Catherine Nielsen is an experienced food and drug attorney who counsels domestic and foreign corporations on the regulatory compliance of food additives, food contact materials, and drug and medical device packaging before the U.S. Food and Drug Administration (FDA), as well as its international counterparts, including in Canada, Europe, Central and South America, and the Pacific Rim.  

Catherine brings innovative legal and sound scientific strategies to clients seeking to achieve broadened markets for their products, assisting companies in obtaining explicit regulatory listings of packaging components (such as polymers, additives, coatings, printing inks, adhesives, and polymer production aids), food additives, and color additives in global jurisdictions, including the United States (U.S.), MERCOSUR, and the European Union (EU). 

Catherine helps food and food contact companies assess challenging adulteration issues and advises on potential recalls. In addition, she counsels clients on compliance with California’s Proposition 65 and the Coalition on the Northeastern Governors “Toxics in Packaging” legislation, in addition to other state legislation dealing with toxic substance exposure issues.

Catherine is a contributing author to packaginglaw.com, as well as related industry publications, and is frequently invited to speak at international food contact conferences.  

Representative Matters

• Assisted multiple plastics manufacturers in conducting risk assessments of non-intentionally added substances/impurities in Europe and in the U.S., respectively
• Achieved multiple clearances of additives, polymers, and can coatings through the successful prosecution of numerous Food Contact Notifications (FCNs) in the U.S.
• Audited the regulatory compliance of a client’s products for sales into food and drug packaging in the U.S. and Canada, based on a review of client’s and suppliers’ records, formulations, and compliance statements
• Guided a major polymer producer in communications with FDA on changes in manufacture to a food contact substance, avoiding the need for a new FCN submission
• Counseled a major producer of a food contact polymer on its recall obligations and strategy, in the wake of a significant leak in a processing chemical during production
• Achieved FDA regulatory compliance of a color additive for cosmetic applications under Part 74 of FDA’s regulations
• Oversaw the generation of a No Significant Risk Level (NSRL) under California Proposition 65, in the absence of an Office of Environmental Health Hazard Assessment (OEHHA) level, and evaluated compliance of resin product with Prop. 65 based on that assessment 
• Conducted training seminars for clients on food contact regulations in the U.S., Europe, China, MERCOSUR, and India

Memberships

• American Bar Association (ABA), Natural Resources & Environment Section
• Food and Drug Law Institute (FDLI)