U.S. Food and Drug Administration (FDA)
Established in 1906 as a result of the Federal Food, Drug, and Cosmetic Act , the FDA is responsible for ensuring that the following products are safe: food, human and veterinary products, biologic products, medical devices, cosmetics, and electronic products. The FDA is also responsible for ensuring that product information is accurate. The following is a summary of FDA responsibility for each category:
1. Food: The FDA ensures that food labeling contains accurate information. Also, the FDA regulates the safety of all food except poultry and meat and oversees bottled water, dietary supplements, infant formulas, and food additives.
2. Veterinary products: The FDA has oversight of the production of livestock feed, pet food, and veterinary drugs and devices.
3. Human drugs: The FDA has regulatory oversight of both prescription and over-the-counter (OTC) drug development and labeling, which includes the manufacturing standards for these drug products.
4. Biologics: The FDA has oversight of vaccines, blood and blood products, cellular and gene therapy products, tissue and tissue products, and allergenics.
5. Medical devices: The FDA has authority for premarket approval for any new devices, as well as developing standards for their manufacturing and performance, and also must track reports of any malfunction of these devices. The FDA has oversight of dental devices.
6. Cosmetics: The FDA oversees both the safety and labeling of cosmetic products.
7. Electronic products: The FDA develops and regulate standards for microwaves, television receivers, and diagnostic equipment such as X-ray equipment, laser products, ultrasonic therapy equipment, and sunlamps. It also must accredit and inspect any mammography facilities.
8. Tobacco products: Cigarettes, cigarette tobacco, roll your own tobacco, and smokeless tobacco. The FDA regulates the manufacture, distribution and marketing of all tobacco products. Starting in August 2016, the FDA will begin to apply and enforce key provisions of the Family Smoking Prevention and Tobacco Control Act as it relates to the sale, marketing, and manufacturing of e-cigarettes.
The FDA is also responsible for advancing public health by speeding up innovations to make medicine and food more effective, safer, and more affordable. It is also responsible for ensuring that the public receives accurate information to be able to make informed decisions about using medicine and food products. The FDA also plays a significant role in the nation’s counterterrorism capability. The FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats ( USFDA, 2016 ).