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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

FDA announces allowable level for DEHP in bottled water
  • Kelley Drye & Warren LLP
  • USA
  • October 19 2011

On October 19, 2011, the Food and Drug Administration (“FDA”) published a final rule amending its bottled water quality standard regulations by establishing an allowable level of di (2-ethylhexyl)phthalate (“DEHP”).

FDA issues compliance policy guide that provides potential business advantage for filing new drug application for marketed, unapproved drug
  • Duane Morris LLP
  • USA
  • September 30 2011

On September 19, 2011, the U.S. Food and Drug Administration issued a Compliance Policy Guide titled "Marketed Unapproved Drugs," which revises the FDA's 2006 CPG regarding the same topic.

Corporate officers to be prosecuted for corporate violations of the Food, Drug, and Cosmetic Act without knowledge of criminal conduct
  • Latham & Watkins LLP
  • USA
  • August 24 2011

The Food and Drug Administration (FDA) has released aggressive guidelines for prosecutions under the Food, Drug, and Cosmetic Act1 (FDCA) that put corporate officers at risk of criminal liability merely because of their position within a violating company.

Recalls of FDA-regulated products - do you need to call the FDA?
  • Jones Day
  • USA
  • June 9 2011

Almost every day, the Food and Drug Administration announces product recalls.

Former CEO sentenced to one month imprisonment and ordered to pay $1.9 million
  • Jones Day
  • USA
  • April 21 2011

On March 10, 2011, the former CEO of K-V Pharmaceutical, Marc Hermelin, was sentenced to 30 days in prison after pleading guilty to two federal charges of misbranding drugs.

Dietary supplement firms, CGMPs and the park doctrine
  • Saul Ewing Arnstein & Lehr LLP
  • USA
  • April 12 2011

As FDA continues to inspect dietary supplement manufacturers under the new CGMP framework, it is clear that many manufacturers share similar deficiencies.

FDA issues "non-binding" park doctrine criteria for potential referral of "responsible corporate officials" for prosecution for alleged violations of the Food, Drug and Cosmetic Act
  • Duane Morris LLP
  • USA
  • February 10 2011

The U.S. Food and Drug Administration ("FDA") recently set forth, in its Regulatory Procedures Manual for FDA personnel, criteria for when it would refer a matter for potential prosecution under the Park doctrine.

The FDA Food Safety Modernization Act: what you need to know now
  • Kelley Drye & Warren LLP
  • USA
  • February 4 2011

The FDA Food Safety Modernization Act (FSMA), which became law on January 4, 2011, makes significant amendments to the Federal Food, Drug & Cosmetic Act (FDCA) which are designed to strengthen food safety protections in ways that help minimize the risk that unsafe food will enter the U.S. market, and expedite the removal of food that is discovered to be unsafe after it has entered the market.

FDA-related issues in the OIG 2011 Work Plan
  • Alston & Bird LLP
  • USA
  • October 28 2010

The Office of Inspector General (OIG) recently released its Fiscal Year (FY) 2011 Work Plan.