FDA Regulation (Food Drug Administration) Consultants: 6

Tracy L. Skaer, PharmD, FASHP, FASCP is a Professor Emeritus of Pharmacotherapy with over 30 years of pharmaceutical experience. Dr. Skaer's research and professional experience include pharmacy practice, chronic pain, mental health, substance abuse, and complementary and alternative medicine. She is licensed pharmacist in California, Idaho, and Washington.

Dr. Skaer’s current research involves the use of mindfulness and multiple family group problem solving for the Treatment of Chronic Pain in those with high risk of Opioid Use. Her plans are to expand this intervention to manage chronic insomnia and post-traumatic stress disorder in children and adolescents, American Indians, veterans, and other populations. Other research interests include chronic pain, comorbid mental illness in chronic disease, depression, anxiety disorders, insomnia, mindfulness, complementary and alternative medicine, and pharamcoeconomics and pharmacoepidemiology. Her research has been supported by over $3.2 million in grants from foundations and pharmaceutical industry.

Dr. Skaer has published 110 professional abstracts, 82 research papers, 43 review articles, and 6 book chapters. She serves on the editorial boards of 3 medical professional journals, Clinical Therapeutics, Journal of Sleep Medicine and Disorders, and Pain Studies and Treatment. Dr. Skaer's publications have appeared in numerous journals including, Drugs, Clinical Drug Investigation, PharmacoEconomics, Journal of Clinical Pharmacy & Therapeutics, American Journal of Medicine, Harvard Review of Psychiatry, and the New England Journal of Medicine among others.

View Dr. Skaer's Expert Witness Profile.

Tom Jonaitis, DABT, is a Board Certified Toxicologist and Consumer Product Safety / Regulatory Consultant with 18 years of experience. He has broad expertise in the areas of Safety and Exposure Assessment, Regulatory Compliance, and Toxicology Evaluations.  

Mr. Jonaitis helps companies efficiently navigate and comply with various regulations and obstacles in the consumer product, food, cosmetic, dietary supplement, building material, and chemical industries. His has co-authored several manuscripts in peer-reviewed journals on the topics of safety, risk assessment, and other research.

Background Experience - Prior to forming RegTox Solutions, Mr. Jonaitis served as Manager of Toxicology & Regulatory Affairs at Intertek Scientific & Regulatory Consultancy (2005-2018). He worked as subject-matter expert (SME) and client contact for matters related to California Proposition 65, including presenting webinars and presentations. He also conducted human exposure assessments in relation to chemicals in food, dietary supplements, consumer products, cosmetics, as well as deriving exposure limits for carcinogens, reproductive / developmental or other toxins using traditional and benchmark dose modeling approaches.

Business Consultant Services:

• Regulatory Compliance Evaluations
• Scientific Literature Hazard Reviews and Summaries for Chemicals / Substances
• Creating Pre-Market Quality and Safety Dossiers for Novel Food / Dietary Supplement Ingredient Applications (primarily for US, Canada, Australia)
• Safety Assessments
• Label Claims Analysis and Compliance
• Deriving Exposure Limits
• HazComm, Pesticide Applications, and various other niche areas
• California Proposition 65 Compliance (and how to avoid costly enforcement)

Packaging Technology & Research LLC provides Food Packaging Consulting, Tailored Packaging Science, and Value Chain Solutions that improve   packaging in the Food and Beverage Industry. 

Science-Based Consulting:

Problem Solving and Technical Consulting - Help uncover and shine a spotlight on what’s working and what is NOT to help our clients take bold steps rooted in science-based packaging expertise.

Sustainable Packaging - Unlock the optimal blend of food and packaging science, value chain experience, and consumer insights to achieve more sustainable packaging for clients. This includes food packaging system, flexible packaging, and packaging materials that support food packaging sustainability.

Increase Shelf Life and Prevent Food Waste - Empower clients with packaging solutions to prevent food waste, meet bold commitments on addressing UNSDGs, food justice, hunger, and GHG. reduction. F

Strategy and Roadmaps - Steer clients’ futures by developing science-based, systems-thinking strategies and roadmaps to ensure both an intelligent plan and a strong business case. From food packaging for frozen food to edible packaging and pet food packaging 

Clients: Food Companies, Produce Companies, Frozen Food Manufactures, Meal Kit Delivery Companies, Food and Packaging Wholesaler, Restaurant Chains, Industry Associations, Packaging Companies, Bakeries, Pet Food Companies, Packaging Manufacturers, Quick Service Restaurants, Environmental Advocacy Groups, Chemical Companies, Dairy Farms, Butchers, Copackers, Meat Delivery Companies, Restaurants.

Claire K. Sand, PhD, is a Global Packaging Technology  Leader with over 35 years of Food Science and Packaging experience. Dr. Sand's background includes working with Total Quality Marketing, Nestle, General Mills, Kraft Heinz, Safeway, and academia, as well as in basic research, development market research, and marketing in Germany, Colombia, and Thailand. 

Dr. Sand is the owner and founder of Packaging Technology and Research, LLC, as well as Gazelle Mobile Packaging Inc. She is also an Adjunct Professor at Michigan State University and CalPoly. She is an IFT Fellow, the Riester-Davis-Brody Lifetime Achievement in Food Packaging Award recipient, a member of numerous Editorial Boards, the author of the Packaging Value Chain, and the co-chair of pacfoodwaste. Dr. Sand received her doctorate in Food Science and Nutrition from the University of Minnesota, as well as master's and bachelor's degrees in packaging from Michigan State University.

View Dr. Claire K. Sand's Expert Witness Profile.

Principal, John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies. 

Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices.

View Mr. Stevens' Expert Witness Profile.

Dr. Ewen Todd is a Food Safety Expert with over 45 years of experience in the reporting and surveillance of Foodborne Disease, as well as development of analytical methods for identifying foodborne pathogens. As a result of his knowledge of foodborne disease and work researching different pathogens and toxins, Dr. Todd has influenced research programs and regulatory approaches taken by the Health Protection Branch of Health Canada. In the US, he held the position of Director of the National Food Safety and Toxicology Center and the Food Safety Policy Center at Michigan State University.

A leader in microbial research, foodborne disease surveillance, costing of outbreaks, food safety policy, seafood toxins, standard-setting, risk assessment, risk management and risk communication, his presentations and food safety programs have been influential in many countries including China, Cambodia, Japan, United Arab Emirates, Lebanon, Kuwait, Saudi Arabia, Europe, as well as Canada, and the USA. Dr. Todd has delivered over 400 presentations and posters at national and international meetings, with over 200 invitations to speak and teach workshops.

An acclaimed author in the field of Foodborne Illness, he has written 109 research papers, 16 reviews, 36 book chapters and booklets, 40 departmental publications, 37 conference proceedings, 9 laboratory methods, 56 investigational and editorial articles, 90 published abstracts, and 3 editings of proceedings or books. Dr. Todd has received 20 appointments and awards, including the Excellence in Science Award for 1998, the first to be awarded by Health Canada. He is a Fellow of the American Association for the Advancement of Science, the International Association for Food Protection and MSU University Outreach and Engagement as well as Editor in Chief for the Elsevier Encyclopaedia of Food Safety.

Dr. Todd's Consulting services are available to businesses and governments internationally. He responds to telephone calls, emails, and written requests for information on food and waterborne disease.

Consulting Services Include

• General Food Safety and Spoilage Issues
• HACCP and GHP Systems
• Standards for Poultry
• Listeria Monocytogenes in Soft Cheeses
• Standards for Poultry
• Seafood Toxins
• Food Workers
• Investigation of Foodborne and Waterborne Illnesses
• Foodborne Disease Surveillance Systems
• Risk Assessment, Risk Management and Risk Governance
• Safety of Aquaculture Systems
• Norovirus in Elder Care and Other Facilities
• Salmonella and Shigella in Schools and Child Care Centers
• Salmonella in Tahini and Other Oil-based Foods
• Escherichia coli O157:H7 in Leafy Greens
• Staphylococcus aureus in Cheese, Clostridium botulinum in Canned or Preserved Food and Native American / Inuit Fermented Food
• Listeria monocytogenes in Deli Meats and Soft Cheeses
• Controlling Listeria monocytogenes in Ready-to-eat Foods
• Hydrophobic Grid Membrane Filter Systems

View Expert Witness Profile.