FDA Finally Outlaws Soda Ingredient Banned Around the World
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Speaker : JOSE IGNACIO MORA
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When : Thursday, October 17, 2024
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Time : 01 : 00 PM EST
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José Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time, he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.
José led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa’s business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, where he led the successful tooling, process development and qualification of Cordis’ first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place.
By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose’s leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop, and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
For several decades, vegetable oils have been touted as healthy and the use of a brominated vegetable oil (BVO) as an ingredient would not normally have raised any concerns. BVO is a vegetable oil that is modified with bromine. Up to now, its use has been authorized by the FDA in small amounts to keep the citrus flavoring from separating and floating to the top of some beverages.
Dietary supplements and food additives have a long history of making claims that have not always been supported by science and the public can be easily swayed by marketing and advertising campaigns as well as the news media.
Nevertheless, in 1970, the FDA determined that BVO was no longer “Generally Recognized as Safe” (GRAS) and began to oversee its use under food additive regulations. Many beverage manufacturers have reformulated their products over the years to replace BVO with an alternative ingredient, so its current use in the US is limited to a few beverages.
The FDA reviews chemicals in food based on risk, science, and its regulatory jurisdiction. BVO has had a long history of use in foods and was once considered GRAS.
However, recent toxicology studies conducted in collaboration with the National Institutes of Health (NIH) have provided conclusive evidence to justify the removal of this food additive.
This raises questions as to how the FDA approves and later retracts approval, its processes, and how it responds to new information, other regulatory bodies, as well as public opinion. “The proposed action is an example of how the agency monitors emerging evidence and, as needed, conducts scientific research to investigate safety-related questions, and takes regulatory action when the science does not support the continued safe use of additives in foods.”
Areas Covered
- History of BVO as a food additive
- FDA’s role in both approving and revoking the authorization to use BVO
- Understanding the concept of Generally Recognized as Safe (GRAS)
- California’s role in banning ingredients, including BVOs
- Introduction to the proposed Human Foods Program (HFP) and the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation
Who Should Attend
- Food manufacturers
- Regulatory affairs personnel
- Consumers with an interest in food additives
- Management and engineers in the food industry
Why Should You Attend
- To better understand the background of how this additive came into use
- To better understand the FDA monitoring and reaction to new information
- To better understand the proposed Human Foods Program (FHP) and the creation of the Office of Food Chemical Safety, Dietary Supplements, and Innovation
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$199.00
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