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, with a particular expertise on regulatory structures in the United States, European Union, 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.

Representative Matters

• Strategized the submission of numerous FCN filings to FDA to establish clearances for substances used in food-contact applications
• Assisted both domestic and foreign companies in obtaining NOLs for recycled plastic
• Assisted companies with DMF submissions to FDA
• Worked on California Proposition 65 assessments to determine whether warning language is required
• Drafted opinion letters evaluating the food-contact status of various products for companies to use internally to assure compliance or for marketing purposes
• Assessed MERCOSUR compliance status of products intended for use in food-contact applications
• Counseled clients on GMPs related to the manufacture of food packaging