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September 7, 2016, Covington Alert
Yesterday, FDA published its final rule regulating certain active ingredients found in over-the-counter (“OTC”) consumer antiseptic wash products that are intended to be used with water and rinsed off after use, such as hand or body washes, which FDA refers to as “consumer antiseptic washes” (the “Final Rule”). In the Final Rule, FDA deems 19 active ingredients to be “nonmonograph,” meaning that they are not generally recognized as safe and effective (“GRAS/GRAE”). As a result, once the Final Rule becomes effective, OTC consumer antiseptic washes containing these active ingredients will be misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act and constitute new drugs for which premarket approval is required. FDA has deferred further rulemaking for three active ingredients to allow for the development and submission of new safety and effectiveness data.
July 14, 2016, Bloomberg BNA
Miriam Guggenheim is quoted in a BNA article regarding legislation passed by Congress creating a national standard for food makers to disclose genetically-modified ingredients. According to Guggenheim, while there is considerable will in the administration to resolve the GMO labeling issue, agency resources would also play a role in the rulemaking timeline. ...
May 25, 2016, Law360
Miriam Guggenheim is quoted in a Law360 article regarding the FDA’s new rule requiring companies to include information about added sugars on nutrition labels. According to Guggenheim, "There will be those who assert that FDA has not met its First Amendment burden to justify the compelled commercial speech." She continues, "A number of recent cases have ...
April 10, 2015, Am Law's The Litigation Daily
Covington's Paul Schmidt and Michael Imbroscio were named "Litigators of the Week" by AmLaw for their successful representation of Hoffmann-La Roche Inc.:
"Not so long ago, Hoffmann-La Roche Inc. faced a grim reality in sprawling litigation over the acne medication Accutane."
"In 2007, New Jersey judge Carol Higbee handed an edge to plaintiffs lawyers at ...