• 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...
  • DIY Fixes Don't Meet CGMP: FDA Slams Manufacturer for Fixes Involving Tape, Rubber Bands

    Do-it-yourself fixes are a point of pride for many, from knowledgeable handymen to frugal college students. Gutters on your house leaking? Nothing some tack welding can't fix. Rubber hose in your car sprung a leak? A quick patch with some duct tape will do in a pinch. But as a new Warning Letter from the US Food and Drug Administration (FDA) to a dietary supplement manufacturer illustrates, shoddy DIY isn't compatible with current good manufacturing processes (CGMP). Ru...
  • Legislation Would Create New Registration, Warning Requirements for Supplements

    Dietary supplements have long been held to a different, more lax standard of marketing access than their pharmaceutical counterparts, which require substantial evidence of safety and efficacy to be presented to regulators before being allowed to be marketed to US consumers. But in the wake of numerous safety scandals involving supplements-which require no premarket review by the US Food and Drug Administration (FDA) and are regulated more similarly to food products-two se...
  • In Response to MDUFA Commitments, FDA Prepares to Make Changes to IDE Submission System

    Medical device regulators at the US Food and Drug Administration (FDA) are planning to unveil a new technology platform in August 2013 through which industry will be expected to submit clinical trial requests, the agency announced today. The change is occurring as a result of FDA's commitments to industry under the Medical Device User Fee Act of 2012, a subset of the Food and Drug Administration Safety and Innovation Act (FDASIA) . As outlined in a commitment letter a...
  • FDA Plans Meeting to Assess How to Enhance Safety Monitoring of Dietary Supplements

    The safety of the pharmaceutical supply chain may be of perennial concern for regulators with the US Food and Drug Administration (FDA), but now dietary supplements are due to get some added scrutiny as well thanks to an upcoming meeting on chemical hazards. Background Unlike pharmaceuticals, dietary supplements are technically regulated more closely to food substances, avoiding the lengthy premarket approval process and the clinical trials required to generate substant...
  • NIH Opens up Supplement Labels to Public Researchers, Industry

    Consumers and industry alike have long been able to look up the approved labeling for prescription medication using the US Food and Drug Administration's (FDA) Drugs@FDA online database. Starting today, the National Institutes of Health (NIH) is making the labeling for a related class of products available as well: Dietary supplements. Background: Supplement Requirements Drug and supplement labeling are different from one another, with the former strictly regulated dire...