David Rosen Featured for Insight on Looming FDA Final Rule for Cosmetic Manufacturing

Foley & Lardner LLP partner David Rosen is featured by CosmeticsDesign for his insights on the U.S. Food and Drug Administration’s final rule establishing Good Manufacturing Practices for the cosmetics industry in the article, “Preparing for MoCRA’s 2025 cGMP deadline: What cosmetic manufacturers and suppliers need to know.” 

While the deadline for the FDA’s publication of the final rule remains over a year away, Rosen said that manufacturers and suppliers should begin evaluating their current practices and supply chains to avoid a last minute scramble, adding that novel challenges from safety substantiation, supply chain adjustments, and post-market surveillance requirements will arise.  

“Cosmetic product facility registration and cosmetic product listing are some of the most burdensome provision,” Rosen explained, noting too that manufacturers will have to confront the significant challenge of having written standard operating procedures to comply with applicable good manufacturing practices. Rosen also anticipates an impact on the industry’s supply chain. “There may be fewer suppliers because companies have to substantiate the safety of ingredients in formulations,” he commented.

He emphasized it is critical for companies to embark on the compliance process immediately, highlighting the value in strategic planning and early engagement with manufacturing partners and suppliers centered around core products, simplified ingredient lists, and overall preparation to succeed under the final rule.