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Results: 1-10 of 33

FDA proposes two groundbreaking food safety rules
  • Sidley Austin LLP
  • USA
  • January 8 2013

On January 4, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") proposed two major, long-awaited rulemakings required by the Food Safety


FDA Overhauls Design and Content of Nutrition Labeling
  • Sidley Austin LLP
  • USA
  • May 26 2016

On May 20, 2016, the Food and Drug Administration (FDA) announced the release of two final rules amending its nutrition labeling regulations. The


FDA to finalize GRAS notification rule; potential for more stringent standards
  • Sidley Austin LLP
  • USA
  • December 4 2014

On October 20, 2014, the Food and Drug Administration (FDA) entered into a consent decree under which the Agency is obligated to finalize its 1997


FDA addresses oversight of general wellness products, device accessories
  • Sidley Austin LLP
  • USA
  • January 22 2015

On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


FDA changes course on INDs for food and supplement studies, but not for cosmetics
  • Sidley Austin LLP
  • USA
  • October 30 2015

FDA announced today that it is indefinitely staying portions of the Guidance, "Investigational New Drug Applications - Determining Whether Human


Shifting gears, FDA seeks input on use of the term “natural” in food labeling
  • Sidley Austin LLP
  • USA
  • November 12 2015

On Thursday, November 12, 2015, the Food and Drug Administration (FDA) announced that it was opening a docket to accept public comments on "natural"


European Parliament calls for additional medical device safety measures
  • Sidley Austin LLP
  • European Union
  • June 18 2012

On 14 June 2012, the European Parliament (“EP”) adopted a Resolution calling on EU Member States and the European Commission to introduce and implement new measures aimed at ensuring the safety of medical devices


SFDA issues draft rules to define its discretionary power in imposing administrative penalties
  • Sidley Austin LLP
  • China
  • September 27 2012

On September 19, 2012, China’s State Food and Drug Administration (“SFDA”) issued draft Rules on Exercising Discretionary Powers when Imposing Administrative Penalties involving Drugs and Devices (“Draft Rules”), soliciting public comments by September 26, 2012


FDA issues warning letter to Lancôme for anti-aging claims
  • Sidley Austin LLP
  • USA
  • September 14 2012

On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics


European Commission allows submission of new data in support of probiotic health claims
  • Sidley Austin LLP
  • European Union
  • June 20 2011

The European Commission has opened a four-month window, starting on June 1 and closing on September 30, 2011, during which stakeholders can submit new data to Member States in support of certain probiotic health claims rejected by the European Food Safety Authority