You may be like many people and wonder what does the FDA do. The United States Food and Drug Administration (USFDA or FDA) is a federal agency responsible for ensuring public health by controlling and supervising things such as electromagnetic radiation emitting devices (ERED), food safety, medical devices, tobacco products, over-the-counter pharmaceutical drug, dietary supplements, medical devices, prescriptions, veterinary products, cosmetics as well as animal foods, feed and more.

Law Enforcement

One of the main responsibilities of the FDA is its enforcement of federal laws. It also is responsible for enforcing a variety of laws such as Section 361 of the Public Service Act. This is designed to stop the entry and spread of communicable diseases between states as well as their entry from foreign countries. The FDA also enforces many other similar regulations.

Published Standards

The FDA uses a published set of standards for products it is responsible for regulating. Conducting facility inspections is an effective method used by the FDA for enforcing these published standards. Determining the potential risk of a product is part of the regulatory powers given to the FDA. This agency is responsible for regulating all aspects of prescription drugs including safety, testing, efficacy, labeling, marketing, and advertising. It is also responsible for regulating the safety and labeling of cosmetics and more.

Regulatory Shaming

An effective tactic used by the FDA is known as regulatory shaming. This involves the FDA publishing online warning letters known as shaming lists concerning companies that are in non-compliance with federal regulations. This is designed to appeal to the sensitivity of firms that want to avoid damaging their reputation.

Food and Dietary Supplements

There are various statutes passed into law by the United States Congress. They determine the regulation of dietary supplements as well as food to be monitored by the FDA and more. The FDA has the responsibility of interpreting the statutes enacted by Congress. The FDA has the legal authority to determine the quality level of substances made available as food in the United States. This agency is responsible for overseeing all claims made concerning the health benefits as well as the composition of food. The FDA is also responsible for making certain distributors and manufacturers of dietary ingredients and dietary supplements meet all necessary federal requirements.

Food Processing

The applied coatings utilized in the food processing industry do not need to have approval from the FDA. The agency does not test or inspect materials such as the composition of nonstick coatings and more. The FDA does provide a set of regulations that must be followed covering the use of nonstick coatings as well as their formulation and manufacturing. These materials are not able to be considered approved by the FDA. They can be labeled as FDA acceptable or FDA compliant.\

New Medications

Utilizing a process known as new drug application (NDA), the FDA puts new drugs through intense scrutiny. All over-the-counter drugs must first be approved by the NDA process. When these drugs are approved by the FDA, they can then claim to be “safe and effective when used as directed”. New medications are required to go through a multi-step approval process. It involves testing in controlled clinical trials and more. As a new drug moves from state 1 to stage III, more individuals are added to the studies, and they become longer and more involved. The approval process can take years. It can involve clinics, drug companies, hospitals, government laboratories, medical schools, and more.

Cosmetics

This industry is regulated by a branch of the FDA known as the Center for Food Safety and Applied Nutrition (CFSAN). Unless a cosmetic company makes claims about their product’s structure or function, they are not required to have premarket approval by the FDA. The FDA must approve all color additives before a company can include them in any cosmetic product sold in the United States. Cosmetic labeling is regulated by the FDA. Should a cosmetic product not be safety tested, it must have a warning stating it. If it becomes necessary to protect the public, the FDA will intervene in cosmetic premarket testing or approval.

FDA Expert Witnesses

These are professionals who have decades of experience in their industry. They are experienced in many different state public health programs. These professionals are also knowledgeable about state regulations and compliance. An FDA expert witness can help determine the efficacy and safety of a product. They can also determine if regulations and FDA guidelines have been properly followed. Many of the FDA expert witnesses consist of former FDA officials, former FDA reviewers, former FDA investigators as well as an FDA drug expert, and others.

The FDA is responsible for providing services to all 50 United States. Their responsibilities extend to American Samoa, District of Columbia, Virgin Islands, Puerto Rico, Guam, and all U.S. possessions and territories. The answer to the question of what does the FDA do is simple: they protect public health by assuring products intended for use by humans are safe, properly labeled, effective and more.

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