FDA Law Update : FDA Regulation Lawyer & Attorney : Sheppard Mullin Law Firm : Food & Drug Administration Product Regulations

By Mike Emmick

In the fervor of the U.S.'s current anti-foreign-corruption efforts, a particularly misguided proposal has occasionally reared its ugly head: Requiring “mandatory debarment” for any company that violates the Foreign Corrupt Practices Act (“FCPA”).

On the merits, such a proposal is completely wrong-headed. Debarment is a severe, forward-looking administrative remedy – the corporate “death penalty” – not a vehicle to “boost” the penalties for past criminal FCPA violations.

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By Mike Emmick and Joseph Barton

Corporate executives in the health care and environmental industries are rapidly coming to appreciate the implications of the responsible corporate officer doctrine, a recently-revitalized weapon in U.S. Department of Justice’s battle against corporate crime.

This doctrine is a peculiar exception to the usual requirements for a criminal prosecution. Ordinarily, criminal law requires a defendant to have committed a criminal act, and to have done so with criminal intent.

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Welcome to the first monthly update on FDA's enforcement over regulated tobacco products. This update will examine trends in Warning Letters, and cover some unique Warning Letters and enforcement actions that have occurred in the previous month. As the first post regarding tobacco products, we begin with an alert regarding FDA's issuance of civil money penalty complaints. The update also provides a summary of tobacco related Warning Letters issued by the FDA to date.[1]

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