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    The impact of Brexit on food supplements and specialized food products

    This article examines the impact of diverging regulations and practices for food supplements and specialized food products since the UK left the EU market in 2020.   Keywords – Brexit, divergence, food supplements, UK, Northern Ireland   Background and introduction On 23 June 2016, the UK, comprising England, Northern Ireland, Scotland, and Wales, held a referendum on whether the UK should remain in the EU or leave. Based on an overall majority of 51.9% on ...
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    June’s Regulatory Focus: Nutrition in health and disease management

    Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.   Safety, disruptions, and responsive policy  China has improved its overall food safety situation significant...
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    An update of China’s food safety regulatory framework

    This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Keywords – infant formula; food for special medical purposes; food regulatory control; food safety; food standards   Introduction Since the m...
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    FDA finalizes guidance on food effect studies, issues draft on contamination prevention for non-penicillin beta-lactam drugs

    The US Food and Drug Administration (FDA) recently issued two guidances for industry: a final guidance on how to conduct food effect studies for oral drugs being considered for investigational new drug (IND) and new drug applications (NDAs), and a draft guidance outlining a current good manufacturing practice (CGMP) framework for preventing penicillin from cross contaminating non-penicillin beta-lactam drugs and compounds. Food effect studies   The final guidance on...
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    Global regulatory trends in CBD use in food and food supplements

    This article examines the regulatory trends for using cannabidiol (CBD) as an ingredient in foods and food supplements and provides guidance for companies to interpret current regulation and predict its future direction. The author discusses navigating current regulatory complexity to realize commercial opportunities and outlines the challenges and opportunities for bringing food and food supplement products containing CBD to markets around the world.   Introduction ...
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    Latin America market opportunities for food supplements: Navigating regulatory complexities

    This article discusses the growth opportunities in Latin America for food supplement businesses. It provides guidance for companies eager to interpret current regulation, predict future direction, and plan successful commercial strategies. The author addresses the commercial advantages going along with increased regional and global harmonization and how to navigate current regulatory complexities to realize commercial opportunities and meeting the challenges and opportunit...
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    Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

    This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures 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 dru...
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    FSMA and its Impact on Dietary Supplement Companies

    This article discusses FSMA-related regulations and stresses the impact the regulations will have on the dietary supplement industry. Introduction 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. 1 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 ...
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    The US Regulatory Environment for Probiotics in Food

    This article discusses 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. It outlines the opportunities for probiotics as medical foods, as well as the potential regulatory challenges associated with this category. The author encourages probiotics manufacturing companies to engage in 'self-regulatory ...
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    Intractable Epilepsy and the Value of Formulated Ketogenic Diet Products

    This article discusses the benefits of the Ketogenic Diet (KD) and the Modified Atkins Diet (MAD) for adults and children as treatments for intractable epilepsy. It offers a patient-oriented interpretation of regulatory requirements for medical foods as well as study data demonstrating KD efficacy. The article was 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 mat...
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    Overcoming Distinctive Regulatory Barriers for the Development of Medical Foods

    This article compares the legal definitions of drugs and medical food and outlines the distinctive regulatory hurdles for medical food, in particular, the need for substantiating distinctive nutritional requirements. The authors also make recommendations on how those regulatory hurdles could be overcome with definitive regulatory guidance for both distinctive nutritional requirements (DNR) and modification of normal diet alone (MODA). Introduction Novel nutrition ther...
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    FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND

    The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency. FDA officials advised the company last July, before initiating the clinical trial that “although these were Medical Foods and no NDA would be applied for, Targeted Medical Pharma should still apply for an IND.”...