U.S. Food and Drug Administration (FDA) - Definiton

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Definition:

The U.S. Food and Drug Administration (FDA) is often cross-associated with various organic products but is not an organic organization.

What the FDA is responsible for is protecting public health. They attempt to assure and regulate the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the United States food supply, cosmetics, and products that emit radiation.

Furthermore, the FDA tries to help improve public health by using their clout and resources to speed up medical innovations and post information for the public that relates their opinions on and of accurate, science-based information surrounding medicines and foods.

What does the FDA regulate?

  • Safety of all food products
  • Food labeling
  • Bottled water
  • Food additives
  • Infant formulas
  • Dietary supplements
  • Human drugs
  • Product approvals
  • OTC and prescription drug labeling
  • Drug manufacturing standards
  • Medical devices from the simple to complex, i.e. tongue depressors to pacemakers.
  • Premarket approval of new medical devices
  • Manufacturing and performance standards of medical devices
  • Reports of device malfunctioning and serious adverse reactions
  • Electronic products that give off radiation, such as microwave ovens and X-ray equipment
  • Ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
  • Mammography facilities
  • Cosmetic safety and labeling
  • Veterinary products including livestock feed, pet food and veterinary drugs and devices
  • Tobacco products

The FDA does not regulate:

  • Advertising of products that are not prescription drugs, medical devices or tobacco products
  • Alcoholic beverages
  • Consumer products, such as paint, child-resistant packages, baby toys, and household appliances, unless the product gives off radiation
  • Illegal drugs such as heroin and marijuana
  • Health insurance
  • Restaurants and grocery stores
  • Vaccines for infectious animal diseases

When do the FDA and National Organic Program (NOP) cross paths?

Often FDA pops up when discussing organics and it can be confusing because not only does the FDA not regulate organic certification or labeling, but they're not huge organic supporters. In fact, they state quite clearly on their website (in numerous areas) that organic products are no better or safer than any other products.

In most cases, when the FDA and NOP cross paths, it has to do with organic body care, cosmetics and other personal care items that may be labeled as organic because the FDA does regulate cosmetics. That said, the FDA regulates cosmetics under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) not under NOP policy or standards. FD&C Act and FPLA do not define the term “organic, ” so neither does the FDA.

If a cosmetic is labeled as organic, and thus regulated by NOP, it is still subject to any cosmetic laws and regulations enforced by the FDA. Meaning, any cosmetic products labeled with organic claims must comply with both NOP organic certification rules and FDA regulations for labeling and safety requirements for cosmetics.

Another area of confusion regarding FDA vs. NOP is food. The FDA does indeed regulate food safety and various meats (for example, game meats like venison, ostrich, and snake). However, the FDA does not regulate basic meat products, which are regulated by the U.S. Department of Agriculture or organic livestock products which are duel-regulated by the U.S. Department of Agriculture and NOP.

The FDA also does not regulate any organic food labeling issues, though they do regulate other food labeling issues so any food products labeled with organic claims must comply with both USDA organic rules and FDA food labeling regulations.