New Adverse Event Report Requirements for Dietary Supplements

By: Daniel J. Gerber

01.01.00

The FDA published updated guidelines for dietary supplement manufacturers, distributors and sellers outlining their obligations to report serious adverse reactions (SAEs) regarding their products to the federal government. 

What constitutes a serious adverse event (SAE)?

The FDA defines an SAE as “a complication that results in death, a life-threatening experience, inpatient hospitalization, a 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 intervention to prevent an outcome described above.”

Who is obligated to report an SAE and when should the report (SAER) be submitted?

The manufacturer identified on the product packaging. Reports can also be made by physicians, friends or family, and the patient. MedWatch 3500 forms are available online.

How can the industry best address allegations made by politicians that SAEs are underreported?

Being diligent in reporting for one thing. Also, understanding that it gets tricky real fast if the doctor or a family member reports something and you (the manufacturer) do not. Also, regular auditing occurs to ensure that manufacturers are compliant.

Are SAERs admissible as evidence in a law suit?

No, FDA regulations and the form itself say it is not.

Should manufacturers reflect SAE information through warning labels on the product?

They should work with trade groups and legal counsel to determine when a warning should be included and the strength of the warning. Also, being diligent in investigating SAERs can help signal whether additional reporting is required.

Should insurance companies be informed each time an SAER is filed?


A manufacturer’s insurance policy language governs whether an SAER should be reported or not. The purpose for an SAER is not for a person to make a claim, so the most logical solution under most insurance policies would be that no claim reporting is required to the insurance carrier.  However, given that Congress specified that these are not admissible and are often only anecdotal and rarely lead to a reportable claim.

How does the expanded reporting requirements affect insurance coverage?

Dietary supplement manufacturers  must be aware that insurers may request SAER filings or summaries before one is bound within an insurance agreement. You cannot avoid the SAER duty simply because you are concerned it may affect your insurance coverage. However, you should be aware that excessive SAER filings may result in higher insurance coverage or no coverage at all.