Registrar Corp, a leading provider of U.S. Food and Drug Administration (FDA) compliance services, recently received data from FDA detailing the number of registered food facilities in the Agency’s database. The data reveals that as of December 31, 2019, there are 221,843 FDA-registered food facilities, 127,420 (57%) of which are located outside of the United States.
Compared to similar reports Registrar Corp has received over the previous three years, the data illustrates a gradual increase of 14,190 (7%) registered food facilities between December 2016 and December 2019.
The table below shows a year-to-year comparison of total FDA registrations. The decreases represent periods where FDA cancelled thousands of registrations, likely from the facilities failing to renew during required registration renewal periods.
FDA Registered Food Facilities (December 2016 - December 2019) (Percentages represent changes from the previous period) |
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Dec 2016 | Jan 2017 | Jan 2018 | Dec 2018 | Feb 2019 | Dec 2019 | |
U.S. Registrations | 86,773 | 79,958 (-7.9%) | 93,871 (+17.40%) | 102,207 (+8.88%) | 82,921 (-18.87%) | 94,423 (+13.87%) |
Non-U.S. Registrations | 120,880 | 70,972 (-41.29%) | 115,647 (+62.95%) | 131,444 (+13.66%) | 103,103 (-21.56%) | 127,420 (+23.59%) |
Total Registrations | 207,653 | 149,930 (-27.80%) | 209,518 (+39.74%) | 233,651 (+11.52%) | 186,024 (-20.38%) | 221,843 (+19.26%) |
Countries with the Most FDA Food Facility Registrations
As of December 2019, the five countries with the most FDA-registered food facilities are China, Japan, France, Italy, and Mexico. These countries are home to 25% of all FDA-registered food facilities and 44% of all Non-U.S. registered facilities.
Statistics from the Office of the United States Trade Representative show that the United States’ top food and beverage imports from these countries include fruit and vegetable products, snack foods, and alcoholic beverages. The top food imports from each country in 2018 are listed below.
China
- Processed fruits and vegetables ($1.2 billion)
- Fruit and vegetable juices ($393 million)
- Snack foods ($222 million)
- Spices ($167 million)
- Fresh vegetables ($160 million)
European Union
- Wine and beer ($6.4 billion)
- Snack foods (including chocolate ($1.7 billion)
- Vegetable oils ($1.4 billion)
- Processed fruits and vegetables ($1.3 billion)
Japan
- Wine and beer ($72 million)
- Snack foods ($65 million)
- Tea ($63 million)
- Vegetable oils ($47 million)
- Processed fruits and vegetables ($34 million)
Mexico
- Fresh vegetables ($5.9 billion)
- Fresh fruit ($5.8 billion)
- Wine and beer ($3.6 billion)
- Snack foods ($2.2 billion)
- Processed fruits and vegetables ($1.7 billion)
A significant amount of FDA-registered facilities are also located in countries such as Canada, Spain, the Republic of Korea, India, and Germany. The table below shows the countries with the most FDA food facility registrations in December 2019.
Countries with the most FDA Food Facility Registrations | |||
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Country | Dec 2019 Registrations | % of Total Registrations | % of Non-U.S. Registrations |
CHINA/HONG KONG SAR | 12,349 | 5.57% | 9.69% |
JAPAN | 12,057 | 5.43% | 9.46% |
FRANCE | 11,328 | 5.11% | 8.89% |
ITALY | 10,777 | 4.86% | 8.46% |
MEXICO | 8,958 | 4.04% | 7.03% |
CANADA | 6,296 | 2.84% | 4.94% |
SPAIN | 5,028 | 2.27% | 3.95% |
KOREA, REPUBLIC OF | 4667 | 2.10% | 3.66% |
INDIA | 4,262 | 1.92% | 3.34% |
GERMANY | 2,395 | 1.08% | 1.88% |
The graph below illustrates the change in FDA-registered facilities for these countries between December 2016 and December 2019.
Registrar Corp assists more than 20,000 food facilities worldwide with FDA registration and U.S. Agent requirements. Our service includes numerous year-round benefits such as free prior notice filings, FDA Compliance Monitoring of your facility, detention assistance, and more. For assistance with registration or other U.S. FDA requirements, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7.