FDAat a GLANCE

From the OFFICE OF THE COMMISSIONER | January 2024

FDA REGULATED PRODUCTS AND FACILITIESFDA oversees the safety of more than

FDA-regulated products
account for about$3.6 trillion

21 cents

worth of food, tobacco, andmedical products produced in theU.S. and abroad.

of every dollar spent byU.S. consumers.

There are over
20,000 prescription
drug products approved
for marketing.

About 82% of active
pharmaceutical ingredient
manufacturers arelocated outside of the U.S.

FDA regulates about 78%of the U.S. food supply;
except meat, poultry, andsome egg products.

FDA oversees over
6,500 different medical
device products.

About 47% of medical
devices used in the U.S.
are imports.

FDA regulations cover about:

There are about
1,600 FDA-approved
animal products.

About 8% of animal
product sales areimports.

There are about
896 FDA-licensed
biologics products.

About 80% of biologics
sales are imports.

FDA-regulated products are manufactured or
handled at nearly 280,000 registered facilities,
more than half of which are outside of the U.S.
FDA-Registered Facilities
Program

About 60% of fresh fruit,
39% of vegetables, and 92%of seafood consumption by
volume are imports.

■ 35,000 produce farms■ 300,000 restaurant foodestablishments

FDA oversees over
100,000 tobacco products,not including ENDS.

■ 10,500 vending machine
operators

About 4% of tobacco
product sales are imports.

FDA-regulated products account for 14% of U.S.
imports and 17% of exports.
U.S. Imports and Exports by FDA Program

Domestic

Foreign

Total

ProgramAnimal Drugs

985

720

1,705

Animal Food

Imports (Billions)

Exports (Billions)

$4.50

$7.24

Animal Food

17,9698,204

26,173

Biologics

5,226

649

5,875

Biologics$46.91$34.85

Human & Animal Drugs$107.90$34.26

Human Drugs

4,577

3,843

8,420

Human Food & Cosmetics$217.10$151.20

Human Food

84,886

122,678

207,564

Medical Devices$83.04$49.27

Medical Devices

13,01012,891

25,901

Tobacco

$1.82

$0.23

Tobacco

1,559

01,559FDA Total$461.27$277.05

Total

128,212

148,985

277,197

USA Total$3,254.27$1,747.05

FDA
at a GLANCE
Distribution of FDA Budget by Program and Source(millions of dollars)
Budget Authority

Human Drugs

User Fees

33.3%

Foods

99.0%
100.0%

TobaccoDevices/
Radiological
HealthBiologics

55.5%

Infrastructure

69.7%

FDA
Headquarters

61.5%

Animal Drugs
and Feed

79.8%

1.0%

$746.2
(11%)

39.8%

44.5%

$478.5(7%)

20.2%$288.4(4%)

OtherPrograms

45.4% | 54.6%$110.0(2%)

Toxicology
Research

100% | 0%$0

■ provided by federal budget authorization(53% or $3.6 billion) and industry user fees
(47% or $3.1 billion).
■ equivalent to $10.78 per American per year.
■ inclusive of 18,654 full time equivalents (FTEs).

$362.3(5%)

38.5%

FDA’s budget for Fiscal Year 2023 is:■ approximately $6.7 billion.

$490.5(7%)
30.3%$1,207.9(18%)$677.2
(10%)

0%

60.2%

$2,283.7
(34%)

66.7%

The share of a program’s funding paid byindustry user fees varies from about 1% forFoods to 100% of Tobacco regulatory activities.

$76.9(1%)
$500

$1000

$1500

$2000

$2500

Notes: Infrastructure includes rent, rent-related activities, FDA buildings and facilities, and White Oakconsolidation. Other Programs includes Export Certification and Color Certification Fund.

FDA, an agency within the U.S. Department of Health and Human Services, protects public health by regulating human and veterinary
drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, electronic
radiation emitting products, and tobacco products. FDA at a Glance is published annually by FDA’s Office of Economics and Analysis(OEA), within the Office of Policy, Legislation, and International Affairs, Office of the Commissioner. OEA’s mission is to provide publichealth, economic, and strategic analysis and evaluation to inform FDA’s policy and rulemaking decisions.
U.S. FOOD & DRUG ADMINISTRATION
10903 New Hampshire Ave
Silver Spring, MD 20993

Office of Economics and Analysis
For more information, please contact: Economics@fda.hhs.gov