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
Hey there. I’m Lisa, an FDA compliance attorney. Today I’m talking to private labelers specifically — because there’s a lot of confusion about whether private label companies need to register with the FDA.
The short answer: it depends on what you do.
If you’re a private labeler who only affixes a label to a product manufactured entirely by someone else, and you don’t do any manufacturing, processing, packing, or holding of the dietary supplement yourself, you may not be required to register.
However, if you’re involved in any step of the manufacturing or packaging process — even repackaging the product into final containers with your label — that activity may trigger the facility registration requirement under 21 CFR Part 1.
Here’s the practical reality: most private labelers do have some activity that brings them within the registration requirement. And even if you’re technically exempt, being registered is a proactive step that reduces your regulatory risk.
Beyond registration, private labelers are still responsible for the labeling and claims on their products. You can’t outsource that responsibility to your contract manufacturer.
If you’re a private labeler and you’re not sure about your registration obligations, get a regulatory assessment. We can help you figure out exactly where you stand. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.