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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


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


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


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


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 import tolerances for unapproved new animal drugs
  • Kelley Drye & Warren LLP
  • USA
  • February 1 2012

The FDA published a proposed rule to establish procedures by which a person may request that the agency establish, amend or revoke tolerances for unapproved new animal drugs in edible portions of animals imported into the United States as part of its implementation of the Animal Drug Availability Act of 1996


GAO investigation concerning herbal dietary supplements fuels legislative debate: does FDA need more authority to protect elderly consumers?
  • Kelley Drye & Warren LLP
  • USA
  • June 8 2010

On May 26, 2010, the Special Committee on Aging of the U.S. Senate (the Committee) held a hearing entitled, “Dietary Supplements: What Seniors Need to Know,” in response to a recent U.S. Government Accountability Office (GAO) investigation which found that sellers of certain retail dietary supplement products commonly used by the elderly relied on deceptive and unfounded disease-related claims to market their products, encouraging consumers to use such products to prevent or treat diabetes, cancer, heart disease, Alzheimer’s disease, and other serious conditions


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


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


Sysco agrees to pay $19.4M to settle California enforcement challenging the company’s food safety practices and related public statements
  • Kelley Drye & Warren LLP
  • USA
  • July 23 2014

The world's largest food distributor, Sysco Corp., has entered into a settlement with the California Department of Public Health to resolve