New Food Regulatory Paradigms: The Right Paths for Nutrition, Health and Disease Management
The August collection of feature articles for Regulatory Focus explores the changing healthcare paradigms when food (health) and drug (disease) systems, once separate silos, are now moving closer together. This creates new opportunities, yet also gray zones, making historic pharmaceutical and nutrition "models" prone to be revisited. Leading global experts in their respective fields have come together for the first time to present a holistic approach to nutrition and respective paradigm changes in the health related food environment, dietary supplements, medical foods, food safety, non-communicable diseases and future of prevention vs. therapeutic approaches. All articles were peer reviewed by the 'Who's Who' in their area.
Editor's Note: this targeted August collection of feature articles on nutrition, health and disease was co-led by Manfred Ruthsatz, PhD (Nestlé Health Science, Epalinges, Switzerland); Elizabeth (Betty) Campbell (EAS Consulting Group, Alexandria, VA) and Loek Pijls, PhD (Loekintofood, Brussels, Belgium).
The Board of Editors and issue leads would like to express their sincere appreciation to the following peer reviewers: Prof. Yolanda Sanz (EFSA NDA Panel; IATA-CSIC, Valencia, Spain); Vijayalakshmi Varma, PhD (FDA/NCTR, Jefferson, AR); Donna Mendrick, PhD (FDA/NCTR, Silver Spring, MD); Prof. Patrick Stover (Cornell University, NY; President ASN, Bethesda, MD); Cathy Bushell (Vitaflo, Liverpool, UK); Junjie Wang (Nestlé Health Science, Beijing, China); Maryam Olesen, Josy Giordano, PhD (both Nestlé Health Science, Epalinges, Switzerland); Himanshu Gupta (Nestlé, Vevey, Switzerland); and Sandy Bigelow, PhD (Vanguard, Tucson, AZ).
The following is a summary of the August collection:
In the article, "Surviving Your First FSMA Inspection," Levitt, Hermida and Fawell provide an overview of provisions and regulations in FDA's new Food Safety Modernization Act of 2016 (FSMA) and recommend steps to take in preparation for FSMA inspections. The law shifts the focus of federal regulatory oversight from responding to contamination to preventing it. The article provides guidance on new requirements for preventive controls, supply chain management, how to implement good record keeping practices and why food companies should seek scientific consultants to best prepare for FSMA implementation and subsequent inspections.
Jaffe's article, "Genetically Engineered Foods and their Regulation: the Way Forward after 20 Years of Adoption," reviews the US history and impact of genetically engineered (GE) crops over two decades, discusses public attitudes toward GE foods and not only offers better ways to communicate safety information, but recommends regulatory advice to federal agencies that have authority over GE crops and foods.
The Codex Alimentarius Commission (CAC) is an international body whose mandate is to develop internationally harmonized food safety and quality standards to protect the health of consumers and ensure fair practices in the food trade. Food standards may be developed at various levels, including national, bilateral, regional and multilateral settings. However, the food standards and related texts developed by the CAC are unique. Ochieng Pernet's article, "International Food Regulatory Framework: the Codex Alimentarius Commission," reviews the mission of the CAC and its plan to adhere to certain core values, including collaboration, inclusiveness, consensus building and transparency.
The Chinese government places great importance on food safety as one of the top priorities in the government's agenda. Chen, a leading authority in food safety risk assessment, discusses the revolutionary changes in the regulatory control aspects of food safety in China in the past decades in his article, "China Food Safety Regulatory Framework."
"The US Regulatory Environment for Promoting Nutritional and Healthful Aspects of Food" by Hoadley presents FDA's regulatory framework for food for human consumption and how various regulations regarding information about nutritional content and health-related aspects of food should be presented on food labels.
Label claims permitted for dietary supplements include nutrient content claims, structure/function claims and health claims. In "Regulation, Substantiation Requirements and Enforcement of Dietary Supplement Claims in the US," Wong discusses these claim categories, along with recent regulatory developments and enforcement activity that help marketers understand the evolving regulatory climate and substantiation requirements.
Ruthsatz and Morck provide global food for thought on "Medical Food/Food for Special Medical Purposes (FSMP): Global Regulatory Challenges and Opportunities." The unique category created for specially formulated foods that meet distinctive nutritional requirements of patients with diseases or conditions has evolved over the past decades in the US, EU and via Codex Alimentarius also in most of the world. The authors address current regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It captures the regulatory framework governing this specific category in the US, EU and other parts of the world. Overcoming challenges limiting category growth depends on cooperation among scientific, medical, policy, and reimbursement systems. Opportunities for stakeholder alignment around the safe, cost-effective, and medical importance of the role of advanced nutrition in patient and disease management are addressed.
Medical Foods are intended for the dietary management of a disease or medical condition for which there are distinctive nutritional requirements (DNRs) which cannot be met by the modification of the normal diet alone. Giordano, Durga, Brito and Schneider feature in their article, "Medical Foods Intended to Meet Distinctive Nutrition Requirements: Scientific and Regulatory Perspective," an algorithm for investigating Distinctive Nutrition Requirements with the goal of guiding research in this important area and to support the development of innovative medical food products to improve quality of care for patients.
Observational studies evaluating nutritional and biochemical status in specific disease populations will aid in identifying nutrient shortfalls, a key step in the development of a medical food. In the article, "Medical Foods: Guidelines for Development and Usage," Johnson, Barnett and Meydani discuss the importance ofunderstanding the effectiveness and safety of a medical food and the need for evidence from well-designed randomized-controlled clinical trials.
Kaput, Draper, Descombes, Rezzi and Kussmann describethe latest omics technology developments, focusing on genomics, proteomics, and nutritional (metabolic) profiling in their article, "Targeted (Personalized) Nutrition." In addition, they also review the challenge of using population-based data for translation to personal risk or therapeutic benefit and describe the 'emerging' research approach based on n-of-1 studies and analyses that may be more easily translated to utility in clinical practice.
More Feature Articles in August
From the Corner Office
Senior level executives Gordon, James, Knapp, Yetemian and Mannix offer insight and guidance on how to act, what to look for in due diligence exercises and what areas to further explore as one partakes in due diligence activities in the article, "Reflections on Mergers and Acquisitions in the Healthcare Product Industry." The authors outline critical process points, seven reflections from recent Merger and Acquisition (M&A) experiences and suggest best practices for optimizing M&A due diligence from several perspectives. The content was adapted from a session at the RAPS 2015 Regulatory Convergence in Baltimore, Maryland.
"Entering the China Market: Go-to-Market Strategies–Part 2," by Lack explores Go-To-Market strategies and options for finding the right distribution partner(s). For the majority of device manufacturers looking to import to China, navigating the vast marketplace requires some form of partnership. Multinational Corporations and giant domestic state-owned enterprises may have sizeable resources and distribution networks, but still may not be the best choice. Establishing exactly which approach is required for your product to gain favor with Key Opinion Leaders, and finding the right kind of long-term support to best enable these efforts, are crucial strategic choices. Part 1 of this two-part series covered pre-market considerations and registration options.
Gedeon's article "Plain Language Labelling Requirements," describes the requirements of the guidance document published by Health Canada on plain language labelling.
September to Highlight the Changing Times of Advertising and Promotion
Feature articles in September will take a closer look at the evolution of prescription drug and medical device advertising and promotion, from the history that helped shaped the regulations to modern day case law involving the First Amendment. Along the way, we have noted a shift in FDA's enforcement with respect to their areas of focus and frequency of enforcement action. Even though the recent enforcement landscape has been relatively quiet, regulatory professionals must remain vigilant in addressing the day-to-day needs for compliant product promotion. Just as the regulations and case law have morphed over the years, so have industry-wide promotional trends, which now pose new challenges for Regulatory reviewers. When regulations were initially written product promotion was largely a paper-based activity; over time, new mediums for promotion have been introduced requiring reviewers to brainstorm how to apply the existing regulations to these new forms of promotion. For instance, the thought process on press releases has evolved with the internet, underscoring the need for a careful eye. Television and broadcast ads are costly and time consuming and may have broad public-health impact; thus, this issue will provide some insight and recommendations to assist in these reviews. In addition, social media and adaptive designs can be can-dos or can-fails, depending on how they're presented to, and reviewed by, promotional review teams. Even without much noise in recent enforcement, regulatory professionals must stay current on the industry trends, including the interpretation of the regulations, First Amendment developments, and the existence and functionality of new promotional vehicles, to help ensure the reviews of promotional materials are compliant and in support of protecting public health.