Under the law, supplement manufacturers are required to notify the Food and Drug Administration (FDA) when consumers or doctors report an “adverse event.” A dietary supplement adverse event means that a consumer or doctor has reported that a dietary supplement has caused a health issue. Reviewing dietary supplement adverse event reports may give athletes and supplement users an idea about the types of reactions people may have to dietary supplements.
USADA obtains certain dietary supplement adverse event reports from the FDA through a Freedom of Information act (FOI) request. One important thing to keep in mind is that obtaining and reviewing dietary supplement adverse event reports through a FOI request is not all that easy. The results are also not incredibly clear and are often compiled in difficult to read documents and require extensive time to review. If anything, this should highlight why very few consumers are fully informed when it comes to dietary supplements. Click here to view an example of a dietary supplement adverse event report.
When reviewing dietary supplement adverse event reports, it’s important to keep in mind that an adverse event is not proof that a particular supplement was responsible for the adverse events. A dietary supplement adverse event report just shows the association of an adverse outcome with a particular product.
The FDA uses adverse event reports to monitor trends, and if a particular product is associated with the same adverse event in many people, then the FDA can investigate that product to see if there is a causal relationship. At the very least, this process should alert dietary supplement users that control of dangerous dietary supplements is reactive and occurs after consumers have already been affected. It should be another reminder that dietary supplements do not have to be proven safe prior to their sale.
Additionally, these reports refer to serious adverse events only, like when a supplement product is associated with a racing heart, stomach problems, or some other serious side effect. Reviewing adverse event reports can give you an idea about the types of reactions people may have to supplements that you use.
Products are often associated with one or more adverse events, and after reading the details of the adverse events, users need to make up their mind as to whether the product is likely to be causally related to the adverse events. Either way, reviewing adverse events is a step consumers can take to be fully informed.
Dietary supplement users may also wish to submit their own FOI requests for adverse event reports. The FDA provides guidelines on this process here.
Dietary supplement users may also wish to submit their adverse events. The FDA provides guidelines on this process here.