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Results: 1-10 of 36

FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
  • Kelley Drye & Warren LLP
  • USA
  • January 24 2018

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved


FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
  • Kelley Drye & Warren LLP
  • USA
  • January 24 2018

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved


“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report
  • Kelley Drye & Warren LLP
  • USA
  • October 2 2017

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the


FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements
  • Kelley Drye & Warren LLP
  • USA
  • June 13 2017

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition


Senate Hearing on FDA Commissioner Nominee Scott Gottlieb Provides Insights on the Future of Food Safety and Labeling
  • Kelley Drye & Warren LLP
  • USA
  • April 13 2017

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as


FDA Continues FSMA Implementation, Finalizes Guidance on Voluntary Qualified Importer Program to Expedite Food Imports
  • Kelley Drye & Warren LLP
  • USA
  • November 18 2016

The Food & Drug Administration (FDA) released last week a final version of its guidance for industry on the Voluntary Qualified Importer Program


FDA Releases Final Rules Revising Supplement and Nutrition Facts and Certain Serving Sizes; Industry Given Two to Three Years to Comply
  • Kelley Drye & Warren LLP
  • USA
  • June 9 2016

On May 20, FDA announced that it was finalizing two previously proposed rules that will require industry to overhaul Supplement and Nutrition Facts


FDA Releases Final Rules Revising Nutrition Facts Label and Certain Serving Sizes; Industry Given Two to Three Years to Comply
  • Kelley Drye & Warren LLP
  • USA
  • May 20 2016

FDA announced today that it was finalizing two previously proposed rules that will require industry to overhaul Nutrition Facts panels on all food


FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules
  • Kelley Drye & Warren LLP
  • USA
  • May 16 2016

On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a


FDA approves genetically engineered Atlantic salmon as safe and effective for human food and releases related draft guidance on voluntary labeling
  • Kelley Drye & Warren LLP
  • USA
  • November 24 2015

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of