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Criminal Liability Federal Food Drug and Cosmetic Act (FFDCA)

Gardner Law

FDA Violations and the Park Doctrine Threat

Gardner Law on

Did you know… As a leader at an FDA-regulated company, you could be held criminally liable for misdemeanor FDA violations even if you did not know about the activities leading to the violation....more

Oberheiden P.C.

Did You Receive an FDA Warning Letter? Here's What to Do Next

Oberheiden P.C. on

What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more

Saul Ewing LLP

The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know

Saul Ewing LLP on

In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...more

McDermott Will & Emery

Florida Federal District Court Rules GRAS Regulation Preempts Florida Statute Criminalizing Ingredient

McDermott Will & Emery on

In an important ruling dismissing a proposed class action, the US District Court for the Southern District of Florida ruled that the US Food and Drug Administration’s (FDA’s) generally recognized as safe (GRAS) regulation...more

Stinson LLP

The Proposed Corporate Executive Accountability Act - Bending the Space-Time Continuum to Find Criminal Culpability of Corporate...

Stinson LLP on

Two core principles of American criminal liability are: (1) a crime does not occur unless the accused has both criminal intent (mens rea) and commits a criminal act (actus reus); and (2) the intent and the act must occur at...more

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