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 also must be fit-for-purpose to stimulate innovation. The feature articles posted throughout June 2019 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 was led by Manfred Ruthsatz, PhD, RAC, FRAPS (Nestlé Health Science, HQ, Switzerland) and members of the Council for Responsible Nutrition (CRN), Washington, DC, US. The June 2019 edition is Part 4 of an annual series for Regulatory Focus
and the editorial leads worked tirelessly to bring together authors and reviewers regarded as the top global experts in their respective fields. Part 1
was published in August 2016, Part 2
in October 2017 and Part 3
in July 2018. Look for Part 5 in June 2020.
Staying Abreast of the Latest Trends in Nutrition in Health
Healthcare systems are under continuous pressure due, in part, to the increasing incidence of non-communicable diseases, often linked to changing demographics and modified dietary patterns.
Leading nutrition experts, Kathleen D’Hondt
, Jim Kaput
and Manfred Ruthsatz
explore this issue in “Personalized Nutrition for Better Health: Targeting the Human Microbiome
.” The articles depicts the strategic role of nutrition and the human microbiome in personalizing health and disease management, requiring diligent regulatory and policy action while science and technology are evolving fast.”
As the dietary supplement industry prepares to observe the 25th anniversary of the passage of the Dietary Supplement Health and Education Act (DSHEA)
, it is worth pausing to consider how this law has overseen the phenomenal growth of the dietary supplement industry in the US and around the globe. The president of CRN trade association, Steve Mister,
discusses the passage of the Dietary Supplement Health and Education Act
) in 1994 and its effects on the dietary supplement industry in “Dietary Supplements and Public Safety: A Defense of DSHEA’s “Three-Legged Stool
.”” The author addresses criticism of DSHEA
and defends the intent and subsequent benefits of the legislation by identifying the “three legs of the stool” of the legislation—protection, safety and watchfulness.
Since the introduction of the Dietary Supplement Health and Education Act of 1994 (DSHEA
), the dietary supplement market has flourished with the addition of various product streams including products containing one or more botanical/herbal ingredients. In parallel, substantial advancements in analytical methodologies have led to a better understanding of the complexity and diversity of botanical chemistry and botanical preparations. In “the Botanical Safety Consortium (BSC): The Development of a 21st Century Framework for Assessing the Safety of Botanical Dietary Supplements
,” experts Daniel Marsman
, Joseph Dever
, Stefan Gafner
, Cynthia Rider
, Sibyl Swift
and James Griffiths
share their insights into steps to improve the safety of botanicals in dietary supplements. These leaders explore several US legislative initiatives and efforts by several nongovernmental organizations, such as the Council for Responsible Nutrition and the American Botanical Council, to track patterns of botanical use, and the Congress of the European Societies of Toxicology’s efforts to approach safety issues, including its establishment of the Botanical Safety Consortium and its working groups.
Legal authorities, Rend Al-Mondhiry
and Ashish Talati
cover the regulatory status for using cannabidiol (CBD) as a dietary supplement and presents the US Food and Drug Administration’s (FDA’s) position as well as conflicting viewpoints taken by some in the industry. “Update on the Regulatory Status of Cannabidiol in Food and Dietary Supplements and Future Prospects
” evaluates the impact of the Agricultural Improvement Act
of 2018 (2018 Farm Bill
) and the future prospects for CBD.
Steadily Improving the State of Medical Nutrition
, Claudine Blache
and Heinrich Schneider
explore “Regulatory Challenges in Medical Foods: Natural Variations in Ingredients of Agricultural Origin
.” The authors examine the sources of variability in raw materials from “natural origins” and how Foods for Medical Purposes (FSMP) companies cope with and overcome the challenges posed by regulated nutrient levels. The authors examine the sources of this variability using the examples of one vitamin (B12) and one trace mineral (selenium) and consider how FSMP companies work with the challenge of narrow acceptance criteria set by the regulations. The authors propose that regulatory authorities take the natural variation of nutrients in raw material from agricultural sources into account when they review their FSMP regulations and do so in addition to considering scientific reference values which are used as the basis for determining minimum and maximum levels of nutrients in FSMP.
addresses the Canadian government’s opportunity to modernize its medical nutrition regulations for food and presents key learnings from the structure and implementation of several regulatory frameworks for Food for Special Medical Purposes (FSMP) globally. “Modernizing Canada’s Medical Nutrition Regulations for Food
” outlines an improved framework in Canada to better address the needs of patients and healthcare professionals.
In “Severe Acute Malnutrition (SAM): the Value of a Ready to use Therapeutic Food (RUTF) Guideline
discusses the value of a Ready-to-use Therapeutic Food (RUTF) and the guidelines for its use. The author explains that because RUTFs are used in the treatment of children with Severe Acute Malnutrition (SAM) without medical complications, a guideline could help ensure products are safe, efficacious and of good quality. She concludes by noting how careful consideration of what should be included in the guideline, as well as provision for consultation with various stakeholders, are required to ensure safety and efficacy being achieved.
shares the value of thickeners for patients suffering from “dysphagia,” a term used to describe difficulty in swallowing. “The Critical Role of Thickeners in the Therapeutic Medical Management of People with Dysphagia
” covers the health risks of untreated dysphagia, particularly for geriatric populations, thickening agents for food and drinks, levels of thickness, the economic consequences of untreated dysphagia, prescriptions for treating dysphagia and supervision by qualified healthcare professionals and regulatory considerations from an EU perspective.
presents an argument for the value that trade associations bring to healthcare in terms of promoting best practices, policies, regulations and standards in “The Value of Engagement With Trade Associations in Policymaking, Regulation and Standardization
.” The author defines trade associations and lays out their functions and the value of those functions for regulators and policy makers and also presents defining characteristics of good regulations and good policies. The focus is on foods for special medical purposes and the author shares examples from the work of the Medical Nutrition International Industry (MNI) in these areas.
The Editorial Advisory Committee and issue leads would like to express their sincere appreciation to the following peer reviewers for devoting their time and talent to this series:
Nuria Barcons, Nestlé Health Science, ES
Estrella Bengio, Abbott, ES
Mathilde Bridier, Nutriset, FR
Thomas Couaillet, Nutriset, FR
Mike Cusack, GEDSA
Elena Micelli, MNI, BE
Hannah Mullen, Nestlé Health Science, CH
Kathy Musa-Veloso, Intertek, CA
Nancy Weindruch CRN, US
Andrea Wong, CRN, US
What’s Coming in July?
Feature articles in July will explore regulatory operations for drugs and devices. Topics will include FDA and EU differences in cleanroom specifications, global differences between regional eCTD validation and acceptance criteria, comparing EU and US accelerated pathway programs as well as data requirements for the approval of a biosimilar versus the reference medicine. Other articles will cover India’s new drug and clinical trial rules, China’s new guidance on regulatory inspection and analytical testing documentation, one company’s journey to transform regulatory operations and medical device cybersecurity regulatory pathway. Look for these topics and more throughout July.
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