Update Nov Dec 2013 - (Page 19)

Enforcement metrics, and records replace outdated guidance documents and generalized statutory definitions. The ability to build class actions for minor economic damages took shape while the industry waited for new rules. Class actions for labeling claims provide the clearest example of this growing precedent in state and federal courts. Together, FSMA and new access to class action status, present a challenge to compliance. The hypotheticals are endless. Plaintiffs could sue for small bouts of food poisoning using discovery to find what risks were identified and controlled or mismanaged. Suits could also arise for economic adulteration as foreign imports come under scrutiny. This background to the new rule requires strategic compliance over strict compliance. The aim remains the same - protect the consumer to protect the brand - but the means of achieving that aim has fundamentally changed. For example, a hazard analysis could serve as a roadmap to investigators and plaintiffs alike. FSMA is asking industry to do more and trusting the incentive to avoid litigation will ensure compliance with the new rules. areas for comment. It will be paramount Conclusion with complications as the FDA entrusts The rules are dense with details and for each facility to understand how the proposed rules will impact their industry and operations. The consequences for ignoring the new rules are real. Not only does the FDA carry new enforcement powers like facility registration suspension or high-risk facility designations, but the litigation risks are potent. Beyond FDA enforcement compliance now matters as a key component of avoiding litigation. The litigation terrain is mired enforcement of FSMA to facilities. Local team. Global resources. Meeting regulatory needs in China and around the world. Learn more at www.ropesgray.com/china-life-sciences ©Ropes & Gray, 2013 FDLI November/December 2013 Update 19 http://www.ropesgray.com/china-life-sciences

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013