Contains Nonbinding Recommendations Show
FDA develops regulations based on the laws set forth in the Federal Food, Drug, and Cosmetic Act or other laws under which FDA operates. To further support the public health goals of the Dietary Supplements Health and Education Act (DSHEA), FDA also issues guidance documents containing nonbinding recommendations to help industry understand and comply with all regulations and the law. You can access guidance and other regulatory documents by clicking on the links below. We solicit information and comments, announced in the Federal Register and posted in dockets on Regulations.gov, from concerned citizens, industry, and organizations on a wide range of issues related to the implementation of DSHEA. For additional information, see the Dietary Supplements webpage. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. This guidance document provides guidance to the dietary supplement industry for complying with the adverse event reporting and recordkeeping requirements prescribed for dietary supplement manufacturers, packers, and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462). As required by section 3(d)(3) of this law, FDA (or “we”) issued this guidance document to describe the minimum data elements for serious adverse event reports for dietary supplements. This guidance document also provides guidance on (1) how, when, and where to submit a serious adverse event report for a dietary supplement; and (2) records maintenance and access for serious and non-serious adverse event reports and related documents. Further, this guidance document also provides guidance on how to electronically submit a serious adverse event report for a dietary supplement. (We identify recent changes to the guidance document’s questions and answers by identifying the date of the most recent change.) We have issued a separate guidance document on the reporting of serious adverse events for over-the-counter (nonprescription) human drug products marketed without an approved application. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance documents means that something is suggested or recommended, but not required. For purposes of this guidance document, “you” refers to the dietary supplement industry. On December 22, 2006, the President signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to adverse event reporting and recordkeeping for dietary supplements and non-prescription drugs marketed without an approved application. This guidance document contains questions and answers relating to the Dietary Supplement and Nonprescription Drug Consumer Protection Act’s requirements concerning the mandatory reporting to FDA of serious adverse events for dietary supplements, the minimum data elements to be submitted in such reports, and records of serious and non-serious adverse events reported to a dietary supplement manufacturer, packer, or distributor. This guidance document also provides guidance to the dietary supplement industry on how to submit a serious adverse event report for a dietary supplement via the FDA Safety Reporting Portal (formerly referred to as the MedWatchPlus investment). Electronic submission is voluntary. A manufacturer, packer, or distributor of a dietary supplement who is unable to or chooses not to submit their mandatory serious adverse event report using the FDA Safety Reporting Portal may continue to submit their report by mail on the paper MedWatch form, Form FDA 3500A. For purposes of this guidance document, in several locations, we refer to Form FDA 3500A as the “paper version” and the FDA Safety Reporting Portal as the “electronic version” of the required “MedWatch form” as prescribed by the Dietary Supplement and Nonprescription Drug Consumer Protection Act.
This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The time required to maintain the dietary supplement adverse event records recommended in this guidance and required by section 761(e)(1) of the FD&C Act is estimated to average 30 minutes per record, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. Send comments regarding this burden estimate or suggestions for reducing this burden to: Office of Nutrition, Labeling, and Dietary Supplements, Division of Dietary Supplement Programs, HFS - 810, Center for Food Safety and Applied Nutrition Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740. This guidance also refers to previously approved collections of information found in the FD&C Act. Submission to FDA of serious adverse event reports for dietary supplements and follow-up reports of new medical information is required by section 761(c)(1)-(2) of the FD&C Act. The electronic submission of dietary supplement adverse event information to us via the FDA Safety Reporting Portal has been approved under OMB Control No. 0910-0645, while submission of dietary supplement adverse event information to us using the original paper forms (Forms FDA 3500 and 3500A) has been approved under OMB Control No. 0910-0291. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0910-0635 (expires 3/31/2019). [1.] This guidance has been prepared by the Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. [2.] Under section 403(e)(1) of the FD&C Act (21 U.S.C. 343(e)(1)) and 21 CFR 101.5, dietary supplements and other foods in package form must bear a label containing the name and place of business of the product's manufacturer, packer, or distributor. [3.] Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)) requires the manufacturer, packer, or distributor of a dietary supplement to submit to FDA "any report received" of a serious adverse event associated with the dietary supplement when used in the United States. Accordingly, where a report is required, responsible persons must provide FDA with the information about the serious adverse event supplied by the initial reporter. Moreover, section 761(d) of the FD&C Act (21 U.S.C. 379aa-1(d)) requires serious adverse event reports to be submitted using the MedWatch form. The MedWatch form, Form FDA 3500A, in existence when the Dietary Supplement and Nonprescription Drug Consumer Protection Act was adopted, includes Section C, which seeks information about "Suspect Product(s)" known to the responsible person. The electronic version of the MedWatch form available via the FDA Safety Reporting Portal also includes a section for “Suspect Product(s).” Therefore, manufacturer A must report information about manufacturer B's products on the MedWatch form in the example above even though manufacturer A did not manufacture, pack or distribute those products. [4.] See Question 6 and Appendix A for guidance on how FDA interprets the term "inpatient hospitalization" and the other criteria defining a serious adverse event. This document supercedes the previous version, issued June 2009. Revised 2013. |