Along with other federal, state, and local agencies and public health officials across the country, the FDA continues critical work to protect public health during the COVID-19 pandemic. Find the most recent FDA updates on our Coronavirus Disease 2019 page.
The frequently asked questions (FAQs) on this page are for a general public or consumer audience. Other audiences may want to refer to additional FAQs:
- Hand sanitizers and COVID-19 FAQs
- Testing for SARS-CoV-2 FAQs
- Medical glove FAQs
- Surgical mask and gown shortage FAQs
- 3D Printing of Medical Devices & Parts FAQs
- FAQs on Ventilators
- Manufacturing, Supply Chain, and Drug Inspections FAQs
- Food Safety and COVID-19 FAQs for Industry
- Animal Food Safety and COVID-19 Industry FAQs
- Face Mask and Surgical Mask FAQs
A: Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. CDC has information on COVID-19 symptoms and caring for yourself and others. COVID-19 is a new disease, caused by a novel (or new) coronavirus that has not previously been seen in humans.
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: In certain types of emergencies, the FDA can issue an emergency use authorization, or EUA, to provide more timely access to critical medical products that may help during the emergency when there are no adequate, approved, and available alternative options. The EUA process is different than full FDA approval, clearance, or licensing because the EUA standard requires significantly less data than otherwise would be required for approval, clearance, or licensing by the FDA. This enables the FDA to authorize the emergency use of medical products that meet the criteria for issuance within weeks rather than months to years. Under the EUA authority, the FDA evaluates requests for authorization very quickly using the evidence that is available, carefully balancing the risks and benefits of the product as we know them, in addition to evaluating other criteria. EUAs are in effect until the emergency declaration ends but can be revised or revoked as we evaluate the needs during the emergency, or as products meet the criteria to become approved, cleared, or licensed by the FDA. The What is an EUA? video provides a short summary of this information.
On February 4, 2020, the HHS Secretary determined that there is a public health emergency involving COVID-19, and subsequently issued declarations justifying the use of EUAs for medical products to prevent, treat and diagnose COVID-19. To date, over 100 EUAs have been issued to allow emergency access to tests, medical devices, personal protective equipment and therapeutics. See the EUAs that have been issued for COVID-19.
A: COVID-19 is thought to spread mainly through close contact from person-to-person. Some people without symptoms may be able to spread the virus. We are still learning about how the virus spreads and the severity of illness it causes. The CDC has additional information on how COVID-19 spreads.
A: The best way to prevent illness is to avoid being exposed to the virus. CDC recommends everyday preventive actions to help prevent the spread of respiratory diseases.
CDC recommends washing your hands often with soap and water for at least 20 seconds especially after you have been in a public place, or after blowing your nose, coughing, or sneezing. If soap and water are not available, CDC recommends using an alcohol-based hand sanitizer that contains at least 60 percent alcohol.
A: CDC recommends wearing masks in public when other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission of the coronavirus. The purpose of wearing a mask in public is to slow the spread of the virus and help people who may have the virus and do not know it from transmitting it to others. Find more information about how to select, wear, and clean your mask.
The FDA does not regulate masks or cloth face coverings worn by the general public. The FDA does regulate medical devices, including personal protective equipment (PPE) such as surgical masks and N95 respirators. PPE should be reserved for use by health care workers, first responders, and other frontline workers whose jobs put them at much greater risk of acquiring COVID-19. Read more about types of face masks and the FDA’s emergency use authorization for non-surgical face masks.
A: Currently there are no FDA-approved medicines specifically for COVID-19. However, the FDA has granted emergency use authorizations for some medicines to be used for certain patients hospitalized with COVID-19. The National Institutes of Health provides more information about treatment options.
People with COVID-19 should receive supportive care to help relieve symptoms. People with mild symptoms are able to recover at home. If you experience a medical emergency such as trouble breathing, call 911 and let the operator know you may have COVID-19. Never take a prescription medicine or drug if it is not prescribed for you by your doctor for your health condition.
A: No. Disinfectant products such as sprays, mists, wipes, or liquids are only to be used on hard, non-porous surfaces (materials that do not absorb liquids easily) such as floors and countertops, or on soft surfaces such as mattresses, sofas, and beds.
Disinfectants should not be used on human or animal skin. Disinfectants may cause serious skin and eye irritation.
Disinfectants are dangerous for people to inject, inhale, or ingest. If you breathe, inject, or swallow disinfectants you may be seriously hurt or die. If someone near you swallows, injects, or breathes a disinfectant, call poison control or a medical professional immediately.
View the current list of disinfectants that meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19.
A: Currently there are no data showing that spraying people with aerosolized disinfectants, or having people walk through tunnels or rooms where disinfectant is in the air, can treat, prevent, or lower the spread of COVID-19.
Surface disinfectants should not be used on people or animals. Disinfectant products, such as sprays, mists, wipes, or liquids are only to be used on hard, non-porous surfaces (materials that do not absorb liquids easily) such as floors and countertops, or on soft surfaces such as mattresses, sofas, and beds. CDC provides information regarding disinfectant practices for surfaces in the Reopening Guidance for Cleaning and Disinfecting Public Spaces, Workplaces, Businesses, Schools, and Homes.
Human antiseptic drugs, such as hand sanitizers, are intended for use on human skin, but are not intended for aerosolization (to be sprayed in the air in very small droplets). Due to serious safety concerns, including the risk of inhalational toxicity and flammability, the FDA’s temporary policies for alcohol-based hand sanitizers during the COVID-19 public health emergency specifically do not apply to aerosol sprays. In addition, hand sanitizers are intended for use on the hands, and should never be used over larger body surfaces, swallowed, or inhaled.
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. 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: The best way 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.
A: Many retail stores and pharmacies sell hand sanitizers. However, we understand that many stores have run out of hand sanitizers and they may be difficult to find. To help increase the availability of hand sanitizers, the FDA has issued guidance for the temporary preparation of alcohol-based hand sanitizers by some companies and pharmacies during the COVID-19 public health emergency.
The FDA does not recommend that consumers make their own hand sanitizer. If made incorrectly, hand sanitizer can be ineffective, and there have been reports of skin burns from homemade hand sanitizer. The agency lacks verifiable information on the methods being used to prepare hand sanitizer at home and whether they are safe for use on human skin.
A: Call your doctor if you experience a serious reaction to hand sanitizer. 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).
A: The FDA is warning consumers and health care professionals about hand sanitizers contaminated with potentially toxic types of alcohol.
- Methanol, also known as wood alcohol, is a dangerous and toxic substance. Methanol can cause serious side effects when absorbed through the skin and can cause blindness or death when swallowed.
- 1-propanol, or 1-propyl alcohol, is used to make industrial solvents (a type of cleaner) and can also be toxic to humans when swallowed. 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. Learn more about potential side effects.
FDA advises consumers not to use any hand sanitizer products produced by the manufacturers identified on this list, and to continue checking this list often as it is being updated regularly. Check your hand sanitizer products to see if the manufacturer is included on this list and if they are, dispose of the hand sanitizer products immediately, ideally in a hazardous waste container. If a product on the list does not identify the manufacturer on the label, consumers can contact the distributor whose name appears on the label to find out who manufactured the product. If the distributor refuses to clarify this information when contacted by a consumer, FDA advises consumers not to use that product.
Most hand sanitizers found to contain methanol or 1-propanol do not list it as an ingredient on the label (since it is not an acceptable ingredient in the product), so it’s important to check the FDA’s list to see if the product is on the list. Visit FDA Updates on Hand Sanitizers Consumers Should Not Use for more information.
A: If you have one of the products the FDA's do-not-use list of hand sanitizers, you should 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 FDA’s hand sanitizer do-not-use list, including a description of how to search for manufacturers and distributors on the label.
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.
People who have been exposed to contaminated hand sanitizer and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects.
FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):
A: Currently, there are no FDA-approved products for the prevention or treatment of COVID-19. The FDA advises consumers to be cautious of websites and stores selling products that claim to prevent, treat, or cure COVID-19. If you have a question about a treatment found online, talk to your health care provider or doctor.
Please report websites selling fraudulent medical products.
Read more in the consumer update on fraudulent products.
Please report safety concerns to the FDA’s MedWatch Adverse Event Reporting program:
A: Smoking cigarettes can leave you more vulnerable to respiratory illnesses, such as COVID-19. For example, smoking is known to cause lung disease and people with underlying lung problems may have increased risk for serious complications from COVID-19, a disease that primarily attacks the lungs. Smoking cigarettes can also 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’s Every Try Counts campaign 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.
A: The FDA regulates vaccines. Vaccines undergo a rigorous review of laboratory and clinical data to ensure the safety and effectiveness of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects.
There are currently no vaccines available for the prevention of COVID-19. The FDA is expediting clinical trials for vaccines by providing timely advice to and interactions with vaccine developers. The FDA is also supporting product development and scaling up of manufacturing capacity for high priority vaccines for COVID-19. Vaccine developers can find more info about the review process here.
A: Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues.
A: At this time there is no vaccine to prevent coronavirus disease 2019 (COVID-19). The FDA is working with vaccine developers and other researchers and manufacturers to help expedite the development and availability of medical products such as vaccines, antibodies, and drugs to prevent COVID-19. Read more about what the FDA is doing to mitigate the effects of COVID-19.
For information about vaccine clinical trials for COVID-19 visit clinicaltrials.gov and the COVID-19 Prevention Network. Note: The information on clinicaltrials.gov is provided by the sponsor or principal investigator of a clinical trial. The listing of a study on the site does not reflect evaluation or endorsement of the trial by the Federal government.
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.
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.
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 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: At this time, 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: 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.
A: Respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps). The potential for transmission of COVID-19 by HCT/Ps is unknown at this time. There have been no reported cases of transmission of COVID-19 via HCT/Ps.
Routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors. Read more about HCT/Ps.
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 the use of convalescent plasma in hospitalized patients. It is being investigated for the treatment of COVID-19 because there is no approved treatment for this disease. Based on scientific evidence available, the FDA concluded this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product for patients hospitalized with COVID-19. Learn more about donating from this video.
A: COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood. Individuals must have had a prior diagnosis of COVID-19 documented by a laboratory test and meet other laboratory criteria. Individuals must have fully recovered from COVID-19, with complete resolution of symptoms for at least 14 days before donation of convalescent plasma. You can ask your local blood center if there are options to donate convalescent plasma in your area. Learn more about how to donate.
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, maintaining and securing drug supply chains, providing guidance to food and medical device manufacturers, advising developers on clinical trial issues during a public health emergency, 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, while helping to ensure that trials are properly designed and safe. Read more about FDA efforts to accelerate treatments and other actions related to coronavirus.
A: Currently there are no FDA-approved medicines specifically approved for the treatment or prevention of COVID-19. During public health emergencies, the FDA may in certain circumstances authorize use of unapproved drugs or unapproved uses of approved drugs for life-threatening conditions when there are no adequate, approved, and available options and other conditions are met. This is called an Emergency Use Authorization (EUA).
Researchers are studying new drugs, and medicines that are already approved for other health conditions, as possible treatments for COVID-19. The FDA created the Coronavirus Treatment Acceleration Program (CTAP) to use every available method to move new treatments to patients. Additionally, the FDA is working with the National Institutes of Health, drug manufacturers, researchers, and other partners to accelerate the development process for COVID-19 treatments. FDA’s Sentinel System is being used to monitor the use of drugs, describe the course of illness among hospitalized patients, and evaluate the treatment impact of therapies actively being used under real-world conditions.
For information about clinical trials for COVID-19 treatments visit clinicaltrials.gov and the COVID-19 Prevention Network. Note: The information on clinicaltrials.gov is provided by the sponsor or principal investigator of a clinical trial. The listing of a study on the site does not reflect evaluation or endorsement of the trial by the Federal government.
A: No. Veklury (remdesivir) is an investigational antiviral drug. It is not currently FDA-approved to treat or prevent any diseases, including COVID-19.
In August 2020, Gilead announced publicly the submission of their New Drug Application (NDA) for Veklury (remdesivir) for the treatment of COVID-19.
In May 2020, the FDA issued an Emergency Use Authorization (EUA) that authorized Veklury for the treatment of hospitalized adult and pediatric patients with severe COVID-19. On August 28,2020, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients. The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.
A: The safety and efficacy of Veklury (remdesivir) for the treatment of COVID-19 are being evaluated in multiple ongoing clinical trials. Data from multiple phase 3 clinical trials suggest that Veklury (remdesivir) might benefit patients with COVID-19.
In Vitro Data:
In vitro (laboratory) testing of Veklury (remdesivir) demonstrated it is active against SARS-CoV-2 (the virus causing COVID-19).
Data from Phase 3 Clinical Trials:
NIAID ACTT-1 Trial
Preliminary results from a Phase 3, placebo-controlled clinical trial of Veklury (remdesivir) by the National Institute for Allergy and Infectious Diseases suggested that patients taking Veklury (remdesivir) experienced faster time to recovery as compared to patients taking a placebo. This trial included a sizeable proportion of patients who were receiving mechanical ventilation or extracorporeal membrane oxygenation (ECMO) at baseline. Based on these findings, the Fact Sheet for Health Care Providers details a 10-day treatment course for patients receiving mechanical ventilation or ECMO.
Gilead GS-US-540-5773 Trial
Preliminary results from a different Phase 3 trial evaluating 5-day and 10-day dosing durations of Veklury (remdesivir) in hospitalized patients with severe COVID-19 disease reported that patients receiving a 5-day treatment course demonstrated similar clinical status at Day 14 as those taking a 10-day treatment course; however, importantly, very few patients in this trial were receiving mechanical ventilation or ECMO at baseline. Therefore, based on these findings, the Fact Sheet for Health Care Providers details a 5-day treatment course for patients who are not receiving mechanical ventilation or ECMO. Patients who receive a 5-day treatment course but do not demonstrate clinical improvement are eligible to continue to receive Veklury (remdesivir) for an additional 5 days.
Gilead GS-US-540-5774 Trial
Data from a randomized clinical trial of hospitalized patients with confirmed COVID-19 and radiological evidence of pneumonia without an oxygen requirement during screening compared treatment with Veklury (remdesivir) for 5 days and 10 days with standard of care. The odds of improvement in clinical status were higher in the 5-day Veklury (remdesivir) group at Day 11 when compared to those receiving the standard of care. The odds of improvement in clinical status with the 10-day treatment groups when compared to patients receiving the standard of care were not statistically significant.
Because Veklury (remdesivir) may help hospitalized patients, the FDA is allowing this drug to be provided to hospitalized patients, irrespective of disease severity, under an expansion of the EUA issued on August 28, 2020. Under the EUA, health care providers and patients are provided with information about the risks of Veklury (remdesivir). However, a review of final data from clinical trials included in the New Drug Application (NDA) is necessary for us to determine whether the drug is safe and effective in treating COVID-19.
A: HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) announced the allocation plan for Veklury (remdesivir) in May 2020. On June 29, 2020, HHS announced an agreement between HHS and Gilead to secure large supplies of Veklury (remdesivir) through September 2020. These supplies will be allocated in the same way that Gilead’s donation of approximately 120,000 treatment courses of Veklury (remdesivir) were allocated: HHS allocates product to state and territorial health departments based on COVID-19 hospital burden, and health departments allocate it to hospitals. Healthcare providers interested in administering Veklury (remdesivir) in accordance with the authorized use under the EUA should contact their state health department. More information about allocation of Veklury (remdesivir) can be found here.
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 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.
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 for the prevention or treatment of COVID-19. You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.
A recently released research article described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19. Read more about ivermectin.
A: We have established a cross-agency task force dedicated to closely monitoring for fraudulent COVID-19 products. In response to internet scammers, the FDA has taken – and continues to take – actions to stop those selling unapproved products that fraudulently claim 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. As of June 2020, the FDA has issued over 90 warning letters to sellers making bogus COVID-19 claims about their products. The FDA also has taken enforcement action against certain sellers that continued to illegally market products as treatments for COVID-19.
Additionally, the FDA also has reached out to major retailers to ask for their help in monitoring online marketplaces for fraudulent COVID-19 products. The task force has already worked with marketplaces and platforms, resulting in the removal of dozens of these types of online product listings. You can report websites selling fraudulent 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: Currently, there is no evidence to support transmission of COVID-19 associated with imported goods, including food and drugs for humans and pets. There have not been any cases of COVID-19 in the United States associated with imported goods. Learn more about the FDA’s Import Program and Importing COVID Supplies.
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.
A: Yes, the FDA has authorized two different types of tests (diagnostic and antibody tests) for use during the COVID-19 emergency. Though there are currently no FDA-approved or cleared tests for COVID-19, the FDA has issued over 200 Emergency Use Authorizations (EUAs) for such tests . These EUAs allow the emergency use of tests during the COVID-19 emergency when the FDA determines certain criteria are met. These criteria include that the test may be effective at diagnosing or detecting antibodies to COVID-19 and that the known and potential benefits outweigh the known and potential risks. Read more about COVID-19 tests and find a community-based testing site.
A: In general, for diagnostic tests, samples are collected from a person’s nose and/or throat using swabs or other collection devices by a healthcare provider in a health care setting. A health care professional swabbing the back of the nasal cavity through the nostril is the preferred way to collect a sample to test for COVID-19. Alternatively, a health care professional may swab the back of your throat or the inside of the front of the nose. Certain tests may also allow collection of alternative sample types. Additionally, the FDA has authorized some tests for use with home sample collection kits that are prescribed by a doctor and allow the patient to collect the sample at home and send it directly to the lab for analysis. Learn more about Coronavirus Testing Basics.
A: No, at this time, the FDA has not authorized any COVID-19 test to be completely used and processed at home. However, the FDA has issued emergency use authorizations (EUAs) for certain COVID-19 molecular diagnostic tests to be used with samples collected by a person using a home collection kit that is sent to a laboratory for processing and test reporting. In general, a healthcare provider determines whether a person can use a home collection kit as explained in each test’s EUA.
The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection options, and we are actively working with test developers to expand the use of such options.
A: The FDA is actively working with test developers and issues Emergency Use Authorizations (EUAs) frequently for EUA requests with sufficient supporting data.
A: There are two different types of tests – diagnostic tests and antibody tests.
- A diagnostic test can show if you have an active coronavirus infection and should take steps to quarantine or isolate yourself from others. Currently there are two types of diagnostic tests – molecular (RT-PCR) tests that detect the virus’s genetic material, and antigen tests that detect specific proteins on the surface of the virus. Samples are typically collected with a nasal or throat swab, or saliva collected by spitting into a tube.
- An antibody test looks for antibodies that are made by the immune system in response to a threat, such as a specific virus. Antibodies can help fight infections. Antibodies can take several days or weeks to develop after you have an infection and may stay in your blood for several weeks after recovery. Because of this, antibody tests should not be used to diagnose an active coronavirus infection. At this time, researchers do not know if the presence of antibodies means that you are immune to the coronavirus in the future. While there is a lot of uncertainty with this new virus, it is also possible that, over time, broad use of antibody tests and clinical follow-up will provide the medical community with more information on whether or not, and how long, a person who has recovered from the virus is at lower risk of infection if they are exposed to the virus again. Samples are typically blood from a finger stick or blood draw. Learn more about antibody tests.
Learn more about the different types of tests and the steps involved in the FDA’s Consumer Update on Coronavirus Testing Basics.
A: No. Surgical masks and N95s need to be reserved for use by health care workers, first responders, and other frontline workers whose jobs put them at much greater risk of acquiring COVID-19. The cloth face coverings recommended by CDC are not surgical masks or N95 respirators. Surgical masks and N95s are critical supplies that must continue to be reserved for health care workers and other medical first responders, as recommended by CDC.
A: The FDA has been working closely with PPE and ventilator manufacturers to understand their supply capabilities during this pandemic. The agency is also aware of challenges throughout the supply chain that are presently impacting the availability of PPE products and is taking steps to mitigate shortages that health care facilities are already experiencing.
The FDA issued new guidance to give ventilator manufacturers and non-medical device manufacturers more flexibility to start making new ventilators and parts. We adjusted our screening of PPE and medical devices at U.S. ports of entry to expedite imports of legitimate products into the U.S. With CDC we took action to make more respirators, including certain N95s, available to health care personnel for use in health care settings. Read more about PPE.
The FDA encourages manufacturers and health care facilities to report any supply disruptions to the device shortages mailbox at firstname.lastname@example.org.
A: Personal protective equipment (PPE) includes protective clothing, gowns, gloves, face shields, goggles, face masks, and respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. While it is possible to use 3D printing to make certain PPE, there are technical challenges. 3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators. The CDC has recommendations for how to optimize the supply of face masks. Find more information about 3D printing during the COVID-19 pandemic.
A: DIY ventilator makers may request that their product be added to the Emergency Use Authorization (EUA) that the FDA issued on March 24, 2020, to legally market the product in the U.S. Instructions on how to do so, and the criteria for ventilator safety, performance and labeling, may be found in the Letter of Authorization and Appendix A for the EUA related to ventilators, anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories.
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 United States. The FDA protects consumers from unsafe foods through research and methods development; inspection and sampling; and regulatory and legal action.
A: In some cases the inventory of certain foods at your grocery store might be temporarily low before stores can restock. Food production and manufacturing generally are widely dispersed throughout the U.S., however; there is a significant shift in where consumers are buying food during the pandemic. While food use in large-scale establishments, such as hotels, restaurants, sports arenas/stadiums and universities suddenly declined, the demand for food at grocery stores increased.
The FDA has issued temporary guidance to provide flexibility in packaging and labeling requirements to support food supply chains and get foods to the consumer retail marketplace. The FDA is closely monitoring the food supply chain for any shortages in collaboration with industry and our federal and state partners. We are in regular contact with food manufacturers and grocery stores. Watch a video on food safety and availability during the coronavirus pandemic.
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.
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.
A: There are no nationwide shortages of animal food, although in some cases the inventory of certain foods at your grocery store might be temporarily low before stores can restock. Animal food production and manufacturing are widely dispersed throughout the United States and no widespread disruptions have been reported in the supply chain.
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.
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 4 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 4 key steps of food safety—clean, separate, cook, and chill.
A: Currently there is no evidence of animal food or food packaging being associated with transmission of COVID-19.
SARS-CoV-2, which causes COVID-19, is a virus that causes respiratory illness. Foodborne exposure to this virus is not known to be a route of transmission.
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 is spreading from person-to-person in some communities in the U.S. 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.
A: CDC recommends that employees who have symptoms of acute respiratory illness stay home and not come to work until they are free of fever (100.4° F [37.8° C] or greater using an oral thermometer), signs of a fever, and any other symptoms for at least 24 hours, without the use of fever-reducing or other symptom-altering medicines (e.g. cough suppressants). Employees should notify their supervisor and stay home if they are sick. We recommend that businesses review CDC’s interim guidance for businesses and employers for planning and responding to coronavirus disease. Also see the FDA’s Retail Food Protection: Employee Health and Personal Hygiene Handbook.
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.
A: The FDA approves and regulates animal drugs to ensure they are safe and effective. In addition, the FDA helps ensure that animal food (including pet food) is safe and truthfully labeled. The FDA has post-market authority over veterinary medical devices.
A: There is a very small number of pets around the world reported to be infected with the virus that causes COVID-19 after having contact with a person with COVID-19. There is currently no evidence that animals are a source of COVID-19 infection in the United States.
Until we learn more about how this virus affects animals, treat pets as you would other human family members to protect them from a potential infection.
- Do not let pets interact with people outside the household.
- Keep cats indoors when possible to prevent them from interacting with other people.
- Walk dogs on a leash, maintaining at least 6 feet (2 meters) from other people.
- Avoid dog parks or public places where a large number of people gather.
Talk to your veterinarian if your pet gets sick or if you have any concerns about your pet’s health. Learn more about Pet Safety & COVID-19.
A: Certain veterinary diagnostic laboratories have developed diagnostic tests for SARS-CoV-2, the virus that causes COVID-19, for use in pets if needed.
Diagnostic tests for animals are regulated differently than those for humans. The FDA does not require approval or clearance of a 510(k), PMA, or any other pre-market submission for devices, including diagnostic tests, intended for animal use. The FDA does, however, have post-market regulatory oversight over devices intended for animal use and can take appropriate regulatory action if an animal device is misbranded or adulterated.
Certain private, state, and university veterinary diagnostic laboratories have developed diagnostic tests for SARS-CoV-2, the virus that causes COVID-19, for use in dogs and cats. The FDA is also aware of at least two veterinary tests for COVID-19 in pets developed by commercial laboratories initially for internal surveillance, but the agency has not evaluated the validity of these tests. The tests are not currently available for routine testing. The decision to test pets should be made collaboratively between local, state, or federal public and animal health officials.
A: Routine testing of pets for COVID-19 is not recommended at this time. There is currently no evidence that animals are a source of COVID-19 infection in the United States. Based on the limited information available to date, the risk of pets spreading the virus 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: We currently don’t fully understand how COVID-19 affects different animal species. We are aware of a very small number of pets, including dogs and cats, reported to be infected with the virus that causes COVID-19 after close contact with people with COVID-19.
On April 22, 2020, the United States Department of Agriculture (USDA) and the Centers for Disease Control and Prevention (CDC) announced the first confirmed cases of SARS-CoV-2 (the virus that causes COVID-19) infection in two pet cats. These are the first pets in the United States to test positive for SARS-CoV-2. The cats lived in two separate areas of New York state. Both had mild respiratory illness and are expected to make a full recovery. SARS-CoV-2 infections have been reported in very few animals worldwide, mostly in those that had close contact with a person with COVID-19.
A tiger at a zoo in New York has also tested positive for the virus; it was the first confirmed case of COVID-19 infection in an animal in the United States.
Recent research shows that ferrets, cats, and golden Syrian hamsters can be experimentally infected with the virus and can spread the infection to other animals of the same species in laboratory settings. Pigs, chickens, and ducks did not become infected or spread the infection based on results from these studies. Data from one study suggest that dogs are not as likely to become infected with the virus as cats and ferrets. These findings were based upon a small number of animals and do not indicate whether animals can spread infection to people.
For any animal that tests positive for SARS-CoV-2 at a private or state laboratory, USDA's National Veterinary Services Laboratories performs additional testing to confirm the infection and posts results of positive animals on its website.
A: We are still learning about this virus and how it spreads, but it appears it can spread from humans to animals in some situations. The FDA is aware of a very small number of pets, including cats, reported to be infected with the virus that causes COVID-19. The majority of these cases were linked to close contact with people who tested positive for COVID-19.
At this time, there is no evidence that pets, including cats and dogs, play a role in spreading COVID-19 to people. The virus that causes COVID-19 spreads mainly from person to person, typically through respiratory droplets from coughing, sneezing, or talking.
People sick with COVID-19 should isolate themselves from other people and animals, including pets, during their illness until we know more about how this virus affects animals. If you must care for your pet or be around animals while you are sick, wear a cloth face covering and wash your hands before and after you interact with pets.
A: The FDA, USDA and CDC recommend that any testing of animals should be conducted using kits not required when testing people. USDA’s National Veterinary Services Laboratories (NVSL) and the laboratories of the National Animal Health Laboratory Network (NAHLN) use tests developed for animal testing that are not used for testing in people. This avoids placing additional stresses on human testing resources while also recognizing the potential importance of animal testing to supporting public health.
Although animal and human tests are generally similar, this type of testing has to be adjusted in each species and for each sample type (blood, feces, nasal swab). Human and animal tests are not intended to be interchangeable. Some testing performed on animals is based on the published tests used in people, but animal testing is not likely to reduce the availability of tests for people if labs follow recommendations from the FDA, USDA, and CDC that animal testing be conducted using tests developed for animals.
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.
There are no products that are FDA-approved to disinfect the hair or coats of pets, but if you do decide to bathe or wipe off your pet, first talk to your veterinarian about suitable products. Never use hand sanitizer, counter-cleaning wipes or other industrial or surface cleaners, as these can penetrate the skin or be licked off and ingested by your pet. If you have recently used any of these products on your pet, or your pet is showing signs of illness after use, contact your veterinarian.
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. Similarly, APHIS CVB has not licensed any products to treat or prevent COVID-19 in animals.
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: Yes. Coronaviruses are a large family of viruses. Some coronaviruses like COVID-19 cause cold-like illnesses in people, while others cause illness in certain types of animals, such as cattle, camels, and bats. Some coronaviruses, such as canine and feline coronaviruses, only infect animals and do not infect humans. For example, bovine coronavirus causes diarrhea in young calves, and pregnant cows are routinely vaccinated to help prevent infection in calves. This vaccine is only licensed for use in cattle for bovine coronavirus and is not licensed to prevent COVID-19 in cattle or other species, including humans.
Dogs can get a respiratory coronavirus, which is part of the complex of viruses and bacteria associated with canine infectious respiratory disease, commonly known as “kennel cough.” While this virus is highly contagious among both domestic and wild dogs, it is not transmitted to other animal species or humans.
Most strains of feline enteric coronavirus, a gastrointestinal form, are fought off by a cat’s immune system without causing disease. However, in a small proportion of these cats, the virus can cause feline infectious peritonitis (FIP), a disease that is almost always fatal.
Other species, like horses, turkeys, chickens, and swine, can contract their own species-specific strains of coronavirus but, like the other strains mentioned above, they are not known to be transmissible to humans. More information is available in the American Veterinary Medical Association’s fact sheet about coronaviruses in domestic species.
A: There are no data to suggest that current or previous infection with another strain of coronavirus would make your pet more or less likely to get COVID-19.
A: Species-specific coronavirus vaccines are unlikely to work against this type of coronavirus because it is a new virus that is different from the species-specific strains of coronavirus targeted by the vaccine.
A: While you should not avoid necessary visits to your veterinarian due to the COVID-19 outbreak, you should exercise reasonable caution just like you would if you were going to any other public place. If you are concerned about your own health or that of your pet when going to the veterinarian, contact their office in advance to discuss any recommended precautions.
A: There is no reason to think that any animals, including shelter or rescue pets, in the United States, might be a source of COVID-19. The virus that causes COVID-19 spreads mainly from person to person, typically through respiratory droplets from coughing, sneezing, or talking.
A: The FDA has been and is continuing to closely monitor how the COVID-19 outbreak may impact the animal medical product supply chain.
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.