PCPSA's 'No Harm' Standard Would Set High Bar For FDA Ingredient Review

Regulatory consultants have concerns about the draft Personal Care Products Safety Act's proposed standard for FDA ingredient review – reasonable certainty of no harm. The standard's de facto application in FDA's review of new dietary ingredients in the supplement space has resulted in a fail rate of around 75%.

The draft Personal Care Products Safety Act proposes that FDA review cosmetic ingredients against a standard that has proven challenging for the dietary supplement industry and could set unrealistically high consumer expectations, experts suggest.

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