Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework
In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and the heads of four major cosmetics industry groups have called on Congress to pass legislation that would modernize FDA's regulatory framework for dietary supplements and cosmetics.
In October, Former FDA Commissioners Scott Gottlieb and Mark B. McClellan called on Congress to act in an article in JAMA Forum. They called Congress’ failure to advance provisions regarding dietary supplements and cosmetics as part of legislation that will reauthorize user fee programs that help fund FDA work “a profound missed opportunity.”
The provision relating to dietary supplements would require 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, they wrote.
In discussing the provision regarding oversight of cosmetics, the two said that while most cosmetics are safe, consumers “currently have no reliable way to know what is in their products, to be alerted if a product has safety issues, or to be protected if a manufacturer fails to act to address clear safety problems.”
They said the proposed legislation would give FDA authority to recall cosmetics found to contain ingredients that are likely to cause serious harm. The proposed legislation would also require cosmetics companies to report serious adverse health effects to FDA.
Their article follows a September 15 letter to lawmakers from the presidents and CEOs of the Personal Care Products Council, Fragrance Creators Association, Independent Beauty Association and Consumer Healthcare Products Association.
The groups thanked the lawmakers for their work on the Modernization of Cosmetics Regulations Act of 2022 and said they stand ready to work with Congress and other stakeholders on “a bipartisan, comprehensive and uniform national framework for cosmetics regulation that advances science, safety, innovation, and consumer confidence.”
“[FDA] and the personal care products industry continuously strive to ensure cosmetics safety – beauty and personal care products have an excellent safety record,” they said in the letter. “However, because the key statutory provisions authorizing FDA regulation of these products have not been updated since enactment of the Federal Food, Drug, and Cosmetic Act of 1938, we support modernizing cosmetics regulation to ensure that FDA has the appropriate authority and resources it needs to oversee our sector for decades to come.”
Read more stories in the Dietary Supplement and Cosmetics Legal Bulletin>>