FDA MoCRA: The New Reality for US Formulators
Regulatory
The Modernization of Cosmetics Regulation Act of 2022 ends the era of unregulated US cosmetics. Facility registration and serious adverse event reporting (within 15 days) are mandatory.
Core Analysis
Formulation and regulation are intrinsically linked. An ingredient that provides excellent yield stress might be restricted to 0.1% in the final formula due to toxicological concerns. Always cross-reference functional desires with regulatory constraints.
| Parameter | Critical Value | Impact |
|---|---|---|
| Temperature | >45°C | Accelerates degradation kinetics |
| pH Range | 4.5 - 5.5 | Optimal for skin microbiome & organic acids |
| Water Activity (aw) | < 0.6 | Microbes cannot proliferate |
Frequently Asked Questions
Are small businesses exempt from MoCRA?
Partially. Facilities with <$1M average gross annual sales are exempt from GMP and facility registration, UNLESS they make products applied near the eye, injected, internal, or altering appearance for >24 hours.
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