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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


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


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


IOM issues Phase II report recommending energy star-type ratings for a food front-of-package nutrition rating system
  • Kelley Drye & Warren LLP
  • USA
  • October 24 2011

In 2009, Congress requested an Institute of Medicine study examining "front-of-package" ("FOP") nutrition labeling systems and symbols and the effect that FOP labeling could have on consumer food choices


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


California amends Proposition 65 to help curb lawsuits
  • Kelley Drye & Warren LLP
  • USA
  • October 15 2013

Restaurants, bars, and parking garages, among others, are set to receive relief from the most onerous aspects of California's "Proposition 65," the


Non-profit sues 34 sellers of "organic" cosmetics
  • Kelley Drye & Warren LLP
  • USA
  • June 29 2011

Last week, the Center for Environmental Health, a non-profit organization, filed a complaint in California Superior Court alleging that 34 cosmetics companies violated the California Organic Products Act of 2003 (“COPA”) by selling, labeling, or marketing cosmetic products containing less than 70 organic ingredients as “organic.”


FDA releases guidance on administrative detentions on the heels of its first post- FSMA seizure
  • Kelley Drye & Warren LLP
  • USA
  • October 25 2011

Today, the Food and Drug Administration (“FDA”) released a guidance document for industry titled “What You Need to Know About Administrative Detention of Foods.”


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


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