. Pay Attention to Registration Validity

Understanding the Registration Period

FDA food facility registrations must be renewed every even-numbered year between October 1 and December 31. This biennial renewal is mandatory regardless of when you initially registered.

Importance of Timely Renewal

Missing renewal deadlines can result in:

• ✔️ Registration being considered expired or canceled
• ✔️ Products being detained at ports of entry
• ✔️ Possible penalties for operating without proper registration

Set calendar reminders well before renewal periods to ensure FSVP compliance.

6. Additional Considerations

State and Local Regulations

FDA registration doesn’t exempt you from state or local requirements. Many states have additional licenses, permits, or registrations for food businesses. Research these requirements for all areas where you’ll sell your products.

Maintaining Compliance with Safety Standards

Registration is just the first step. Ongoing compliance includes:

• ✔️ Following Current Good Manufacturing Practices (cGMPs)
• ✔️ Implementing food safety plans (HACCP or preventive controls)
• ✔️ Maintaining proper records
• ✔️ Preparing for FDA inspections

Preparing for FDA Inspections

The FDA conducts inspections to verify compliance. Be ready by:

• ✔️ Keeping thorough documentation
• ✔️ Training staff on food safety procedures
• ✔️ Conducting regular internal audits
• ✔️ Maintaining sanitary conditions

7. Seek Assistance if Needed

Consulting Professionals for Guidance

Many companies find value in working with:

• ✔️ FDA regulatory consultants
• ✔️ Food industry attorneys
• ✔️ Experienced U.S. agents for foreign facilities, including FSVP services.

These experts can clarify complex requirements, review documentation, and help resolve issues that arise during the registration process.

Utilizing FDA Resources and Tools

The FDA provides several helpful resources:

• ✔️ Industry guidance documents
• ✔️ Online tutorials for registration
• ✔️ FDA Technical Assistance Network (TAN)
• ✔️ Public workshops and webinars

Conclusion

Successfully registering your food product with the FDA requires attention to detail and understanding of regulatory requirements. By following these steps—understanding regulations, determining specific requirements, preparing documentation, completing registration through the FDA portal, maintaining registration validity, addressing additional regulatory needs, and seeking assistance when necessary—you’ll navigate the process more efficiently.

Remember, FDA registration isn’t a one-time task but an ongoing commitment to compliance that protects both your business and consumers.

Need help navigating FDA registration for your food products? Global Import Agent specializes in making FDA compliance straightforward for food manufacturers and exporters. Our team of FDA regulatory experts can handle your registration process from start to finish, ensuring your documentation meets all requirements the first time.

We’ve helped hundreds of food businesses successfully enter the U.S. market without delays or detentions at customs. From facility registration to product labeling review, our affordable packages are designed to save you time and prevent costly mistakes. Contact us today for a free consultation and discover how we can simplify your path to FDA compliance.