Beauty Firms Face Adverse Event Reporting, GMP Requirements Under Bill
This article was originally published in The Rose Sheet
Executive Summary
A discussion draft of the Food and Drug Administration Globalization Act of 2008 in circulation proposes to mandate adverse event reporting, good manufacturing processes and registration with FDA for cosmetic facilities serving American consumers
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FDA Globalization Act of 2009
Rep John Dingell, D-Mich., former Energy and Commerce Committee chairman, has revived his proposal for sweeping regulatory and import safety reforms amid a recent flurry of recalls related to salmonella-contaminated peanut butter, according to a Jan. 28 release. Although the latest food contamination outbreak - which has sickened nearly 500 people and been linked to eight deaths - is emphasized most in the sponsors' remarks, the bill seeks to equip FDA with appropriate funding and authority for regulating not only food but drugs, devices and cosmetics as well. Similar to the version that circulated in draft form in 2008, the bill would require cosmetic manufacturers to register their facilities with FDA, submit ingredient statements and report serious and unexpected adverse events (1"The Rose Sheet" April 21, 2008, p. 4). Rep. Frank Pallone, D-N.J., chairman of the Health subcommittee and a recognized ally of the dietary supplement industry, and Dingell protégé Rep. Bart Stupak, D- Mich., who chairs the Oversight and Investigations subcommittee, are co-sponsors of the bill. While some experts believe the focus of the 111 Congress will be on economic and health-care issues, "the fact that Dingell, Stupak and Pallone are all on the bill means that this is a top priority," according to John Manthei, a food and drug attorney at Latham & Watkins and former Energy and Commerce majority counsel
FDA Globalization Act of 2009
Rep John Dingell, D-Mich., former Energy and Commerce Committee chairman, has revived his proposal for sweeping regulatory and import safety reforms amid a recent flurry of recalls related to salmonella-contaminated peanut butter, according to a Jan. 28 release. Although the latest food contamination outbreak - which has sickened nearly 500 people and been linked to eight deaths - is emphasized most in the sponsors' remarks, the bill seeks to equip FDA with appropriate funding and authority for regulating not only food but drugs, devices and cosmetics as well. Similar to the version that circulated in draft form in 2008, the bill would require cosmetic manufacturers to register their facilities with FDA, submit ingredient statements and report serious and unexpected adverse events (1"The Rose Sheet" April 21, 2008, p. 4). Rep. Frank Pallone, D-N.J., chairman of the Health subcommittee and a recognized ally of the dietary supplement industry, and Dingell protégé Rep. Bart Stupak, D- Mich., who chairs the Oversight and Investigations subcommittee, are co-sponsors of the bill. While some experts believe the focus of the 111 Congress will be on economic and health-care issues, "the fact that Dingell, Stupak and Pallone are all on the bill means that this is a top priority," according to John Manthei, a food and drug attorney at Latham & Watkins and former Energy and Commerce majority counsel
FDA Globalization Act Too Taxing For Small Biz? Group Lobbies For Exemption
The draft version of the FDA Globalization Act of 2008 may be amended to include exemptions for small cosmetics firms that otherwise would be "decimated" under the legislation in its current form, according to a group of small business owners and representatives that has been active on Capitol Hill