Lipstick — a Prohibited Ingredient
Lead Content Over the Limit
Situation
A lipstick exporter used FDA-approved colorants and prepared a clean label, but never tested the lead content of one of its raw materials before exporting.
Problem
An FDA routine market-monitoring sample test found lead content over FDA's recommended level. The product was classified as adulterated, and the Responsible Person was asked to conduct a voluntary recall.
Timeline
- During market monitoring — FDA routine sample collection
- Test results — lead content confirmed over FDA's recommended level
- Afterward — voluntary recall requested, full recall, relaunch after switching raw materials
Losses
Full recall costCost of switching raw materials and relaunchingDamage to brand credibility
📌 An approved colorant doesn't guarantee the raw material is free of impurities. Heavy-metal testing is standard for lip products.