5 Industries Regulated by the FDA

5 Industries Regulated by the FDA

The Food and Drug Administration (FDA) is the U.S. government agency that, according to its mission, “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

To fulfill this mission, the agency regulates several major industries that produce consumer products critical to public health and safety. If the products do not meet certain quality standards, they have the potential to be harmful to the public. The FDA regulates each of these industries differently, with different approvals and oversight based on the uses and effects of the products. They also regulate products differently within each industry.

The main industries that the FDA has a hand in regulating include the food, drug, vaccines, blood, and biologics, medical device, and cosmetics industries. Here, we will take a look at each of these industries and discuss the role the FDA plays in regulating them.

Food

The U.S. food industry, which includes both retail and out-of-home consumption sectors, is a $6.2 trillion industry. It is the largest industry regulated by the FDA and the one that basically every person in the country interacts with. More than 250 food borne illnesses can sicken people, so regulating this industry is critical.

The FDA oversees many aspects of the food industry that govern the entire process from the creation of food to the time it reaches your table. They regulate things like:

They also set the guidelines for Current Good Manufacturing Practices (CGMPs). These practices govern all aspects of production of food. This runs the gamut from personal hygiene practices to food plant design, construction, equipment, and maintenance to facility sanitation to production processes, and more.

Drugs

The second main industry that the FDA regulates is the drug industry. Obviously, pharmaceutical drugs can be incredibly dangerous and can do great public harm if they do not conform to the highest standards–the 1960s-era thalidomide tragedy is evidence of that. In addition to safety, the FDA also helps ensure that pharmaceutical drugs are effective as well. A drug that doesn’t work for its intended purpose can be just as dangerous to people in certain situations than one that is overtly unsafe.

The drug lifecycle has several distinct stages and each is regulated by the FDA in different ways. The agency oversees the entire creation process from initial research and science through the manufacturing and testing phases. Once the testing stage is passed, it is up to the FDA to approve each drug for its intended uses. After the drug is available to the public, the FDA helps regulate the drug’s availability and is responsible for maintaining all the needed information and warnings for the public.

Vaccines, Blood, And Biologics

Once a lesser-known aspect of what the FDA does, their oversight of the vaccines, blood, and biologics sector jumped into the public consciousness in 2020 with the race for a COVID-19 vaccine. In addition to vaccines, this division of the FDA is responsible for:

Developing a vaccine usually takes years, and the FDA approval process often takes several years beyond that. In 2020, both those processes were significantly but safely hastened because of the desperate need for a COVID-19 vaccine. Even in this unprecedented situation, the FDA still ensures that the vaccines are both safe and effective before approving them. To do this, FDA commissioner Stephen Hahn recently noted that although the process needs to move much faster than normal, it will remain “transparent and guided by data.”

Medical Devices

The medical device industry is a $400 billion-plus industry that is growing at a very fast rate in the 21st century. The industry encompasses everything from simple examination gloves to COVID test kits to complicated machinery such as ventilators and pacemakers. The FDA is responsible for regulating the quality assurance process of creating these machines as well as their use afterward.

While much of the regulation of the creation process in the past revolved around manufacturing, that has shifted in recent years. The advent of new technology such as software as a medical sevice (SaMD) has increased the importance of the FDA regulating digital healthcare as well as physical devices. To deal with this emerging industry, the FDA created the Digital Health Center of Excellence. To learn more about these types of medical devices and how they are revolutionizing this industry, Orthogonal’s guide to SaMD has some helpful info on software as a medical device.

Cosmetics

One industry you may not think of in the FDA’s portfolio is the cosmetics industry. These products do go on the skin and can be absorbed into the body so though so it is important that they are regulated. The FDA regulates the cosmetics industry but does not approve cosmetic products before they come on the market as it does drugs or vaccines. It does, however, approve most color additives that go into cosmetics.

The FDA regulations in the cosmetics industry mostly involve proper labeling of cosmetic products. If a product misrepresents itself on the label or is unsafe when used according to the directions on the packaging, the FDA can take action against the cosmetics company or even recall the product.

The FDA plays a very important role in keeping the public safe. Its regulation of the food, drug, vaccine, blood, and biologics, medical devices, and cosmetics industry can help consumers feel comfortable that the products they buy are safe. This is important for both public health and safety as well as overall consumer confidence.