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  • Regulatory NewsRegulatory News

    Guest Editorial: Does Nutrition Have a Role in Disease Management?

    This editorial is meant to encourage discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases. Introduction The current regulatory approach, with respect to food and nutrition, tends to categorize individuals as consumers or patients and yet these stat...
  • Regulatory NewsRegulatory News

    Nutrition, Health and Disease Management, Hot Topics and a Preview of September

    New Food Regulatory Paradigms: The Right Paths for Nutrition, Health and Disease Management 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. This creates new opportunities, yet also gray zones, making historic pharmaceutical and nutrition "models" prone to be revisited. Leading global experts in their respective fi...
  • Feature ArticlesFeature Articles

    The US Regulatory Environment for Promoting Nutritional and Healthful Aspects of Food

    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. Regulatory Categories Food and Drugs Products marketed in the US, other than tobacco products and alcoholic beverages, and intended for ingestion, are regulated either as foods or drugs. This regulatory scheme has been in place since the pa...
  • Feature ArticlesFeature Articles

    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...
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    Petition Calls on FDA to Pull All Fluoride Supplements From the Market

    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. The petition, submitted to FDA on Monday, follows the agency’s issuance of a warning letter in January to Kirkma...
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    Grouping Supplements for CMC Changes: FDA Outlines New Policy

    The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) on Tuesday released a new document outlining how supplements can be grouped together and submitted concurrently for the same chemistry, manufacturing and controls (CMC) changes to multiple approved new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biological license applications (BLAs) submitted by the same applicant. The agency says the goal of its new policy is ...
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    FDA Unveils New Office of Dietary Supplement Programs

    As part efforts to elevate the regulation of dietary supplements, the US Food and Drug Administration announced on Monday the creation of the new Office of Dietary Supplement Programs (ODSP). The new office, which previously worked as a division under the Office of Nutrition Labeling and Dietary Supplements, comes as the supplement industry has more than quadrupled in the 20 years since the establishment of that first division – from about $6 billion to more than $35 bil...
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    US Government Agencies Crack Down on Dietary Supplement Manufacturers

    In partnership with the Department of Justice, Federal Trade Commission and others, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced, an 11-count indictment unsealed Tuesday against Dallas-bas...
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    FDA Inaction Pushes McCaskill to Target Picamilon Retailers Directly

    Sen. Claire McCaskill (D-MO) is calling on ten major retailers to pull all supplements containing the ingredient picamilon after what she says has been “weeks of inaction” by the US Food and Drug Administration (FDA). The letters sent Monday to Amazon, the Vitamin Shoppe, CVS, Wal-Mart, Google, Vitamin World, Walgreens, Target, eBay and General Nutrition Corporation (GNC) call on them to pull from their shelves any dietary supplements containing picamilon as FDA has decl...
  • Regulatory NewsRegulatory News

    FDA Cracks Down on Powdered Caffeine Distributors

    The US Food and Drug Administration (FDA) issued five warning letters to distributors of pure powdered caffeine as part of its efforts to help prevent additional deaths from the use of these products, which have already resulted in the deaths of two teens. "The difference between a safe amount and a toxic dose of caffeine in these pure powdered products is very small," FDA  cautioned . "Furthermore, safe quantities of these products can be nearly impossible to measure ac...
  • Regulatory NewsRegulatory News

    Attorneys General Call on FDA to Strengthen Supplement Safeguards

    • 03 June 2015
    The attorneys general of New York and Indiana are urging the US Food and Drug Administration (FDA) to "overhaul" the way in which it regulates the manufacture of dietary supplements. Background In the US, dietary supplements are defined as an oral product containing a "dietary ingredient," including vitamins, minerals, herbs, botanical ingredients, amino acids or other dietary substance. Despite commonly being used to support consumer health, dietary supplements are re...
  • Regulatory NewsRegulatory News

    FDA Considers Relaxing Clinical Testing Requirements for Some Biotherapeutic Products

    The US Food and Drug Administration (FDA) is considering making it easier for companies to test certain "live biotherapeutic products" like probiotics in early-stage trials, the agency has announced. Background The guidance document, Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information , was first released in draft form October 2010 by FDA's Center for Biologics Evaluation and Research (CBER) and later finalize...