• Regulatory NewsRegulatory News

    FDA Announces Hire of New Top Food and Dietary Supplements Regulator

    The US Food and Drug Administration (FDA) has announced the hire of a new leader for its Center for Food Safety and Applied Nutrition, just months after announcing that the center's current leader, Michael Landa, is set to retire. FDA said as of January 2015, Dr. Susan Mayne will assume the position of director, CFSAN from the retiring Landa. Mayne, a scientist by training, has extensive experience in nutrition, toxicology and epidemiology, according to FDA. The agen...
  • Regulatory NewsRegulatory News

    FDA Review Finds Storage Problems at Food, Supplement Regulator CFSAN

    The US Food and Drug Administration (FDA) has announced that it has found still more vials of improperly stored hazardous substances in one of its labs, just weeks after the agency announced that it had found dozens of other vials of hazardous substances, including the smallpox virus. Background In July 2014, FDA and the National Institutes of Health (NIH) announced they had discovered previously unknown vials containing variola—the virus which causes smallpox—as well...
  • Regulatory NewsRegulatory News

    CFSAN Director Michael Landa to Retire, Search on for Successor

    Michael Landa, director of the US Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN)—its food, cosmetics and supplement regulatory body—soon plans to retire from the agency, regulators said Thursday. Landa, a long-time veteran of the agency, first joined FDA in 1978. Prior to serving as CFSAN director, he served as its deputy director for regulatory affairs from 2004 to 2010, and as counsel for several of FDA's regulatory divi...
  • 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 Looks to Hire New CIO, CFSAN Compliance Director

    The US Food and Drug Administration (FDA) has announced it is searching for a new chief information officer (CIO) to run technology operations at the agency, as well as a permanent director of its Office of Compliance (OC) for its Center for Food Safety and Applied Nutrition (CFSAN). CIO Position FDA has gone through several CIOs in recent years as it has struggled to upgrade its technology platforms in light of an increasingly global workforce, hacking attempts , new ...
  • FDA Developing New Standardized Form for GRAS Submissions, Seeks Comment

    A Federal Register posting today by the US Food and Drug Administration (FDA) is soliciting comments on the food additive Notification Procedure for Substances Generally Recognized as Safe (GRAS) and its new Form FDA 3667. In particular, FDA invites comments on whether information sought by FDA is necessary, onerous, adequate or efficient. FDA currently regulates food additives through a premarket approval system. Exemptions from this system may be sought by companie...