Rachel A. Bond
Rachel Bond counsels domestic and foreign manufacturers on regulatory compliance of food and drug packaging materials and indirect food and feed additives with the laws and regulations administered by the US Food and Drug Administration (FDA), as well as its foreign counterparts. She advises global clients on a diverse array of packaging components, including polymers, additives, printing inks, and adhesives. Rachel assists companies in obtaining food-contact clearances for their products in the United States, Canada, South America, and the European Union and its individual Member States. She also advises clients on ways to establish a suitable regulatory status for products for which explicit premarket approval is not necessary.
Rachel counsels clients on good manufacturing practice issues, as well as other regulatory schemes that impact packaging components, such as California’s Proposition 65. For trade and industry association clients, she monitors and advises on legislative and regulatory initiatives impacting packaging.
Rachel’s scientific background in biology provided the foundation for her highly technical legal career. Prior to attending law school and joining the firm, she worked in government relations and legislative affairs for a leading lobbying firm in Washington, DC where she developed her extensive knowledge of policymaking.
Rachel is a contributing author to PackagingLaw.com, as well as related industry publications, and is frequently invited to speak at food-contact conferences.
- Evaluated the regulatory status of food-contact materials in jurisdictions throughout the world and provided legal opinions regarding same
- Prepared and submitted Food Contact Notifications (FCNs) to the FDA to obtain premarket clearance for food contact substances
- Prepared Drug Master Files (DMFs) on packaging materials and related submissions to the FDA
- Filed dossiers to obtain premarket authorizations for food-contact materials under the EU Plastics Regulation, the German BfR Recommendations, the MERCOSUR Resolutions in South America, and other comparable international authorities
- Provided guidance on the proper application of the Generally Recognized as Safe (GRAS) principle in the U.S. and worked with clients on the feasibility of establishing a self-determined GRAS position
- Counseled clients on good manufacturing practice (GMP) considerations, including conducting GMP audits of client facilities
- Advised on the use of post-consumer recycled plastics in food-contact applications, including preparation of No Objection Letter (NOL) requests to FDA regarding plastics recycling technologies
- Interpreted and developed supplier and customer assurance documentation