We specialize in food regulatory compliance.

The following facilities do not have to register with FDA:  

• Foreign facilities where food undergoes further manufacturing or processing, which includes packaging by another facility outside the United States 
• Farms 
• Retail food establishments 
• Restaurants 
• Nonprofit food establishments 
• Fishing vessels that do not process fish 
• Facilities regulated exclusively by the U.S. Department of Agriculture (USDA) 
• Private residences of individuals 
• Non-bottled water collection and distribution centers 
• Transport Vehicles that hold food 

Certain conditions apply to each of these exemptions, so be sure to confirm FDA’s definition of each exempt category.  

Yes. FDA’s definition of the exempt “restaurant” category includes pet shelters, kennels, and veterinary facilities which provide food to animals, which means these facilities do not have to register. 

No. Fishing vessels are exempt from FDA registration if they head, eviscerate, or freeze fish with the sole intention of preparing them for holding on board a harvest vessel. 

According to the Code of Federal Regulations, a facility is defined as any establishment or structure(s) under one ownership at one general physical location, or, if a mobile facility, traveling to multiple locations, that manufactures, processes, packs, or holds food for consumption in the U.S. A facility may have one or more adjacent structures and a single building can house more than one facility if they are under separate ownership.  

Individual private residences and nonbottled drinking water collection and distribution establishments are not considered facilities. 

Yes. These facilities must register because rawhide chews are consumed by animals and are therefore defined as “food” by FDA. 

You may be considered a Qualified Facility (QF) or a Very Small Importer (VSI) if your establishment (including any subsidiaries or affiliates) averages less than $1,000,000 in human food  or $2,500,000 in animal food annual sales plus the market value of food that is imported, manufactured, processed, packed, or held without sale. The average must consider the totals of the previous three calendar years. 

Not sure if your facility qualifies as a QF? Use our free Qualified Facility Wizard to determine your status. 

Food products sold online for the U.S. market must typically meet the same FDA requirements as those selling through more traditional channels like ocean freight, air freight, or by truck. These may include: 

• Registering the food facility with FDA and renewing registration biannually 
• Designating a U.S. Agent for non-U.S. food facilities 
• Submitting Prior Notice of imported foods 
• Complying with FDA labeling regulations 
• Ensuring that a Food Safety Plan or HACCP Plan, a Food Defense Plan, or a Recall Plan was developed and implemented at the food facility, if applicable  
• Ensuring the U.S. importer has developed and implemented a verification program for imported foods as required under FSVP or HACCP requirements, if applicable 

Facilities located outside the U.S. that refuse an FDA inspection may be placed on Import Alert 99-32, otherwise known as “Detention Without Physical Examination of Products from Firms Refusing FDA Foreign Establishment Inspection.” All products exported to the U.S. by a facility on Import Alert 99-32 will be subject to detention until FDA inspects the facility.  

If a U.S.-based facility refuses an FDA inspection, FDA can seek a warrant to compel the inspection. The facility may also be subject to criminal penalties under the Federal Food, Drug, and Cosmetic (FD&C) Act. 

Many U.S. state governments have additional requirements for bottled water offered for sale within their borders. These can include licensing, certification, or additional labeling statements not specified in FDA regulation.  

Registrar Corp offers unique reports for each state’s bottled water laws and requirements, which you can sign up for here.