FAQs By Topic
The Frequently Asked Questions (FAQs) below, as well as others reached through the links on the right, cover basic and timely information and guidance for those interested in the many products FDA regulates and other agency responsibilities. Answers usually include further links to in-depth information included throughout FDA's Web site, as well as on the sites of other government agencies.
If you can't find the answer to a question here, try one of the following options:
- Search the FDA Website.
- Check out the FDA Website index.
- Refer to the site map.
- Go to Information for Consumers for more consumer-oriented materials or to learn how to contact the agency directly.
What does FDA do?
FDA ensures that the food we eat is safe and wholesome, that the cosmetics we use won't harm us, and that medicines, medical devices, and radiation-emitting consumer products such as microwave ovens are safe and effective. FDA also oversees feed and drugs for pets and farm animals. Authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and several other public health laws, the agency monitors the manufacture, import, transport, storage, and sale of $1 trillion worth of goods annually, at a cost to taxpayers of about $3 a person. More about FDA.
What should I do if I have a food or drug product that has been recalled?
If you have a recalled medical product, talk to your health professional about the best course of action. For other products, take it back to the place of purchase and ask for a refund. Stores generally have a return and refund policy when a company has announced a recall of its products.
What does FDA do with defective products?
Products found to be unfit for consumers are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. These products usually are destroyed, or in some cases, they are reconditioned to be in compliance with FDA regulations. Recent recalls.
Is there an FDA food safety hotline?
For general food safety questions, call the FDA Food Safety Hotline at 1-888-723-3366. If the situation is critical, phone FDA's emergency number, 301-796-8240 or 1-866-300-4374, which is staffed 24 hours a day. If your questions involve meat or poultry products, call the U.S. Department of Agriculture's hotline at 800-535-4555. More on food safety can be found at www.foodsafety.gov.
Does FDA control pesticides in foods?
The Environmental Protection Agency regulates the sale and use of pesticides. But FDA regularly tests foods to determine if pesticides are present in unacceptable amounts. If elevated levels are found, FDA takes corrective action.
Does FDA regulate illegal drugs?
Controlling the illegal use of "street" drugs such as heroin, cocaine and marijuana is the job of the federal Drug Enforcement Administration (DEA). However, if a street drug were to be studied for legitimate medical uses, FDA would regulate it as an investigational drug. FDA-regulated prescription drugs such as barbiturates and amphetamines are sometimes abused and wind up as street drugs. These cases then fall into DEA's jurisdiction.
What should I do if I've had an adverse reaction to an over-the-counter or prescription medicine?
Contact your doctor right away and urge him or her to report the problem to the FDA MedWatch hotline, 800-FDA-1088 or online at https://www.accessdata.fda.gov/scripts/medwatch. Your doctor, however, is not required to report to FDA. Therefore, consumers can report problems directly. For more information, visit the MedWatch Website.
How can I participate in FDA's process for making its rules?
In general, any citizen can submit comments on rules FDA proposes. The agency announces rules in the Federal Register and usually accepts comments for 60 days. The Federal Register is available in many libraries or on FDA's Website. FDA urges consumers to participate in the rulemaking process.
How can I make a Freedom of Information Act request to FDA?
FOIA requests are best made by sending a letter specifying exactly what material you seek to FDA, Freedom of Information Staff (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. For more on FOIA requests, call 301-827-6567 or go to the Handbook for Requesting Information and Records from FDA.
How can a regulated company complain to FDA about an agency action?
Contact the FDA Office of the Chief Mediator and Ombudsman, 301-827-3390. If the complaint concerns human drugs, contact the Center for Drug Evaluation and Research's ombudsman at 301-594-5443; for biologics, 301-827-2000; for veterinary drugs, (240) 276-9015.
Whom should I contact if I am interested in a job at the FDA?
See Working at FDA for information on current vacancies, employment benefits, and career descriptions. Additionally, the Office of Personnel Management (OPM) has a site to obtain "Applications for Federal Employment". To contact the FDA on personnel issues send correspondence to:
Division of Human Resources Management
5600 Fishers Lane
Room 7B-43, Mail Code HFA-415
Rockville, MD 20857
How can I contact the FDA?
If you want to communicate your comments, questions or suggestions to FDA, please start with our "Contact FDA" page.