Dean Cirotta, President, and COO
- European Contract Manufacturers: Preparing for US Client Compliance Expectations, July/August 2017 – Teknoscienze Publisher: Science for Industry
- Quality Agreements and the FDA, August 21, 2015 – Natural Products Insider
- The Importance of Quality Agreements, August 20, 2015 – Natural Products Insider
- The Importance of Preparing for GMP Certification, January 22, 2015, Natural Products Insider
- “FDA Data: Supplement cGMP Compliance Rates Show Modest Improvement”, February 27, 2014, in Natural Products Insider
- “Own-Label Distributors Still Struggle with GMP Compliance,” Regulatory Roundup, published with the August 2013 Natural Products Insider
- Cirotta authors “Own Label Distributors Must Face Supplement GMP Responsibilities” for November 26, 2012, The Tan Sheet
- Cirotta interviewed September 24, 2012, Tan Sheet cover story “GMPs Send Smaller Supplement Firms Into Contract Manufacturers’ Arms.”
- Cirotta authors “A Closer Look: FDA’s New Directive Provides Insight on the Agency’s Approach to GMP Inspections,” for July/August 2010 issue of The Nutritional Outlook.
- Cirotta authors chapter in The Food and Drug Law Institute’s Tobacco Regulation and Compliance: An Essential Resource March 2012.
Edward Steele, Chairman, and CEO
Edward Steele and Steven Sundlof, Independent Advisor, Animal and Human Food Safety:
- “Implementation of FSMA and What it Means to Manufacturers”, Blog for Food Product Design, October 16, 2012
- Edward Steele, John Kvenberg, Declan Conroy and Michael Olson authored chapters in The Food and Drug Law Institute (FDLI) recently published, The Food Safety Modernization Act: A Comprehensive, Practical Guide to the Landmark Legislation; an in-depth analysis of FSMA’s history, major provisions, and implementation.
Ed Steele, Chairman and CEO, Charles Breen, Independent Advisor, Food Safety Consulting Services, Betty Campbell, Independent Advisor, Labeling and Claims and Robert Martin, Ph.D. Independent Advisor, Food and Color Additive Safety
- coauthored an article “Food Regulations and Enforcement in the USA” in the Reference Module in Food Sciences published by Elsevier
Ed Steele, Chairman and CEO and Amy Scanlin
- co-author chapter on US Food and Drug Administration: History, Mission, Organization, and How It Operates. Reference Module in Food Sciences published by Elsevier
Bryan J. Coleman, Senior Manager, Pharmaceutical & Device Consulting Services
- “Have a Plan Before FDA Arrives” in Tablets and Capsules magazine, October 2016.
- Safe Quality Food – Mitigation Strategies for Food Safety Fundamentals WholeFoods Magazine April 27, 2017
- Undeclared Allergens and Automation: The Crossroad of Food Safety and the Reduction of Recalls, Food Safety Magazine, December 20, 2016
Kaiser Aziz, Ph.D., Independent Consultant
- FDA‘s Design Control Requirements for Biomarkers in Drug Development, September 2016 – Drug Development Drug Development and Delivery
John Bailey, Independent Advisor, Colors and Cosmetics
- John Bailey was interviewed in the March 17, 2014, issue of FDLI’s The Rose Sheet on the FDA’s recent rejection of the cosmetic industry’s legislative proposal for updated cosmetic regulation.
- John Bailey was interviewed for the cover story on a recent cluster of FDA warning letters to cosmetics companies for overreaching claims in the October 22, 2012, issue of the FDLI’s The Rose Sheet published by Elsevier.
- EAS Independent Consultant John Bailey was interviewed in the March 17 issue of The Rose Sheet (subscription required) on the FDA’s recent rejection of the cosmetic industry’s legislative proposal for updated cosmetic regulation.
- April 13, 2016, Rose Sheet article in which he expressed concern over the draft Personal Care Products Safety Act’s proposed standard for FDA ingredient review titled PCPSA’s ‘No Harm’ Standard Would Set High Bar For FDA Ingredient Review.
Charles Breen, Independent Advisor, Food Safety Consulting Services
- Navigating FSMA and Reducing the Risk of Recalls – Webinar with Loftware
- Interviewed for an April 2017 article in ProFood World on the need for food processors to better qualify their suppliers and understand what hazards their suppliers are responsible for controlling. [Here’s the link for hyperlinking to ProFood World: http://www.profoodworld.com/article/monitoring-ingredient-suppliers-imperative
Betty Campbell, Independent Advisor, Labeling and Claims
- The potential of a delay to Nutrition Facts label changes should not slow compliance efforts – April 25, 2017, FoodNavigator-USA
- Independent Advisor, Labeling and Claims, Betty Campbell, interviewed June 26, 2014, issue of Food Navigator Magazine in article “Is Your Product Ready for Nutrition Label Changes”
- Why do Dietary Supplement Manufacturers Need to Know about Food Label Changes? Blog for Natural Products Insider, November 22, 2013
- Interviewed on Food Chemical News Knife and Fork Show, season 1, episode 32 on the meaning of “Gluten Free”
- Interviewed on Food Chemical News Knife and Fork Show, season 1, episode 33 on Food Allergens
- Comments on Nutrition Facts Panel Proposal in Food Chemical News 2013 Regulatory Outlook
- Campbell interviewed for May/June 2012 issue of Organics Processing on labeling claims for organic products.
Steve Sundlof, Ph.D., Independent Advisor, Animal and Human Food Safety
Susan Glenn, Independent Consultant
- Interviewed for Food Chemical News Knife and Fork Show on USDA Generic Labeling Rules
- The Knife and Fork Show – Season 2 Episode 1 – USDA’s generic labeling rule
- The Knife and Fork Show – Season 2 Episode 2 – FDA’s new Nutrition Facts panels
Tim Hansen, Independent Consultant, and Ivonne Lozano, Independent Consultant
- discussed Chile’s salmon industry in a May 9, 2016, article (in Spanish) published online by salmonexpert.cl of Chile.
Tara Lin Couch, Ph.D., Senior Director, Dietary Supplements and Tobacco Services
- Auditing a Contract Laboratory, September 20, 2017 – Natural Products INSIDER
- Healthy INSIDER Podcast 87: FDA’s Thinking on Supplement GMPs, June 21, 2017 – Natural Products INSIDER
- Scientifically Sound Specifications: No “By-Inputs” Here, August 28, 2015 – Natural Products INSIDER
- Independent Consultant, Tara Couch, publishes article “Ensure the Quality of your Component Supplier” May 21, 2014, issue of Natural Products INSIDER
Tamika Cathey, Independent Consultant
- Former FDA Inspector Offers Insight into Identity Testing Procedures, Q&A for Nutra Ingredients –USA, October 29, 2013
James Hoadley, Ph.D., Independent Consultant
- “Evoluation of FDA Regulation of Dietary Fiber Substantiation”, Natural Products Insider, March 30, 2017
- Premium Series: Dietary Supplement Safety: From Mice to Men—How Animal Studies Translate into Human Advisories and What You Can Do To Protect Your Company, Webinar for Council for Responsible Nutrition, September 4, 2013
- EAS Independent Consultant James Hoadley, Ph.D., is the co-author of an article titled Launching a New Food Product or Dietary Supplement in the United States: Industrial, Regulatory, and Nutritional Considerations, published in the in the Annual Review of Nutrition. Vol. 34: 421-447. 2014. The other co-authors were John Weldon Finley, John Wescott Finley, and Kathleen Ellwood.
- EAS Independent Consultant James Hoadley, Ph.D. is the co-author of a chapter on FDA perspectives on food label claims in the U.S. for the book Nutraceutical and Functional Food Regulations in the United States and Around the World, Second edition, published by Elsevier as part of the Food Science and Technology, International Series.
Joe Baca, Independent Consultant
- EAS Independent Consultant, Joe Baca, in an article titled “What Importers Can Expect from FSMA,” in the upcoming issue of Organic Processing Magazine
John Hathcock, Independent Consultant
- Independent Consultant, Dr. John Hathcock, along with the Council for Responsible Nutrition science team helped to revise the third edition of the “Vitamin and Mineral Safety” book, 2013
L. Robert Lake, Esq., Independent Consultant
- Interviewed for Knife and Fork Show on What’s Next with Food Allergens, season 1, episode 33.
Susan Crane, Independent Consultant
- The Facts about Supplement Facts WholeFoods Magazine, April 19, 2017
- EAS Independent Consultant Susan Crane discussed the relevance of social media for an article in The Rose Sheet, Beauty Can Benefit From FDA Guidance On Third-Party Misinformation Online, posted online September 22, 2014.
- Independent Consultant, Susan Crane’s August 2014 EAS-e-News Issue of the Month runs in the August 13, 2014, issue of Medical Device Summit Newsletter
Vincent Paolillo, Independent Consultant
Color Coding: Adding Discipline to a Food Processor’s Preventive Control Program, February 21, 2017 – Food Safety Magazine