Getting A Jump On Cosmetic GMPs: How Ready Is Your Business?

 
• By Rachel Raphael and Marcha Isabelle Chaudry
  
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Cosmetics companies should familiarize themselves with current good manufacturing practices standards, namely ISO 22716:2007 and NSF/ANSI 455-3-2021, and begin building out their quality programs accordingly. HBW Insight guest columnists Marcha Isabelle Chaudry, attorney and founder of The Equity and Wellness Collaborative, and Rachel Raphael, partner at Morgan, Lewis & Bockius, offer preparation tips ahead of US FDA rulemaking.

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By the end of 2024, the US Food and Drug Administration is expected to issue a notice of proposed rulemaking on Good Manufacturing Practices (GMPs) applicable to cosmetics sold in the United States. Products that are not manufactured according to these GMPs are considered “adulterated,” and the manufacture and sale of adulterated cosmetics are strictly prohibited under the US Food, Drug & Cosmetics Act. This means potentially serious consequences in the form of civil and criminal penalties, injunctions, seizures, and product recalls.

It is critical that cosmetic companies take stock of where they (and any manufacturing partners) stand in terms of GMPs...

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