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Food, Dietary Supplement & Cosmetics Regulatory Update Vol. III, Issue 13
  • Jones Day
  • USA, OECD, European Union
  • October 6 2016

On September 28, 2016,FDA announced it has started a public process to redefine the "healthy" nutrient content claim for food labeling. On December 1


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 12
  • Jones Day
  • USA
  • September 15 2016

On August 12, 2016, FDA finalized a long-awaited proposed rule, "Substances Generally Recognized as Safe." The final rule sets forth the mandatory


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 11
  • Jones Day
  • USA, Brazil, European Union
  • August 12 2016

On July 29, 2016, President Obama signed into law S.764, the bill that creates the "National Bioengineered Food Disclosure Standard." As discussed in


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 6
  • Jones Day
  • USA, United Kingdom, European Union
  • August 3 2016

FDA recently released, as a part of President Obama's Precision Medicine Initiative, two draft guidance documents proposing what the Agency is


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 5
  • Jones Day
  • USA
  • July 13 2016

On June 2, 2016, FDA announced the availability of three final guidance documents aimed at simplifying and clarifying expanded access for


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 9
  • Jones Day
  • USA, European Union
  • June 17 2016

FDA has published its last major regulation implementing the Food Safety and Modernization Act ("FSMA"): a final rule on mitigation strategies to


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 4
  • Jones Day
  • USA
  • May 31 2016

Earlier this month, four Republican SenatorsLamar Alexander (TN), Richard Burr (NC), Johnny Isakson (GA), and Orrin Hatch (UT)sent a letter to FDA


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 8
  • Jones Day
  • USA, European Union
  • May 26 2016

Effective July 26, 2016, FDA is amending its labeling regulations for conventional foods and dietary supplements to provide updated nutrition


Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 7
  • Jones Day
  • USA, Canada, China, European Union
  • May 9 2016

On May 4, 2016, FDA announced that both the U.S. and Canada have recognized each other's food safety systems as comparable to each other. This is the


Pharmaceutical & Medical Device Regulatory Update Vol. III Issue 3
  • Jones Day
  • USA
  • May 6 2016

FDA released three new draft guidance documents regarding its implementation of the human drug compounding requirements of Title I of the Drug