Food & Drug Administration
The FDA is responsible for protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled and also ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective.
More info on FDA
FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions. All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. All FDA-regulated products are electronically screened before they enter the U.S.
Products regulated by the FDA are subject to review by the FDA when they are offered for entry into the U.S. The FDA electronically reviews all FDA-regulated entries submitted through the U.S. Customs and Border Protection (CBP). FDA-regulated products imported into the U.S. must comply with all of the FDA’s laws and regulations. The importer is responsible for making sure these products comply with all U.S. requirements. Products which do not comply with U.S. requirements at the time of importation are subject to refusal of admission.
The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. The following is a list of traditionally recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.
In general, FDA regulates:
- Dietary supplements, bottled water, food additives, infant formulas, other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products).
- Prescription drugs (both brand-name and generic) and non-prescription (over-the-counter) drugs.
Medical Devices, including:
- Simple items like tongue depressors and bedpans and complex technologies such as heart pacemakers, also dental devices and surgical implants and prosthetics.
- Color additives found in makeup and other personal care products, from skin moisturizers and cleansers to nail polish and perfume.
- Veterinary Products, including: livestock feeds, pet foods and veterinary drugs and devices.
- Vaccines for human blood and blood products.
- Electronic Products that give off radiation, including: microwave ovens or ultrasonic therapy equipment.
Tobacco Products, including:
- Cigarettes or smokeless tobacco.
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