The document summarizes FDA requirements for reporting adverse events related to over-the-counter drugs and dietary supplements. Serious adverse events must be reported to the FDA using a Medwatch form. A serious adverse event is defined as one that results in death, is life-threatening, requires hospitalization or extended care, causes a significant disability or birth defect. The document provides guidance on when and how to submit Medwatch forms to the FDA for different product types. It encourages voluntary reporting and notes that the FDA may also contact companies directly about adverse events.

1. FDA Notificationsand Medwatch Form Requirements
Adverse Event Reporting for
OTC Drugs and Dietary
Supplements

2. The Background– What YouNeedto Know
Adverse Event (AE) reporting
regulations implement the Dietary
Supplement & OTC Drug
Consumer Protection Act of 2006
(Public Law 109-462).
FDA regulations for adverse
event reporting went into effect in
December 2007. Product label
must contain the address (street
address or P.O. Box) or phone
number at which company or
other responsible person will
receive a serious adverse event
report.
Serious Adverse Event (SAE)
reporting is required for all OTC
Drugs and Dietary
Supplements.

3. Products That Are Covered
All OTC monographed drugs (Rx to
OTC drugs are already required to
report AEs).
All dietary supplements including
vitamins, minerals, herbal or other
botanical products, amino acids, or
any dietary substance used to
supplement the diet by increasing the
total dietary intake.
When the Personal Care Products
Safety Act becomes law, cosmetics will
also be covered.

4. Death: Report if the
patient’s death is
suspected of being
associated with use of
the product by the
patient.
Life-Threatening: Report
if the person was at
substantial risk of dying
at time of the adverse
event or if suspected
that continued use of
product could result in a
person’s death.
Hospitalization: Report if
admission to the hospital
was caused by or related
to an adverse event
associated with use of
the product. Emergency
Room treatment is
sometimes reported too.
Disability: Report if the
adverse event resulted in
a significant or
permanent change,
impairment or damage
to the person’s body
function/structure or
quality of life.
Spontaneous abortion,
congenital anomaly or
birth defect associated
with a product use must
also be reported to the
FDA.
Definition of a Serious Adverse Event (SAE)
Section 761(a)(2) of the F,D, & C Act

5. FDA Notifications- Voluntary SAE Reporting
FDA encourages healthcare
professionals to report serious
adverse events to the agency
for tracking purposes.
FDA’s Center for Food Safety &
Applied Nutrition (CFSAN)
Adverse Event Reporting
System (CAERS) collects reports
about adverse events and
product complaints related to
CFSAN regulated products,
including foods, dietary
supplements and cosmetics.
CFSAN encourages voluntary AE
reports for cosmetics and
conventional foods.
If a company receives a report
of a serious adverse event, you
should report it to CAERS even
if reporting isn’t mandatory for
the product (e.g. a food or
cosmetic).

6. FDA Notifications
Many serious adverse
events are reported to FDA
directly by consumers,
hospitals, or healthcare
professionals.
If FDA receives a serious
adverse event report about
a company’s product they
will contact you and you
must keep that report on
file. Often FDA notification
comes with a request for
more information and
submission of a Medwatch
form with product label.

7. MedwatchFormRequirements(Form 3500A)
Medwatch form must identify the injured person (name, age, sex, full address, etc.). Initials
are used to protect privacy.
An identifiable initial reporter of the event.
Identity and contact information for the responsible party (i.e. the manufacturer, packer,
or distributor representative submitting the AE report to FDA).
Name of the specific product that is suspected of causing the adverse event (not just a
brand name).
Description of the serious adverse event with outcome.

8. Address for MedwatchFormHard Copy
Submission
DIETARY SUPPLEMENTS: FAX NUMBER FOR ALL AEs:
1 800 332 - 0178
FDA Center Food Safety & Nutrition
Office of Food Defense, HFS -11
5100 Paint Brach Parkway
College Park, MD. 20740
OTC DRUGS:
FDA Center Drug Evaluation & Research
Central Document Room
5901-B Ammendale Road
Beltsville, MD. 20705-1266

9. Online Reportingof MedwatchForms
Or http://www.fda.gov/Safety/MedWatch/default.htm
Go to the FDA
website
(www.fda.gov), click
on “Drugs” and enter
“MEDWATCH form”.
Click on “Download
form” or click on
“Recalls & Alerts”
and see bullet called
“MEDWATCH.”
Click on “Report
serious adverse
events online.”

10. Thank You
Fororganizationaltrainingonadverseevent
reportingandFDA compliance,visit
www.complianceonline.com.