Food Law and Regulation
Steve Armstrong has had over 20 years of experience advising leading consumer products companies on marketing and regulatory matters. Prior to EAS, Mr. Armstrong served as the Chief Food Law Counsel at Campbell Soup Company, where he counseled Campbell businesses on food safety, food policy, labeling and regulatory compliance, including matters involving the FDA, USDA and food agencies around the world. He has also served as the Senior Marketing Counsel at Energizer’s Schick-Wilkinson Sword Division and as the Assistant General Counsel for Marketing at Unilever United States. Mr. Armstrong is on the Board of Directors of the Food and Drug Law Institute in Washington, D.C., and is a frequent speaker on food law issues. Mr. Armstrong earned his bachelor’s degree from Harvard College and his law degree from Columbia University.
Colors and Cosmetics
John Bailey Jr., Ph.D., is a former director of FDA’s Office of Cosmetics and Colors, a position he held from November 1992 through August 2002. His 34-year agency career began as a chemist in the Division of Colors and Cosmetics. He soon moved to the Division of Color Technology and advanced to become a senior research chemist. He went on to serve in other prominent agency positions including that of director of the Office of Applied Research and Safety Assessment in the Office of Science. After his retirement from the agency in 2002, he joined the Cosmetic, Toiletry and Fragrance Association as director of cosmetic chemistry, and later joined the Personal Care Products Council as executive vice president for science.
FSMA Consulting Services
Mr. Breen became available to EAS Consulting Group after a distinguished career at the FDA working in areas such as HACCP and LACF and BSE prohibited materials in the dairy. Mr. Breen has worked with the industry on compliance issues related to the Bioterrorism Act of 2003 and led the field and HQ professionals in developing and implementing surveillance and compliance programs, and initial FSMA training implementation. His attention to detail has garnered him an FDA Award of Merit, Outstanding Achievement and five Commissioner Special Citations.
Labeling and Claims
Elizabeth “Betty” Campbell is a former Acting Director in the FDA’s Office of Food Labeling who played a leading role in writing the regulations implementing the Nutrition Labeling and Education Act (NLEA) in the 1990s. She joined EAS as a vice president in October 2006 after a 35-year career with FDA. In the role of independent advisor, she will continue to provide expert consulting advice and guidance to clients on complex labeling and claims issues and will be available to serve as an expert witness in high profile labeling cases.
OTC Drugs and Labeling
Susan Crane is an experienced professional in the pharmaceutical industry specializing in quality and regulatory compliance for over-the-counter (OTC) and dietary supplement products. She has a thorough knowledge of federal regulations pertaining to the marketing, labeling, and distribution of OTC drugs and dietary supplements: Food and Drug Administration (FDA) – Good Manufacturing Practice, Labeling, Enforcement Policy (Recalls), Dietary Supplement and Nonprescription Drug Consumer Protection Act, Consumer Product Safety Commission (CPSC) – Poison Prevention Packaging Act, Consumer Product Safety Improvement Act, OSHA Hazard Communication Standards.
Quality and Compliance
Mr. Fish joined EAS Consulting Group, LLC in November 2006 after ten years consulting for FDA regulated industries. He spent 33 years with Food and Drug Administration (FDA), the last 6 years of that service as Director, Division of Field Investigations (DFI). He was responsible for general policy and guidance for the Agency’s domestic and international investigation activities. He also managed the foreign inspections’ operations. Prior to that position, Mr. Fish was Director of Compliance at the Nashville District Office and was also a Supervisory Investigator at the Nashville District Office. Mr. Fish began his career as an investigator in the Minneapolis District Office in 1962 and subsequently served as an Investigator at the Grand Rapids Residence Post and the Detroit District Office. Mr. Fish is experienced in all aspects of FDA regulated products. He has expertise in compliance matters and Current Good Manufacturing Practice Regulations (GMPs) as they relate to pharmaceutical, device, and biologics manufacture. Further, Mr. Fish is ISO 9000 Lead Assessor Trained and is an AFDO Certified HACCP Instructor. He is a sought-after expert, speaking at international events on FDA inspections and GMPs.
Food and Color Additive Safety
Dr. Robert Martin is a former deputy director of FDA’s Division of Biotechnology and GRAS Notice Review. His 38-year career at the agency included service as a research chemist and as a consumer safety officer in the Division of Food and Color Additives. He became a supervisor and team leader after that division was renamed the Division of Petition Control. Dr. Martin holds a Ph.D. in chemistry from Georgetown University.
FDA Regulatory and Legal Matters
From 1979-1999 Jeffrey Springer served as FDA’s Deputy Chief Counsel. He offers EAS clients 33 years of experience as an attorney in the Office of the Chief Counsel of the FDA and provides a wide range of regulatory consulting services and assistance on compliance matters and strategy. With his background managing legal reviews and litigation and clearing the FDA’s regulations, Mr. Springer is a valuable asset to all FDA regulated industries.
Dietary Supplements
Tim Stewart is a Ph.D. chemist who advises clients on FTC, AG and FDA regulatory compliance issues such as Customs and Border Patrol, Import Alerts, State and Federal observations/violations, Consent Decrees, California Proposition 65 requirements, and vendor qualifications. Prior to consulting, he worked at Paragon Laboratories as a Quality Control Manager and researcher at both Harvard Medical School and the University of Southern California.
Import Operations
Mr. Veneziano is a veteran FDA specialist with over 24 years of Agency experience. He served as director of the FDA’s Division of Import Operations for more than ten years. In that role, he was responsible for oversight of FDA’s import operations program and provided leadership, guidance, and direction to approximately 1,000 field investigators in more than 320 U.S. ports of entry. He also served as co-lead in the development of the FSMA import regulations and was the senior advisor on the implementation of FSMA and the FDA Safety and Innovation Act. Mr. Veneziano began his FDA career in 1992 as a field investigator in the New England District specializing in medical device inspections. In 1998 he became a supervisory investigator in New England overseeing the medical device and import programs.
Pharmaceutical Submissions
Albert Yehaskel joined the EAS network as an Independent Consultant in 2015 and became an Advisor in 2017. He is an accomplished professional with a distinguished record in pharmaceutical regulatory affairs activities. Mr. Yehaskel has been consulting since 2010 and spent 41 years in the industry, serving as vice president of regulatory affairs, compliance, and safety at Indigo Pharmaceuticals, Inc., and in regulatory roles at Shionogi USA, Sankyo Pharma Development, Purdue Pharma and Sanofi Winthrop. Mr. Yehaskel assists clients with the development, review, and submission of pharmaceutical submissions to FDA.