Frequently Asked Questions

United States Federal Government is committed to ensuring the safe and healthful use of all products within U.S. borders.  The range of products in use, of course, is vast—from all kinds of foods and medicines intended for humans or animals; medical devices, supplies and vaccines; and mechanical items of every sort.  The U.S. Federal Government also has a responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health. Problems of life-threatening potential can arise in the use of any of these items—not only from the composition of the products themselves, but stemming from their packaging, labeling, and application.

When you encounter an incident—likely arising from the use of a particular product—that has threatened human or animal health and safety, we encourage you to provide a "safety report," which is a description of the event, so that we may investigate.

Consumers, health professionals, and regulated companies can play an important public health and security role by reporting any adverse reactions or other problems they encounter with a product. The Government is responsible for ensuring that foods, for example, are safe, wholesome, and correctly labeled. It also oversees a variety of medicines, medical devices and supplies, blood products, vaccines, cosmetics, veterinary drugs, animal feed, and a host of electronic and mechanical products to ensure that these items are all safe and effective for use. The U.S. Food and Drug Administration (FDA) is also responsible for reducing the harm of tobacco products.

Testing, which is required by law to establish the safety of certain products such as drugs and medical devices, is typically conducted on small groups before the U.S. Government may approve the product for sale. Some problems can remain unknown—only to be discovered when a product is used by a larger number of people.

Timely reporting of problems allows Federal agencies to take prompt action. Each report is evaluated to determine how serious the problem is and, if necessary, additional information may be requested from the person who filed the report.

• Report what happened as soon as possible. Give names, addresses, and phone numbers of persons affected. Include your name, address, email, and phone number, as well as that of any doctor or hospital, if emergency treatment was provided.
• State the problem clearly. Describe the product as completely as possible, including any codes or identifying marks on the label or container. Provide the name and address of the company on the product label, and the name and address of the store or other source, from which the product was obtained, with the date of purchase. (Don't discard the product packaging and labeling—these provide codes, numbers, and dates that help in tracing the product back to the manufacturing plant.)
• You also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product.

There are other resources to assist you, if your situation is an emergency or otherwise serious. For non-emergency reports and complaints, please see the Safety Report Directory and click on any product names/topics listed to find out how and where to submit your report. For a Directory of Federal Toll-Free Telephone and TDD/TTY numbers, you may also visit the National Contact Center website.

Under certain circumstances, some organizations are required by statute or regulation to submit a safety report to the Federal Government. When a report is required by statute or regulation, the report is termed a "Mandatory" report. Reports that are not required by statute or regulation are termed "Voluntary" reports.

Currently, the following Mandatory reports can be submitted on the Safety Reporting Portal:

• Reportable Food Report- a safety report on a Reportable Food sent by a registered Food Facility or responsible party that manufactures, processes, packs, or holds food for human or animal consumption in the U.S.
• Animal Drug Safety Report- a report on an adverse event and/or product problem with an animal drug; sent by a Marketing Authorization Holder, or their representative
• Gene Transfer Research Adverse Event Report: For adverse events that occur during NIH-sponsored gene transfer clinical trials; sent by a principal investigator or a member of the research team
• Small Pharmaceutical Report- an adverse event report on Marketed Human Drugs and Biologics
• Premarket Safety Report- an adverse event report on Premarket Human Drugs and Biologics
• Tobacco Problem Report- an adverse experience report involving a tobacco product as specified in the marketing authorization order

Other Mandatory reporting events do exist; however, the Portal does not accept those reports at this time. To find out where to submit reports not listed above, please see the Safety Report Directory

Voluntary reports, though not required by statute or regulation, help make the Federal Government aware of any problems that may cause harm to the public. Voluntary reports currently accepted by the Safety Reporting Portal include:

• Animal Food Safety Report- which could be either Pet Food or Livestock Food Safety report - can be submitted by animal owners, farm managers, veterinarians and other professionals, or concerned citizens on an adverse event and/or product problem with pet food or livestock food.
• Reportable Food Report- a safety report on a Reportable Food sent by a federal, state, or local public health official
• Tobacco Product Report- a report on a product problem and/or health-related problem involving a tobacco product, whether about a user or a non-user, using reporting pathways built for a consumer/concerned citizen, healthcare professional, manufacturer or researcher. Tobacco product retailers and distributors as well as research sponsors will find these reporting pathways to be relevant.

If the ZIP/Postal code is not applicable to your address, please type "NA" in the field.

The Safety Reporting Portal currently supports safety issues submitted in English.

Guidance documents for reporting safety issues involving animal drugs are available here.

Information regarding animal drugs can be found here.

Information regarding how drug manufacturers report animal adverse drug events through the SRP can be found here.

Guidance documents for reporting safety issues involving pet foods are available here.

Information regarding pet foods can be found here.

Guidance documents for reporting safety issues involving human or animal reportable foods are available here.

Information regarding human or animal reportable foods can be found here.

Information regarding tobacco products can be found here.

Yes. System users can get most questions answered within these FAQs. Account holders can practice by saving a draft report that they can return to for revision and submission or deletion. When system users encounter technical difficulties, they can reach out to the help desk, SRPSupport@fda.hhs.gov.

A reportable food is a food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to the food will cause serious adverse health consequences or death to humans or animals (Sections 201(ff) and 417(a)(2) of the FD&C Act). Information for a mandatory Reportable Food Registry (RFR) report is typically submitted to FDA by a responsible party such as a manufacturer and/or a party within the supply chain. Voluntary RFR reports can be submitted by government public health officials only.

When entering a safety report in the Portal, the names or titles of each page of the report appear in the navigation bar on the left side of the screen. Alongside each page name, there is a small square box that is used to indicate your progress through the various report pages. When you first start a report, all the boxes are white. The white color indicates a page that has not yet been visited. After you visit a page, the box changes to a partially (half) filled square. If you complete all the required fields on a page, the box changes to a completely-filled blue square.

When you choose to submit a report and click on the Submit button, the system will scan the report to see if you have missed any required fields. A page will appear listing the sections where required fields were missed. These incomplete pages are also indicated by a half-filled box. In order to successfully submit a safety report, all required fields must be answered, and the completely-filled box next to the page name will serve as a visual indication that those requirements have been satisfied.

You may attach files that support the safety report you are submitting, including medical documents, lab reports, photographs, and other types of documentation. For a full list of the different types of attachments, click on the "Type of Attachment" drop down field in the Attachment section of the report.

The time it takes to complete a report can vary quite a lot—depending on how much information you wish (or are able) to provide, and whether you are required by statute or regulation to submit the particular safety report to the Federal Government (mandatory reports) or not (voluntary report).

For an estimate on the time it takes to complete a report, click here.

If you are unable to complete and submit your report for any reason, you may find it more convenient to provide whatever information you can and then return at a later time to finish. In order to return to a partially-completed report, you will need to create a user account. To create a user account, click here.

Yes. However, for the Portal to save whatever you've entered and recognize you when you return, you will need to establish a user account. Setting up an account is quick and easy—and having an account can make your reporting easier, as well. To create an account, click here.

Yes. The Safety Reporting Portal is maintained on a secure network site.

Upon completion of the report, you will be presented with a confirmation page that includes an Individual Case Safety Report ID (ICSR). The ICSR is your official confirmation that FDA or NIH have received your completed report.

The confirmation page contains links to an html and PDF version of your report containing all submitted information, which can be printed from your browser, or downloaded onto your computer.

The report you downloaded requires Adobe Acrobat Reader to view the file. If you do not have Adobe Acrobat, follow this link to download Adobe's free Acrobat Reader¹ software.

Your report helps to ensure that products marketed in the United States are safe and properly manufactured, labeled, and handled. Every report is evaluated to determine the seriousness of the problem and what follow-up is needed.

Depending on your issue's seriousness, it will either be investigated immediately or designated for other action (such as reviewing the information at the next inspection of a facility that may have manufactured the product).

In cases where the product could be a health hazard, you may be contacted in order to gather more information about the problem. An investigator may also visit retailers and wholesalers that distributed the product, as well the product's manufacturer, to find out whether there have been other complaints. Especially if illness, injury, or death arose from using the product, and problems appeared widespread, a recall would be instituted to remove the product from the market, and the media would be contacted to notify the public.

Your report is an important part of the nation's monitoring system and helps ensure that the products we all rely on are safe to use.

You can only see a history of your submitted reports if you created an account and have submitted reports via that account. When you log in, you will be brought to the My Report History page where a listing of your previously submitted reports is displayed.

After you've submitted a report, you may discover additional information (such as packaging material, additional test results or a change in the condition of an affected person or animal) that would change or add to the information already provided or there is a transcription error in a previous submission. In such cases, please submit a "follow-up report."

Account Holder Instructions:

If you submitted your original report through this Portal, and you were logged into a Portal user account when you submitted it, use the steps below:

1. Log in to your account
2. Locate and select your report record from the “My Reports” page; available reports are listed in “Submitted Reports Available for Follow-up”
3. Select “Start Follow-up Report”
4. Select the follow-up reason (if question appears on your report)
5. Proceed to modify or add to your earlier report material

You may submit as many follow-up reports as you wish - just note that your follow-up always refers to your most recent report (even if that, too, was a follow-up).

Guest User Instructions:

If you submitted your original report through this Portal as a guest (i.e., without setting up an account by selecting “Report as Guest” from the home page), you can submit a follow-up report that modifies or adds to the initial report only if you have the “Report Key” from the last report you submitted. The Report Key is provided to you on the Report Submission Confirmation screen when you submit a report. It is also in the report if you printed/saved a copy. To submit a follow-up report:

1. From the home page, after selecting “Report as Guest,” select “Follow-up on a report previously submitted as a guest portal user”
2. Type the “Report Key” into the open field for “Enter the Report Identification Key” and select “Begin Report”
3. You can then correct or add to the last submitted information

Without the Report Key, you can submit only another new report, although it is helpful to include a statement that you submitted related information in a previous report.

Please note:

1. Only the most recent information is saved and submitted to the FDA. Previous information is not saved on SRP once corrections or changes are made.
2. The questions presented to you in follow-up reporting are from the same version of the SRP as the original report you submitted. If you choose to submit a brand-new report, you may see different questions or answer options if a newer version of SRP has been launched.

If you have reason to believe that a product is related to a condition in more than one animal or person, please submit a separate report for each individual and NOT a follow-up.

The Feedback feature allows you to provide input regarding your experience using the Portal. It is available as a link in the horizontal menu at the top of the screen. It can be used as a means to submit positive and/or negative comments concerning your experience with the system, including suggestions for improvement. The information is relayed to the Federal Government and system administrators, and is used to improve your experience with the system.

For the Mandatory Reportable Food Report, you can choose to submit a report as a guest or as an account holder. When you log in as an account holder to create your report, certain fields are pre-populated from your user account. These include fields like first name, last name, and certain pieces of contact information. Some of the contact information questions are required when you report using your account. However, when you enter a report as a Guest, some of these fields are not required.

Users who choose to submit a report as a guest must complete the report in one sitting. There is no ability to save a draft and return to the report later to complete it. Also, there is no ability to see a list of your previously submitted reports. These capabilities exist only for users who have created a user account via logging into their account.

To establish a Portal account for reporting Gene Transfer Research adverse events, you will need to first create an account on the NIH GeMCRIS system.

If you already have a GeMCRIS account, and you are a principal investigator or a study sponsor, a Safety Reporting Portal account was automatically created for you. Information regarding this account was sent to the address you provided when you registered on the NIH system.

If you are new to reporting Gene Transfer Research adverse events, you must first register with the NIH GeMCRIS system. When you register, if you are a primary investigator or study sponsor, you will automatically have a Safety Reporting Portal account created for you. You will receive a letter in the mail with your account information and instructions for logging in to the system.

The benefits of having an account are as follows:

• Faster data entry
• Save a report and finish it later
• See a list of your submitted reports
• Easier follow-up submissions

If you haven't used the Portal during the past 365 days or you cannot enter the portal, your account may be deactivated. Go to the Portal's Home page where you log in and click the "Reset Password/Unlock Account or Reactivate Account" link.

If you tried more than three (3) times to log in and failed, your account is locked. Go to the Portal's Home page where you log in and click the "Reset Password/Unlock Account or Reactivate Account" link.

Your SRP password expires every 120 days. The system will require you to change your password after 120 days since your last password reset/change.

Go to the Portal's Home page where you log in and click the "Reset Password/Unlock Account or Reactivate Account" link.

When you log in with your account credentials you will be taken to your My Report History page. Click on the My Account option in the left navigation menu. You will be taken to your account profile where you can update your address and personal settings. Click on the Change Password and Security Question button. The system will take you to a screen that will allow you to change your password.

When you log in with your account credentials, you will be taken to your My Report History page. Click on the My Account option in the left navigation menu. You will be taken to your account profile where you can update your address and personal settings, and save the changes you make.

No. This is due to validation, authentication, and other technology limitations. Previous versions of the RFR reports cannot be loaded into the Safety Reporting Portal. If you need to amend an RFR report that was previously submitted to FDA in the earlier version, please consult FDA by calling your assigned investigator or your FDA district office. If you are required to amend your report after consultation with FDA, you will need to re-submit the latest information (including information that was captured in the previous version of the RFR system) to the Safety Reporting Portal and provide a statement in the narrative field with the following verbiage "This is an amended report to ICSR xxxxxxx.", replacing the 'xxxxxxx' with the ICSR number that you originally received.

When you are reporting or accessing the My Reports or My Account page, the Back button functionality is overridden to maintain integrity of data collected through these forms. You can use the Portal's navigation links or buttons to navigate between pages or exit the data collection forms. You can, however, use the Back button on informative pages or links such as ABOUT THE PORTAL, SAFETY REPORT DIRECTORY, FAQS, RELATED LINKS and CONTACT US.

The HHS Privacy Policy outlines the information we learn when you visit our site and how we use this information.

When you first submit a report, the document can be downloaded and viewed as a PDF. This version of the report is also available in the "Submitted Reports Available for Follow-Up" table on the My Reports page.

If you choose to submit a follow-up report, the file moves into the Draft Reports table on the My Reports page where you may edit and save drafts to the follow-up instance. The originally submitted report remains available in a PDF format in the Submitted Reports Available for Follow-Up Table. You may have only one active follow-up version of a submitted report at any time.

Once you submit the follow-up report, the file moves into the Submitted Reports Available for Follow-Up Table. Since you can only submit a follow-up report on the most recently submitted report version, the original report is no longer available for viewing. Therefore, if you need access to all submitted versions of a report, please download the PDF version.

The Download XML File button is available on the Report Submission Confirmation page when a user submits a Reportable Food Report (Mandatory v3 or Voluntary v2). By clicking on the button, the user can download the XML file for the Report the user just submitted. For more details on the XML file, contact SRP Support (SRPSupport@fda.hhs.gov) and request a copy of a document that will describe the XML file.

Cloning is a convenience feature which creates a new draft report using the responses from a previously submitted report. It is intended to reduce the time for data entry. In SRP, cloning of reports is supported for Animal Drug Report (GL42v2), Pet Food Report (1002), Tobacco Investigational Report (TIR) Reports and Tobacco Product Report (TPR) Reports. Reporters may clone a report when the data in certain sections of the report is/are either identical or very similar to a report available to be cloned. In TIR, for example, in the cloned report, the reporter will find fields in sections such as Contact Information, Research Summary, and Study Tobacco Products pages pre-populated with values from the cloned report. The prepopulated fields should be closely examined for their accuracy and relevance with respect to the new report to be submitted; they can be edited as needed. Note that cloning is not the same as creating a follow-up report.

When a connection is interrupted, submitters should not navigate away from nor close the browser or screen. SRP has a 30-minute grace period, during which all data is preserved. If the device reconnects to SRP during this grace period, users can continue to report from where they left off. If the device cannot reconnect for more than 30 minutes, all guest user's entries are lost. For registered users, SRP saves the unfinished report as a draft. Thus, registered users are able to return and continue at a later time. (You are encouraged to register for an account to save your data; however, it is not required.)

The Safety Reporting Portal (SRP) supports the following web browsers:

• Microsoft Internet Explorer: Version 11.0
• Microsoft Edge: Version 86.0.622.69 and above
• Mozilla Firefox: Version 65.0 and above
• Google Chrome: Version 72.0 and above
• Apple Safari: Version 11.0.1 and above

If you encounter a browser problem, please send an email to the helpdesk (SRPSupport@fda.hhs.gov) describing the issue and indicating the browser and version number that you are using.

Viewing documents in the Portal requires a Portable Document Format (PDF) reader. If one is not installed on your system, you can download a free reader from Adobe here.

The listed supported browsers are all free to download on the internet.

Follow the steps below to disable compatibility mode:
1. Click Tools (looks like a gear) at the top right of the browser.
2. Click on Compatibility View Settings.
3. When the Compatibility View Settings window pops up, make sure that the box next to 'Display intranet sites in Compatibility View' is unchecked.

The Safety Reporting Portal was designed to support optimal viewing at a resolution (or pixel dimensions) of 1024 X 768 pixels.

In Microsoft Windows®, you can generally change your screen resolution by doing the following:

• Open Display in Control Panel.
• On the Settings tab, under Screen resolution, drag the slider, and then click Apply.
• [Note: In the Vista operating system, you would navigate to: Control Panel => Personalization => Display Settings.]
• When prompted to apply the settings, click OK. Your screen will turn black for a moment.
• Once your screen resolution changes, you have 15 seconds to confirm the change: Click Yes to confirm the change; click No or do nothing to revert to your previous setting.

With Apple® systems, to change your screen resolution, follow these steps:

• Navigate in the Apple menu to System Preferences => Displays.
• Click on the desired resolution in the Resolution section of the control panel.  (The new resolution will be displayed after you select it.)
• Close the Displays control panel by clicking the close box in the upper-left corner.

JavaScript, not to be confused with Java, is a client-side programming language used to recognize the user's inputs and to respond to them. While there are many programming languages, only JavaScript is recognized by all standard browsers.

When accessing the Portal using the Chrome browser, the spell checker dialog box goes behind the main window and the next time you click on the spell checker icon, the dialog box does not display. You can work around this problem by minimizing or moving the main window and then closing the spell checker. Or, you can use a different tested browser. See above for a list of tested browsers.

To email a question about supporting requirements, policy, or legal assistance, please visit the Contact Us page for more information.

The group access feature allows people, within the same organization, to submit reports for a single report type. Groups also allow people to share their reports with other users in the organization, including editing and submitting other users' draft reports, and creating follow-up reports for other user submitted reports.

The Group Access system is wholly managed by the user(s) in the group(s), not the FDA or Federal Government. Group Access users are encouraged to be vigilant about maintaining user access.

Groups can be created only for Reportable Food Reports, Animal Drug Report, Pet Food Report, Livestock Food Report, and Tobacco Product Reports.
Any SRP registered user can create groups for the above listed reports; guest users cannot create groups.

No. Any individual can use this feature to submit the various types of group-supported SRP reports using a single SRP account.

Yes.

Click the "Create New Group" button on the My Groups page. Complete the information in the pop-up window that displays and click "Save".

Yes. During creation of the group, you will be prompted to select a report type for the group. The default selected will be the report type you are registered with, but you will be able to select any report type from the list.

Group Administrators can add themselves as a Group Member or Group Lead.

Note: Group Leads can view, edit, and submit all group users' draft reports.

Note: Group Members can only view and follow up on their own draft reports. Reportable Food Reports DO NOT have a Group Member role.

Each group must have at least one Primary Group Admin. A Backup Group Admin can be added to perform the same tasks as the Primary Group Admin.

There is no limit on the number of Group Leads and Group Members a group can have.

Yes. As a registered SRP user, you can continue to submit individual reports. They will appear on the My Reports page when you select "My Reports"
from the Select Group drop down.

No. You cannot access any report you created and/or submitted in a group after you leave that group. However, reports that you created/submitted outside of the group as an individual will still be available to you.

You cannot access any report created and/or submitted by a group after you leave the group.

Users who have been removed from a group cannot access any report created and/or submitted by the group, including reports they created or submitted for the group.

To rejoin a group, contact a Group Admin or Group Lead of that group.

Yes.

Yes. To add a previous user back to a group, use the same procedure for adding a new member.

It is possible to recover deleted reports. A support request from the Group Admin must be sent to the SRP Technical Support Team (SRPSupport@fda.hhs.gov), specifying the ICSR number(s) for submitted reports, or Report ID(s) for draft reports. After the SRP Technical Support Team verifies the existence of these reports, the request will be forwarded to the corresponding FDA center for approval. A response will be sent back to you as soon as the SRP Technical Support Team receives the FDA center's response.

The user cannot be added to a group because they are registered to a report that does not support the group access feature.

A group can only be deleted after all members of the group have been removed from the group.

Once a group is deleted, it cannot be recovered. You must create a new group.

Do not check the checkbox in the Delete Group confirmation window.

Groups submitting Reportable Food reports do not have the Group Member role.

No. CFSAN (DSRV) and CTP (TPR) offer mobile-friendly optimized reports. CVM reports can be submitted via mobile device but have not been optimized to be mobile-friendly. CDER reporters must be registered users and use a desktop or laptop computer. CDER reporters are not permitted to use mobile devices for report submission.

All reports in the SRP (except CDER) can be submitted via mobile devices. However, the following reports (food, infant formula, dietary supplements, cosmetics, and a limited tobacco report for guest users; and the food, infant formula, dietary supplements, and cosmetics for registered user) have been optimized to be mobile device-friendly.

No, this is a mobile-friendly report and does not require you to download an app to report on SRP using your mobile phone or device.

While the mobile-friendly reports are formatted to work with FDA-supported browsers, depending on your device, you may have to resize your screen. Reports submitted on your mobile devices will have an abbreviated set of questions compared to the desktop version.

As a guest report submitter, you must submit the report all at once, as there is no option to save the report and return to complete at a later time. As a registered user reporting on food, infant formula, dietary supplements, and cosmetics, you can save your progress and submit later from either your desktop or mobile device. (You are encouraged to register for an account to save your data; however, it is not required.)