What Does FDA Regulate?
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.(including)
Foods
- Dietary supplements
- Bottled water
- Food additives
- Infant formulas
- Other food products.
Drugs
- Prescription drugs (both brand-name and generic)
- Non-prescription (over-the-counter) drugs
Biologics
- Vaccines for humans
- Blood and blood products
- Cellular and gene therapy products
- Tissue and tissue products
- Allergenics
Medical Devices
- Simple items like tongue depressors and bedpans
- Complex technologies such as heart pacemakers
- Dental devices
- Surgical implants and prosthetics
Cosmetics
- Color additives found in makeup and other ✓Personal care products
- Skin moisturizers and cleansers
- Nail polish and perfume
Veterinary Products
- Livestock feeds
- Pet foods
- Veterinary drugs and devices
Tobacco Products
- Cigarettes
- Cigarette tobacco
- Roll-your-own tobacco
- Smokeless tobacco
- Cigars
- Hookah
- E-cigarettes (tobacco and non-tobacco derived nicotine)
The following are for government agencies that have functions related to that of FDA:
1. Alcohol
The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB), regulates aspects of alcohol production, importation, wholesale distribution, labeling, and advertising.
2. Consumer Products
The Consumer Product Safety Commission (CPSC), works to ensure the safety of consumer products such as toys, cribs, power tools, cigarette lighters, household chemicals, and other products that pose a fire, electrical, chemical or mechanical hazard.
3. Drugs of Abuse
The Department of Justice’s Drug Enforcement Administration (DEA).
4. Meat and Poultry
The U.S. Department of Agriculture’s Food Safety and Inspection Service
5. Pesticides
The Environmental Protection Agency (EPA)
6. Vaccines for Animal Diseases
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS),
7. Water
The Environmental Protection Agency (EPA)
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Resource Person: Dr.Prasadhi Shiva
