Practices  |  Consumer Product Regulation

Recalls and Reverse Distribution

Overview

Wiley Rein represents companies defending products that are subject to phaseout and removal from the marketplace because of alleged environmental, health, or safety issues under a wide range of regulatory authorities, including the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Consumer Product Safety Act (CPSA), the Federal Food, Drug and Cosmetics Act (FFDCA), and the Toxic Substances Control Act (TSCA). We regularly provide clients with strategic advice on implementing product removals and phaseouts to minimize potential business disruptions and public relations challenges.

We have extensive experience representing clients before regulatory agencies engaged in product regulation, such as the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Consumer Product Safety Commission (CPSC) – specifically with respect to negotiating the terms of product cancellations, recalls, and phaseouts. We are particularly known for our expertise in counseling clients with respect to FIFRA stop sale orders and FDA food-related recalls.  

Wiley Rein’s lawyers and regulatory analysts work closely with in-house counsel, company management, engineers, and scientists to develop plans and effective strategies for addressing reverse distribution situations arising from product defects and regulatory non-compliance. When recalls are necessary, we work with clients on a wide range of issues from the logistics of reverse distribution to root cause investigations and corrective actions to prevent future non-compliance. We have successfully developed and obtained regulatory approval for innovative solutions to product phaseouts and removals that avoided or narrowly limited removal/recall obligations.

Representative Experience:

  • Successfully representing a nationwide electronics retailer before CPSC on initiating and managing multiple recalls and defect evaluations for toys, electronics, and home goods. And successfully defended the retailer in a CPSC investigation into sales of recalled products.
  • Defending manufacturers and retailers in a CPSC investigation on whether they met their reporting obligations under Section 15(b) of the CPSA and in avoiding the release of potentially damaging information under Section 6(b) of that statute and the Freedom of Information Act.
  • Representing numerous pesticide manufacturers and distributors with FIFRA cancellation and stop sale orders.
  • Providing counsel to large consumer products company with multiple pet food recalls and voluntary withdrawals involving FDA and state agricultural agencies.

Contact Us

Tracy Heinzman
202.719.7106 | theinzman@wileyrein.com

Sonali P. Gunawardhana
202.719.7454 | sgunawardhana@wileyrein.com

Roger H. Miksad
202.719.7193 | rmiksad@wileyrein.com

Our People