Adverse Event Reporting

for OTC Drugs and

Dietary Supplements
FDA Notifications and Medwatch Form Requirements

The Background What You Need to 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.

Products That Are Covered

All OTC monographed drugs
(Rx to OTC drugs are already
required to report AEs).

When the Personal Care

Products Safety Act becomes
law, cosmetics will also be
covered.

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.

Definition of a Serious Adverse Event

(SAE)
Section 761(a)(2) of the F,D, & C
Act

Death: Report if the

patients 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 persons 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
persons 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.

FDA Notifications - Voluntary SAE

Reporting

FDA encourages
healthcare professionals
to report serious adverse
events to the agency for
tracking purposes.

FDAs 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 isnt
mandatory for the
product (e.g. a food or
cosmetic).

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
companys 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.

Medwatch Form Requirements (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.

Address for Medwatch Form Hard

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

Online Reporting of Medwatch Forms

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.

Or http://www.fda.gov/Safety/MedWatch/default.htm

For organizational training on adverse

event reporting and FDA compliance, visit
www.complianceonline.com.

Thank You