This article discusses current diverging regulations for probiotics as ingredients in foods and dietary supplements and the trends and translational science that have demonstrated probiotic benefits. It emphasizes how aligning a global probiotic harmonized regulatory framework can help navigate the confusion around the regulations to ensure global consumer access to beneficial products of quality.   Keywords – Codex, harmonization, regulations, probiotics, probioti...

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 ...

A Utah-based manufacturer and seller of herbal remedies and nutritional supplements has agreed not to market or sell its wares until products and labeling are compliant with federal drug regulations. Acting on behalf of the US Food and Drug Administration (FDA), the Department of Justice filed the complaint that triggered the consent degree of permanent injunction between Grandma’s Herbs, Inc., its owners, and the US government. The consent decree was entered by the US Dis...

Correction and Editor’s note: The article, ‘Immune’ claims and COVID-19 (published 30 June 2021) incorrectly stated that Vi-Jon Inc. had received a warning letter from the FDA, when in fact it had not received such a letter. The article was corrected on 15 July 2021, but the correction was not appropriately noted on our website. The article was further updated on 27 August 2021 to remove an extraneous reference. Regulatory Focus regrets these errors and apologizes. ...

The mammoth online retailer Amazon received an untitled letter from The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) identifying 26 sexual enhancement and weight loss products that contain “undeclared” and “potentially harmful” drug ingredients, according to FDA’s testing of the products.   In this letter — not the first correspondence the agency has had with Amazon on the matter —the firm was called out for marketing unapprove...

This issue marks the 6th annual RAPS series on nutrition in health and disease management, and the gut microbiome, in which global experts write about food, nutrition, and dietary supplements from regulatory, trade, marketing, and legal perspectives. In keeping with the series, articles in the current issue examine US Food and Drug Administration (FDA) regulatory guidance and requirements, especially regarding dietary supplements, bioengineered products, probiotics, and CO...

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 ...

FDA observations for adulterated dietary supplements have remained consistent since 2010, even during 2020, when inspections were down 47% and accommodations for compliance were made because of the COVID-19 pandemic. These include requirements to establishment specifications, testing to determine if specifications are met, use of master manufacturing records, preparation of batch production records, and ensuring quality responsibilities are defined. The pandemic has also r...

Although third-party audit, certification, and retail standard programs highlight reputable companies and help ensure that dietary supplements on store shelves are safe and unadulterated, multiple standards create a complicated patchwork of requirements that are difficult for manufacturers and consumers to navigate. Responsible industry has emphasized the need to harmonize standards by eliminating duplicative, costly testing and allowing retailers to confirm a manufacturer...

Nearly 3 years have passed since the US Food and Drug Administration (FDA) issued its draft guidance for industry on the labeling of probiotic quantity. During that time, consumer interest in probiotics has increased, product innovation has expanded, and the body of scientific research has grown – all with no final guidance or updates from the agency. With the growth of this category and continued regulatory uncertainty, responsible industry has stepped up with best practi...

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...

This article discusses sarcopenia, a newly recognized skeletal muscle 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 multivitami...