Omega-3 Capsules — a Supplement Facts Formatting Error
How EPA/DHA Content Should Be Displayed
Situation
An omega-3 supplement was launching in the U.S. The manufacturer designed the Supplement Facts panel in-house, listing 'EPA 180mg, DHA 120mg' as a separate line below 'Fish Oil 1000mg.'
Problem
EPA and DHA are subcomponents of fish oil and must be indented underneath it, not listed as a separate line — the format was wrong. The panel also failed to specify the source fish species, leaving the raw-material information incomplete.
Timeline
- Day 1 — label inspection after arrival
- Day 5 — FDA flags the Supplement Facts formatting error and insufficient raw-material information
- Day 12 — label correction plan submitted, conditional clearance granted, corrected label required starting with the next lot
Losses
12 days of storageLabel redesign cost
📌 The Supplement Facts format is a matter of regulation, not aesthetics. Build it to FDA's official template.