• 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...
  • New Facility Registration Requirements Come into Effect for Supplement Manufacturers

    A new guidance for industry published by the US Food and Drug Administration (FDA) includes information about new registration requirements established under the Food Safety Modernization Act (FSMA) , including for dietary supplement manufacturers. The requirements of FSMA came into effect on 22 October and mandate that all food production facilities-of which supplement manufacturers are by definition a part-register with FDA to mitigate the impact of any potential ...
  • 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, ...
  • Filing Review Process to See Changes Under Proposed CDRH Guidance

    • 30 July 2012
    The US Food and Drug Administration (FDA) on 30 July released new draft guidance aimed at reducing the variability and subjectivity of when premarket applications (PMAs) submitted to the Center for Devices and Radiological Health (CDRH) are deemed to be "administratively complete." The draft guidance, Acceptance and Filing Review for Premarket Approval Applications , is particularly aimed at "assuring the consistency of our acceptance and filing decisions," FDA expl...
  • FDA: Bausch & Lomb Marketed Product Using Rejected Claims for Years

    A warning letter sent to Rochester, NY-based medical device manufacturer Bausch & Lomb, Inc by the US Food and Drug Administration (FDA) accuses the company of marketing its PureVision 2 contact lenses using an explicitly unapproved indication. In its 11 June 2012 letter, FDA explains Bausch submitted a supplement for the device-a tinted contact lens with an approved indication for extended wear -to the agency in 2010 seeking approval for a revised labeling stat...
  • Reports: FDA to Overhaul New Dietary Ingredient Guidance

    The US Food and Drug Administration's (FDA) much-discussed New Dietary Ingredient (NDI) draft guidance could be receiving a series of significant revisions after a meeting this week between members of Congress and the agency. In a press statement, the Natural Products Association (NPA), a trade group representing numerous dietary supplement manufacturers, said it was aware of a 19 June meeting between FDA Commissioner Margaret Hamburg, FDA Deputy Commissioner Mike Taylor...
  • Agency Increasing Number of Supplement Inspections, Says Fabricant

    The number of inspections conducted by the US Food and Drug Administration (FDA) is increasingly rapidly as the agency moves to crack down on violators of quality regulations, the Director of FDA's supplement program said, reports Natural Products Insider . Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs, said the agency is starting to use its authorities more aggressively-something Regulatory Focus took note of in April 2012 and May 2...
  • CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal staff the guidelines for expediting the review of Abbreviated New Drug Application (ANDA) supplements. FDA's 5240.1: Requests for Expedited Review of Supplements to Approved ANDAs , posted  27 April, describes how ANDA supplement sponsors "may ask FDA to expedite ...