Key takeaways:
The Food and Drug Administration (FDA) is a government agency that’s in place to protect public health. It does this by ensuring the safety, effectiveness, and security of many products you use every day.
Foods, cosmetics, medications, and more are regulated by the FDA. Each has to meet specific requirements — either before and/or after — they’re available to the public.
The FDA is responsible for approving new medications before they hit the market. This ensures they’re safe and effective for their intended use.
From your favorite early morning brew and perfume you wear for a special occasion to the pain reliever you take for headaches — it all goes through the Food and Drug Administration (FDA) before it gets to you. This is the case for many products that you touch; they’re likely regulated by the FDA.
The FDA needs to approve certain products, like medications and vaccines, before they reach the public. Some products, like cosmetics, dietary supplements, and infant formula, have different FDA requirements for marketing.
Generally, FDA standards help establish accountability so manufacturers aren’t selling you products that may be harmful. And it forces them to be honest and clear about the ingredients they use in their products.
Search and compare options
Here, we’ll dive deeper into what the FDA does and how it protects public health.
What is the FDA?
The FDA is a government agency within the Department of Health and Human Services (HHS). Its existence dates back to 1848 with the creation of the Agricultural Division, and it became a federal agency in 1906 when the Pure Food and Drugs Act was passed.
Today, the FDA is responsible for regulating the safety, effectiveness, and security of many products including:
Food (dietary supplements, bottled water, food additives, infant formula)
Medications (prescription and over-the-counter)
Vaccines
Medical devices
Radiation-emitting products, like microwaves
Cosmetics (nail polish, perfume)
Animal and veterinary products (pet food)
Tobacco products
The FDA oversees more than $2.7 trillion in consumption of the products listed above. All 50 states in the U.S., as well as its districts and territories, are under FDA supervision.
Who runs the FDA?
The FDA is run by the FDA commissioner who is appointed by the president with the help of the senate. The current FDA commissioner is Robert M. Califf, M.D. Under the commissioner are four directors that each oversee specific areas, like medical products, food, and operations.
What does the FDA do?
The FDA plays many roles in the development and safety of products. Its function is to advance and encourage the making of reliable and useful products.
Enforce FDA standards
The FDA ensures that products under its oversight meet specific requirements before and/or after they’re on the market. Prescription medications, for example, are required to go through many steps before making it to your local pharmacy.
Inspect manufacturing facilities
The FDA also inspects facilities making certain products to ensure they’re following good manufacturing practices. In most cases, a facility is required to register with the FDA.
Monitor product safety
After a product is on the market, the FDA monitors complaints and adverse events (an unexpected reaction that may be caused by a medication). It does this through a few different reporting tools, including:
MedWatch: Healthcare professionals and consumers can report adverse events potentially caused by prescription and OTC medications, medical devices, food ingredients, and more.
Vaccine Adverse Event Reporting System (VAERS): Healthcare professionals, vaccine manufacturers, and the public can report adverse events potentially caused by vaccines.
CFSAN Adverse Event Reporting System (CAERS): Anyone can report adverse events and complaints about foods, cosmetics, and dietary supplements.
Safety Reporting Portal: Anyone can report safety issues from a variety of products, including tobacco products.
What are the FDA’s responsibilities?
The FDA has many responsibilities that vary based on the product at hand. A few examples are listed below.
| Product type | Examples of FDA responsibilities |
| Prescription medications |
|
|
|
|
|
|
Food |
|
|
Dietary supplements |
|
|
|
|
Radiation-emitting products |
|
|
Cosmetics |
|
|
Tobacco products |
|
How does the FDA approve medications?
There are a few different steps a medication goes through before it’s approved. But even before a pharmaceutical company submits an application, there needs to be evidence of safety and effectiveness for the FDA to review. This typically includes both animal studies and three phases of clinicals trials in people.
Application process
If a medication is found to be safe and effective in human clinical trials, the drug sponsor may request approval from the FDA. But this process depends on the type of medication:
New Drug Application (NDA): Process for new prescription medications, certain OTC medications, and Rx-to-OTC switch. The FDA ensures a medication is safe and effective for its intended use.
Biologics License Application: Process for biologic medications — medications that come from living sources — like vaccines and gene therapies. This process has greater focus on where and how the medication is made compared to the NDA process.
If a medication will treat a serious condition and fills an unmet medical need, it may qualify for designations that make the application or review process faster.
Review and approval
The FDA takes action on an application within 6 to 10 months of submission, depending on priority. When the application is reviewed, the FDA determines if the medication is safe and effective for its intended use, and if its benefits outweigh its risks. The FDA also reviews the product labeling and inspects the manufacturing facility that will make the medication.
Sometimes, the FDA will convene a panel of experts (called an advisory committee) to vote on whether or not they recommend the new medication’s approval. The FDA’s decision is usually aligned with the advisory committee, but not always. The FDA has the final call to either approve or not approve the medication.
What about generic medications?
Generic medications don’t go through the same three phases of clinical trials as new medications. They just need to show they provide the same clinical benefit and work the same way as their brand-name counterpart. Generic manufacturers request approval by submitting an Abbreviated New Drug Application.
What about OTC medications?
Some OTC medications go through the NDA process and need to be approved before they’re available for purchase. Others can be marketed if they comply with a specific OTC monograph. An OTC monograph is a rule book an OTC medication must comply with based on product type (e.g., OTC sleep aids).
How and why does the FDA issue recalls?
Recalls are the FDA’s way to protect you from defective products that could potentially be harmful by removing them from the market. This is done either by the manufacturer or by FDA request or order. Recalls are categorized based on the likelihood of serious health consequences.
Products may be recalled for a number of different reasons. For example, the most common reasons for medication recalls include:
Contamination
Mislabeling
Adverse reaction
Wrong potency (strength)
Defective product
The public isn’t always alerted about a recall unless the FDA determines it’s necessary to protect consumers’ health. For example, products that have been widely distributed or have caused significant harm may warrant public notification.
The bottom line
The FDA is here to protect public health. It has systems in place to regulate a number of products you encounter every day, from foods to medications. Some products need to be approved before they’re available. Others have a different set of requirements to follow. But everything under the FDA’s oversight is monitored on an ongoing basis to keep you safe.
Why trust our experts?
References
Hall, K. H., et al. (2016). Characteristics of FDA drug recalls: A 30-month analysis. American Journal of Health-System Pharmacy.
Food and Drug Administration. (n.d.). Advisory committees.
Food and Drug Administration. (n.d.). Drug approval process.
Food and Drug Administration. (n.d.). New drug applications (NDA) vs. biologics license applications (BLA).
Food and Drug Administration. (2014). Recalls background and definitions.
Food and Drug Administration. (2017). Frequently asked questions about the FDA drug approval process.
Food and Drug Administration. (2017). The FDA's drug review process: Ensuring drugs are safe and effective.
Food and Drug Administration. (2018). Information about reporting adverse events to FDAs MedWatch program.
Food and Drug Administration. (2018). When and why was FDA formed?.
Food and Drug Administration. (2020). Drug applications for over-the-counter (OTC) drugs.
Food and Drug Administration. (2020). Fact sheet: FDA at a glance.
Food and Drug Administration. (2021). Biologics license applications (BLA) process (CBER).
Food and Drug Administration. (2021). FDA fundamentals.
Food and Drug Administration. (2022). Abbreviated new drug application (ANDA).
Food and Drug Administration. (2022). CFSAN adverse event reporting system (CAERS).
Food and Drug Administration. (2022). FDA commissioner.
Food and Drug Administration. (2022). Is it really 'FDA approved'?.
Food and Drug Administration. (2022). MedWatch: The FDA safety information and adverse event reporting program.
Food and Drug Administration. (2022). New drug application (NDA).
Food and Drug Administration. (2022). What does FDA regulate?.
U.S. Capitol Visitor Center. (n.d.). The Pure Food and Drug Act.
U.S. Department of Health and Human Services. (n.d.). About HHS.
U.S. Department of Health and Human Services. (n.d.). Safety reporting portal.
