Amber Grover counsels domestic and international clients on regulatory and compliance matters in food and drug law, with an emphasis on food and drug packaging, medical devices, pharmaceuticals, food additives, and cosmetics. She assists clients in obtaining regulatory clearances for food contact materials, food additives, and color additives from the U.S. Food and Drug Administration (FDA) and comparable international agencies. She also has experience with premarket notifications for medical devices (510(k) notices) and investigational new drug applications (NDAs).

Amber drafts legal opinion letters evaluating packaging components such as additives, printing inks, adhesives, polymer components, and color additives used in plastics, paper and paperboard, and coatings. She also counsels clients on good manufacturing practice (GMP) issues related to the manufacture of food packaging and on establishing self-determined Generally Recognized as Safe (GRAS) positions.

Amber has experience advising companies on compliance with state and local laws, such as food ware restrictions for quick-service restaurants, California’s Proposition 65, and the Plastic Pollution Prevention and Packaging Producer Responsibility Act (SB 54). She is also well-versed in regulatory requirements related to environmental issues, as well as recycled materials intended for use in food contact applications.

With an undergraduate degree in Molecular Biology and a master’s degree in Biomedicine and Law, Amber has the ability to understand and interpret complex scientific issues as they relate to the governing legal and regulatory requirements. Her scientific background is valuable in assisting clients with technical aspects of regulatory work, such as determining the appropriate data needed to support new Food Contact Notification (FCN) submissions to FDA.

Prior to joining Keller and Heckman, Amber was a Research Associate at a global independent nonprofit research institute, where she developed and implemented technical protocols, standardized operating procedures, and directed and managed preclinical toxicology studies moving through the pharmaceutical pipeline. She has also co-authored scientific papers in the life science field.

While in law school, Amber was paired with a supervising attorney to advise early-stage biotechnology companies on intellectual property and business opportunities by conducting freedom-to-operate analyses and intellectual property landscape reviews. Amber was the President of the UC Law SF Health Law and Policy Society and a Co-Executive Articles Editor of the Constitutional Law Quarterly legal journal. 

Representative Matters

• Advised clients regarding compliance with California’s Proposition 65 and other California regulations on toxics in packaging
• Performed regulatory reviews of food contact materials to assess compliance with FDA food contact laws and regulations
• Provided assistance to multinational clients with securing Letters of No Objection (LNOs) for their plastic recycling processes
• Advised multiple clients on environmental claims related to recyclability, biodegradability, and compostability
• Performed reviews of marketing claims on a wide variety of products, including dietary supplements

Memberships

• Queen’s Bench Bar Association