In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa, an FDA compliance attorney. No dietary supplement brand ever wants to think about a product recall — but being prepared before one happens can make an enormous difference in how well you handle it.
First, let’s distinguish between voluntary recalls and FDA-mandated recalls. Most dietary supplement recalls are voluntary — the company initiates the recall because it identifies a problem with the product. Under MoCRA and existing FDA authority, the FDA can also mandate a recall if it determines a supplement poses a serious adverse health consequence or death.
When a recall is necessary, you need to act quickly. The key steps include notifying your distribution chain — everyone who received the product needs to know to stop selling it and return it. You need to identify the scope of the recall — which lots are affected, where they were distributed, and how to reach affected consumers. And you need to notify the FDA.
Your records are critical here. If your batch records, distribution records, and traceability documentation are solid, you can execute a targeted recall of only the affected lots. If your records are poor, you may end up recalling far more product than necessary.
After the recall, the FDA will want to understand what went wrong and what you’re doing to prevent a recurrence. Your response to that question — your corrective action — is a significant factor in how the agency views your company going forward.
Building recall preparedness into your compliance program before you ever need it is the right approach. We help supplement companies build and test their recall readiness. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.