Nutrition, Health and Disease Management, Advertising, Promotion, Labeling and a Preview of November's MDR, IVDR Update

Regulatory NewsRegulatory News
| 07 November 2017 | By Gloria Hall 

Feature articles over the past several weeks covered two main themes: nutrition, health and disease management and advertising, promotion, labeling. Articles highlighted nutrition's role in disease management; the impact of regulatory developments on dietary supplements; regulatory hurdles for medical food and the need for substantiating distinctive nutritional requirements; the role of post-market surveillance in ensuring dietary supplement safety; legal definitions of drugs and medical food; benefits of the Ketogenic Diet (KD) and Modified Atkins Diet (MAD) as treatments for intractable epilepsy and patient-oriented interpretation of regulatory requirements for medical foods; key provisions introduced by the Nutrition and Supplement Facts Labels rule and how to manage different aspects and potential implications of the new requirements; a European public-private healthcare initiative to implement Optimal Nutrition Care for All (ONCA) for patients; US regulatory environment for probiotics in food; and the Supplement Online Wellness Library (OWL), its history, and how it will serve regulatory audiences, retailers, and consumers. Continuing with the advertising, promotion, labeling theme from September, articles demonstrated the value of developing a promotional claims compendium and the implications of recent draft guidance on FDA-required labeling.

Editor's Note: this month's collection of feature articles on innovative paths in nutrition, 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) and is part 2 of an annual series. Part 1 was published in August 2016. The leads brought together authors and reviewers representing global experts in their respective fields.

The Right Paths for Nutrition, Health and Disease Management, Part 2

The current regulatory approach, with respect to food and nutrition, tends to categorize individuals as consumers or patients and yet these states often occur simultaneously and must be managed by the individual and his or her healthcare provider on an ongoing basis as a part of the daily routine. In addition, research in medicine and health is increasingly moving toward options that personalize healthcare and have the potential to engage individuals more directly in monitoring and managing their health and medical conditions. In the guest editorial, "Does nutrition have a role in disease management?" Schneeman encouraged discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases.

There have been a few differences in opinion between the dietary supplement industry and the US Food and Drug Administration (FDA). Yet, industry's reaction to FDA's publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) seemed to be measured in comparison to reactions following the previous draft's release. In the article, "NDI Guidance: the Waiting Game," Adams and Talati discussed FDA's publication of its revised draft and the implications regarding the lack of finalization in the year following its publication. The authors make suggestions regarding what companies may begin doing prior to and in anticipation of eventual finalization.

Since the Food Safety Modernization Act (FSMA) was signed into law in January of 2011, regulatory professionals in the food and dietary supplement areas have been barraged. Seldom has one act had as many touch points in food regulation. For dietary supplement companies, FSMA's broad scope and hefty volume have made it a challenge to assess responsibilities. "FSMA and its Impact on Dietary Supplement Companies" by Atkinson and Jacobs discussed FSMA-related regulations and stresses the impact the regulations will have on the dietary supplement industry.

The combined genomes of the microbial ecosystems that live in symbiosis or as commensals with the human body can be defined as the human microbiome. Different microbial ecosystems colonize the mouth, the skin, the vaginal and intestinal tract. In the article, "Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward," D'Hondt, Sanz and Ruthsatz covered policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. The authors captured some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and drugs to support innovation to benefit society, while guaranteeing safety and efficacy of products and ensuring the science base.

Novel nutrition therapies promise new perspectives and innovative solutions to currently unmet medical needs. However, food products, with a therapeutic target and clinical benefit in a medical condition often cannot meet the requirements of their appropriate regulatory classification 'medical food.' There are uncertainties as to how to interpret and comply with significant aspects of the legal definition of the medical food category. In the article, "Overcoming Distinctive Regulatory Barriers for the Development of Medical Foods," Giordano-Schaefer, Ruthsatz and Schneider compared the legal definitions of drugs and medical food, outlined the distinctive regulatory hurdles for medical food and the need for substantiating distinctive nutritional requirements. The authors also recommended how those regulatory hurdles could be overcome with definitive regulatory guidance for both distinctive nutritional requirements (DNR) and modification of normal diet alone (MODA).

Current laws regarding Dietary Supplement (DS) regulation by the US Food and Drug Administration (FDA) are robust and comprehensive as they relate to the agency's ability to ensure a product's consumer safety. FDA has multiple areas of oversight and can exert regulatory authority to prevent or remove from market products or ingredients that pose a safety issue. Kingston covered the topic in the article, "Surveillance of Adverse Events for Dietary Supplements" and discussed past and present congressional legislation and FDA regulations pertaining to reporting dietary supplement adverse events. The author focused on the value of post-market surveillance to protect consumers and defined and clarified the regulatory professional's role in communicating product safety.

Based on a presentation given at the 2017 RAPS Convergence, during the medical food session on Modification of Diet Alone (MODA) vs. access and convenience matters, Kossoff discussed the benefits of the Ketogenic Diet (KD) and the Modified Atkins Diet (MAD) for adults and children as treatments for intractable epilepsy. In the article, "Intractable Epilepsy and the Value of Formulated Ketogenic Diet Products," the author offered a patient-oriented interpretation of regulatory requirements for medical foods as well as study data demonstrating KD efficacy.

In May 2016, the US FDA published in the Federal Register its final rule on Food Labeling: Revision of the Nutrition and Supplement Facts Labels and its final rule on Serving Sizes of Foods That can Reasonably be Consumed at one Eating Occasion; Dual-Column Labeling; and Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed. These new rules represent the first time FDA has engaged in rulemaking on nutrition labeling in more than 20 years. Muniz summarized several key provisions introduced by FDA's new Nutrition and Supplement Facts Labels rule with a specific focus on their effect on the development and marketing of dietary supplements in the article, "Preparing for Dietary Supplement Label Changes Under the Final Rule for Nutrition and Supplements Facts Labels."

The author presented the potential implications of the new requirements and suggestions for managing various aspects of the new rule.

Disease-related malnutrition and undernutrition in patients is a significant, often still unrecognized, health issue in Europe as well as other parts of the world. The European Nutrition for Health Alliance (ENHA)-driven ONCA campaign is a multi-stakeholder initiative aligning national stakeholders, such as healthcare professionals, patient groups, industry associations and public authorities, behind agreed-upon objectives. In the article, "Innovating Patient Driven Nutritional Care Across Europe:

the Optimal Nutritional Care for All (ONCA) Multi-Stakeholder Initiative," de Man, Smit, and Ruthsatz addressed the importance of this effective multi-stakeholder approach in 16 participating countries, based on sound policymaking. They advocate for a fit-for-purpose, innovation-friendly regulatory framework to help provide appropriate, timely, and cost-efficient healthcare solutions for increased patient access.

Probiotics are one of the fastest growing segments of the dietary supplement industry and with the rise in popularity comes an influx of products to the dietary supplement marketplace and a concomitant exploration of categories outside of the supplement space. Wong's article,"The US Regulatory Environment for Probiotics in Food," discussed the US Food and Drug Administration's (FDA's) revised draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, and its potential impact on the regulatory status of probiotic ingredients. The author outlined the opportunities for probiotics as medical foods, as well as the potential regulatory challenges associated with this category.

When the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 industry, there was finally an official regulatory structure specifically for dietary supplements which granted FDA the authority and ample enforcement tools to protect consumers while still allowing them the desired access to a wide variety of affordable, high quality, safe, and beneficial dietary supplement products.

In another article by Wong, "The Supplement OWL: the Dietary Supplement Industry's Hallmark Self-Regulatory Initiative," the author discussed the role industry self-regulation plays in fostering trust from regulators, lawmakers, and consumers and introduced an important self-regulatory initiative for the dietary supplement industry - the Supplement Online Wellness Library (OWL) - laying out its history and how it will serve regulatory audiences, retailers, and ultimately, consumers.

Advertising, Promotion, Labeling

Reviewing promotional materials is a necessity in the pharmaceutical industry. Rules and regulations implemented by the US FDA regarding promotional advertising help ensure patient safety by ensuring companies are not relaying false or misleading product information to consumers. In her article, "The Life and Times of a Promotional Claims Compendium," Torres discussed developing a "promotional claims compendium" to review pharmaceutical marketing materials. She highlighted the advantages of using a compendium for a variety of purposes and the potential value it could bring to not only the review team, but the entire organization.

Regulatory advertising and promotion professionals are accustomed to working amidst ambiguity or in the gray zone and FDA has attempted to provide clarity regarding how they evaluate information that is "consistent with the label. In her article, "Medical Product Communications Consistent With FDA-Required Labeling Draft Guidance: Navigating the Gray Zone," Foeller provided the changing landscape for promotional review regarding the shift in evidentiary standards introduced in the 2017 Draft Guidance. It also highlights industry perspectives for consideration to companies looking to apply the principles outlined in the Draft Guidance or in preview to what could be addressed in a future revision.

Feature Articles Coming Throughout November

November feature articles will include an update on the MDR/IVDR regulations and cover a variety of topics, including key steps toward global EU-MDR implementation, post-market surveillance, general safety and performance requirements, CE marking, the role of the Medical Device Coordination Group, classification rules in India, third party certification for drugs associated with an import alert exception, an executive interview with regulatory expert Jennifer Kerr, and cybersecurity resources for regulatory professionals. Look for these feature articles and other topics throughout November. If you have a suggestion for a feature article, contact me at


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