HHS—Food and Drug Administration

www.fda.gov

About the Food and Drug Administration

The Food and Drug Administration is part of the Department of Health and Human Services. The FDA regulates human and animal drugs, including over the counter medications and oversees some foods and food ingredients, blood supplies, cosmetics, and medical devices. Altogether, it regulates about $1 trillion annually worth of products.

How much the FDA regulates each of those products varies. Drug companies, for example, have to prove that the drugs are safe and effective before they can be sold, a process that can take years but is speeded up for drugs considered urgently needed. Food companies can market their products immediately, and the FDA just regulates food safety for products sold in interstate commerce. (It does not regulate meat and poultry. This is the job of the USDA.)

It also regulates labeling for all of the products it oversees. It has limited power over dietary supplements, and can only take those off the market when it can prove they are dangerous. And it can't require food or cosmetic recalls, instead asking for voluntary recalls by the manufacturer. The FDA inspects cosmetics manufacturing facilities and collects samples. If a product is misbranded, FDA can ask the Department of Justice to remove it from the market.

The FDA employs about 10,000 people and has more than 160 field offices around the country. FDA employees in those offices conduct local inspections; do lab work, and also some public education. The Washington, D.C. and Maryland offices are where regulations are set, reviewed and enforced, and where new products are evaluated.

Resources for Regional Stories

There are seven major divisions within FDA. They all have their own websites within the fda.gov website. Probably the most important for reporters is the Center for Drug Evaluation and Research. That's the arm that evaluates and approves new drugs. Its website has information on all drug approvals and updates on drugs that have had to issue additional warnings because of problems. There are also dates of meetings of the advisory committees. These committee meetings can give you insight into some of the issues the FDA is looking at, and potential problems with a drug: http://www.fda.gov/cder/index.html.

The Office of Regulatory Affairs is the arm that oversees inspections of imported foods and cosmetics. It also supervises the labs that test products. There are regional offices throughout the country. If you want to find out about local recalls or other regional issues, contacts for your region can be found here: http://www.fda.gov/ora/about/default.htm.

The FDA also handles outbreaks of food-related illnesses for the foods it regulates (everything but meat, poultry and pasteurized eggs). Those regional contacts linked above can help here. There is also an emergency contact available 24 hours a day. The Division of Emergency and Investigational Operations is at 301-443-1240.

One place to look for regional stories is the warning letters that the FDA sends out to companies telling them that they are potentially in violation of FDA rules. If you click on the link to search by issuing office, you can narrow it down to some pretty specific cities: http://www.fda.gov/foi/warning.htm.

Information on recalls and safety alerts can be found here (the data includes the location of the recall, so there can be good regional stories): http://www.fda.gov/opacom/7alerts.html and a list of all recalls is here: http://www.fda.gov/opacom/Enforce.html:

There are a number of email lists you can get on to receive updates, depending on your level of interest: http://www.fda.gov/emaillist.html.

Additional press contacts listed by subject area at: http://www.fda.gov/opacom/moremedia.html#phone

Does this agency's information need updating? programs@nationalpress.org