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  • Regulatory NewsRegulatory News

    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...
  • "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...
  • 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...
  • Regulators Try to Clarify Definition of 'Liquid Supplements' in Wake of Energy Drink Safety Scare

    As most regulatory professionals well know, there is much that the US Food and Drug Administration (FDA) deals with that is less than clear. If the letter of the law is intended to be black and white, what emerges in regulatory practice is often gray in hue, offering challenges and opportunities for regulators and industry. Background In recent years, one gray area of increasing public health concern has been caffeinated beverages, and especially those loaded with enoug...
  • FDA Makes it Easier to Report Safety Problems Associated with Dietary Supplements

    Manufacturers and sponsors of dietary supplement products in the US will now have a new, more streamlined method of reporting adverse events to the US Food and Drug Administration (FDA), officials said today. In a 13 January 2014 announcement , FDA's Center for Food Safety and Applied Nutrition (CFSAN) wrote that the agency is now accepting online submission of voluntary and mandatory supplement adverse event reports. Previously, Forms FDA-3500 and -3500A, the forms u...
  • FDA Continues Crackdown on DMAA-Containing Supplements, Seizes $2 Million in Product

    More than $2 million in dietary supplements adulterated with 1, 3-Dimethylamylamine HCl-more commonly known as DMAA-were seized by federal officials on 12 November 2013, the latest move by the US Food and Drug Administration (FDA) to crack down on products containing the ingredient. Background DMAA has been the subject of intense scrutiny by public health officials and by FDA in particular. In warnings sent out in April 2013, FDA said the supplement could be associated ...
  • Paintbrush, Cardboard and Black Residue Earn Supplement CMO a Warning Letter

    One week after logging a record low for posted Warning Letters-that is, zero posted-the US Food and Drug Administration (FDA) is back in action, logging a normal, if slightly higher, number of letters. And at least one of those letters shows rampant and disturbing violations at a dietary supplement manufacturer's facility. The letter to New Jersey-based DNE Nutraceuticals, a self-described contract manufacturer, references a lengthy inspection conducted by FDA between 19...
  • Dietary Supplements Slammed by Hospital, Citing Regulations--Could Others Follow its Example?

    At a fundamental level, the regulation of healthcare products is about trust. Every time a drug, device, biologic or other product is prescribed by a doctor, dispensed by a pharmacist or taken by a patient, they do so with the basic understanding that a product is more likely than not to help alleviate symptoms or suffering. While this doesn't seem like much, it's a far cry from the days of old when the trust one had in a product was based on faith or its marketing. No...
  • With Food Safety Division hit by Shutdown, FDA Tries to Confront Outbreak of Hepatitis Related to Supplement

    The US government shutdown has left the US Food and Drug Administration (FDA) without many of its employees at its Center for Food Safety and Applied Nutrition (CFSAN). Now a major safety notice issued by the agency is illustrating why that could not have come at a worse time for its dietary supplements division. In a statement published on 8 October 2013, the agency said it was coordinating with the Centers for Disease Control and Prevention (CDC)-another agency that ...
  • Trust but Verify: Supplement Manufacturer's Reliance on Trust not Sufficient to Meet CGMPs, Says FDA

    Trust is the foundation of many good relationships, but as a new Warning Letter to a dietary supplement manufacturer illustrates, it's not the foundation of a good manufacturing practices (GMP) system. The 15 April 2013 letter to Irenda Corporation of Los Angeles, CA, references a September 2012 inspection during which FDA inspectors reportedly found "significant violations" of current GMP regulations for dietary supplements under 21 CFR 111. The reported violations we...