• 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    Nearly 3 years have passed since the US Food and Drug Administration (FDA) issued its draft guidance for industry on the labeling of probiotic quantity.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...
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    Digesting FDA’s New Regulatory Definition of Dietary Fiber and its Impact on the US Food and Dietary Supplement Industry

    This article outlines the new regulatory definition of dietary fiber under the US Food and Drug Administration’s final rule for Nutrition and Supplement Facts labeling, including requirements for declaring ingredients as dietary fiber on the label outlined in the regulation. The author offers a timeline on FDA’s activities in the area of dietary fiber and discusses implications for the food and dietary supplement industry. FDA’s Final Rule on Nutrition and Supplement Lab...
  • Regulatory NewsRegulatory News

    The Supplement OWL: the Dietary Supplement Industry's Hallmark Self-Regulatory Initiative

    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. Introduction When the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 industry ...
  • Regulatory NewsRegulatory News

    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    This article discusses the US Food and Drug Administration's (FDA's) revised draft guidance, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues, and its potential impact on the regulatory status of probiotic ingredients.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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    Regulation, Substantiation Requirements and Enforcement of US Dietary Supplement Claims

    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. Introduction A recent survey reveals 68 percent of American adults take dietary supplements. 1 Users of dietary supplements report taking such products for overall health and wellness, as well as for specifi...