FDA-Regulated Products and Facilities
FDA is responsible for the oversight of more than $2.7 trillion in consumption of food, medical products, and tobacco.
FDA-regulated products account for about 20 cents of every dollar spent by U.S. consumers.
FDA regulates about 78 percent of the U.S. food supply. This includes everything we eat except for meat, poultry, and some egg products.
There are over 20,000 prescription drug products approved for marketing.
FDA oversees over 6,700 different medical device product categories.
There are over 1,600 FDA-approved animal drug products.
There are about 621 FDA-licensed biologics products.
FDA oversees over 100,000 tobacco products, not including ENDS products.
FDA-Registered Facilities
FDA regulations cover about 35,000 produce farms, 300,000 restaurant chain establishments, and 10,500 vending machine operators.
FDA products are manufactured or handled at nearly 275,000 registered facilities, more than half of which are overseas.
About 78 percent of active pharmaceutical ingredients manufacturers are located outside of the U.S.
FDA-regulated products account for 15 percent of U.S. imports and 15 percent of U.S. exports.
Program Funding
FDA’s budget for Fiscal Year 2021 is:
approximately $6.1 billion.
provided by federal budget authorization (54%, or $3.3 billion) and user industry fees (46%, or $2.8 billion).
equivalent to $10.01 per American per year and includes 18,062 full time equivalents (FTEs). The share of a program’s funding paid by industry user fees varies from about 1% for Foods to 100% of Tobacco regulatory activities.
About 84 percent of biologics sales are imports.
About 57 percent of fresh fruit, 34 percent of vegetables, and 93 percent of seafood consumption by volume are imports.
About 44 percent of medical devices used in this country are imports.
About 5 percent of animal product sales are imports.
About 3 percent of tobacco product sales are imports.
Program Funding
FDA’s budget for Fiscal Year 2021 is:
approximately $6.1 billion.
provided by federal budget authorization (54%, or $3.3 billion) and user industry fees (46%, or $2.8 billion).
equivalent to $10.01 per American per year and includes 18,062 full time equivalents (FTEs). The share of a program’s funding paid by industry user fees varies from about 1% for Foods to 100% of Tobacco regulatory activities.
FY 2021 FDA Budget by Program (Total = $6.1 billion)
Notes: Infrastructure includes rent, rent related activities, FDA buildings and facilities, and White Oak consolidation. Other Programs includes Export Certification and Color Certification Fund.
Human Drugs regulatory activities account for 33 percent of FDA’s budget; 65 percent of these activities are paid for by industry user fees.
Devices and Radiological Health regulatory activities account for 10 percent of FDA’s budget; 35 percent of these activities are paid for by industry user fees.
Foods regulatory activities account for 18 percent of FDA’s budget; 1 percent of these activities are paid for by industry user fees.
Biologics regulatory activities account for 7 percent of FDA’s budget; 42 percent of these activities are paid for by industry user fees.
Animal Drugs and Feeds regulatory activities account for 4 percent of FDA’s budget; 22 percent of these activities are paid for by industry user fees.
Excluding tobacco user fees, federal budget authorization funds about 61 percent of FDA’s budget. The remaining 39 percent is paid for by industry user fees.
FY 2021 FDA Budget Appropriation
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