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U.S. Food and Drug Administration

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For over 100 years, the United States Food and Drug Administration has been protecting American consumers by enforcing several public health laws, primarily the Federal Food, Drug and Cosmetic Act. With approximately 9,000 employees, the FDA monitors nearly $1 trillion worth of products in the categories of food, drugs, biological products, veterinary medicines and cosmetics.1 The FDA also publishes the Model Food Code, which state and local health departments use as a guide to draft their own laws and regulations to monitor food service establishments.

What the FDA Regulates
The FDA Model Food Code

Beginning in 1993, the FDA began publishing a Food Code to assist food regulators at all levels of the government. The Food Code’s purpose is to provide a scientifically sound technical and legal basis with which to regulate the retail food service industry. As of 2007, 51 of the 56 States and territories that fall under FDA jurisdiction have adopted one of the five versions of the code.2

The FDA has a team of investigators that inspect more than 15,000 facilities each year and collect more than 80,000 domestic and imported samples that are sent to a laboratory and tested for safety.3 The following list highlights the specific product categories regulated by the FDA:

 

  • Biologics. Biologics include the nation’s blood and human tissue supply. The FDA researches and monitors existing standards and works to improve testing methods.
  • Cosmetics. Cosmetic supplies are tested for safety and to assure products are labeled correctly.
  • Drugs. The FDA tests both over the counter and prescription drugs for effectiveness and safety. It also monitors high quality standards for drug manufacturers.
  • Foods. All domestic and imported foods - excluding meat, poultry and eggs – are inspected for both safety and correct labeling. The FDA also regulates bottled water.
  • Medical Devices. New devices are inspected and must achieve FDA approval before entering the market. The agency also tracks reports of malfunctions or serious adverse effects.
  • Radiation-Emitting Electronic Products. X-ray equipment and microwaves are two products regulated to ensure they do not subject users to levels of radiation that cause harm.
  • Veterinary Products. Livestock feed, pet food and veterinary drugs and tools are regulated by the FDA for both safety and effectiveness.

 

CFSAN
Regulating Food and Product Safety 4

The CFSAN monitors product safety from their processing facility all the way to the point of sale. As of 2001, the center was responsible for:

  • $240 billion worth of domestic food.
  • $15 billion worth of imported foods.
  • $15 billion worth of cosmetics sold across state lines.

The Center for Food Safety and Applied Nutrition is the department within the Food and Drug Administration that is responsible for monitoring all of America’s cosmetics and 80% of the food supply.5 The CFSAN regulates all food products except meat, poultry and eggs; those are regulated by the USDA. » Learn More

The CFSAN employs more than 800 people in scientific and academic disciplines including chemists, microbiologists, nutritionists and mathematicians.6 By conducting research and providing guidance to lawmakers, the CFSAN team helps provide a safe American food supply. Their duties include the following:

  • Conducting inspections. All establishments that produce, distribute or handle food that is regulated by the FDA are regularly inspected to assure compliance with local health regulations.
  • Monitoring imports. All foods that enter this country are subject to American food safety standards. Any products found to be sub-standard are rejected at the boarder.
  • Premarket review. Just as a new car must pass a safety inspection before release, all food additives are scrutinized for safety before they are made available for human consumption.
  • Consumer focus groups. Before new products are approved for human consumption, like a new food additive, consumers are given the opportunity to voice their opinion about the possible benefits/dangers of the new product.
  • Outreach and education. The CFSAN regularly releases reports to inform the public not only of current recalls, but of new foods or additives entering the market.
Other FDA Departments
The FDA’s Limited Recall Authority

The FDA only has the authority to order recalls on infant formula, medical devices and human tissue products. But they can also request that a company recall other products, like food, drugs and cosmetics, if tainted products are found.

In addition to the CFSAN, the FDA has five other departments that play crucial roles to ensure that products on the market for American consumers are among the safest in the world.

  • Center for Biologics Evaluation and Research (CBER). The CBER regulates biological-related products like blood, vaccines, allergenics, tissues and cellular and gene therapy.
  • Center for Devices and Radiological Health (CDRH). The CDRH ensures the safety and effectiveness of medical devices and minimizes unnecessary human exposure to forms of radiation generated by medical and consumer products. For example, CDRH regulates commercial microwave ovens to ensure that the radiation they emit does not pose a threat to human health.
  • Center for Drug Evaluation and Research (CDER). The CDER ensures that safe and effective drugs are available for human use. The center also regulates infant formula.
  • National Center for Toxicological Research (NTCR). The NTCR conducts peer-reviewed scientific research to determine the toxicity of FDA-regulated products and develops methods to better assess how those products affect human health.
  • Office of Regulatory Affairs (ORA). The ORA works to maximize compliance with FDA regulations and minimize the risk associated with FDA-regulated products.
1 U.S. Food and Drug Administration, “Overview of the Food and Drug Administration,” http://www.cfsan.fda.gov/fdaoview.html (accessed October 26, 2008).
2 U.S. Food and Drug Administration, “Real Progress in Food Code Adoptions,” http://www.cfsan.fda.gov/~ear/fcadopt.html#adopt (accessed October 28, 2008).
3 U.S. Food and Drug Administration, “Overview of the Food and Drug Administration,” http://www.cfsan.fda.gov/fdaoview.html (accessed October 26, 2008).
4 U.S. Food and Drug Administration, “Center for Food Safety and Applied Nutrition,” http://www.cfsan.fda.gov/~lrd/cfsan4.html (accessed October 26, 2008).
5 U.S. Food and Drug Administration, “FDA 2006 Accomplishments: Advances in Protection of Food, Animal Feed and Drugs, Product Integrity and Scientific Research,” http://www.fda.gov/oc/accomplishments/protection.html (accessed October 26, 2008).
6 U.S. Food and Drug Administration, “Center for Food Safety and Applied Nutrition,” http://www.cfsan.fda.gov/~lrd/cfsan4.html (accessed October 26, 2008).

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