Substantiating a product claim is required by U.S. law and can help brands avoid regulatory action or provide an effective defense in litigation. For example, in April 2023, the US Federal Trade Commission (FTC), responsible for enforcing federal laws against anticompetitive, deceptive, or unfair business practices, sent notices to approximately 670 companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, or functional foods.[1] The agency placed the companies on notice that they could incur significant civil penalties -- up to $50,120 per violation-- if they fail to adequately substantiate their product claims. FTC specifically identified as unlawful those practices failing to have competent and reliable evidence for health or safety claims, misrepresenting the level or type of substantiation for a claim, or misrepresenting that a product claim has been scientifically or clinically proven.
As a member of the Certified Group and Food Safety Net Services, EAS clients have access to world-renowned testing laboratories that meet your organization’s sophisticated needs. In this column, you’ll hear about their capabilities, environmental challenges and more. We hope you’ll enjoy a look “under the microscope.”
Reviewed and Approved by Steven Taormina, Certified Laboratories Regional Business Development Director – West, Cosmetic, OTC, and Supplements
To help cut through the confusion, we answer some frequently asked questions.
What’s Changed in Amazon's New Dietary Supplements Policy?
Amazon's 2024 policy update introduced a shift in how dietary supplement sellers must manage their product listings. Amazon prioritized three supplement categories for these requirements:
Sexual Enhancement
Weight Management
Bodybuilding & Sports Nutrition
A critical element of this update is that Certificates of Analysis (COAs) must now be submitted to Amazon through a third-party Testing, Inspection, and Certification (TIC) company that Amazon has approved. This change aims to enhance the chain of custody and ensure the authenticity and safety of supplements sold on Amazon in the United States.
Sign up today for our upcoming webinar on Good Auditing Practices, Making the Most of Your Internal Review presented by EAS Consulting Group Senior Consultant Jeb Hunter. This virtual short course will take place on July 17 and 18 from 11am-3pm ET. Pricing and additional information are available online.
Sign up today for our upcoming webinar on Cosmetic Safety Substantiation presented by EAS Consulting Group Senior Consultant Paula Brock. This seminar will take place on July 25 from 1pm-3pm ET. Pricing and additional information are available online.
Read Food Processing’s latest food safety article on “Heavy Metals: As They Stand Today” by EAS Consulting Group’s Tom Jonaitis. “Companies should be on guard to ensure their sourcing, testing and safety analysis is as robust and accurate as possible,” advises Jonaitis. View the article online: https://www.foodprocessing.com/food-safety/article/55057170/heavy-metals-as-they-stand-today
Heading to the Institute of Food Technologists’ IFT First Annual Event & Expo starting July 14 in Chicago? We’d love to meet you at the EAS Consulting Group and Certified Group exhibitor tables! Event information and registration details are available at IFTevent.org.
John Bailey will speak at the Naturally Kiawah Symposium happening October 8-11, 2024, in Kiawah Island, SC, on regulation updates, MoCRA, product testing, PFAS, and more. Visit https://www.scconline.org/CarolinaSCC/Naturally-Kiawah for more information.
In May, the EAS team enjoyed celebrating the 75th anniversary of FDLI’s 2024 Annual Conference in Washington, DC. Our own Paula Brock joined a fantastic panel discussion and Cosmetics Boot Camp on Cosmetic Safety Substantiation. Thank you to the FDLI for a fantastic event!
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A senior safety and regulatory professional with extensive experience leading global Safety and Regulatory Affairs initiatives, Dr. Ansell founded Bellevue Toxicology LLC to provide comprehensive human safety science and regulatory services to the Personal Care Products and Specialty Chemicals industries.
Previously, as Vice President – Cosmetic Programs at the Personal Care Products Council, he provided technical support to Council members and staff, Committees and International NGOs addressing safety science at the state, national, and international levels.
Dr. Ansell came to the Council from Yves Rocher, a France-based personal care products company, and before had been Vice President of Product Safety and Regulatory Affairs at two international specialty chemical companies.
Dr. Ansell has published more than thirty papers and reports, given numerous presentations on safety and risk assessment, served as Chair of the U.S. Technical Advisory Group to ISO TC 217-Cosmetics, and is past President of the International Society of Regulatory Toxicology and Pharmacology.
Trained as a chemist, Dr. Ansell received his B.A. from Gettysburg College, Gettysburg, Pennsylvania, an M.S. from Marshall University in Huntington, West Virginia, and completed his graduate studies with a Ph.D. from Binghamton University – State University of New York. He is a certified Diplomat of the American Board of Toxicology and included in the European registry of Toxicologists.
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