What is the Food and Drug Administration?

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Definition:

The Food and Drug Administration (FDA) is a government agency that helps protect the public by overseeing the safety and security of particular food, drug, cosmetic, and medical products.

🤔 Understanding the Food and Drug Administration

The Food and Drug Administration (FDA) is a government agency that is responsible for protecting public health. The agency consists of different departments that oversee the safety of particular products for humans and animals. It regulates medicine and medical products, food, cosmetics, and radiation-producing products. It got its start with the passage of the 1906 Pure Food and Drugs Act, which allows the FDA to make sure products are safe and effective before they are marketed to consumers. While not all products need FDA approval before they’re sold, the FDA can step in to regulate products after they’ve hit store shelves if it’s determined that public health is at risk. Most of the money to support FDA programs comes from the federal budget. The rest of the money comes from private funding in the form of user fees, primarily from drug and medical device manufacturers.

Example

If you fall and break your arm, there’s a good chance the doctor will request an x-ray. This way, the doctor can see what kind of fracture you have and determine the best treatment option for you. X-rays are a type of radiation, which can damage DNA and increase your risk of getting cancer. For this reason, the FDA oversees manufacturers of x-ray machines. It helps to make sure you’re not exposed to unnecessary risks while getting an x-ray of your broken arm.

Takeaway

The Food and Drug Administration (FDA) is like a gatekeeper…

A gatekeeper stands guard and controls access, much like the FDA oversees and controls public access to certain foods, medical products, drugs, dietary supplements, and more. If drug manufacturers want to market a new drug to help diabetic patients, for example, they must comply with all rules and regulations from the FDA first. Otherwise, the FDA will protect consumers from possible harm by not letting the medicine through the gate.

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What is the Food and Drug Administration (FDA)?

The US Food and Drug Administration (FDA) was the first consumer protection agency in the United States. The FDA protects the public health by regulating human and veterinary food, medical products, drugs, dietary supplements, cosmetics, and biological products.

As a regulatory authority, it also governs the tobacco industry by providing oversight for the production, marketing, and distribution of tobacco products.

People primarily associate the FDA with products for human consumption, but protecting animal health is part of its responsibility, too. The agency regulates food, additives, drugs, and medical devices for pets.

The FDA is part of the US Department of Health and Human Services. It separates itself into four offices, namely Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. Each office is responsible for a different division of the organization.

Products under FDA regulation account for about 25% of the economy in the United States. As part of its commitment to public safety, the agency routinely collects data from multiple sources, such as patients, health care providers, and product manufacturers. The organization uses the voluntary reports to gauge the effects products can have on public health and deem whether intervention is needed.

Why was the FDA created?

The federal government has had its hand in consumer protections since 1848. Back then, the Agricultural Division in the Patent Office was in charge of collecting, analyzing, and distributing seeds and plants to farmers. There was little to no oversight of the food or drug industry at the time, which sometimes led to the mislabeling of products and questionable food processing practices.

In 1906, a journalist named Upton Sinclair published his book, The Jungle, which exposed unsanitary conditions in the Chicago meat-packing industry. It was this book that led the U.S. to regulate food safety.

The same year, Congress passed the Pure Food and Drugs Act to stop mislabeling and contamination of food and drugs being sold to consumers. The government established the Food and Drug Administration (FDA) to administer the new laws.

However, the agency didn’t have the power to set food standards until 1938. It was then that Congress passed the Food, Drug, and Cosmetic Act following the death of 100 people who died after taking a new but untested drug.

What does the FDA do?

The FDA primarily exists to protect public health. The agency sets conditions that govern the safety and security of products for human and animal consumption. In addition to food, drugs, and medical products, it regulates the tobacco industry.

The FDA aims to reduce tobacco use by minors through strict regulation of the manufacturing, marketing, and distribution of tobacco products.

Ensuring the safety and efficiency of medical products is also the responsibility of the organization. The FDA helps to get medical innovations to market more quickly while ensuring their safe use. It also aims to make products more affordable for consumers.

Initially, the organization focused its efforts on the safety of goods produced and distributed in the U.S. However, increased imports led to the expansion of the FDA’s authority. Global food and health security under the FDA now include items that are imported into and sold in the U.S.

Which products does the FDA regulate?

When you think of the FDA, you can probably guess that they regulate food and drugs based on the agency’s name. And you’re right. They control medicines and dietary supplements, and about 77% of the food you eat. The exceptions are meat, poultry, and egg products, which the US Department of Agriculture (USDA) regulates.

The agency’s reach stretches far beyond simple food and drugs to include food additives, prescription and over-the-counter medications, human blood products, first aid kits, cosmetics, animal food, veterinary drugs, tobacco, and radiation-emitting products.

The products the FDA oversees can be broken down like this:

  • Devices: 48%
  • Human foods: 31%
  • Housewares and food-related: 8%
  • Cosmetics: 6%
  • Radiological health: 3%
  • Drugs and biologics: 2%
  • Animal feed: 1%
  • Tobacco products: less than 1%

What does FDA approval mean?

FDA approval means the items can demonstrate that they are safe and effective and that the benefits outweigh the risks.

Contrary to what you may have thought, the FDA does not have to approve all products before they’re distributed and sold. Infant formula, dietary supplements, and cosmetics, such as perfume, makeup, shampoo, and skin cleansers, are some of the products that do not require FDA approval. However, the agency can step in to regulate them as needed after they’re already for sale.

Some products, including new drugs and some medical devices, require approval before they can be marketed and sold. In addition to getting FDA approval, goods can also be FDA cleared. While approval requires an in-depth review process, a product can get FDA clearance if it’s similar to another item already being marketed.

When it comes to pharmaceutical drugs, FDA approved does not mean the agency has done clinical trials of the medication. The company asking for approval is responsible for laboratory and other testing to ensure a product is safe and effective, and the FDA reviews the results of the testing.

Over-the-counter medications generally have even lower standards. Companies can often make and market these kinds of medicines without pre-approval as long as they follow preset FDA specifications.

How is the FDA funded?

In 2019, the FDA budget was $5.7 billion. The funding comes from two sources: Federal funding and industry fees. Federal funding from the Treasury’s General Fund provides 55% of the money the agency needs, while the remaining 45% comes from user fees paid by companies seeking the approval of medical drugs and devices.

Under the Prescription Drug User Fee Act (PDUFA), there are user fees for approval of new drugs or certain biological products. Congress added user fees to other items, in addition to the ones required under the PDUFA — Companies seeking approval of medical devices, animal drugs, tobacco products, and food recalls, among other items, must also pay user fees.

The FDA anticipated more than $1 billion in funding to come from fees under the PDUFA in fiscal year 2019. While the prescription drug industry covered the largest percentage of collections, the tobacco industry and generic drug industry closely followed, with $712 million and $502 million, respectively. Other money comes from medical devices, animal drugs, generic drugs, mammography, color additives, and more.

Why do we need the FDA?

Before the FDA, people and companies could market products without regard for truth, safety, or effectiveness. Companies were selling new drugs to consumers that were potentially harmful and sometimes deadly.

The FDA requires companies and products to follow specific standards and regulations to protect public health. The FDA keeps the food and drug supply safe for people and veterinary animals in the U.S.

Without the agency, life-saving medications and vaccines might not be available, or they might not be as safe and effective as they are. The nation’s food supply could also be in jeopardy without the FDA’s focus on preventing foodborne illness.

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