What Is the FDA's Role in Product Safety?

The FDA is one of the most wide-ranging regulatory agencies in the U.S. government. Knowing what it covers, and what it does not, helps you know where to turn when you have a product safety concern.

What the FDA Regulates

Food: All packaged foods and beverages (except meat, poultry, and processed eggs, which are USDA territory). The FDA oversees food safety standards, labelling requirements, and food additive approvals.

Drugs: Both prescription and over-the-counter medications must be approved by the FDA before sale. Drug approvals require clinical evidence of safety and effectiveness.

Medical devices: From bandages to MRI machines to implantable pacemakers. The level of FDA oversight scales with risk, high-risk devices require the most rigorous pre-market approval; lower-risk devices require less.

Dietary supplements: Unlike drugs, supplements do not require FDA approval before sale. The FDA can take action after the fact if safety problems are identified. This is a significant distinction consumers should understand.

Cosmetics: Cosmetics do not require pre-market approval. The FDA can act on safety problems after they are reported.

Tobacco: The FDA regulates tobacco products under the Family Smoking Prevention and Tobacco Control Act.

Veterinary products: Drugs and some foods for animals.

What the FDA Does Not Regulate

• Most household consumer products (CPSC)
• Motor vehicles (NHTSA)
• Pesticides (EPA)
• Firearms and ammunition (ATF)

The FDA Approval Process

For drugs, the FDA requires manufacturers to submit clinical trial data demonstrating safety and efficacy before approval. This process typically takes years and involves multiple phases of testing. "FDA-approved" for a drug is a meaningful regulatory standard.

"FDA-cleared" (used for many medical devices through a process called 510(k)) is different, it means the device is substantially equivalent to a device already on the market, not that it underwent independent efficacy testing.

"FDA-registered" means a facility is registered with the FDA, not that its products have been approved or cleared.

FDA Recalls

The FDA oversees recalls for drugs, food, cosmetics, medical devices, and supplements. Recalls are classified:

• Class I: Serious adverse health consequences or death
• Class II: May cause temporary adverse health consequences; serious consequences are remote
• Class III: Unlikely to cause adverse health consequences

Find current FDA recalls at fda.gov/safety/recalls.

How to Report a Problem to the FDA

MedWatch is the FDA's safety reporting programme for adverse events related to medical products (drugs, devices, supplements, cosmetics).

For food safety problems (contamination, illness):

• Online
• Or contact your local health department for immediate foodborne illness