Adverse Event Guidelines for Dietary Supplements

Dietary supplements have become a popular choice for individuals who want to improve their health.  

However, the U.S. Food and Drug Administration (FDA) does not regulate dietary supplements the same way as prescription or over-the-counter drugs are regulated. In fact, the FDA does not approve dietary supplements before they are available for purchase in the marketplace. To mitigate the potential risk dietary supplements pose to the safety and health of consumers, the FDA requires all supplement labels to list how adverse reactions can be reported.

How does the FDA regulate dietary supplements?

The FDA regulates dietary supplements with the adverse event reporting system. Anyone who experiences an adverse reaction and suspects that a dietary supplement could be the cause can submit an adverse event report. The report is made to either the supplement manufacturer or distributor via the adverse event reporting information provided on the label. The FDA requires this reporting information to include a physical address and phone number in the United States.

What happens if the FDA determines that a dietary supplement is dangerous?

Receiving an adverse event report from a consumer does not necessarily mean your business will face disciplinary action. Before the FDA takes any action, they must first determine if the supplement is safe for consumption. Since adverse events can be caused by food, beverages, medicine and more, they need to discover whether or not the dietary supplement caused the reaction. 

If the FDA finds a connection between a supplement and an adverse event, then they need to determine if the product is dangerous to consumers. If so, they then have the authority to prevent the supplement from being distributed in the U.S. market. Regulatory action can include product detentions upon arrival at a U.S. port, mandatory recall, issuing warnings to consumers and manufacturers, product seizures, and even fines and criminal prosecution.

What if my business does not have a United States address or phone number?

If your business is located outside of the United States and does not have a U.S. physical address and phone number, you will need to get an Adverse Event Agent. An Adverse Event Agent will act as your agent to collect and document consumer adverse event reports, then forward them to your business. The business can list the Adverse Event Agent’s U.S. address and phone number on their labels to comply with the FDA’s adverse event reporting requirements.

US Imports can serve as your Adverse Event Agent

Need a U.S. address and phone number for your dietary supplement labels? We can help. US Imports can serve as the Adverse Event Agent for your dietary supplement business. Our regulatory specialists can document and collect adverse event reports and forward them directly to you. This will save your business headaches, time and, most importantly, keep you in compliance with FDA regulations.