Holly Foley specializes in numerous regulatory areas, including foods, food packaging, drugs, and related environmental issues.
Holly's primary expertise is in the evaluation of the status of food ingredients and packaging materials, the development of testing plans to obtain needed data, and the preparation of food additive petitions and food contact notifications (FCNs) to achieve U.S. Food and Drug Administration (FDA) clearances; she also has expertise in similar submissions to comparable foreign agencies.
With nearly 40 years of experience at Keller and Heckman, Holly has helped our clients establish regulatory compliance for thousands of products. She has developed hundreds of submissions to FDA and regulatory authorities in the European Union (EU), China, and MERCOSUR countries. Holly is also a key part of the firm’s work in developing bases for establishing compliance for products in the absence of specific clearances.
Holly’s achievements include helping clients to obtain FDA clearance for non-nutritive sweeteners and enzyme preparations used in food and food processing, refrigerants, and blowing agents used as chlorofluorocarbon (CFC) substitutes in accordance with the Montreal Protocol, and international approvals for novel biocides used in food safety applications. She is uniquely qualified to provide detailed guidance to clients on chemical, toxicological, and environmental testing, to work in collaboration with testing labs, and to assist in interpretation of data.
Holly is skilled at presenting and defending data to agency personnel, and in bringing creative thinking and analysis to a wide range of products spanning all types of packaging, processing materials, and food ingredients. She has conducted numerous trainings for clients and industry groups throughout the United States (U.S.), Europe, and Japan. She uses her analytical skills and understanding to bridge regulatory and scientific considerations and to facilitate favorable resolutions for our clients’ most complex and challenging issues.