Colleen M. Evale

Colleen Evale advises domestic and foreign corporations on regulatory compliance with U.S. Food and Drug Administration (FDA) matters related to indirect food additives. She counsels global clients on an array of food contact materials and has extensive experience with regulatory structures in the United States (U.S.), the European Union (EU), Canada, and South America.

Colleen assists multinational companies with obtaining clearances for new substances used in contact with food through the filing of Food Contact Notifications (FCN) with FDA, as well as drafting opinion letters to establish suitable regulatory status for use of polymers, additives, inks, coatings, and adhesives in food contact applications in various jurisdictions. She counsels clients with regard to good manufacturing practice (GMP) issues relating to the manufacture of food packaging, and has experience obtaining No Objection Letters (NOL) from FDA for recycled plastic. In addition, Colleen regularly submits Drug Master Files (DMF) to FDA for materials used in drug packaging.

Colleen is a presenter at Keller and Heckman’s Annual Food Packaging Law Seminar.

Insights & In the News

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