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Results: 1-10 of 42

Sunscreen Innovation Act changes FDA review process for more than just OTC sunscreens

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • December 10 2014

On November 26, 2014, the President signed into law the "Sunscreen Innovation Act." The Act is primarily intended expedite the Food and Drug

FDA proposes new user fees to finance food & cosmetic safety

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • April 12 2013

On April 10, 2013, the U.S. Food and Drug Administration ("FDA") announced a proposal that could increase the cost of doing business for the food and

Highlights of FDA’s implementation of the Food Safety Modernization Act in 2013

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • December 6 2013

On January 4, 2011, President Obama signed into law the Food Safety Modernization Act (FSMA), which has been touted as the most sweeping legislation

8th Circuit Court of Appeals rules false advertising allegations regarding organic claims are not preempted by Organic Foods Production Act of 1990

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • September 22 2010

The U.S. 8th Circuit Court of Appeals recently ruled that certain false advertising claims based on state consumer protection and anti-deception statutes were not preempted by the Organic Foods Production Act of 1990 (OFPA) a federal Act that establishes national standards for the sale and labeling of organically produced agricultural products, and creates a certification program through which agricultural products may be certified to produce organic products

GAO concludes FDA should strengthen its oversight of GRAS ingredients

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 12 2010

On March 5, 2010, the General Accountability Office (GAO) issued a report evaluating the Food and Drug Administration's (FDA's) policies concerning food ingredients that have been determined to be "Generally Recognized As Safe" (GRAS

Far-reaching PCA criminal indictments: a harbinger for things to come under FSMA?

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • February 28 2013

Last week, the Department of Justice brought a sweeping indictment against several former Peanut Corporation of America executives alleging egregious

FDA proposes rule mandating unique device identifiers for medical devices

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • July 23 2012

On July 10, 2012, the Food and Drug Administration published a proposed rule implementing Federal Food, Drug, and Cosmetic Act provisions establishing a unique device identification system for medical devices

FDA targets antibacterial soaps in new proposed rule

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • December 17 2013

On Monday, FDA announced a new proposed rule that would amend the 1994 TFM for OTC antiseptic drug products. The change would require companies that

Settlement with Indoor Tanning Association regarding claims characterizing disease risks for tanning and vitamin D supplements

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • May 19 2010

On May 19, 2010, the Federal Trade Commission (FTC) approved a final settlement order with the Indoor Tanning Association charging that the association exaggerated the health benefits of indoor tanning and misrepresented that indoor tanning increases the risk of skin cancer

FDA's new Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • March 26 2010

On March 25, 2010, FDA announced its new guidance for industry entitled, "Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007