New How-to on FDA Compliance
Handbook offers advice from leading lawyers
Peter Quinter, partner in charge of the Customs and International Trade Law Departments at Becker & Poliakoff, and frequent guest columnist on Datamyne’s blog, is a contributing author to a new handbook on legal compliance with Food and Drug Administration regulations.
The book is written for the C-level executive who needs to keep abreast of the latest FDA compliance requirements and enforcement policies, a particular challenge in the wake of the Food Safety Modernization Act (FSMA) of 2010.
For instance, in enlarging the FDA’s regulatory authority, FSMA empowered the agency to recall products. The handbook covers what companies must know about how and when to establish whether a product is safe or defective and, if defective, to initiate a voluntary recall. The handbook also explains the FDA’s labeling requirements, and goes into detail on statements about the use of a product that may be construed as false and misleading and so be deemed “mislabeling” by the FDA. Readers will also learn which violations are handled administratively by the FDA Office of Regulatory Affairs (ORA) – and which suspected violations are investigated by the FDA Office of Criminal Investigations (OCI). Knowing the difference, says Quinter, and how to handle each of these types of inquiries, audits, or investigations can help a business avoid incurring a fine, or a company officer being arrested.
Recent Developments in Food and Drug Law, 2012 ed.: Leading Lawyers on Dealing with Increased Enforcement, Keeping Up-to-Date with FDA Requirements, and Developing Compliance Practices is available for $90.00 from Thomson Reuters Westlaw.
10 May 2012: Peter Quinter is now a Shareholder in the law firm of GrayRobinson and Chair of the firm’s Customs & International Trade Law Group. Based in the firm’s Miami and Ft. Lauderdale offices, Quinter principally represents persons and companies involved in international trade and transport. You can contact him at [email protected] or at (954) 270-1864.
The opinions expressed in this article are those of its author and do not purport to reflect the opinions or views or Descartes Datamyne. In addition, this article is for general information purposes only and it’s not intended to provide legal advice or opinions of any kind and my not be used for professional or commercial purposes. No one should act, or refrain from acting, based solely on this article without first seeking appropriate legal or other professional advice.
Date posted: March 1, 2012