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  • 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...
  • 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...
  • What's a Dietary Supplement? Definition of 'Ingestion' Continues to Lead to Warning Letters

    Dietary supplement manufacturers have long been infamous for their chronic noncompliance with federal regulations, and in particular those related to good manufacturing practices (GMPs) and proper branding. But a Warning Letter released this week has the agency taking aim at a supplement manufacturer for an issue rarely cited in recent years: A banned method of consumption. Background Under Section 201(ff)(2)(A) of the Federal Food, Drug and Cosmetic Act (FD&C Act)...
  • Legislators Fire off Letters to FDA, Industry Seeking Information about 'Illegal' Supplement

    The US Food and Drug Administration (FDA) often finds itself in the firing line of US legislators. The reasons vary-unsafe drugs, a deficient supply chain, too much regulatory activity, too little regulatory activity, and seemingly everything in between. But one area has been relatively free from congressional interference in recent years: Dietary supplements. That is, until now. In a series of letters sent to FDA regulators and several companies on 8 May 2013, Republica...
  • Government Report Says FDA Could Do a Better Job at Leveraging Adverse Event Data

    A new report published by the US government Accountability Office (GAO), a intra-government watchdog that assesses programmatic weaknesses, has informed the US Food and Drug Administration (FDA) that it could be doing a better job at utilizing the information it collects on adverse events for dietary supplement products. Background The 18 March 2013 report reflects a complicated regulatory area for the agency, in which products-some of which contain pharmaceutical or ph...
  • New FDA Compliance Guide Outlines How Agency Can Detain Dietary Supplements

    The US Food and Drug Administration (FDA) is out with a new final guidance and compliance guide for small businesses regarding how it treats the administrative detention of foods, including supplement products. Background The guide references regulations released in 2004 per the Bioterrorism Act of 2002, which authorized FDA to detain or otherwise deny entry to any article of food if it had credible evidence that the food could cause serious injury, harm or death to ...
  • US Regulators Crack Down on Supplement Manufacturers

    The US Food and Drug Administration (FDA) has moved against three dietary supplement manufacturers for allegedly marketing their products using claims that would cause them to be drugs under the Federal Food, Drug and Cosmetic Act , as well as quality deficiencies. The three announcements came between 23 and 25 October-an unusually high rate of enforcement activity against a particular sector. The first action , taken against New York-based Confidence, Inc., related t...
  • FDA Slams Supplement Manufacturer for Unsterile Practices, Unknown Boxes of Product

    • 23 October 2012
    The US Food and Drug Administration (FDA) has sent a warning letter to dietary supplement manufactured Advanced Nutritional Technology (AN) Inc . after regulators said an inspection found deficiencies that caused the products to be adulterated under federal law. AN calls itself an international, specialist manufacturer of all-natural nutritional supplements. FDA's warning letter, sent 16 October 2012 and published on 23 October, largely concerns violations of federal c...
  • Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

    Two new reports released by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) call for additional oversight over the dietary supplement industry, with government investigators chiding the industry for routinely flouting federal requirements and being difficult to track . That supplement companies routinely run afoul of US Food and Drug Administration (FDA) regulation should be of no surprise to its regulators. Its officials, ...
  • Report: Regulatory Framework for Supplements Lacking Necessary Safeguards

    • 07 August 2012
    Be careful of vitamins and supplements, warns a new report out from consumer product watchdog Consumer Reports (CR). In its 3 August 2012 piece, 10 Surprising Dangers of Vitamins and Supplements , CR explains consumers shouldn't assume so-called "all natural" supplements, vitamins or herbal supplements are safe or effective. "They may be neither," CR remarked. Adverse event signals-not necessarily signs of causation, but cause for further investigation-poured into ...