MoCRA Check-In: FDA Guidance Urgently Needed As Year-End Compliance Deadlines Loom

On 27 March 2023, FDA posted its first announcement in response to the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on its website. That’s almost 90 days of anxiously awaiting implementation guidance. The second post shortly followed on 14 April 2023, which included a short YouTube video where FDA officials further introduced the key elements of MoCRA and provided some information about implementation. In the meantime, there have been several (many?) webinars from different perspectives attempting to analyze and describe the elements of MoCRA and to speculate on what the new law will require and how the regulated industry will need to comply, as well as offering thoughts on how to prepare for this major paradigm shift. Most have been from non-FDA presenters. Industry will need to NOW fundamentally evaluate changing many of their processes and procedures and, given the short timelines, need to be engaged in substantive efforts to assess their systems and develop a gap analysis. Unfortunately, this will be developing without concise interpretations and guidance from FDA in many areas. This is also a big challenge for FDA since the legislation set very tight deadlines. But it would be very helpful in supporting an orderly and efficient transition if FDA could comment and explain their expectations and, importantly, how they will approach enforcement actions.