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Filtering on: "topics nutritional and dietary supplements"

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Nutrition, Health and Disease Management, Advertising, Promotion, Labeling and a Preview of November's MDR, IVDR Update By Gloria Hall - Published 07 November 2017

Feature articles over the past several weeks covered two main themes: nutrition, health and disease management and advertising, promotion, labeling.

Categories: Features, Advertising and Promotion, Labeling, Nutritional and dietary supplements

Tags: Regulatory Focus, Feature Articles, Editorial

Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward By Kathleen D'Hondt, Yolanda Sanz, Manfred Ruthsatz - Published 06 November 2017

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 drugs to support innovation to benefit society, while guaranteeing safety and efficacy of products and ensuring the science base.

Categories: Features, Europe, US, EC, FDA, Nutritional and dietary supplements

Tags: Microbiome, Diet, Medical Food, Health Claims

Surveillance of Adverse Events for Dietary Supplements By Rick Kingston, PharmD - Published 03 November 2017

This article discusses past and present congressional legislation and FDA regulations pertaining to reporting dietary supplement adverse events. It also focuses on the value of post-market surveillance to protect consumers and defines and clarifies the regulatory professional's role in communicating product safety as technology continues to expand data access.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Dietary Supplements, Adverse Events

The Supplement OWL: the Dietary Supplement Industry's Hallmark Self-Regulatory Initiative By Andrea Wong, PhD - Published 01 November 2017

This article discusses the role industry self-regulation plays in fostering trust from regulators, lawmakers, and consumers. It introduces 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.

Categories: Features, Nutritional and dietary supplements

Tags: Dietary Supplements

The US Regulatory Environment for Probiotics in Food By Andrea Wong, PhD - Published 31 October 2017

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 initiatives.'

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Probiotics, Food

FSMA and its Impact on Dietary Supplement Companies By Gisele Atkinson, Nicki Jacobs - Published 31 October 2017

This article discusses FSMA-related regulations and stresses the impact the regulations will have on the dietary supplement industry.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Dietary Supplements, FSMA, Food

NDI Guidance: The Waiting Game By Jennifer M. Adams, JD, Ashish R. Talati, JD, MS, RAC - Published 30 October 2017

This article discusses FDA's publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) 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.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: New Dietary Ingredient Notifications, NDI

Preparing for Dietary Supplement Label Changes Under the Final Rule for Nutrition and Supplements Facts Labels By Jesús Muñiz, MS - Published 27 October 2017

This article summarizes 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. Potential implications of the new requirements and changes are presented and suggestions are provided for managing various aspects of the new rule.

Categories: Features, US, FDA, Labeling, Nutritional and dietary supplements

Tags: Dietary Supplements, Labeling, Label Changes, Supplements Fact Label

Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods By Gloria Hall - Published 04 October 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in October.

Categories: Features, Canada, Europe, US, FDA, Health Canada, MHRA, NICE, Advertising and Promotion, Labeling, Nutritional and dietary supplements, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND By Zachary Brennan - Published 18 April 2017

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.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Nutritional and dietary supplements, Research and development

Tags: warning letter, LA medical foods, medical food clinical trial

Asia Regulatory Roundup: CFDA Begins Verifying Trial Data (8 November 2016) By Nick Paul Taylor - Published 08 November 2016

China's Food and Drug Administration (CFDA) has verified data generated in clinical trials sponsored by AstraZeneca, Johnson & Johnson and Sanofi among the first batch of 55 clinical trials to be verified by the regulator under its data audit initiative.

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Generic drugs, Medical Devices, Nutritional and dietary supplements, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

Health Canada Looks to Raise the Bar for Regulating Natural Health Products By Zachary Brennan - Published 04 October 2016

A controversial new proposal from Health Canada would add new regulatory scrutiny for natural health products and bring them in line with higher scientific standards used to regulate over-the-counter drugs.

Categories: News, Canada, Health Canada, Cosmetics, Over the counter drugs, Nutritional and dietary supplements

Tags: Health Canada, natural health products, cosmetics, OTC drugs, non-prescription drugs

EMA to Revise Herbal Medicines Guideline By Zachary Brennan - Published 01 September 2016

The European Medicines Agency (EMA) on Thursday opened for public comment a draft revision to its scientific guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicines.

Categories: News, Europe, EMA, Nutritional and dietary supplements

Tags: herbal medicine, EMA guidance

Nutrition, Health and Disease Management, Hot Topics and a Preview of September By Gloria Hall - Published 01 September 2016

The August collection of feature articles for Regulatory Focus explores the changing healthcare paradigms when food (health) and drug (disease) systems, once separate silos, are now moving closer together.

Categories: Features, News, Nutritional and dietary supplements

Tags: Food, Medical foods, Nutrition, Dietary supplements, FSMA

Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities By Manfred Ruthsatz, PhD, Timothy Morck, PhD - Published 01 September 2016

This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world.

Categories: News, Africa, China, India, Japan, Canada, Europe, Middle East, Oceania, US, FDA, Nutritional and dietary supplements

Tags: Medical Food, Food for Special Medical Purposes

Surviving Your First FSMA Inspection By Joseph A. Levitt, Maile Gradison Hermida, Elizabeth Barr Fawell - Published 01 September 2016

This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices.

Categories: Features, US, FDA, Manufacturing, Nutritional and dietary supplements

Tags: FSMA, Food Safety Modernization Act, Inspections

Medical Foods: Guidelines for Development and Usage By Elizabeth J. Johnson, PhD, Junaidah B. Barnett, PhD, Simin N. Meydani, DVM, PhD - Published 01 September 2016

This article presents the definition of medical foods, applicable regulations and the clinical trials process, including issues pertaining to study design, institutional review boards, study participants, trial managers responsibilities toward participants, data analysis and peer review.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Medical Foods

The US Regulatory Environment for Promoting Nutritional and Healthful Aspects of Food By James Hoadley - Published 31 August 2016

This article presents FDA's regulatory framework for food for human consumption and how the various legislation regarding information about nutritional content and health-related aspects of food should be presented on food labels.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Foods, Medical foods, Dietary supplements

Targeted (Personalized) Nutrition By Jim Kaput, Colleen Draper, Patrick Descombes, Serge Rezzi, Martin Kussmann - Published 26 August 2016

This article discusses the latest omics technology developments, focusing on genomics, proteomics and nutritional (metabolic) profiling and presents the main challenges for targeted nutrition and regulatory issues related to omics technologies.

Categories: Features, FDA, Nutritional and dietary supplements

China Food Safety Regulatory Framework By Dr. Junshi Chen - Published 25 August 2016

This article discusses changes in the regulatory control aspects of food safety in China over the past three decades, including the Ministry of Agriculture's continuing responsibility for primary agricultural food products control, the 2009 Food Safety Law1 and the newly established China Food and Drug Administration (CFDA). Health food and vitamin supplements also are discussed.

Categories: Features, China, CFDA, Nutritional and dietary supplements

Tags: Food Safety

Genetically Engineered Foods and their Regulation: the Way Forward after Twenty Years of Adoption By Gregory Jaffe - Published 24 August 2016

This article reviews the US history and impact of Genetically Engineered (GE) crops over two decades, explains the federal oversight of GE crops and suggests improvements to federal oversight to ensure the safety of GE crops and greater consumer confidence in GE foods. The article also discusses public attitudes toward GE foods and the issues surrounding the labeling of those foods, including the law requiring mandatory disclosure signed by President Obama on 29 July 2016.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Genetically Engineered Foods, GE Foods

Regulation, Substantiation Requirements and Enforcement of US Dietary Supplement Claims By Andrea W. Wong, PhD - Published 17 August 2016

This article discusses claim categories for dietary supplements and recent related regulatory development and enforcement activity to help those who market dietary supplements understand the evolving regulatory climate, legalities and substantiation requirements.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Dietary Supplements, Nutrient Content, Recommended Dietary Allowances

International Food Regulatory Framework: the Codex Alimentarius Commission By Awilo Ochieng Pernet - Published 12 August 2016

This article reviews the mission of the of the Codex Alimentarius Commission (CAC), an international body whose mandate is to develop internationally harmonised food safety and quality standards to protect the health of consumers and ensure fair practices in the food trade.

Categories: Features, Nutritional and dietary supplements

Tags: Codex Alimentarius Commission

Medical Foods Intended to Meet Distinctive Nutritional Requirements: Scientific and Regulatory Perspective By Josy Giordano-Schaefer, Jane Durga, Fernando Henrique Xavier de Brito, Heinrich Schneider - Published 10 August 2016

This article proposes an algorithm for investigating Distinctive Nutritional Requirements (DNRs) with the goal of guiding research and supporting the development of innovative medical food products to improve quality of care for patients.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Medical foods

Petition Calls on FDA to Pull All Fluoride Supplements From the Market By Zachary Brennan - Published 18 May 2016

The Fluoride Action Network (FAN) and the International Academy of Oral Medicine & Toxicology (IAOMT) are calling on the US Food & Drug Administration (FDA) to expedite the removal from the market all unapproved, unsafe, unnecessary and ineffective sodium fluoride-containing drops, tablets and lozenges sold for the intended purpose of preventing tooth decay.

Categories: News, US, FDA, Nutritional and dietary supplements, Product withdrawl and retirement

Tags: fluoride, fluoride supplements, Walmart, Walgreens, CVS, Rite Aide