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 Capote, an FDA compliance attorney. A question I get from dietary supplement brands all the time: do third-party certifications actually matter?
The short answer is yes — but not in the way you might think. Third-party certifications like NSF International, USP, Informed Sport, and others are voluntary. The FDA does not require them. Having a certification doesn’t mean you’re automatically FDA-compliant, and not having one doesn’t mean you’re in violation of any FDA rule.
However, third-party certifications do matter for several important reasons. First, they provide independent verification that your product contains what the label says it contains — in the right amounts, without harmful contaminants. This builds consumer trust and supports your product claims.
Second, for certain markets — professional athletes, military personnel, healthcare professionals — certifications like Informed Sport or NSF Certified for Sport are effectively required. Without them, your product won’t be considered by those consumers or their advisors.
Third, a good third-party certification program typically evaluates your manufacturing practices in ways that overlap significantly with FDA cGMP requirements. The process of achieving certification can strengthen your overall compliance posture.
Think of third-party certifications as complementary to FDA compliance — not a substitute for it. You still need to meet all FDA regulatory requirements. But certifications add value on top of that baseline.
If you’re evaluating which certifications make sense for your brand, we can help you think through the options. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.