Congress Gives FDA Oversight Over Cosmetics, Punts on Dietary Supplement Reforms

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In a year-end $1.7 trillion spending package in late December, Congress voted to increase FDA's oversight of cosmetics and their ingredients. A portion of the bill titled the Modernization of Cosmetics Regulation Act requires cosmetic manufacturers to register each of their facilities within one year.

Companies are also required by the new law to give FDA information including a list of ingredients in their products, including fragrances, and update that information on an annual basis. The law also gives FDA the authority to issue mandatory product recalls.

The Personal Care Products Council applauded the legislation's passage. In a statement, the group said the legislation creates a comprehensive and uniform national framework for cosmetics regulation.

“This truly historic moment took over a decade, bringing together a diverse group of stakeholders to support a contemporary approach to cosmetics oversight and further strengthen consumer trust in the products they use every day,” PCPC President and CEO Lezlee Westine said, thanking the bill's sponsors from both sides of the aisle. “This landmark legislation would not have been possible without their leadership and commitment.”

In the same spending bill, Congressional leaders were unable to pass regulatory reform involving FDA’s oversight of dietary supplements. Two former FDA commissioners called on Congress to pass such legislation, along with the MCRA, in an October article in JAMA Forum.

An earlier provision relating to dietary supplements would have required all dietary supplement manufacturers to notify FDA when a product is introduced or modified, as well as disclose the composition of ingredients and factors, such as the product's intended dosage and serving size.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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