We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 47

FDA partially stays controversial policy of requiring INDs for clinical studies evaluating food, dietary supplements and cosmetics
  • Kelley Drye & Warren LLP
  • USA
  • November 10 2015

On Friday, October 30, 2015, FDA issued a Federal Register Notice announcing a partial stay of the agency's controversial Final IND Guidance entitled


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


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


California Court of Appeal affirms early dismissal of food labeling class action
  • Kelley Drye & Warren LLP
  • USA
  • October 1 2013

On September 25, 2013, in a published decision, the California Court of Appeal affirmed the dismissal of a consumer class action at demurrer against


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 issues final rule regarding "Listing of Color Additives Exempt From Certification; Bismuth Citrate"
  • Kelley Drye & Warren LLP
  • USA
  • March 29 2010

On March 26, 2010, the Food & Drug Administration (FDA), issued a final rule titled, "Listing of Color Additives Exempt From Certification; Bismuth Citrate," amending the color additive regulations to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp


New FDA Guidance doubles-down on 1980 fortification policy and potential misbranding risks of “inappropriate fortification”
  • Kelley Drye & Warren LLP
  • USA
  • November 20 2015

FDA recently released its Guidance for Industry: Questions and Answers on FDA's Fortification Policy (Guidance) to "clarify the existing policy" in


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


Court’s decision over “spreadable butter” claims upheld on appeal
  • Kelley Drye & Warren LLP
  • USA
  • November 22 2013

The 2nd District Court of Appeals agreed with the lower court's decision that no reasonable consumer would be misled into thinking that a product


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