COVID-19 Frequently Asked Questions
A: The FDA, along with other federal, state, and local agencies and public health officials across the country and internationally, plays a critical role in protecting public health during the COVID-19 pandemic. FDA staff are working around the clock to support development of medical countermeasures and are providing regulatory advice, guidance, and technical assistance to advance the development and availability of vaccines, therapies, diagnostic tests and other medical devices for use diagnosing, treating, and preventing this novel virus. The FDA continues to monitor the human and animal food supply and take swift action on fraudulent COVID-19 products.
A: An emergency use authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, tests, and medicines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, the FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to the FDA.
- Learn more about EUAs in this video
- Read more about COVID-19 tests
- Find a community-based testing site
A: The best way to prevent COVID-19 is to get vaccinated with an FDA-approved or FDA-authorized COVID-19 vaccine and stay up to date on your COVID-19 vaccines.
In addition, the CDC recommends everyday preventive actions to help prevent the spread of COVID-19.
Learn how to protect your family in this Consumer Update.
A: The FDA has approved and authorized treatments for COVID-19 for emergency use during this public health emergency. View the FDA’s Emergency Use Authorization (EUA) page to see all products authorized to treat COVID-19. Read our article: Know Your Treatment Options for COVID-19.
A: No. Miracle Mineral Solution does not cure COVID-19 and has not been approved by the FDA for any use. The solution, when mixed as directed, forms industrial bleach that may cause serious and potentially life-threatening side effects. The FDA took action against Genesis II Church of Health and Healing for unlawfully distributing Miracle Mineral Solution for the treatment of COVID-19 and other diseases. Learn more: Danger: Don’t Drink Miracle Mineral Solution or Similar Products.
A: One of the best ways to prevent the spread of infections and decrease the risk of getting sick is by washing your hands with plain soap and water, advises the CDC. Washing hands often with soap and water for at least 20 seconds is essential, especially after going to the bathroom; before eating; and after coughing, sneezing, or blowing one’s nose. If soap and water are not available, CDC recommends consumers use an alcohol-based hand sanitizer that contains at least 60% alcohol.
To stay informed, visit the FDA’s Hand Sanitizers and COVID-19 page. Also, take our hand sanitizer quiz.
Q: What do I do if I get a rash or other reaction to hand sanitizer? What do I do if I have been exposed to contaminated hand sanitizer?
A: Call your doctor if you experience a serious reaction to hand sanitizer. People who have been exposed to contaminated hand sanitizer and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects.
The FDA encourages consumers and health care professionals to report adverse events experienced with the use of hand sanitizers to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Include as much information as you can about the product that caused the reaction, including the product name, the manufacturer, and the lot number (if available).
See Q&A for Consumers: Hand Sanitizers and COVID-19 and Safely Using Hand Sanitizer for more information.
A: Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who accidentally swallow these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk.
Swallowing or drinking a hand sanitizer with 1-propanol can result in decreased breathing and heart rate, among other serious symptoms, and can lead to death. Hand sanitizer with 1-propanol contamination can irritate your skin (or eyes, if exposed). Although it is rare, some people have reported allergic skin reactions. Learn more about methanol and 1-propanol toxicities.
Q: What should I do with hand sanitizer on the FDA's list of hand sanitizers that consumers should not use?
A: If you have one of the products on the FDA's list of hand sanitizers consumers should not use, immediately stop using it and dispose of the product, ideally in a hazardous waste container. Do not pour these products down the drain or flush them. Contact your local waste management and recycling center for more information on hazardous waste disposal. Learn how to search the FDA’s hand sanitizer list, including a description of how to search for manufacturers and distributors on the label.
Q: Does spraying people with disinfectant, or having people go through disinfectant tunnels, walkways, or chambers, lower the spread of COVID-19?
A: No. The FDA does not recommend spraying humans with aerosolized disinfectant. At this time, there is a lack of data to demonstrate that sanitation tunnels are effective in reducing the spread of or in treating COVID-19.
Chemicals used in sanitation tunnels can irritate the skin, eyes, or airways and cause other health issues.
Hand sanitizers are only for use on the hands and are not to be used over larger body surfaces, ingested, inhaled, or injected. Given serious safety concerns and the lack of data to demonstrate that sanitation tunnels are effective in reducing the spread of or in treating COVID-19, the FDA strongly discourages the use or development of sanitation tunnels at this time, as described in this February 2022 guidance titled “COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels.”
Surface disinfectants or sprays should not be used on humans or animals. They are intended for use on hard, non-porous surfaces (materials that do not absorb liquids easily). CDC provides information regarding disinfectant practices for surfaces. CDC states you should never eat, drink, breathe or inject disinfectants into your body or apply directly to your skin as they can cause serious harm.
Q: Products online claim to prevent or treat COVID-19. Where can I report websites selling products with fraudulent claims?
A: The FDA advises consumers to be beware of websites and stores selling products that claim to prevent, treat, or cure COVID-19. If you have a question about a product sold online that claims to prevent, treat, or cure COVID-19, talk to your health care provider or doctor.
Read this Consumer Update to learn how to protect yourself and your family from coronavirus fraud.
Please report websites selling products with fraudulent claims about treatment or prevention of COVID-19. If you have experienced a bad reaction to a product sold with COVID-19 claims, report it to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
Include as much information as you can about the product that caused the reaction, including the product name, the manufacturer, and the lot number (if available).
A: Yes. Data shows that when compared to never smokers, cigarette smoking increases the risk of more severe illness from COVID-19, which could result in hospitalization, the need for intensive care, or even death. Smoking cigarettes can cause inflammation and cell damage throughout the body, and can weaken your immune system, making it less able to fight off disease.
There’s never been a better time to quit smoking. If you need resources to help you quit smoking, the FDA has supportive tips and tools to help you get closer to quitting for good.
A: E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of COVID-19 or the severity of COVID-19 outcomes is not known. However, many e-cigarette users are current or former smokers, and cigarette smoking increases the risk of respiratory infections, including pneumonia.
Vaccines, Biologics, Human Tissues, and Blood Products
Q: What is the FDA process for a COVID-19 vaccine authorized for emergency use versus an FDA-approved COVID-19 vaccine?
A: Emergency use authorizations (EUAs) can be used by the FDA during public health emergencies to provide access to unapproved vaccines (or unapproved uses of an approved vaccine) that may be effective in preventing a disease. Emergency use authorization is a tool that the FDA can use in a declared public health emergency, like the current pandemic, to more rapidly make available potentially life-saving products under very specific conditions. In determining whether to issue an EUA for a vaccine, after the FDA receives a request for an EUA, the agency evaluates the data submitted, conducts its own analyses and assesses any known or potential risks and any known or potential benefits.
For the COVID-19 vaccines that the FDA has authorized for emergency use, the agency evaluated data submitted by the manufacturers about the vaccine’s safety and effectiveness, conducted its own analyses of the data, and determined that the vaccine has met the statutory criteria for issuance of an EUA. The FDA has determined that the totality of the available data provide evidence that the vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people.
A vaccine that the FDA approved for use in the U.S. has undergone the agency’s standard scientific and regulatory evaluation processes. The FDA’s process to evaluate the safety and effectiveness of a vaccine relies upon the submission of a Biologics License Application (BLA) by a company. By submitting a BLA to the FDA, a company is seeking permission to distribute and market a vaccine for use in the United States. The FDA’s evaluation to determine the safety and effectiveness of vaccines is among the most comprehensive in the world. This includes the agency’s independent verification of analyses submitted by the company in the BLA, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities.
For the COVID-19 vaccines, a BLA builds upon the data and information that supported the EUA, such as preclinical and clinical data, as well as details of the manufacturing process and the sites where the vaccine is made. After its evaluation, the FDA decides whether to approve (also known as to license) the vaccine for use in the U.S. If the FDA approves the vaccine, the company is permitted to market it in the U.S. for use in the population for which it is approved.
A: FDA-approved COVID-19 vaccines:
- Comirnaty (COVID-19 Vaccine, mRNA) – frequently asked questions (FAQs)
- Spikevax (COVID-19 Vaccine, mRNA) – FAQs
COVID-19 vaccines authorized for emergency use in the U.S.:
- Janssen (J&J) COVID-19 Vaccine
- Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent
- Novavax COVID-19 Vaccine, Adjuvanted
- Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent
A: Individuals may receive a single booster dose of one of the authorized bivalent mRNA COVID-19 vaccines, when eligible, as follows:
Children who are 6 months through 5 years of age who received primary vaccination with Moderna COVID-19 Vaccine may receive a single booster dose of the Moderna COVID-19 Vaccine, Bivalent at least two months after completion of primary vaccination.
Children who are 6 months through 4 years of age who received primary vaccination with three doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine may receive a single booster dose of the Pfizer -BioNTech COVID-19 Vaccine, Bivalent at least 2 months after completion of primary vaccination.
Children who are 5 years of age who received primary vaccination with Moderna COVID-19 Vaccine may receive either the Moderna COVID-19 Vaccine, Bivalent or Pfizer-BioNTech COVID-19, Bivalent as a single booster dose at least two months after completion of primary vaccination.
Children who are 5 years of age who received primary vaccination doses with Pfizer-BioNTech COVID-19 Vaccine, including children whose third dose was with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, may receive only the Pfizer-BioNTech COVID-19 Vaccine, Bivalent as a single booster dose at least two months after completion of primary vaccination.
Individuals who are 6 years of age and older may receive a single booster dose with either the Moderna COVID-19 Vaccine, Bivalent or the Pfizer-BioNTech COVID-19, Bivalent at least 2 months after either:
- Completion of a primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
- The most recent booster dose with any FDA-authorized or approved monovalent COVID-19 vaccine.
Certain individuals may receive a monovalent COVID-19 vaccine authorized for use as a single booster dose as follows:
The Novavax COVID-19 Vaccine, Adjuvanted is authorized for use as a first booster dose in the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine:
- Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate.
- Individuals 18 years of age and older who elect to receive the Novavax COVID-19 Vaccine, Adjuvanted because they would otherwise not receive a booster dose of a COVID-19 vaccine.
The Janssen COVID-19 Vaccine is also authorized for use as a first booster dose in certain individuals 18 years of age and older at least 2 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine.*
*FDA has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
Q: Which COVID-19 vaccines have the FDA authorized for administration of an additional primary series dose for immunocompromised individuals?
A: For individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, the following COVID-19 vaccines are authorized for administration of an additional primary series dose:
- The Pfizer-BioNTech COVID-19 Vaccine is authorized for administration as a third primary series dose at least 28 days following the second dose in these immunocompromised individuals 5 years of age and older.
- Comirnaty (COVID-19 Vaccine mRNA) is authorized for administration as a third primary series dose at least 28 days following the second dose in these immunocompromised individuals 12 years of age and older.
- The Moderna COVID-19 Vaccine is authorized for administration as a third primary series dose at least one month following the second dose in these immunocompromised individuals 6 months of age and older.
- Spikevax (COVID-19 Vaccine, mRNA) is authorized for administration as a third primary series dose at least one month following the second dose in these immunocompromised individuals 12 years of age and older.
Q: How does the FDA ensure the quality of COVID-19 vaccines and other medical products authorized for emergency use in the U.S.?
A: The FDA takes very seriously its responsibility to ensure the quality of vaccines and other medical products for use during this pandemic. The agency is using a variety of inspectional tools to help ensure that products being produced in different facilities meet the high-quality standards that the public has come to expect. The FDA will continue to work with companies to ensure that the quality standards that it expects for products distributed under an emergency use authorization are met, and will continue to work diligently to help bring needed medical products in a timely manner to Americans during this public health emergency.
A: If you experience a severe allergic reaction or any life-threatening symptoms such as trouble breathing, call 911, or go to the nearest hospital.
Call the vaccination provider or your health care provider if you have any side effects that bother you or do not go away. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include the name of the vaccine in the first line of box #18 of the report form.
You may also be given an option to enroll in v-safe. V-safe is a voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.
A: There is no scientific evidence to suggest that FDA-authorized or FDA-approved COVID-19 vaccines could cause infertility in women. In addition, infertility is not known to occur as a result of natural COVID-19 disease, further demonstrating that immune responses to the virus, whether induced by infection or a vaccine, are not a cause of infertility. Reports on social media have falsely asserted that the COVID-19 vaccine could cause infertility in women and the FDA is concerned that this misinformation may cause women to avoid vaccination to prevent COVID-19, which is a potentially serious and life-threatening disease. The symptoms of COVID-19 vary and are unpredictable; many people have no symptoms or only mild disease, while some have severe respiratory disease including pneumonia and acute respiratory distress syndrome (ARDS), leading to multi-organ failure and death.
SARS-CoV-2 is the virus that causes COVID-19. The mRNA COVID-19 vaccines (Comirnaty, Moderna, Pfizer-BioNTech, and Spikevax) contain a piece of the SARS-CoV-2 virus’s genetic material that instructs cells in the body to make the virus’s distinctive “spike” protein. The Janssen COVID-19 vaccine uses a type of adenovirus that cannot replicate to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus.
After a person is vaccinated, their body produces copies of the spike protein, which does not cause disease, and triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. Contrary to false reports on social media, this protein is not the same as any involved in formation of the placenta.
A: No. The FDA’s authority includes authorizing or approving COVID-19 vaccines for use in the U.S., but the FDA is not responsible for vaccine distribution. Search vaccines.gov, text your zip code to 438829, or call 1-800-232-0233 to find COVID-19 vaccine locations near you.
Go to the CDC website to find your state and local health departments who are responsible for COVID-19 vaccine distribution. All questions and concerns related to vaccine distribution should be sent to your state government or local health department.
If you are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam. The Federal Trade Commission has easy tips on how to avoid COVID-19 vaccine scams. The FDA encourages you to report a potential COVID-19 drug or medical product scam on our website.
Q: Do any of the COVID-19 vaccines authorized for emergency use or approved by the FDA contain a live form of the SARS-CoV-2 virus (the virus that causes COVID-19 disease)?
A: None of the currently FDA-authorized or approved vaccines contain the live SARS-CoV-2 virus, and you can’t get COVID-19 from the vaccines.
A: No. The COVID-19 vaccines currently authorized or approved by the FDA are not manufactured using egg products or egg culture. See COVID-19 vaccines for more information.
A: In general, respiratory viruses are not known to be transmitted by blood transfusion, and there have been no reported cases of transfusion-transmitted coronavirus worldwide.
Q: What steps are being taken to protect the U.S. blood supply from SARS-CoV-2, the virus that causes COVID-19?
A: Blood donors must be healthy and feel well on the day of donation. Routine blood donor screening measures that are already in place should prevent individuals with clinical respiratory infections from donating blood. For example, blood donors must be in good health and have a normal temperature on the day of donation.
Donors are instructed to contact the donor center if they become ill after donation, so that their blood or plasma will not be used. Even when a donor develops COVID-19 after donation, however, there have been no cases of COVID-19 linked to donor blood or products made from blood.
The FDA has provided additional information to blood establishments on its website.
A: The FDA does not recommend using laboratory tests to screen blood. Someone who has symptoms of COVID-19, including fever, cough, and shortness of breath, is not healthy enough to donate blood. Standard screening processes already in place will mean that someone with these symptoms will not be allowed to donate.
A: It is imperative that eligible individuals continue to donate blood and blood components, including source plasma, during the pandemic. If you are healthy and interested in donating blood, the FDA encourages you to contact a local donation center to make an appointment. One way to make a difference during a public health emergency is to donate blood if you are able.
- AABB: www.aabb.org; +1.301.907.6977
- America’s Blood Centers: www.americasblood.org
- American Red Cross: www.redcrossblood.org; +1.800.RED CROSS (+1.800.733.2767)
- Armed Services Blood Program: www.militaryblood.dod.mil; +1.703.681.8024
- Blood Centers of America: www.bca.coop
A: Yes, individuals who receive a nonreplicating, inactivated or mRNA-based COVID-19 vaccine can donate blood without a waiting period.
A: Convalescent refers to anyone recovering from a disease. Plasma is the yellow, liquid part of blood that contains antibodies. Antibodies are proteins made by the body in response to infections. Convalescent plasma from patients who have already recovered from coronavirus disease 2019 (COVID-19) may contain antibodies against COVID-19. The FDA has issued an emergency use authorization for convalescent plasma for the treatment of COVID-19 in either the outpatient or inpatient setting. The FDA has issued guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma during the public health emergency. The guidance also provides recommendations to blood establishments on collection of COVID-19 convalescent plasma.
A: FDA approval of a drug means that the agency has determined, based on substantial evidence, that the drug is effective for its intended use, and that the benefits of the drug outweigh its risks when used according to the product’s approved labeling. The drug approval process takes place within a structured framework that includes collecting clinical data and submitting an application to the FDA. Learn more about the FDA’s drug review process.
A: The FDA carries out many activities to protect and promote public health during a public health emergency, including helping to accelerate the development and availability of potential treatments, protecting the security of drug supply chains, providing guidance to food and medical device manufacturers, advising developers on clinical trial issues, and keeping the public informed with authoritative health information.
The FDA is committed to supporting the development of new drugs, and the potential repurposing of existing drugs, to address COVID-19 by working with potential drug makers and sponsors to rapidly move products into clinical trials, helping to ensure that trials are properly designed and safe, and protecting the public from potentially unsafe products.
Read more about FDA efforts to accelerate treatments and other actions related to coronavirus.
A: The FDA has approved and authorized treatments for COVID-19 for emergency use during this public health emergency. View the FDA’s Emergency Use Authorization (EUA) page to see all products authorized to treat COVID-19. Products that have been approved to treat COVID-19 without any remaining EUA authorized uses can be found on the FDA’s COVID-19 Drugs page. Read our article: Know Your Treatment Options for COVID-19.
A: Monoclonal antibodies are laboratory-produced molecules that act as substitute antibodies that can restore, enhance or mimic the immune system's attack on cells. Monoclonal antibodies for COVID-19 may block the virus that causes COVID-19 from attaching to human cells, making it more difficult for the virus to reproduce and cause harm. Monoclonal antibodies may also neutralize a virus.
A: The following websites contain information regarding access to monoclonal antibody treatments for COVID-19:
Monoclonal antibody treatments for COVID-19 may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and have the ability to activate the emergency medical system (EMS), if necessary. Please speak with your doctor or contact your local or state public health department for more information.
A: No. Hydroxychloroquine sulfate and some versions of chloroquine phosphate are FDA-approved to treat malaria. Hydroxychloroquine sulfate is also FDA-approved to treat lupus and rheumatoid arthritis.
On March 28, 2020, the FDA issued an emergency use authorization (EUA) for chloroquine phosphate and hydroxychloroquine sulfate to treat adults and adolescents hospitalized with COVID-19 for whom a clinical trial was not available or participation was not feasible. Based on the FDA’s continued review of the scientific evidence available, the criteria for an EUA for chloroquine phosphate and hydroxychloroquine sulfate as outlined in Section 564(c)(2) of the FD&C Act are no longer met. As a result, the EUA for these two drugs was revoked on June 15, 2020. Read more about this action.
Q: Should I take chloroquine phosphate used to treat disease in aquarium fish to prevent or treat COVID-19?
A: No. Products marketed for veterinary use, “for research only,” or otherwise not for human consumption have not been evaluated for safety or effectiveness and should never be used by humans. The FDA is aware that chloroquine phosphate is marketed to treat disease in aquarium fish, but these products have not been evaluated by the FDA to determine if they are safe, effective, properly manufactured, and adequately labeled. The agency continues to work with online marketplaces to remove these items, and many have been removed based on these efforts. Patients should not take any form of chloroquine unless it has been prescribed by a licensed health care provider. Chloroquine products also should not be given to pets or livestock unless prescribed by a veterinarian.
A: No. Antibiotics do not work against viruses; they only work on bacterial infections. Antibiotics do not prevent or treat COVID-19, because COVID-19 is caused by a virus, not bacteria. Some patients with COVID-19 may also develop a bacterial infection, such as pneumonia. In that case, a health care professional may treat the bacterial infection with an antibiotic.
A: No. While there are approved uses for ivermectin in people and animals, it is not approved or authorized for the prevention or treatment of COVID-19. Read more about why you should not use ivermectin to treat or prevent COVID-19.
Read this Consumer Update to learn more about some of the available COVID-19 treatments and how to get more information about them.
Q: What is the FDA doing to protect people from products being distributed with fraudulent COVID-19 claims?
A: We have established a cross-agency team dedicated to closely monitoring for fraudulent COVID-19 products. In response to internet scammers, the FDA has taken – and continues to take – actions regarding unapproved products that are distributed with fraudulent claims to prevent, treat, diagnose or cure COVID-19. The FDA and the Federal Trade Commission (FTC) issue warning letters to companies and individuals that are unlawfully selling unapproved products with fraudulent COVID-19 claims. The FDA also has taken enforcement action against certain sellers that continued to illegally distribute products for prevention or treatment of COVID-19.
Additionally, the FDA also has reached out to major retailers to alert them about monitoring their online marketplaces for fraudulent COVID-19 products. You can report websites suspected of unlawfully selling medical products to the FDA through our website, by phone at 1-800-332-1088, or email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov. Read more in the consumer update on fraudulent products.
A: The FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.
We have been reaching out to manufacturers as part of our approach to identifying potential disruptions or shortages. We will use all available tools to react swiftly and mitigate the impact to U.S. patients and health care professionals when a potential disruption or shortage is identified.
Find real-time information about drug shortages.
Learn more in our drug shortages frequently asked questions.
A: If you have additional questions, call the FDA’s Division of Drug Information at (855) 543-3784 or email us at email@example.com.
Medical Devices Including Tests for COVID-19
A:There are different types of COVID-19 tests. Diagnostic tests can show if you have an active COVID-19 infection. Antibody or serology tests look for antibodies in a blood sample to determine if an individual has had a past infection with the virus that causes COVID-19 but cannot be used to diagnose current COVID-19 infection.
There are two types of COVID-19 diagnostic tests:
- Molecular tests, such as polymerase chain reaction (PCR) tests
- Antigen tests, often referred to as rapid tests
Learn more about COVID-19 tests and how to find a test that meets your needs in our article COVID-19 Test Basics.
A: Search the list of FDA-authorized at-home over-the-counter (OTC) COVID-19 diagnostic tests.
A: The SARS-CoV-2 virus, which causes COVID-19, has mutated over time, resulting in genetic variants over the course of the COVID-19 pandemic. COVID-19 diagnostic tests are designed to detect all known variants. However, they are typically not able to identify the specific type of SARS-CoV-2 variant (such as, delta or omicron) present in a patient sample. The FDA continues to conduct analyses to identify tests for which performance may be impacted for known SARS-CoV-2 variants. Additionally, the FDA has authorized genotyping tests that can specifically identify and differentiate SARS-CoV-2 variants or lineages. Learn more about SARS-CoV-2 viral mutations and COVID-19 tests.
A: Find FDA's guidance about 3D printing during the COVID-19 pandemic.
A: The FDA continues to work with manufacturers and sponsors of ventilators and other respiratory support devices and accessories to help make these devices available through the emergency use authorization (EUA) process.
See more information about ventilators and ventilator accessories EUAs.
A: Please see Contacts for Medical Devices During the COVID-19 Pandemic.
If you need information about the development of a test for SARS-CoV-2, please see our FAQs on Testing for SARS-CoV-2.
A: To protect public health, the FDA monitors domestic firms and the foods that they produce. The FDA also monitors imported products and foreign firms exporting to the U.S. The FDA protects consumers from unsafe foods through research and methods development; inspection and sampling; and regulatory and legal action.
Q: Why is the FDA providing flexibility to food manufacturers, under limited circumstances during the COVID-19 public health emergency, to make minor changes in ingredients without reflecting those changes on the package label?
A: Due to limited shortages of specific ingredients and foods, or unexpected supply chain disruptions in some industries, food manufacturers may need to make small changes to some ingredients during the COVID-19 public health emergency. Manufacturers may not be able to relabel their products to reflect these minor changes on the food label without slowing down the processing or distribution of the food.
To avoid slowing down food processing or distribution during the coronavirus pandemic, the FDA issued a guidance titled "Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines." The temporary policy provides food manufacturers with flexibility to make minor formulation changes in certain, limited circumstances without making conforming label changes on packages as long as any substitutions or omissions of ingredients do not pose a health or safety issue (such as allergens), and do not cause significant changes in the finished product.
Q: What do I need to know about the temporary policy for food labeling of minor ingredient changes during the COVID-19 public health emergency if I have food allergies?
A: Although the temporary policy allows some flexibility, the eight major food allergens under the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 cannot be substituted for labeled ingredients by manufacturers without a corresponding label change. While the temporary policy does not list all ingredients known to cause sensitivities in some people, manufacturers should avoid substituting ingredients with major food allergens or with ingredients recognized as priority allergens (such as sesame, celery, lupin, buckwheat, molluscan shellfish, and mustard) in other parts of the world without a label change. These flexibilities are intended to remain in effect only for the duration of the COVID-19 public health emergency in the United States. However, when this public health emergency is over, extensions may be needed if the food and agriculture sectors need additional time to bring supply chains back into regular order. For more information please see more Questions and Answers on FDA’s Temporary Policy on Food Labeling Changes During the COVID-19 Pandemic.
Q: What are the most important things I need to know to keep myself and others safe when I go to the grocery store during the pandemic?
A: There are steps you can take to help protect yourself, grocery store workers and other shoppers, such as wearing a face covering, practicing social distancing, and using wipes on the handles of the shopping cart or basket. Read more tips in Shopping for Food During the COVID-19 Pandemic - Information for Consumers.
Q: Are food products produced in the U.S. or other countries affected by COVID-19 a risk for the spread of COVID-19?
A: There is no evidence to suggest that food produced in the United States or imported from countries affected by COVID-19 can transmit COVID-19.
A: Currently there is no evidence of food, food containers, or food packaging being associated with transmission of COVID-19. Like other viruses, it is possible that the virus that causes COVID-19 can survive on surfaces or objects.
If you are concerned about contamination of food or food packaging, wash your hands after handling food packaging, after removing food from the packaging, before you prepare food for eating and before you eat. Consumers can follow CDC guidelines on frequent hand washing with soap and water for at least 20 seconds; and frequently clean and disinfect surfaces.
It is always important to follow the four key steps of food safety—clean, separate, cook, and chill.
A: Currently there is no evidence of food or food packaging being associated with transmission of COVID-19.
Unlike foodborne gastrointestinal (GI) viruses like norovirus and hepatitis A that often make people ill through contaminated food, SARS-CoV-2, which causes COVID-19, is a virus that causes respiratory illness and not gastrointestinal illness, and foodborne exposure to this virus is not known to be a route of transmission.
It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads. It’s always important to follow the four key steps of food safety—clean, separate, cook, and chill.
A: Currently, there is no evidence of food or food packaging being associated with transmission of COVID-19. However, the virus that causes COVID-19 spreads from person-to-person. The CDC recommends that if you are sick, stay home until you are better and no longer pose a risk of infecting others.
Anyone handling, preparing and serving food should always follow safe food handling procedures, such as washing hands and surfaces often.
Q: Should food facilities (grocery stores, manufacturing facilities, restaurants, etc.) perform any special cleaning or sanitation procedures for COVID-19?
A: CDC recommends routine cleaning of all frequently touched surfaces in the workplace, such as workstations, countertops, and doorknobs. Use the cleaning agents that are usually used in these areas and follow the directions on the label. CDC does not recommend any additional disinfection beyond routine cleaning at this time.
View the current list of products that meet EPA’s criteria for use against SARS-CoV-2, the cause of COVID-19.
Restaurants and retail food establishments are regulated at the state and local level. State, local, and tribal regulators use the Food Code published by the FDA to develop or update their own food safety rules. Generally, FDA-regulated food manufacturers are required to maintain clean facilities, including, as appropriate, clean and sanitized food contact surfaces, and to have food safety plans in place. Food safety plans include a hazards analysis and risk-based preventive controls and include procedures for maintaining clean and sanitized facilities and food contact surfaces. See: FSMA Final Rule for Preventive Controls for Human Food.
A: The virus that causes COVID-19 is a virus that causes respiratory illness. Viruses like norovirus and hepatitis A that can make people sick through contaminated food usually cause gastrointestinal or stomach illness. Currently there is no evidence of food, food containers, or food packaging being associated with transmission of COVID-19.
The CDC, FDA, and USDA continue to work with state and local partners to investigate foodborne illness and outbreaks during the COVID-19 pandemic. The FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network manages outbreak response, as well as surveillance and post-response activities related to incidents involving multiple illnesses linked to FDA-regulated human food products. During this coronavirus outbreak, CORE’s full-time staff will continue to operate to prepare for, coordinate and carry out response activities to incidents of foodborne illnesses.
The FDA’s Center for Veterinary Medicine manages outbreak response for animal food and is similarly staffed and prepared to respond to incidents of foodborne illness in animals.
Animals, Pets and Animal Drug Products
A: Based on the information available to date, the risk of pets or other animals spreading COVID-19 to people is considered to be low.
The virus that causes COVID-19 can spread from people to animals including pets, zoo animals and wildlife and may spread to other animals, especially during close contact. If a person inside the household becomes sick, isolate that person from everyone else, including pets and other animals.
If you are sick with COVID-19 (either suspected or confirmed by a test), you should avoid contact with your pets and other animals, just like you would with people. Contact includes petting, snuggling, kissing, licking, sharing food, and sleeping in the same bed.
We know that most pets that get infected do so after close contact with their owner or other household member with COVID-19. Consult CDC’s website for the latest recommendations about how to protect pets from the virus.
Talk to your veterinarian if your pet gets sick or if you have any concerns about your pet’s health.
A: Routine testing of pets for COVID-19 is not recommended at this time. There is currently no evidence that pets are a source of COVID-19 infection people in the U.S. Based on the limited information available to date, the risk of pets spreading the virus to people is considered to be low. If your pet is sick, consult your veterinarian.
Animal testing is reserved for situations when the results may affect the treatment or management of people and animals. If your veterinarian thinks your pet is a candidate for testing, they will consult the state veterinarian and public health officials. Do not contact your state veterinarians directly: they do not have the client/patient-veterinarian relationship that would allow them to fully understand the situation and they are also actively involved in other animal disease-related emergencies as well as response to COVID-19.
A: USDA's National Veterinary Services Laboratories maintains an overview and list of confirmed cases of SARS-CoV-2 on its website: Cases of SARS-CoV-2 in Animals in the United States.
More studies are needed to understand if and how different animals could be affected by COVID-19. CDC updates its site with research and findings from experimental studies: Animals and COVID-19.
A: Although we know certain bacteria and fungi can be carried on fur and hair, there is no evidence that viruses, including the virus that causes COVID-19, can spread to people from the skin, fur, or hair of pets.
However, because animals can sometimes carry other germs that can make people sick, it’s always a good idea to practice healthy habits around pets and other animals, including washing hands before and after interacting with them and especially after cleaning up their waste.
Do not put masks on pets. A mask can cause harm to a pet. Do not wipe or bathe your pet with chemical disinfectants, alcohol, hydrogen peroxide, or other products, such as hand sanitizer, counter-cleaning wipes, or other industrial or surface cleaners. If you have questions about appropriate products for bathing or cleaning your pet, talk to your veterinarian. If your pet gets hand sanitizer on their skin or fur, rinse or wipe down your pet with water immediately. If your pet ingests hand sanitizer (such as by chewing the bottle) or is showing signs of illness after use, contact your veterinarian or pet poison control immediately.
A: No. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” are drugs. The FDA has not approved any drugs for the diagnosis, cure, mitigation, treatment, or prevention of COVID-19 in animals. The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics (CVB) regulates veterinary biologics, including vaccines, diagnostic kits, and other products of biological origin.
The FDA has taken action against unapproved products claiming to prevent or cure COVID-19. The public can help safeguard human and animal health by reporting any products claiming to do so to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov or 1-888-INFO-FDA (1-888-463-6332).
A: In general, pet food is available. There may be intermittent decreased availability of certain brands/flavors, but there has been and continues to be product available to meet pets’ nutritional needs.
If a specific preferred flavor or brand is temporarily unavailable, pet owners may need to opt for a short-term alternative.
There have been some reports of decreased availability of some specially formulated veterinary diets that are used to both provide nutrition and address a diagnosed medical condition, which may make it more difficult to find an alternative diet. If a pet needs a specialty diet, it may be helpful for pet owners to consult a veterinarian to find a recommended alternative diet.
A: The FDA has been and is continuing to closely monitor how the COVID-19 outbreak may impact the animal medical product supply chain.
While the FDA does not have regulatory authority requiring the animal drug industry to report shortages, we have been reaching out to manufacturers as part of our approach to identifying potential disruptions or shortages. We will use all available tools to react swiftly to help mitigate the impact if a potential disruption or shortage is identified.
Learn more on our Animal Drug Shortage Information page. Animal drug shortages can be reported by emailing AnimalDrugShortages@fda.hhs.gov.