What Does the FDA Do? 

The U.S. Food and Drug Administration, commonly known as the FDA, is tasked with ensuring the safety of nearly all of the country’s food, medical and cosmetic products before they reach consumers. Together with the USDA, the FDA oversees the food system in order to protect public health.

What Is the FDA?

The FDA is dedicated to ensuring public health by monitoring the safety and reliability of drugs and other medical products, as well as the safety of cosmetics and foods. While this is the most widely known focus of the agency, the FDA also oversees products emitting radiation or containing tobacco and disseminates health information, among other responsibilities. 

Is the FDA a Government Agency?

The FDA is a federal government agency that falls under the U.S. Department of Health and Human Services, which includes a total of 12 divisions. Other well-known arms of HHS include the Centers for Disease Control (CDC) and the National Institutes of Health (NIH).

What Does “FDA” Stand For?

Many of us know the FDA by its acronym, which is widely used by the media and the agency itself. However, its full name is the U.S. Food and Drug Administration.

Why Was the FDA Created?

The FDA states that its roots trace back to the Patent Office’s Agricultural Division, created in 1848, but the agency’s formal founding in June 1906 was intended to establish a government body that could enforce the Pure Food and Drug Act of that same year.

The FDA’s purpose was to ensure formal regulation of products once typically made by citizens themselves, especially as these products became increasingly manufactured at an industrial scale. The 1938 Food, Drug, and Cosmetic Act widened the FDA’s regulatory powers, partly by putting factory inspections and cosmetic product approval under its authority.

How Does the FDA Regulate Food?

The FDA reviews and approves foods or their ingredients before or after they reach the market. While most of the food we consume in the U.S. goes through some aspect of FDA oversight, foodborne illness remains a significant problem and the agency’s performance has recently come under scrutiny.

A December 2022 report, issued in the wake of a dangerous nationwide baby formula shortage, stated that there had been “missteps,” and that a lack of “communication and engagement” across the different parts of the agency had limited “critical thinking and proactive decision-making.” 

Further, the report concluded that despite one of the FDA’s main purposes being to protect the nation’s food supply, 46 million Americans suffer from foodborne illnesses annually and 3,000 die. This comes at an economic cost of $90 billion per year. “A significant proportion of foodborne illnesses are attributed to FDA-regulated products,” the authors write.

Laws and Regulations

The FDA establishes rules under the Food, Drug, and Cosmetic Act, and the agency states that its “regulations have the full force of law.”

Product Approval

The FDA reviews testing done by companies to determine the safety of food additives. The agency collects and examines food samples to verify that listed ingredient content is correct and that there is no contamination. It may study samples of the environment in which food is produced as well.

In some cases, the agency may consider a product when it is already being sold to consumers rather than before it reaches the market, and the agency states that, “Even when FDA approval is not required before a product is sold, the agency has legal regulatory authority to act when safety issues arise.”

While the FDA does not review finished nutrition labels, the agency does mandate what information is required on such labeling, including total fat (as well as saturated and trans fat content), sodium, cholesterol, carbohydrates and more.

Recalls

While recalls are often voluntarily conducted by manufacturers, others are mandated by the FDA when a product is deemed unsafe or in violation of the agency’s rules. The FDA may recall any food except most meat, poultry and finished egg products, which would be handled by the USDA.

Foods may be recalled due to contamination with substances or harmful levels of bacteria, while others may have packaging defects or contain foreign objects like metal. Some violations, the FDA states, are addressed and then the product is reintroduced to the market.

Recalls are publicly listed by the FDA weekly, and consumers can choose to receive alerts. The public can also report foods they believe have sickened them to the FDA.

Rulemaking

As is the case with other government agencies, the FDA publishes proposed regulations in the Federal Register, to alert the public and to offer the opportunity to comment.

Following the public comment period, the FDA comes to a decision as to any further action. Resulting final rules may be reviewed by the Department of Health and Human Services or other agencies, and are also published in the Federal Register.

What Is GRAS?

The acronym GRAS stands for Generally Recognized as Safe. The term comes from the Federal Food, Drug, and Cosmetic Act and refers to a food additive or ingredient already widely seen by experts as proven safe.

A substance can be accepted as GRAS either through scientific evidence or common experience. The scientific standards required are the same as those for recognizing a new food additive, but regulators recognize a substance as GRAS when it has “a substantial history” of consumption as food among “a substantial number of consumers.”

In some cases, the FDA may prohibit an ingredient that was once generally considered safe. For example, in 2015 the FDA took steps to ban artificial trans fats — which can elevate bad cholesterol levels and raise the risk of heart disease, allowing producers several years to eliminate the fats from their product lines.

How Is the FDA Organized?

The FDA, which underwent a reorganization in March of 2019, is led by the Office of the Commissioner. The Commissioner is supported in running the agency by the Executive Secretariat, the Counselor to the Commissioner and the Chief Information Officer, as well as the Chief Counsel, who reports directly to the HSS General Counsel. The Commissioner oversees eight centers dedicated to various functions of the agency:

• Center for Biologics Evaluation and Research
• Center for Devices and Radiological Health
• Center for Drug Evaluation and Research
• Center for Food Safety and Applied Nutrition 
• Center for Tobacco Products
• Center for Veterinary Medicine
• Oncology Center of Excellence
• National Center for Toxicological Research (unlike the other centers, this falls outside of the Washington metropolitan area and is overseen by the Office of the Chief Scientist)

The following subdivisions also report to the Office of the Commissioner:

• Office of Regulatory Affairs
• Office of Clinical Policy and Programs
• Office of External Affairs
• Office of Food Policy and Response
• Office of Minority Health and Health Equity
• Office of Operations
• Office of Policy, Legislation and International Affairs
• Office of the Chief Scientist
• Office of Women’s Health

How Does It Fit With Other U.S. Food and Health Agencies?

While the USDA regulates many aspects of agriculture, the FDA is responsible for overseeing at least 80 percent of our national food production — including dairy, seafood (except catfish, handled by the USDA), whole eggs and processed produce (when raw, fruit and vegetables are monitored by the USDA).

Furthermore, not all meat falls under the purview of the USDA, which regulates beef, lamb, pork and poultry. The FDA is responsible for all other meats, including “exotic meat” from hunted animals, such as venison (deer) or boar.

The distinction between the two agencies may be confusing to the average consumer. Whether a product falls under the control of the USDA or the FDA can come down to seemingly minute details such as the percentage of raw or cooked meat it contains or even whether it is a closed- or open-faced sandwich.

In addition to these products, the FDA also oversees baby formula, bottled water, some dietary supplements (after they reach the market) and food additives.

Why Is the FDA Important to Consumers?

The FDA plays a huge role in everything we encounter as a consumer. Its mission touches most of the products we eat and use regularly, from much of the food to the medications we rely on to prevent or treat illnesses in us or our pets.

Not only is the FDA responsible for verifying the safety and efficacy of a product before market, but it is also involved in mandated recalls of those items already for sale that have harmed or sickened consumers, or that potentially could. 

However, research from recent years shows that public trust in U.S. health officials varies. A 2021 poll found the nation divided over the performance of the FDA, with 48 percent of respondents saying it is “doing an excellent or good job,” while 24 percent of Americans reported having little or no trust in the agency. Public trust differed greatly according to political affiliation: 47 percent of Democrats had “a great deal” or “quite a lot” of trust in the FDA, compared with 26 percent of Republicans.

What Does the FDA’s Review Process Look Like?

The FDA’s review process varies by product type, as indicated above, and includes sampling foods and places of production as well as surveying research findings. The agency, as authorized by the Nutrition Labeling and Education Act, also evaluates the accuracy of health claims proposed for food packaging, when a petition and scientific evidence are submitted.

In the case of cultivated meat, for which the FDA has given a “no questions” letter of approval, the agency is responsible for review during the growth stages prior to cell harvest, after which the USDA takes over.

Within the agency, the Office of the Ombudsman handles dispute resolution for producers who have a complaint about the approval process.

What You Can Do

Since the FDA is deeply involved in the U.S. food system, it benefits consumers to know how the agency regulates the products we buy and the foods producers can sell.

Recently, the FDA announced that it would strengthen its requirements for the labeling of foods as “healthy,” limiting sodium, saturated fat and added sugar, among other changes. Read this article for what you should know about foods with this label.

You can also visit Sentient Media’s Take Action page for more ways to help repair our food system.