In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hi there. I’m Lisa Capote, an FDA compliance attorney. Whether you’re a supplement manufacturer, a private labeler, or a brand owner, FDA compliance applies to you — and it applies differently depending on your role in the supply chain.
Manufacturers are responsible for cGMP compliance — proper testing, documentation, quality control, and employee training under 21 CFR Part 111. You are the first line of defense for product safety and quality.
Private labelers — companies that put their brand on products manufactured by someone else — are responsible for the labeling and claims on those products. Just because you didn’t make the product doesn’t mean you’re off the hook for compliance. If your name is on the label, the regulatory responsibility follows.
Brand owners who also distribute are responsible for adverse event reporting, and must maintain records of any consumer complaints for at least six years.
All entities in the chain — manufacturer, labeler, distributor — must comply with applicable FDA regulations. The key is understanding exactly where you sit in that chain and what obligations apply specifically to you.
If you’re not sure what your compliance obligations are, a regulatory compliance review is a smart first step. That’s exactly what we do. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.