The FDA ( Food and Drug Administration ) is the United States government agency responsible for regulating food, medicines (human and veterinary), cosmetics, biological medicines ( including blood derivatives ) and vaccines, among others.
FDA Roles and Responsibilities
- Protect public health by regulating medicines for human and veterinary use, vaccines and other biological medicines , medical devices, in the United States , cosmetics, and products that emit radiation.
- Promote public health by promoting innovation
- Provide the public with the necessary, accurate, scientifically-based information that allows them to use medicines, health products and food (new foods or new forms of production) safely and effectively .
- It also has the responsibility of regulating the manufacture, sale and distribution of tobacco, to protect public health and reduce its consumption by minors .
- As can be seen, the scope as a regulatory EU Authorized Representative of the FDA is very broad, and they are related to those of various government agencies.
In general, the FDA regulates:
- Foods, including: dietary supplements , bottled water , food additives , infant formula , other food products (although the US Department of Agriculture plays a major role in regulating some aspects of some meat, poultry, and egg products )
- Drugs , including: prescription drugs ( both brand and generic) ; non-prescription (over the counter) medicines ,
- Biological Drugs including: human vaccines , blood and blood products , cell and gene therapy products , tissues and tissue products , allergens .
- Medical devices, including: simple items like tongue depressors and urinals , complex technologies like cardiac pacemakers , dental devices , surgical implants , and prosthetics
- Electronic products that emit radiation, including: microwave ovens , x-ray equipment , laser products , ultrasonic therapy equipment , mercury vapor lamps , sunlamps .
- Cosmetics, including: color additives found in makeup and other personal care products , skin moisturizers and cleansers , nail polish, and perfume
- Veterinary products, including: livestock feed , pet food , veterinary drugs and devices
- Tobacco products, including: cigarettes , cigarette tobacco , roll -your-own tobacco , smokeless tobacco
FDA 's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guama, the Virgin Islands, American Samoa, and other United States territories and possessions.
What does it mean for a product to be FDA approved?
The FDA is responsible for protecting the public health by regulating drugs , including biological drugs for humans , drugs for animals, medical devices, tobacco products, food (including animal feed), cosmetics, and radiation-emitting electronics.
Sure we have heard many times about FDA approval , but we have to know that not all products undergo pre-market approval, that is, a review of safety and efficacy by experts . FDA and agency approval before a product can be placed on the market.
In some cases, FDA compliance efforts focus on products after they are already on the market . That is determined by the United States Congress, establishing the authority of the FDA. Even when FDA approval is not required , before a product is sold, the agency has regulatory authority to act when safety concerns arise.
The FDA does not “ approve ” companies, facilities, laboratories , manufacturers, or health care facilities . It does have the authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations.
In this post we are going to focus on medical devices, or health products, and medicines :
The FDA approves new drugs and so-called biologic drugs .
New drugs and certain biologic drugs must be proven safe and effective by the FDA before companies can market them in the United States .
Some examples of biologic drugs that require approval are : therapeutic proteins, vaccines, cell therapies, and blood and blood products. Manufacturers must also show that they can make the drug according to federal quality standards.
The FDA does not develop or test products before approving them. However , FDA experts review the results of Clinical evaluation laboratory, animal, and human tests conducted by manufacturers. If the FDA grants an approval , it means that the agency has determined that the benefits of the product outweigh the known risks for its intended use.