Since December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act has required that serious adverse event information be reported to FDA for dietary supplements and OTC drugs not approved through a new drug application.

Sounds simple, doesn’t it?   As with so many FDA requirements, what sounds simple can get rather complicated once you try to comply.

  • What exactly is an adverse event?
  • What exactly is serious?
  • What is considered a valid report of an adverse event?
  • When does the clock start, with regard to being on time with your reporting?
  • Do the manufacturer and distributor both need to submit the same report?
  • What if I get a report about another company’s drug?
  • What records do I have to keep and for how long?

There are many questions that can come up as soon as you dig a little deeper into what is required.  Some answers will be provided here, but these are meant only to call attention to the potential complexity and depth of these requirements.


What is an adverse event?

For OTC drugs, an “adverse event” is defined as “any health-related event associated with the use of a nonprescription drug that is adverse, including (a) an event occurring from an overdose of the drug, whether accidental or intentional; (b) an event occurring from abuse of the drug; (c) an event occurring from withdrawal from the drug; and (d) any failure of expected pharmacological action of the drug.”  For dietary supplements, an “adverse event” is defined as “any health-related event associated with the use of a dietary supplement that is adverse.”  These definitions are fairly broad and do not include any mention of causality; rather, adverse events are “associated with the use of the drug”.

If a patient falls and breaks their arm is that an adverse event? 


What is a serious adverse event?

For both OTC drugs and dietary supplements, an adverse event is serious if it results in death, a life-threatening experience, in-patient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or requires medical or surgical intervention to prevent any of these events.

What if the patient had chest pains and went to an emergency room because they were concerned but they were not admitted?  Is that “life threatening”?  Does any treatment of the chest pains constitute “medical or surgical intervention to prevent” hospitalization? 

 Unless you have information from the reporter regarding the severity and duration of these episodes or about specific treatments that were given, it can be difficult to determine if the events were “serious”.


What is a reportable event?

There are required minimum elements for adverse event reports.  These elements are necessary in order to avoid duplication in the FDA adverse event databases and to assist in assessing the significance of the reported adverse events.  Minimum elements of a reportable event include: 

  1. Identifiable patient
  2. Identifiable reporter
  3. Suspect drug
  4. Serious adverse event

If a report is received that three women experienced an anaphylactic reaction is that reportable?

If not all of these elements are available in the initial report, companies should actively seek information on any element not initially provided.


Who is required to report this information?

The manufacturer, packer or distributer whose name appears on the label must submit serious adverse event reports to FDA.  Retailers whose names appear on the labels as distributors may authorize the manufacturers or packers of the products to submit the required reports to FDA on their behalf, as long as the retailer transmits all reports they receive (meaning both adverse event reports and serious adverse event reports) to the manufacturer or packer.



The labeling must include an address or a domestic telephone number that consumers can use to report adverse events.  If an address is used instead of a phone number, the address must include a full street address and zip code.


When is it required to report this information?:

A report must be submitted through the address or telephone number that is required on the product labeling within 15 business days of receiving the report.  A report must contain the required minimum elements to be reportable.  If all of the elements are not included in the original report, the clock would start when all elements have been obtained.  Again, the FDA expects that companies will diligently pursue the additional information required for a reportable event if the minimum elements were not initially obtained.


How long must adverse event information be kept:

Records related to all adverse event reports must be maintained for 6 years by the “responsible party”. What constitutes a record?  Sometimes the initial report of an adverse event is handled by one department, such as a Customer Service group, while another department handles information that is forwarded to them by the first group, such as a specialized adverse event handling group.  Deciding what records to keep from the Customer Service group and how to keep them can sometimes be challenging.


Electronic Storage or Reporting

Lastly, just a reminder than any electronic systems for storing or reporting adverse event information should be compliant with 21 CFR Part 11.


Again, this is not meant to be a complete summary of all the relevant requirements, but rather to provide a glimpse into the complexity of these requirements.


For questions relative to adverse event reporting, please contact Christine Miller, Pharm.D, at