Misa Morreall supports Keller and Heckman’s Food and Drug Practice through the organization and preparation of Food Contact Notifications (FCN), Drug Master Files (DMF), and Tobacco Product Master Files (TPMF) filed with the U.S. Food and Drug Administration (FDA), Health Canada, and analogous agencies around the world. She writes and submits Freedom of Information Act (FOIA) requests for Food Additive Petitions (FAP), Color Additive Petitions (CAP), Food Contact Notifications (FCN), and FDA Memoranda. She assists our attorneys and scientist and their clients with project management, legal research, and legal writing. She monitors European Union (EU) and Member State legislation applicable food and drug packaging and contributes to informational pieces on food and drug packaging laws and regulatory matters.
Misa assists in constructing and assembling FCNs by establishing FDA’s Form 3480, gathering all attachments and exhibits, and submitting electronic and paper copies to FDA. She also drafts and files DMF and TPMF paperwork including original filings, amendments, entity name changes, Letters of Authorization, and Statements of Commitment which include confidential product recipes, supplier information, and customer details. She drafts legal opinions to clients concerning FDA regulated chemicals and ingredients for food contact materials, and tracks U.S. federal laws and individual state regulations regarding food contact materials and the environment, as well as surveys applicable European Union (EU) legislation for clients.
Prior to joining Keller and Heckman, Misa worked as a Legal Secretary and as a Market Research Analyst in New York State.