• Regulatory NewsRegulatory News

    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...
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    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...
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    FDA Explains how Companies can Modify a Drug Safety Assurance Plan

    A new guidance document issued by the US Food and Drug Administration (FDA) explains the process by which pharmaceutical companies can make changes to policies intended to control the use of, and sometimes access to, potentially dangerous drugs. Background The policies, known as Risk Evaluation and Mitigation Strategies (REMS), were first created under the 2007 Food and Drug Administration Amendments Act (FDAAA) and are meant to ensure the safe use of potentially risk...
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    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...
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    Will FDA Have to Change its Name? New Bill Takes the 'Food' out of FDA

    If a new bill introduced in Congress this week is ultimately passed, the US Food and Drug Administration (FDA) might soon need to change its 85-year-old name—and give up all of its authority to regulate food, including dietary supplements. The bill, known as the Safe Food Act of 2015 , is set to strip several regulatory bodies of their authority to regulate food products and transfer that authority to a new regulator, the Food Safety Administration (FSA), whose sole j...
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    FDA Clarifies how Generic Drug Companies can Change Their Manufacturing Processes

    A new guidance document issued by the US Food and Drug Administration's (FDA) drug and biologics review divisions explains how the agency handles Prior Approval Supplements (PAS) under its generic drug user fee amendments (GDUFA) program. Background A PAS is an application which seeks to make changes to an already-approved application , such as an Abbreviated New Drug Application (ANDA), which is used by FDA to approve generic drugs. Unlike other change notification ...
  • "Our Lady's Tears" Brings Warning Letter to Supplement Maker

    If you didn't know better, seeing an ingredient on a dietary supplement labeled as "Our Lady's Tears" might make you think the manufacturer's process involved forcing a woman to cry into a batch of ingredients destined for further processing. And that, the US Food and Drug Administration (FDA) explained in a Warning Letter recently posted on its website, is a problem-for the manufacturer, that is. FDA's 21 March 2014 Warning Letter to Florida-based Aloe Man Internation...
  • FDA Guidance Clarifies Intent of Bioterrorism Law Affecting Dietary Supplements

    The US Food and Drug Administration (FDA) has released a new guidance document intended to clarify elements of a 2002 law passed in the hopes of better allowing the agency to deal with bioterrorism concerns. Background The Public Health Security and Bioterrorism Preparedness and Response Act (PHSBPR) of 2002 was passed months after a series of terror attacks hit the US in 2001. While airborne attacks on the World Trade Center buildings and the Pentagon are almost un...
  • Company Fails to Pass FDA ‘Smell’ Test--Literally

    Of all the ways to validate the identity and quality of ingredients used during the course of manufacturing, using your nose isn't among the most advisable. That piece of wisdom was included in a recent Warning Letter sent by the US Food and Drug Administration (FDA) to a manufacturer of dietary supplements, NJ-based Herbalist and Alchemist, Inc . FDA's letter indicates that the regulator had inspected the company between 22 October and 16 November 2013, during which t...
  • Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs

    The US Food and Drug Administration (FDA) has published a new draft guidance recommending various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and investigational drug applications. What Does FDA Mean by BA/BE? BA refers to the extent to which a drug is absorbed into the body and is thus available to act upon the drug's intended target, also known as the "site of action" (21 CFR 320.1[a]). For example, if a drug is in...
  • As Supplement Industry Highlights Problems, FDA Reopens IND Guidance for Comment

    The US Food and Drug Administration (FDA) has reopened a comment period for a guidance document that aims to clarify the circumstances in which a research study involving human subjects may be conducted without first filing an investigational new drug application (IND) with the agency. Background: IND Basics The draft version of the guidance was released in September 2013, and is intended to make clear the cases when an IND is not required. In general, any investigat...