Over time, regulatory frameworks have evolved to protect consumers and patients. An unprecedented progression of demographics—including an aging society, noncommunicable chronic diseases, and transforming innovations in healthcare—pose challenges and provide potential opportunities. Action is needed to develop timely, appropriate and affordable healthcare solutions for patients and society. Policies and regulatory frameworks must also be fit-for-purpose to stimulate innovation.
The feature articles posted throughout July 2018 cover nutrition in health and disease management and explore the changing healthcare paradigms as food (health) and drug (disease) systems—once separate silos—move closer together, creating new opportunities and requiring traditional pharmaceutical and nutrition “models” to be revisited.
This collection of feature articles on nutrition in health and disease management was led by Manfred Ruthsatz, PhD (Nestlé Health Science, Epalinges, Switzerland) and Andrea Wong, PhD (Council for Responsible Nutrition, Washington, DC, US). It is Part 3 of an annual series for Regulatory Focus. Part 1 was published in August 2016 ; Part 2 was published in October 2017. The editorial leads brought together authors and reviewers regarded as the top global experts in their respective fields.
New Food Regulatory Paradigms
Innovative Paths to Compliance for Nutrition, Health and Disease Management: Part 3
In August 2017, the dietary supplement industry received a complaint filed by Amarin Pharma and Amarin Pharmaceuticals Ireland Ltd at the US International Trade Commission (ITC) alleging that certain omega-3 fish oil products, synthetically-produced, predominantly eicosapentaenoic acid (EPA) products in ethyl ester or reesterified triglyceride form, known as “concentrated omega-3 products,” were unlawfully labeled and marketed as “dietary supplements.” The outcome of the case could have implications beyond concentrated omega-3 products and the supplement industry as the regulatory classification of such ingredients will continue to receive attention from FDA, retailers and other industry stakeholders. Two legal experts, Rend Al-Mondhiry
and Jennifer Adams
, discuss the history and implications of this unprecedented lawsuit in “Update on the Amarin-ITC Case and the Issues at Stake
“Meal replacement” is a term used in the US and other parts of the world to describe a type of product used to replace a person’s meal or meals during a day. In addition to offering a nutritious meal, many of these products are formulated for and claim to provide an additional functional benefit, such as weight loss, weight control or gaining a performance benefit. Presented by leading regulatory experts, Jesús Muñiz
and Linh Bui,
“Regulatory Requirements for Meal Replacement Products: An International Review
” reviews and discusses the regulatory status of meal replacement products internationally with an emphasis on the Codex Alimentarius Commission (CODEX) standards, relevant product categories, intended purposes and consumer confidence. Restructuring some of the regulations in the US may be useful to both manufacturers and consumers.
Over the last several decades, there has been a long debate regarding the practical use of Food for Special Medical Purposes (FSMPs) in the European Union (EU). In recent years, the EU legislative framework for FSMP has been through a process of in-depth discussion and review, culminating in the publication of two regulations and two guidance documents aimed at providing clarification on the FSMP category. Global regulatory advocates, Cathy Bushell
and Manfred Ruthsatz
, address the 2010-2017 full revision of the regulatory framework in “Revising the EU FSMP Regulatory Framework: Laying a Foundation for Future Nutritional Patient Care
.” The authors summarize key advocacy messages critical to the pragmatic and successful regulation of this special category of foods to ensure their availability to patients and healthcare professionals. Multiple stakeholders involved in the process included the EU Commission, Parliament, Council and Member States, European Food Safety Authority (EFSA), consumer and patient groups, industry associations, healthcare professional and scientific societies.
With the rise in US FDA inspections, companies of all types are being audited for current Good Manufacturing Practice (CGMP) compliance, including companies who outsource all manufacturing, packaging, labeling and holding activities. In the current environment, companies in the dietary supplement industry using contract manufacturers need to better understand their responsibilities and how FDA has chosen to enforce CGMP compliance. Cory Carter
, a leader in the dietary supplement industry, discusses these issues in “CGMP Requirements for Companies Using Contract Manufacturers
,” highlights FDA comments on this issue, presents several court cases determining who is responsible for CGMP compliance and explains four important areas of CGMP concern for companies utilizing contract manufacturers. He also offers ways to stay in compliance, such as auditing the contract manufacturer for CGMP compliance, establishing finished good and labeling specifications, identifying quality personnel and developing and implementing basic standard operating procedures.
Food supplements come in many shapes and sizes and contain vitamins, minerals, botanicals and other substances having physiological effect on those who take them. While these products must comply with a series of European laws, the composition of these products is still largely subject to national legislation, resulting in significant trade barriers even between EU member states. European food law expert, Patrick Coppens,
addresses this issue in “Food Supplements in the European Union: the Difficult Route to Harmonization
,” describes EU food supplements legislation and discusses a number of “stumbling blocks” to full regulatory harmonization, in particular botanicals and minimum and maximum levels of vitamins and minerals. He reviews further EU-wide issues in food supplement legislation, including national versus EU agendas, the “grey zone” between food supplements and medicines, and the problems with food supplement “health claims.” In an effort to help companies be aware of what is coming so they can adjust their strategies accordingly, the author also offers several scenarios and possible obstacles and/or benefits future legislation may bring.
Food and nutrition expert DeAnn Liska
joins legal expert Megan Olsen
to provide insight into how and which scientific evidence for health claims is being assessed today. The FDA’s current guidance on evidence-based review for the science needed to support food and dietary supplement health claims was published in 2009. Although this guidance has not changed in the past decade, as demonstrated by two recent agency decisions regarding health claims, the agency’s interpretation of the guidance appears to be changing. “Evaluating Science for Health Claims: An Evolving Landscape
reviews these two cases—revocation of the existing soy protein and coronary heart disease health claim and the conclusion that there is no credible evidence to support the claim that vitamin D decreases the risk of multiple sclerosis as proposed in a recent petition.
As understanding of the relationship between diet, lifestyle, genetics, the environment and health increases, so does the need for scientific advances in related analytic fields to help document, validate and replicate clinical study results used to substantiate claims made about new, innovative products. In contrast to well-defined disciplines, such as biochemistry, physiology, microbiology or immunology, the field of nutrition integrates many elements from these disciplines into a holistic, systems approach. Some may consider the term “nutrition” to be narrowly constrained to the food and dietary patterns used to fuel the body, with a prerequisite contribution of essential nutrients, unable to be synthesized by humans, yet critical for normal functioning of cells, tissues and organs. Scientific and regulatory expert, Timothy Morck, reviews the legal and regulatory definitions of medical food with emphasis on the Distinctive Nutritional Requirements (DNR) imposed by a disease that differs from the requirements for the normal healthy population. “Opportunities and Challenges in New Nutritional Products Innovation” addresses clarifying the term DNR, identifying and validating more sensitive biomarkers to help explain variability in individual nutrient needs and encourages dialogue among nutritional scientists and researchers in public and private sectors to develop innovative nutritional products with greater confidence for the support the DNR of patients.
Better understanding the relationship between food and disease is essential to develop and promote policies aimed at modifying peoples’ dietary behaviors to reduce health risks. Although policies and public health strategies were based on nutrition recommendations from previous decades, since then, several countries have updated nutrition recommendations based on more recent science and subsequently developed new approaches to systematically review evidence. “Impact of Changing Scientific Recommendations on Nutrition Policies” provides insight into these issues from former FDA regulator and industry expert, Barbara Schneeman, and reviews the evolution of nutrition recommendations and how they are reflected in current policy decisions. A special focus is placed on fat and carbohydrate recommendations and their associated risks for non-communicable diseases.
In May 2016, FDA introduced sweeping changes to food and dietary supplement labeling requirements with the issuance of the final rule for nutrition and supplement facts labeling, representing the first major revision to the nutrition facts label since 1993. One of the major changes affecting both conventional food and dietary supplements is the new definition for “dietary fiber.” Regulatory expert, Andrea Wong outlines the new regulatory definition of dietary fiber under the final rule, including requirements for declaring ingredients as dietary fiber on the label outlined in the regulation. “Digesting FDA’s New Regulatory Definition of Dietary Fiber and its Impact on the US Food and Dietary Supplement Industry” offers a timeline on FDA’s activities in the area of dietary fiber and discusses implications for the food and dietary supplement industry.
Feature Articles Coming Throughout August
August feature articles will include a variety of topics, including risk management, next generation cancer vaccines, biosimilars, 3D printing, drug delivery combinations, pediatric plans and the latest on MDR and IVDR. If you have a suggestion for a feature article, contact me at email@example.com.