This month marks the fifth anniversary of the annual series on nutrition in health and disease management, initiated in 2016 by Manfred Ruthsatz, PhD, RAC, FRAPS (executive director, Nutrition+HealthCARE, Switzerland). Ruthsatz has led all five series to date, this year, together with co-lead, Andrea Wong, PhD (SVP, scientific and regulatory affairs, Council for Responsible Nutrition, Washington DC). They have coordinated authors and reviewers who are global leaders in their respective areas of specialty and expertise to produce a line-up of in-depth articles on food and nutritional supplements from regulatory, trade, marketing, and legal standpoints. Also included are articles advocating for the integration of master files in the new drug indication notification and for a mandatory dietary supplement registry.
Nutrition is the preventive cornerstone of noncommunicable diseases (NCDs), such as obesity and diabetes, cardiovascular diseases, and some cancers. The notion of food as medicine is gaining traction globally, and we are beginning to see more flexible regulatory landscapes in which consumer and patient interests and wellbeing can be more readily addressed and accommodated. Along with the changes come challenges and opportunities, some of which David Pineda Ereño addresses in his article, Latin America market opportunities for food supplements: Navigating regulatory complexities. Pineda Ereño, an expert in strategy, regulatory affairs, and harmonization, provides guidance for companies eager to expand in this diverse and dynamic regional market, including how to interpret prevailing regulations, predict future direction, and plan successful commercial strategies. The author also addresses the commercial advantages that come with increased regional and global harmonization and how to navigate current regulatory complexities to realize commercial opportunities in bringing food supplement products to markets in the region.
A second article by Pineda Ereño, Global front-of-pack nutrition labeling schemes: Impact on marketing strategies, examines the proliferation of front-of-pack nutrition labeling systems, launched in part as a tool to help control and reduce the incidence of NCDs. The author addresses critical changes introduced internationally to food and beverage labels, proposals currently under consideration, and key elements companies should be aware of when planning marketing strategies.
The current US administration has brought changes to US trade policy that have bearing on the dietary supplement industry. In Update on trade issues affecting the dietary supplement industry, authors Kristi Wolff and Melissa Brewer discuss the recent updates, with a specific reference to the trading relationship between the US and its largest trading partners, including China. Wolff, a specialist in advertising, food, and drug law, and Brewer, a specialist in international trade and customs matters, analyze the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. They also discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.
Consumer class actions continue to be a significant risk facing the dietary supplement industry, especially as consumers become more discerning and better informed about products. Rend Al-Mondhiry and Jennifer M. Adams provide an overview of class-action lawsuits targeting the dietary supplement industry in their article, Dietary supplement class actions: Recent overlap with traditional FDA enforcement. They argue that recent trends indicate companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. Al-Mondhiry and Adams, experts in regulatory and compliance matters, outline the key steps companies can take to prevent these lawsuits and offer defenses that courts seem increasingly willing to accept. They argue companies will be well equipped to fight back in these lawsuits if they take a proactive, holistic approach to labeling.
Implementation of a new drug application master file (NDA-MF) system allows dietary ingredient manufacturers the option to seek protection of intellectual property generated through research and development of an NDI, such as information regarding manufacturing, processing, and safety. It is also a useful tool for the US Food and Drug Administration. Other industries have successfully used master files to protect intellectual property. In Integrating master files in the NDI notification process to facilitate innovation in dietary supplements, regulatory expert Haiuyen Nguyen describes the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. Nguyen proposes an NDI master file model, based on the US drug master file, for consideration by FDA.
The Dietary Supplement Health and Education Act struck a balance between protecting public safety and promoting consumer access to dietary supplements, but it did not address company transparency that would facilitate FDA regulation of the industry. In A mandatory dietary supplement registry: Transparency as ‘disinfectant’, Steve Mister discusses how a mandatory product listing could benefit the industry through increased transparency and accountability. Mister, who is president and CEO of the Council for Responsible Nutrition, outlines criticisms from industry skeptics and provides considerations for legislation of this new regulatory tool. The author asserts that a mandatory product listing could play a crucial role in building a safer and stronger dietary supplement marketplace of responsible companies for the benefit of FDA, retailers, and ultimately, consumers.
Physiology professors Mari Carmen Gomez Cabrera and José Vina examine sarcopenia, a skeletal muscle disease now recognized as driven in part by malnutrition, but that improves with timely nutritional intervention. In Sarcopenia: Potential interventions for a newly recognized disease, the authors review the disease, its diagnosis, the role of malnutrition in muscle deterioration, nutritional interventions, and EU regulatory considerations. They conclude that good nutritional health, physical activity, and pharmacologic options are the most effective early interventions. The most promising nutritional interventions are high-quality, protein-enriched supplements and multivitamin/multimineral supplements, with special attention to vitamin D intake.
COVID-19 and regulatory processes
In light of the continuing pandemic, Ginny Hu and Neeta Sharma provide two brief reviews of regulatory approaches for medical devices. In Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers, they examine the regulatory considerations for emergency use authorizations (EUAs) for medical device manufacturers in response to the COVID-19 pandemic. They emphasize the EUA is subject to statutory limits tied to the end of the public health emergency and suggest manufacturers evaluate whether a candidate product is a better fit for EUA or expanded use under enforcement discretion by the FDA.
In Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers, Hu and Sharma summarize FDA enforcement policy during the early months of the COVID-19 public health emergency and outline the regulatory considerations for temporary enforcement discretions. They emphasize the importance of routine and scientific communication between the FDA, industry, and providers to facilitate the long-term directions of these technologies.
What’s coming in July?
July articles will take a closer look at global regulatory strategy for cell and gene therapy, focusing on the inherent complexities of these novel products, the national and international regulations that pertain to them, current and future developments in the field, and regulatory challenges and opportunities. Look for these topics and more throughout July at www.raps.org.
July call for articles
Regulatory Focus will examine global regulatory strategy for cell and gene therapy. The submission deadline is 20 July 2020. To contribute to the July issue or suggest a topic, contact firstname.lastname@example.org.
September call for articles
Regulatory Focus will examine the latest developments around the implementation and acceptance of the new European Union Medical Devices Regulation and its impact on the In Vitro Diagnostic Medical Devices Regulation. The submission deadline is 3 August 2020. To contribute to the September issue or suggest a topic, contact email@example.com.
Citation Matthews R. June issue: Nutrition in health and disease management. Regulatory Focus. June 2020. Regulatory Affairs Professionals Society.