The Learning Portal will be under maintenance Monday, 6 December between 6 AM and 5 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

  • Regulatory NewsRegulatory News

    Consent decree shuts down Utah herbal firm

    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...
  • Feature ArticlesFeature Articles

    ‘Immune’ claims and COVID-19

    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. ...
  • Regulatory NewsRegulatory News

    FDA to Amazon: Stop shipping products that contain undisclosed drugs

    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...
  • Feature ArticlesFeature Articles

    June’s Regulatory Focus: Nutrition in health and disease management, and the gut microbiome

    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...
  • Feature ArticlesFeature Articles

    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 ...
  • Feature ArticlesFeature Articles

    Current status and future FDA enforcement of dietary supplements

    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...
  • Feature ArticlesFeature Articles

    Enhancing consumer confidence and supplement access through harmonized retail standards

    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...
  • Feature ArticlesFeature Articles

    Best practices and education for probiotics amid regulatory uncertainty

    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...
  • Feature ArticlesFeature Articles

    Regulatory Focus, June issue: Nutrition in health and disease management

    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...
  • Feature ArticlesFeature Articles

    Sarcopenia: Potential interventions for a newly recognized disease

    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...
  • Feature ArticlesFeature Articles

    Dietary supplement class actions: Recent overlap with traditional FDA enforcement

    This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...
  • Feature ArticlesFeature Articles

    A mandatory dietary supplement registry: Transparency as ‘disinfectant’

    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 the Food and Drug Administration’s inability to “see” into the marketplace. This article discusses how a mandatory product listing can benefit the industry through increased transparency and accountability. It outlines criticisms from industry skeptics and provides considerations for legislation of th...