1.
FDA & USDA
Import Food Safety Forum
February 28, 2015

2.
Food and Drug Administration
美國食品藥品監督管理局
Food and Drug Administration (FDA) is a federal agency responsible for ensuring public
health through regulating and supervising of the following:
• Food (for human and for animal [foods & feeds])
• Tobacco products
• Drugs (Dietary Supplements, prescriptions, medical device, etc.)
FDA’s authority encompasses both domestic and imported items as listed above.
With its Headquarter in White Oak, Maryland, FDA has 223 field offices and 13
laboratories located throughout all 50 states including US Virgin Islands and Puerto
Rico.
In 2008, FDA began to establish offices in foreign countries such as China, India, Costa
Rica, Belgium and United Kingdom.

3.
FDA Organization Chart

4.
United States Department of Agriculture
美國農業部
United States Department of Agriculture (USDA) is a US federal executive
department responsible for developing and executing federal government
policy on farming, agriculture, forestry, and food.
Similar to FDA, one of USDA primary concerns is food safety.
• In addition, USDA is responsible for
• promoting agricultural trade and production
• meeting the needs of farmers and ranchers
• protecting natural resources
• fostering rural communities
• ending hunger in US and abroad

5.
USDA Organization Chart

6.
How FDA and USDA Work Together
• One of the common goals between FDA and USDA is food
safety for the general public.
• Scope of monitoring between two agencies often
complements each other and yet can be very complex.
Example
FDA would regulate chicken feeds while USDA would regulate the facility in
which chickens lay their eggs.
FSIS (Food Safety and Inspection Services) would inspect the meat in the
sausage while FDA would inspect the casing that encloses the meat

7.
Scenario: Importing Mooncake
USDA
• Agriculture Quarantine Inspection will inspect the container.
• APHIS Animal and Plant Health Inspection Services, a division of USDA, requires the importer
to provide veterinary certificate (normally provided by the manufacturer) to attest to the
quality of the egg yolk, if the mooncake should contain egg yolk.
FDA
• An assigned Compliance Officer will review and assess the product based on the nature of
the product as listed in the import documents submitted upon import.
• FDA will review proper declaration of ingredients and nutritional value of the product.
• FDA will may review the naming or description of the product
• If product falls into the category of an import alert, then FDA will detain the product and may
require importer to take additional actions such as laboratory examination.
Failure to meet USDA or FDA guideline will result in re-export or destruction of the product.

8.
FDA – Labeling Review