FDA update – May 16, 2011

Territories covered by FDA Regulations

Interesting, this question, “what territories are regulated by the FDA?”,  recently came up by one of our clients. It took us a little while to finally get an answer from the FDA. Here is what we learned:

United States means the Customs territory of the United States (i.e., the 50 States, the District of Columbia, and the Commonwealth of Puerto Rico), but not the Territories. Sec. 1.276.

The term "State", except as used in the last sentence of section 702(a), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico .

The term "Territory" means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.

The term "interstate commerce" means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.

FDA Regulations Applies to U.S. Territories which are as follows:

  • American Samoa

  • Federated States of Micronesia

  • Guam

  • Midway Islands

  • Northern Mariana Islands

  • Puerto Rico

  • Republic of Palau

  • Republic of the Marshall Islands

  • U.S. Virgin Islands

U.S. Territories under OIA Office of Insular Affairs

  • Palmyra Atoll - Excluded Areas

  • Wake Atoll - Residual Administration

U.S. Territories under U.S. Fish and Wildlife Jurisdiction or Shared with Johnston Atoll Chemical Agent Disposal System (JACADS)

  • Baker Island

  • Howland Island

  • Jarvis Island

  • Johnston Atoll

  • Midway Atoll

  • North Island - JACADS

  • Sand Island

  • Kingman Reef

  • Navassa Island

  • Palmyra Atoll

For more information on Territories covered under FDA you can contact mdi at info@mdiconsultants.com REF: Territories.