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Specializing in FDA Regulatory Matters

John Bailey Addresses Structure/function Claims in The Rose Sheet

EAS Senior Adviser John Bailey is featured in an article titled Regulatory Roulette: Playing In Today’s Skin-Care Market A Gamble, posted online March 17 by The Rose Sheet.

Recent FDA warning letters to skin-care firms raise questions about the regulatory risks companies must assume to compete effectively in the marketplace. Bailey discusses the strategic decision faced by personal-care companies as they develop their marketing and the potential consequences of using structure/function claims.

“Each company will have to assess the [regulatory] risk and the cost and then decide if it’s worth it to them,” he says. “In other words, if the market value is significant enough, they may be willing to take the risk.”