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Adverse Event Reporting
AER Consulting Project

  Adverse Event Reporting
And the Vitamin Industry
Third Party Evaluation and Reporting System

AER Guide
for Commercial Users and
IHR Associate Members

Home Page History & Media Statute Guide

DRAFT 1.2.2 - released for comment 10/09/07
Comments: aerc-info@usa.net


For Commercial Users and Associate Members
Third Party Evaluating and Reporting System

A Project of the Institute for Health Research


Guide Index: I. Reporting System II. AER Services III Statutory Definitions


AER Screening Guide & Procedures

DRAFT 1.2.2 (10/12/07)


I. System for Reporting Adverse Events

Section I Index:  A. Users  B. Associates  C. Function of System

A. Users

1. Associate Member
2. General Commercial User

B. Associate of the Institute for Health Research

1. Business expense: $500 annual professional membership includes

a. Standard Operating Procedures – Record Keeping Guide
b. 2 adverse event reports annually; 1 hour annual consulting
c. E-newsletter (including cGMP updates)

2. Installment payments available for small entities.


C. Function of the System


AERC (Adverse Event Reporting Consultants) is a public service project of the Institute for Health Research. This Guide is intended as an interim guidance under the Dietary Supplement and Non-Prescription Drug Consumer Protection Act. AERC will screen and evaluate reported Adverse Events; providing a facility to report "serious" Adverse Events, as required by the law. It will not be expected to determine responsibility or corrective action and will be limited to a standard of reasonable care in determining if the allegations meet the “serious” requirement for reporting to the FDA. In the event FDA issues final Regulations implementing the law, those Regulations will supersede this Guide where the Guide is inconsistent therewith. It is intended that this Guide will be modeled on any final FDA Guidance document issued regarding Adverse Event Reporting.


II. Customer Adverse Event Reports (CAERs) & Services

Section II Index:  A. Submission & Payments  B. Categories of Services  C. Initial Screening  D. Further Requirements

A. Submission and Payments

All CAER Reports are submitted by email to IHR (special submission email address and payment system to be provided). Associate Members pay one-half the stated amounts; General Commercial users pay the stated amounts.

B. Categories of Services

• Initial Screening Report: expense, $100 – many reports may fall in the “No Report Required” category and will be returned with a “Not Reportable” letter from the Institute (this category includes reports that do not state any facts that experts in the field could conclude meet the statutory  "adverse" test of "health-related event associated with the use of a dietary supplement that is adverse").


• Determination of "Serious Adverse Event" Status: if the nature of the alleged "event... that is adverse" may come within the statutory harm definition, it will require professional review to determine whether it meets the “serious” threshold. There is an additional minimum expense of $150 (cost will be estimated before services are provided, based on the number of experts needed, additional investigation and length of report, including alternative explanations). Associates will have an opportunity to choose minimum review.

• Serious Adverse Event Report: If the report does rise to the level of a serious adverse event report, the standard report will be completed and submitted to the FDA on behalf of the Associate with all appropriate alternative explanations (such as customer use not as directed and drug interference with the nutrient) – expense, $200.


C. Initial Screening Questions [Draft]

Telephone number
Employee receiving CAER
Email of employee reporting reaction

Name of person who experienced alleged adverse event
Telephone number

Was event reported to a doctor?
Name of doctor
Address of doctor
Telephone number of doctor

What product did the patient take:
• Manufacturer:
• Expiration date
• Batch number
• Date purchased
• Where purchased
• Quantity taken
• Was this product taken previously without reaction?

What was the alleged adverse event: (allergy related)
• Allergy Reaction:
• Rash
• Itch
• Flushing
• Headache
• Indigestion
Other alleged adverse event:

Does the claimant have any food allergies:
• Wheat
• Dairy
• Nuts
• Chocolate
• Caffeine
• Other

Does the claimant have any chronic conditions:
• Diabetes
• High blood pressure
• High cholesterol
• Obesity
• other


State event:
How long did this last?
What was the severity: from mild to incapacitating: 1 – 5
Have you ever had this reaction before?

What other Rx and OTC products were you taking (go back a week before reaction)?

RX (include name and mfr. Of prescription)
• Cholesterol reducing
• Blood pressure
• Thyroid
• Diabetes
• Birth control
• Sexual enhancer
• Immune suppressor
• Weight loss
• Anti-acid
• Anti-depressant
• Anti-inflammatory
• Anti-biotic
• Others list

OTC products
• Aspirin
• Pain killer
• Weight loss
• Cold or flu
• Anti-acid
• Other

Other Nutritional Supplements – state product brand and manufacturer
• Multi-vitamin
• Calcium
• Vitamin C
• Etc

Has the person reporting the event had any inoculations during the past year?

Does the person reporting the event claim any economic damages? If so, detail

Does the person reporting the event claim any permanent harm? If so, explain.


D. Further requirements to determine if an Adverse Event meets the "serious event" test

1. Company to provide batch records and control tests for suspect product; indemnify and hold AER Consultants harmless.

2. Customer to Provide copies of medical, insurance or other professional reports relating to the alleged adverse event.

3. Complaining Customer Required Release:

"The undersigned customer making the above adverse event report hereby consents to the release of all medical and personal records to AER Consultants, to be reviewed privately and hereby permits access to HIPPA records for the purposes of the review of the alleged adverse event. Customer hereby releases AER Consultants of all liability for providing review services."


III. Statutory Definitions

Section III Index:  A. Adverse Event  B. Serious Adverse Event  C. Adverse Event Reporting

Official Text of Act: http://www.fda.gov/cder/regulatory/public_law_109462.pdf

“(a) Definitions- In this section:

 `(1) ADVERSE EVENT - The term `adverse event' means any health-related event associated with the use of a dietary supplement that is adverse.


`(2) SERIOUS ADVERSE EVENT - The term `serious adverse event' is an adverse event that--


`(A) results in--


`(i) death;


`(ii) a life-threatening experience;


`(iii) inpatient hospitalization;


`(iv) a persistent or significant disability or incapacity; or


`(v) a congenital anomaly or birth defect; or


`(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).




The term `serious adverse event report' means a report that is required to be submitted to the Secretary under subsection (b).”

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