Guidance for Industry 
Questions and Answers Regarding 
Adverse Event Reporting and 
Recordkeeping for Dietary Supplements 
as Required by the Dietary Supplement 
and Nonprescription Drug Consumer 
Protection Act 
Additional copies are available from: 
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 
(Tel)240-402-2375 
http://www.fda.gov/FoodGuidances 
You may submit written comments regarding this guidance at any time. Submit written 
comments on the guidance to the Division  of Dockets Management (HFA-305), Food and Drug 
Administration,  5630 Fishers Lane, rm. 1061, Rockville,  MD 20852.  All comments should be 
identified  with the title of the guidance document. 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
September 2013 
OMB Control No. 0910-0635 
Expiration  Date: 02/29/2016 
*See additional  PRA statements in Section IV of this guidance Contains Nonbinding Recommendations 
Table of Contents 
I.  Introduction 
II.  Background 
III.  Questions and Answers 
IV.  Paperwork Reduction Act of 1995 
V.  Appendix:   Instructions  for Completing  the MedWatch Form 
3500A to Report a Serious Adverse Event Associated with a 
Dietary Supplement   
  2  Contains Nonbinding Recommendations 
1
Guidance for Industry  
Questions and Answers Regarding Adverse Event Reporting and 
Recordkeeping for Dietary Supplements  as Required by the Dietary 
Supplement  and Nonprescription  Drug Consumer  Protection Act  
This guidance represents the Food and Drug Administration's  (FDAs) 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 such approach satisfies the 
requirements of the applicable  statute and regulations. If you wish to discuss an alternative 
approach, contact the FDA staff responsible for implementing  this guidance. If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
document. 
 I.  Introduction 
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 documents 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. 
FDAs 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. 
  3   II.  Background 
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 Acts 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.   
 III.  Questions and Answers 
1.  When do the requirements of the Dietary Supplement and Nonprescription Drug 
Consumer Protection Act become effective? 
The effective date for compliance with the law was December 22, 2007. 
2.  What types of foods are covered by the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act requirements? 
The requirements of this law only apply to dietary supplements.  No other types of food 
are covered. 
3.  What is FDA's definition of a dietary supplement? 
Dietary supplements are defined, in part, as products (other than tobacco) intended to 
supplement the diet that bear or contain one or more of the following  dietary ingredients: 
a.  A vitamin; 
b.  A mineral; 
c.  An herb or other botanical; 
d.  An amino acid; 
e.  A dietary substance for use by man to supplement the diet by increasing the total 
dietary intake; or 
  4  f.  A concentrate, metabolite,  constituent, extract, or combination  of any ingredient 
mentioned above. 
Further, a dietary supplement must be labeled as such and must be intended for ingestion. 
A dietary supplement must not be represented for use as a conventional  food or as a sole 
item of a meal or the diet.  Finally,  the dietary supplement category generally does not 
include articles approved as new drugs, licensed as biologics,  or authorized for clinical 
investigation  under an IND, unless the article was previously  marketed as a dietary 
supplement or as a food. The complete statutory definition  can be found in section 
201(ff) of the FD&C Act (21 U.S.C. 321(ff)). 
4.  [Updated September 2013] Does the Dietary Supplement and Nonprescription Drug 
Consumer Protection Act apply to foods other than dietary supplements, and if not, 
are there other mandatory reporting requirements for foods other than dietary 
supplements? 
The requirements of the Dietary Supplement  and Nonprescription  Drug Consumer 
Protection Act do not apply to foods other than dietary supplements.  However, there are 
other mandatory reporting requirements in section 417 of the FD&C Act that requires a 
responsible  party to inform FDA of reportable food, which is defined as an article 
of food (other than infant formula or dietary supplements) for which there is a reasonable 
probability  that the use of, or exposure to, such article of food will cause serious adverse 
health consequences or death to humans or animals.  Also, infant formula manufacturers 
must comply with notification  requirements for violative  infant formula under 21 CFR 
107.240.     
5.  What is an adverse event? 
An adverse event is any health-related event associated with the use of a dietary 
supplement that is adverse.  Section 761(a)(1) of the FD&C Act (21 U.S.C. 379aa-
1(a)(1)). 
6.  What is a "serious adverse event?" 
A "serious adverse event" is an adverse event that: 
  Results in death, a life-threatening  experience, inpatient  hospitalization,  a 
o
persistent or significant  disability  or incapacity,  or a congenital anomaly or birth 
defect; or 
  Requires, based on a reasonable medical judgment,  a medical or surgical 
o
intervention  to prevent an outcome described above. 
Section 761(a)(2) of the FD&C Act (21 U.S.C. 379aa-1(a)(2)). 
FDA considers inpatient hospitalization  to include initial  admission to the hospital on an 
inpatient basis, even if the patient is released the same day, and prolongation  of an 
  5  existing inpatient hospitalization.   Please see the Appendix of this guidance for more 
information  on the criteria for serious adverse events. 
7.  [Updated September 2013] What is a "serious adverse event report?" 
A "serious adverse event report" is a report that must be submitted to FDA using the 
MedWatch form when a manufacturer, packer, or distributor  of a dietary supplement 
receives any report of a serious adverse event associated with the use of the dietary 
supplement in the United States.  See section 761(a)(3) and (b)(1) of the FD&C Act (21 
U.S.C. 379aa-1(a)(3), (b)(1)). 
8.  Who must submit the serious adverse event report for a dietary supplement to 
FDA? 
The manufacturer, packer, or distributor  whose name (pursuant to section 403(e)(1) of the 
FD&C Act)2 appears on the label of a dietary supplement marketed in the United States is 
required to submit to FDA all serious adverse event reports associated with use of the 
dietary supplement in the United States.  Section 761(b)(1) of the FD&C Act (21 U.S.C. 
379aa-1(b)(1)). 
The Dietary Supplement and Nonprescription  Drug Consumer Protection Act usually 
refers to the entity that is required to submit a serious adverse event report to FDA as the 
"responsible  person."  This guidance uses the term "responsible  person" as an alternative 
to "manufacturer, packer, or distributor." 
9.  Are retailers required to submit serious adverse event reports for dietary 
supplements to FDA? 
Usually not, but the answer could be yes in some situations.  Whether a retailer is 
required to submit a serious adverse event report for a dietary supplement it sells will 
depend on two things:  (1) whether the retailer's name appears on the label of the dietary 
supplement; and (2) if so, whether the retailer has entered into an agreement with the 
manufacturer or packer of the dietary supplement transferring responsibility  for 
submitting  adverse event reports for the product to the other firm. 
A retailer whose name appears on the label of a dietary supplement as its distributor  may, 
by agreement, authorize the manufacturer or packer of the dietary supplement to submit 
the required adverse event reports for such dietary supplement to the FDA so long as the 
retailer directs to the manufacturer or packer all adverse events associated with such 
dietary supplement that are reported to the retailer through the address or telephone 
number on the label of the dietary supplement.  Section 761(b)(2) of the FD&C Act (21 
U.S.C. 379aa-1(b)(2)).  If such an agreement is in place and the retailer complies with its 
obligation  to forward the dietary supplement adverse event reports it receives to the other 
party (i.e., the manufacturer or packer), the retailer is under no obligation  to report to 
FDA any serious adverse events for the dietary supplements covered by the agreement. 
Likewise, if the retailer's name does not appear on the label of a dietary supplement,  the 
  6  retailer is not responsible for reporting any serious adverse events associated with the 
supplement to FDA. 
10. [Updated September 2013] When must reports of serious adverse events be 
submitted to FDA? 
Serious adverse event reports received through the address or phone number on the label 
of a dietary supplement,  as well as all follow-up reports of new medical information 
received by the responsible person within one year after the initial  report, must be 
submitted to FDA no later than 15 business days after the report is received by the 
responsible person.  Section 761(c)(1)-(2) of the FD&C Act (21 U.S.C. 379aa-1(c)(1)-
(2)).  For the reasons discussed below, FDA recommends that all other serious adverse 
event reports received by the responsible person also be submitted to FDA within 15 
business days of receipt. 
Section 761(c)(1) of the FD&C Act, which contains the 15-day deadline for submitting 
serious adverse event reports to FDA, expressly applies to serious adverse event reports 
resulting from information  received by the responsible person through the address or 
telephone number on the product label.  Although  the FD&C Act does not expressly 
provide a timeframe for serious adverse event reports that the responsible person receives 
by other means (such as by e-mail or fax), the reporting of such adverse events is 
required by the plain language of section 761(b)(1) of the FD&C Act (providing  that the 
responsible person "shall submit . . . any report received of a serious adverse event 
associated with such dietary supplement when used in the United States . . . ." (emphasis 
added)), and we recommend that such reports be submitted to FDA within the same 
timeframe as reports received by phone or mail, i.e., within 15 business days of their 
receipt by the responsible person. 
Prompt submission  of serious adverse event reports is important for public health 
reasons.  Delayed reporting of some serious adverse events to FDA solely because of the 
medium through which the adverse event was reported to the responsible person would 
lessen the effectiveness of adverse event reporting as an early warning sign of possible 
safety problems with dietary supplements.  Without prompt notification  of all serious 
adverse events associated with dietary supplements, FDA would be unable to investigate 
and follow up promptly,  which in turn could cause delays in alerting the public when 
safety problems are found.  Therefore, we recommend that all serious adverse event 
reports received by the responsible person should be reported to FDA within 15 business 
days of receipt, regardless of the means by which the responsible person received the 
initial  report. 
As soon as all of the minimum  data elements (i.e., identifiable  patient, initial  reporter, 
identity  and contact information  of responsible person, suspect dietary supplement, and 
serious adverse event) are known to the responsible person, the 15-business-day time 
clock begins to run.  That date is Day 0 and should be entered in section G, block 4, on 
the paper version of the MedWatch form.  For the electronic version, this is located on 
the Introduction  page as Enter the date you received the initial  report.  If the 
  7  responsible person does not initially  receive sufficient data for a serious adverse event 
report to FDA, but later receives additional  information  completing  the minimum  data 
elements listed in Question 13, then the responsible person should submit the serious 
adverse event report within 15 business days of the date the additional  information  was 
received, with that date entered in section G, block 4, of the paper version of the 
MedWatch form or on the Introduction  page for the electronic version as indicated 
above. 
Although the FD&C Act does not expressly require a responsible person to take action in 
the event that it receives a report of a serious adverse event in which the initial  reporter 
identifies  the suspect dietary supplement as one manufactured, packaged, or distributed 
by another responsible  person, we recommend that such reports be promptly forwarded to 
that other responsible person.  In the event that a responsible person receives a report of 
an adverse event regarding one of its products from another responsible person, the 
responsible person whose product was involved  must submit a serious adverse event 
report to FDA within the same timeframe applicable to any report received from an initial 
reporter (i.e., 15 business days from receipt), even if a serious adverse event report has 
already been submitted to FDA by the first responsible person (see "Suspect Dietary 
Supplement"  discussion in Question 13). 
11. [Updated September 2013] How is a serious adverse event report for a dietary 
supplement submitted to FDA? 
A serious adverse event report for a dietary supplement is submitted to FDA on either the 
paper or electronic version of the MedWatch form (also referred to as  Form FDA 3500A
for the paper version and the FDA Safety Reporting Portal for the electronic version).  
The manufacturer, packer, or distributor  of a dietary supplement is required by statute to 
use a MedWatch form when submitting  a serious adverse event report to FDA.  The 
statute permits but does not require FDA to modify the MedWatch form for dietary 
supplement reporting.  We initially  determined that the paper MedWatch form, Form 
FDA 3500A, the form used for mandatory reporting of adverse events for other FDA-
regulated products, was also the most appropriate MedWatch form available for 
mandatory reporting of dietary supplement adverse events.  As of September 2013, we 
are making available an electronic option  to submit a serious adverse event report for a 
dietary supplement via the FDA Safety Reporting Portal, the electronic version of the 
MedWatch form.  We encourage industry to use the electronic version of the MedWatch 
form to submit a serious adverse event report for a dietary supplement because the 
electronic version will allow for faster processing of reports and may require less follow 
up by FDA with the responsible person submitting  the paper version.  
12. [Updated September 2013] Are there any instructions available for filling out the 
paper and electronic version of the MedWatch Forms to report a serious adverse 
event for a dietary supplement? 
Yes.  Instructions for filling  out the paper MedWatch form, Form FDA 3500A, for 
serious adverse event reports for dietary supplements are in the Appendix of this 
  8  guidance.  The electronic MedWatch form, the FDA Safety Reporting Portal, provides 
the user with detailed navigation  instructions to include drop-down menus, lists of values, 
controlled  vocabularies, and mouse over help where possible.   
13. [Updated September 2013] What are the minimum data elements that should be 
included in a serious adverse event report for a dietary supplement, and where 
should these data elements be entered on the paper and electronic version of the 
MedWatch Forms? 
The five data elements listed in the bullets below should be included  in any serious 
adverse event report for a dietary supplement.  These elements, at a minimum,  are 
necessary for FDA to avoid duplication  in its adverse event reports database, interpret the 
significance of adverse events, facilitate follow-up,  and detect fraud.  The section where 
each element should be entered on the paper version or electronic version of the 
MedWatch Forms is given in parentheses at the end of the bullet. 
  an identifiable  patient (Section A of the paper version/Problem  Summary  
o
Affected Individual  Information of the electronic version); 
  an identifiable  initial  reporter (Section E of the paper version/Contact 
o
Information  Initial Reporter of the electronic version); 
  identity  and contact information  for the responsible person (i.e., the manufacturer, 
o
packer, or distributor  submitting  the serious adverse event report to FDA) 
(Section G of the paper version/Contact Information  Manufacturer, Packer, or 
Distributor  Site Information and Site Point of Contact Information of the 
electronic version); 
  a suspect dietary supplement (Section C of the paper version/ Suspect 
o
Product(s) of the electronic version); and 
  a serious adverse event or fatal outcome (Section B of the paper version/Problem 
o
Summary  Adverse Event and/or Product Problem Description of the electronic 
version). 
The responsible person should actively seek information  on any minimum  data elements 
that are not initially  provided by the reporter and wait to submit a serious adverse event 
report to FDA until the information  is obtained.  We do not intend to take enforcement 
action for failure to report a serious adverse event where, after diligent  efforts, the 
responsible person is unable to obtain all of the five minimum  data elements.  We 
recommend that the responsible person document its efforts to obtain the basic elements 
for a serious adverse event report.  As discussed below in the questions and answers 
about recordkeeping, the responsible  person must keep records related to any adverse 
event report it receives for six years, regardless of whether the event must be reported to 
FDA.  Section 761(e)(1) of the FD&C Act (21 U.S.C. 379aa-1(e)(1)). 
During initial  contacts with the reporter and subsequent follow-up,  the responsible person 
should make diligent  attempts to obtain complete information.   To this end, we encourage 
responsible persons to use trained health care practitioners to elicit information  from 
reporters, computer-assisted interview technology,  targeted questionnaires,  and/or other 
  9  appropriate methods that help focus the line of questioning.   When the initial  report is 
from a consumer, we recommend that the responsible person seek the patient's 
permission  to contact the health care practitioner(s) familiar with the diagnosis and 
treatment of the adverse event to obtain further information  and relevant medical records, 
as needed. 
Identifiable patient: (Section A - "Patient Information"/Problem  Summary  Affected 
Individual  Information) 
To have an identifiable  patient means providing  enough information  to demonstrate that 
an individual  person experienced a serious adverse event.  For example, filling  in "some 
consumers" under "Patient Identifier"  would not be sufficient; however, a report that 
listed the patient identifier  as "an elderly woman" or "a young man" would be sufficient 
because there is enough information  to assess that a specific person experienced a serious 
adverse event.  One or more of the following  automatically  qualifies a person as 
identifiable:  age or age category (e.g., adolescent, adult, elderly),  gender, initials,  date of 
birth, name, or patient identification  number.  A report stating that "an elderly woman 
had anaphylaxis"  or "a young man experienced anaphylaxis"  would be sufficient.  If a 
report submitted to the responsible person refers to groups of unknown size, such as 
"some" or "a few" college students got anaphylaxis,  the responsible person should follow 
up to find out the number of patients and then submit a separate report to FDA for each 
identifiable  patient.  The responsible person should distinguish  each patient so that it is 
clear that the separate serious adverse event reports are not duplicate reports of a single 
adverse event. 
To protect the privacy of the patient, he or she should not be identified  by name or 
address; instead, the responsible person should assign a code (e.g., the injured  person's 
initials)  to each serious adverse event report.  The assigned code will permit the 
responsible person to cross-reference identifying  information  and contact information  for 
the patient in the event that the responsible person needs to follow up. 
Initial Reporter (Section E  Initial  Reporter/Contact Information  Initial Reporter) 
The initial  reporter is the person who first notifies the responsible person about the 
serious adverse event and can be the patient, a family member, or some other person 
(e.g., doctor, pharmacist).  One or more of the following  automatically  qualifies  a 
reporter as identifiable:  a personal identifier (e.g., name), professional identifier (e.g., 
doctor, nurse, pharmacist), or contact information  (e.g., e-mail address, phone number). 
In addition  to the contact information  requested on the form, the initial  reporter's e-mail 
address should also be provided,  if available. 
Individual  judgment  will be needed at times to decide whether or not a reporter will be 
considered identifiable  for reporting purposes.  If the initial  reporter is a third party who 
has only limited  information  about the serious adverse event (e.g., "my neighbor told me 
that a friend became seriously ill after taking Product X"), the responsible person should 
try to obtain contact information  (such as a phone number or e-mail address) for someone 
  10  with personal knowledge of the adverse event.  The responsible person should then 
follow up with that person to obtain enough information  to submit a serious adverse event 
report to FDA (i.e., the five minimum  data elements). 
If the initial  reporter requests that the responsible person not forward the reporter's name 
and contact information  to FDA, the responsible person can submit a report without 
identifying  the reporter, as long as the responsible person keeps the contact information 
on file so that it may contact the reporter either upon request by FDA or on its own 
initiative.   For these reports, the responsible person should fill in the initial  reporter name 
and address block in section E of the paper version with a statement such as "Requested 
Anonymity."   The same can be entered in the Initial  Reporter section of the Contact 
Information page on the electronic version. 
Responsible Person (Section G - "All Manufacturers"/Contact Information  - 
Manufacturer, Packer, or Distributor Site Information  and Site Point of Contact 
Information) 
This section of the paper and electronic version of the MedWatch forms is for 
information  about the responsible person and the initial  report.  Per the instructions in 
Appendix A, blocks 5 and 6 on the paper version are not required for dietary supplement 
serious adverse event reports.  This information  is not included on the electronic version. 
Suspect Dietary Supplement (Section C - "Suspect Product(s)"/Suspect Product(s)) 
With regard to a suspect dietary supplement, provide the complete product name, 
including  brand name, and any other known product attributes.  The information  provided 
should be sufficient to uniquely  identify the suspect product and distinguish  it from other 
similarly  named products.  For example, "Vitamin  C" or "multi-vitamin"  would not be 
considered complete product names.  Examples of information  that may be needed to 
uniquely  identify  the product include the physical form of the product (e.g., tablet, 
powder, gelcap, bar); strength (e.g., 120 mg); flavor, if any; and packaging form and size 
(e.g., 120-tablet bottle). 
If a serious adverse event involves  multiple  dietary supplements that are manufactured, 
packaged, or distributed  by the same responsible person, the responsible person should 
submit only one serious adverse event report to FDA, listing  all suspect products in 
Section C with the same manufacturer report number in section G, block 9 on the paper 
version and for the electronic version, listing  all suspect products where indicated. 
If the serious adverse event involves a nonprescription  drug product marketed without an 
approved application  and a dietary supplement that is also manufactured, packaged, or 
distributed  by the same responsible person, and the initial  reporter views each product as 
suspect, the responsible person should submit the report about the serious adverse event 
to both CDER and CFSAN.  The report should include information  about both suspect 
products either in section C for the paper version or under suspect products for the 
electronic version and should use one manufacturer report number. 
  11  If a serious adverse event involves  multiple  suspect dietary supplements that were 
manufactured, packaged or distributed by more than one responsible person (e.g., 
manufacturers A and B), and if the event is reported to one of the responsible persons 
(manufacturer A), then that responsible person (manufacturer A) must submit a serious 
adverse event report to FDA that identifies both its own product(s) and manufacturer B's 
product(s) in the Suspect Product section of either the paper or electronic version 
including  a copy of manufacturer A's product label.3  In such a case, we recommend that 
manufacturer A also send manufacturer B a copy of the submitted paper version of the 
report or a copy of the Individual  Case Safety Report generated by the electronic version, 
including  manufacturer A's report number.  In the event that manufacturer B receives 
such a report, manufacturer B must then submit its own serious adverse event report, 
citing manufacturer A's report number in the "Describe Event or Problem" section of the 
paper version (i.e., section B.5) or the Problem Summary section of the electronic 
version, and including  a copy of manufacturer B's product label.  Section 761(b)(1) of the 
FD&C Act (21 U.S.C. 379aa-1(b)(1)). 
 If a serious adverse event involves  a dietary supplement that has been discontinued,  the 
responsible person must still submit a report to FDA.  Responsible persons must submit 
"any report received" of a serious adverse event associated with their products when used 
in the United States.  Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)). 
Where a product involved  in a serious adverse event has been discontinued,  the 
responsible person may make note of this status in Section B.5 of the paper version or in 
the Problem Summary section of the electronic version of the MedWatch forms. 
Serious Adverse Event or Fatal Outcome (Section B - "Adverse Event or Product 
Problem"/Problem  Summary - Adverse Event and/or Product Problem Description) 
A serious adverse event, as defined in section 761(a)(2) of the FD&C Act (21 U.S.C. 
379aa-1(a)(2)), is an adverse event that results in or more of the following  patient 
outcomes or, based on reasonable medical judgment,  requires a medical or surgical 
intervention  to prevent one of the following  patient outcomes: 
  death 
o
  a life-threatening  experience 
o
  inpatient hospitalization4 
o
  a persistent or significant  disability  or incapacity 
o
  a congenital  anomaly or birth defect. 
o
A serious adverse event other than death should, at a minimum,  be described in terms of 
signs (including  abnormal laboratory findings),  symptoms,  or disease diagnosis for 
purposes of reporting.  Thus, a report stating that the patient "experienced unspecified 
injury,"  "suffered irreparable damages," or "was ill"  would not be specific enough.  If the 
initial  reporter does not provide any signs, symptoms,  or diagnosis,  the responsible 
person should follow up as necessary to obtain more information  from that person, the 
patient, or (with the patient's permission)  medical professionals who treated the patient. 
  12  A report of a fatal outcome (death) meets the minimum  description for a serious adverse 
event even if the events that led to the death are unknown,  but such reports should also 
include any other available information  related to the death (e.g., adverse event(s) 
associated with the death). 
14. [Updated September 2013] Can a serious adverse event report be submitted to FDA 
using the MedWatch voluntary reporting form (Form FDA 3500)? 
No.  FDA has determined that dietary supplement manufacturers, packers, and 
distributors  must report serious adverse events associated with their products using either 
the paper MedWatch form, Form FDA 3500A or the FDA Safety Reporting Portal.   
Section 761(d) of the FD&C Act (21 U.S.C. 379aa-1(d)).  However, voluntary reports of 
adverse events associated with a dietary supplement may be submitted using either the 
paper MedWatch form, Form FDA 3500 (note the absence of the letter A), or the FDA 
Safety Reporting Portal.  Voluntary reports of dietary supplement adverse events would 
include: 
  any adverse event report submitted by a consumer, health care provider, or any 
o
other entity that is not a dietary supplement manufacturer, packer, or distributor; 
  a report of a non-serious adverse event submitted by a dietary supplement 
o
manufacturer, packer, or distributor  for one of its products; 
  a report of a serious adverse event submitted by a dietary supplement 
o
manufacturer, packer, or distributor  for one of its products, where the firm is not 
the "responsible  person" who must report the serious adverse event. For example, 
the manufacturer of a dietary supplement might choose to submit a report of a 
serious adverse event to FDA even though the distributor  was the "responsible 
person" because the distributor's  name appeared on the dietary supplement label. 
In such a case, FDA would receive both voluntary and mandatory reports of the 
same serious adverse event. 
15. a. [Updated September 2013] Must a copy of the label of the dietary supplement that 
is the subject of the serious adverse event report be submitted with the report? 
Yes.  Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)).  Wherever possible, 
responsible persons should submit a copy of the full outer carton/container label and 
immediate container label from the product the patient used.  See 21 U.S.C. 321(k); 21 
CFR 1.3(b).  Where the patient's product has been specifically  identified,  but the 
responsible person does not have a copy of the patient's own label, the responsible person 
should submit an original  or photocopied  label that is the same as the label of the product 
the patient used, or as close as the responsible person can come to that label using all 
available information. 
Where the exact label of the patient's dietary supplement cannot be identified  with 
certainty, such as where a label has changed over time or where the patient's exact 
product cannot be identified  with specificity,  the responsible person may submit a copy 
of the label most likely  viewed by the patient, or may submit multiple  labels for those 
  13  products most likely  to be associated with the report.  In addition,  where the label has 
changed since the time of the adverse event, the responsible person may also submit a 
copy of the product's current label. 
For responsible persons submitting  the paper MedWatch form, Form FDA 3500A, this 
information  should be mailed in with the serious adverse event report.  For electronic 
submissions  via the FDA Safety Reporting Portal, responsible persons should attach an 
electronic image of the label in one of the formats listed on the Attachments section.  
15. b. Should anything other than the product label be submitted along with the serious 
adverse event report 
Yes.  As part of the serious adverse event report, we encourage the responsible person to 
attach the following,  as appropriate: (1) hospital discharge summaries, (2) autopsy 
reports, (3) relevant laboratory data, and (4) other critical clinical  data.  Please note that 
this paragraph does not provide an exhaustive list of all the documents or information  that 
may be submitted with the report at the responsible person's option. 
16. Does a sample of the dietary supplement that is the subject of the serious adverse 
event report have to be submitted to FDA? 
No.  There is no requirement that a sample of the dietary supplement be provided  to FDA 
with the adverse event report, and we do not recommend you submit a sample unless 
requested to do so. 
17. Must new medical information received by the manufacturer, packer, or distributor 
of a dietary supplement that is related to a previously submitted serious adverse 
event report also be submitted to FDA? 
Yes, any new medical information  received within one year of the initial  report must be 
submitted to FDA.  Section 761(c)(2) of the FD&C Act (21 U.S.C. 379aa-1(c)(2)).  Even 
if new medical information  is received later than one year after the serious adverse event 
report and therefore does not have to be reported, you must keep it in your file on the 
serious adverse event for six years because it is a record related to the serious adverse 
event report.  Section 761(e)(1) of the FD&C Act (21 U.S.C. 379aa-1(e)(1)).  Although 
you are not required to submit to FDA any new medical information  that is received later 
than one year after the serious adverse event report, we encourage the voluntary 
submission  of such information  so that we obtain a complete report to evaluate. 
18. When must the new medical information be submitted to FDA? 
This new medical information  must be submitted to FDA within 15 business days of 
being received by the manufacturer, packer, or distributor.  Section 761(c)(2) of the 
FD&C Act (21 U.S.C. 379aa-1(c)(2)). 
  14  19. a. [Updated September 2013] How should the new medical information be submitted 
to FDA?  Should another report be filled out and submitted on the MedWatch form, 
Form FDA 3500A, or using the FDA Safety Reporting Portal, in addition to the 
initial serious adverse event report originally submitted? 
No.  A new report does not have to be completed on paper Form FDA 3500A or on the 
FDA Safety Reporting Portal to submit the new medical information  (e.g., medical 
records).  The FDA Safety Reporting Portal allows users to electronically  update a 
serious adverse event report previously submitted via the portal.  To submit a follow up 
report with new medical information,  first electronically  access the previously  submitted 
report: 
Accessing reports submitted as an account holder: Log in from the homepage of 
the Safety Reporting Portal.  Select the appropriate previously  submitted report 
from the "Submitted  Reports Available for Follow-up"  list.  
Accessing reports submitted as a guest: From the Safety Reporting Portal 
homepage, click "Report as Guest." On the "New Guest Report" screen, choose 
"Follow-up  on a report previously  submitted as a guest portal user."  Enter the 
appropriate Report Identification  Key in the text box that appears. 
Once the appropriate report has been chosen for follow up, attach electronic versions of 
the new medical information  on the Attachments section of the follow up report.  If the 
new medical information  cannot be condensed into 5 or fewer files of less than 10 MB 
each (the limitation  of the portal) please submit multiple  follow up reports to transmit all 
of the new information.  .  
To submit new medical information  related to a serious adverse event report previously 
submitted to FDA on paper Form FDA 3500A, simply  attach a copy of the initial  serious 
adverse event report to a copy of the new medical information  in the same form you 
received it.  It is not necessary to re-submit any attachments from the initial  serious 
adverse event report. 
19. b. [Updated September 2013]  Can FDA provide assurance that the new medical 
information submitted will be consolidated into a single report by FDA? 
For submission  of new medical information  related to reports made using the paper 
version, when a copy of the initial  serious adverse event report on MedWatch Form 
3500A is included  with the new medical information,  we will be able to consolidate the 
initial  submission  and the new medical information  into a single report.  Reports 
submitted using the electronic version are linked electronically,  and the new medical 
information  will be associated with the initial  report automatically. 
20. [Updated September 2013] Will FDA confirm receipt of serious adverse event 
reports submitted and provide a tracking number to use for further submissions of 
new medical information related to the initial report? 
  15  If the report is submitted using the FDA Safety Reporting Portal, responsible persons will 
be provided with a confirmation  email containing  a time stamped copy of their report 
upon its submission.   This copy also contains an Individual  Case Safety Report number to 
identify the report in any subsequent communications.   
If the report is submitted using the paper MedWatch form, Form FDA 3500A, no 
confirmation  of receipt or tracking number is provided  to the responsible person at this 
time.  We are working to implement  processes that will provide a confirmation  of receipt 
and tracking number to the responsible person when a serious adverse event report for 
dietary supplements is submitted using the paper version.  We will revise this guidance 
when these processes are implemented. 
21. [Updated September 2013] What is the process for getting a copy of MedWatch
Form 3500A?
MedWatch Form 3500A is on FDA's Internet web site.  If you are unable to access the
paper version of the form on-line,  request a paper copy of the form by calling 1-800-
FDA-1088 or by submitting  a written request to: 
MedWatch: The FDA Safety Information  and Adverse Event Reporting Program
Office Of The Center Director
Center for Drug Evaluation and Research
5515 Security Lane
Suite 5100
Rockville,  MD 20852
22. [Updated September 2013] Where are completed paper versions of serious adverse
event reports for dietary supplements to be submitted?
Please mail completed MedWatch form, Form FDA 3500A, along with a copy of the 
dietary supplement  label and any other attachments (see Questions 15a and 15b), to: 
FDA, Center for Food Safety and Applied Nutrition,  Office of Food Defense, 
Communication  and Emergency Response, CAERS Team, HFS-11, 5001 Campus Drive, 
College Park, MD 20740.
23. [Updated September 2013]  What is the process for submitting serious adverse event
reports for dietary supplements electronically?
The electronic version of the MedWatch form, the FDA Safety Reporting Portal, is
accessible at www.safetyreporting.hhs.gov.   A reporter may choose to submit serious
adverse event reports as an account holder or as a guest.  As noted, the FDA Safety
Reporting Portal provides the user with detailed navigation  instructions  to include drop-
down menus, lists of values, controlled vocabularies,  and mouse over help where
possible.
16  24. Can the paper version of the MedWatch form,  Form FDA 3500A, for a dietary 
supplement serious adverse event report be submitted to FDA by facsimile? 
No.  Dietary supplement serious adverse events reported on the paper version of 
MedWatch form, Form FDA 3500A, along with a copy of the dietary supplement label 
and any other attachments (see Questions 15a and 15b), should be mailed to FDA (see 
answer to Question 22 for address).  We do not accept these reports by facsimile due to 
concerns about the quality  of this form of transmission  (i.e., the clarity and readability  of 
faxed documents). 
25. a. How long should records of serious adverse event reports and related medical 
information be maintained? 
The responsible person must maintain all records related to each report of a serious 
adverse event for a period of 6 years.  Section 761(e)(1) of the FD&C Act (21 U.S.C. 
379aa-1(e)(1)).  These records should include,  at a minimum,  copies of the following: 
  the responsible person's serious adverse event report to FDA, with attachments; 
o
  any new medical information  about the serious adverse event received by the 
o
responsible person; 
  any reports to FDA of new medical information  related to the serious adverse 
o
event; 
  communications  and records of communications  between the responsible person 
o
and  
  the initial  reporter 
  any other person(s) who provided information  related to the adverse event 
25. b Should records of non-serious adverse events reported to the manufacturer, 
packer, or distributor of the dietary supplement involved be maintained? 
Yes.  If a report of a non-serious adverse event associated with a dietary supplement for 
which you are the manufacturer, packer, or distributor,  you must keep the report along 
with any related records (e.g., records of your communications  with the person(s) who 
reported the adverse event to you, records of your assessment of the event as non-
serious).  All such records of non-serious adverse events must be kept for six years, just 
as with records of serious adverse events.  Section 761(e)(1) of the FD&C Act (21 U.S.C. 
379aa-1(e)(1)). 
25. c. Can records of serious and non-serious adverse events reported be maintained 
electronically? 
Yes.  Electronic records created and maintained  to meet the requirements of section 
761(e)(1) of the FD&C Act (21 U.S.C. 379aa-1(e)(1)) are subject to the requirements of 
21 CFR part 11.  Therefore, if you maintain your records electronically,  you must comply 
with the electronic record requirements contained in 21 CFR part 11. 
  17  26. Can FDA examine or inspect adverse event report records? 
Yes.  During an FDA inspection  conducted under the authority of section 704 of the 
FD&C Act (21 U.S.C. 374), we are authorized to have access to all adverse event report 
records that dietary supplement manufacturers, packers, and distributors  are required to 
maintain.  Section 761(e)(2) of the FD&C Act (21 U.S.C. 379aa-1(e)(2)). 
27. Is submission to FDA of a serious adverse event report an admission that the dietary 
supplement involved caused the serious adverse event described in that report? 
No.  We do not construe submission  as an admission that the dietary supplement involved 
caused or contributed to the adverse event being reported.  Any serious adverse event 
report submitted to FDA, including  any new medical information  submitted as a follow-
up to the initial  report, is considered a safety report under section 756 of the FD&C Act 
(21 U.S.C. 379v) and may be accompanied by a statement, which shall be a part of any 
report that is released for public disclosure, that denies that the report or the records 
constitute an admission  that the product involved  caused or contributed to the serious 
adverse event.  Section 761(f)(1) of the FD&C Act (21 U.S.C. 379aa-1(f)(1)). 
Further, we note that both the paper and electronic versions of the MedWatch form 
contain the statement "Submission  of a report does not constitute an admission  that 
medical personnel, user facility,  importer, distributor,  manufacturer or product caused or 
contributed to the event." 
28. [Updated September 2013] If a serious adverse event involves a dietary supplement 
that has been discontinued, must the responsible person submit a serious adverse 
event report to FDA? 
Yes.  See Suspect Dietary Supplement section of Question 13.  The responsible person 
must still submit a report, but may note in Section B.5 of the paper version of the 
MedWatch form or in the Problem Summary section of the electronic version that the 
product has been discontinued. 
 IV. Paperwork Reduction Act of 1995 
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: 
  18  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 02/29/2016). 
V. Appendix: Instructions for Completing the paper version of MedWatch Form 
3500A to Report a Serious Adverse Event Associated with a Dietary Supplement
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.
19  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. 
  20