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US-FDA

FDA, Food and Drug Administration of U.S., is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. 

Finally, FDA plays a significant role in the Nation’s counterterrorism capability. 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.

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. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. 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:

Foods, including:

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)

Drugs, including:

Prescription drugs (both brand-name and generic)

Non-prescription (over-the-counter) drugs

Biologics, including:

Vaccines

Blood and blood products

Cellular and gene therapy products

Tissue and tissue products

Allergenics

Medical Devices, including:

Simple items like tongue depressors and bedpans

Complex technologies such as heart pacemakers

Dental devices

Surgical implants and prosthetics

Electronic Products that give off 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 feeds

Pet foods

Veterinary drugs and devices

Tobacco Products, including:

Cigarettes

Cigarette tobacco

Roll-your-own tobacco

Smokeless tobacco

Advertising

The Federal Trade Commission is a federal agency that regulates many types of advertising. The FTC protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace.

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.

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.

Drugs of Abuse

The Department of Justice’s Drug Enforcement Administration (DEA) works to enforce the controlled substances laws and regulations of the United States, including as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances.

Meat and Poultry

The U.S. Department of Agriculture's Food Safety and Inspection Service regulates aspects of the safety and labeling of traditional (non-game) meats, poultry, and certain egg products.

Pesticides

The Environmental Protection Agency (EPA) regulates many aspects of pesticides. EPA sets limits on how much of a pesticide may be used on food during growing and processing, and how much can remain on the food you buy.

Vaccines for Animal Diseases

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), Center for Veterinary Biologics, regulates aspects of veterinary vaccines and other types of veterinary biologics.

Water

The Environmental Protection Agency (EPA) regulates aspects of drinking water. EPA develops national standards for drinking water from municipal water supplies (tap water) to limit the levels of impurities.

Why Jiushun Management?

Jiushun Management, focused on Medical Device Registration, Certification for 20 years, provided high quality service for more than 5,000 global customers.

The MD industry focus degrees, regulatory familiarity, and rich experience, determine our high efficiency and professionalism.

Our professional technical support, from the early regulations, processes guidance, documentation preparation, to testing assistance, review tracking, as well as years of MD industry resource integration, will greatly shorten the period of your product approval, and well practice our principle "Jiushun Management, create value for you. ".