Michelle Gillice focuses her practice on regulatory compliance and enforcement concerning the US Consumer Product Safety Commission (CPSC) and Drug Enforcement Administration (DEA). Following her tenure at both agencies, she now helps clients find practical solutions that reduce liability risks and protect their brands.

Ms. Gillice has extensive experience as a product safety lawyer, both in private practice and for more than 9 years as a compliance attorney at CPSC. While at CPSC, Ms. Gillice handled numerous defect and regulated product compliance, recalls, and civil penalty investigations involving retailers, importers, and manufacturers. Ms. Gillice now helps companies assess their compliance with CPSC regulations, determine when it is appropriate to notify CPSC of potential safety issues, avoid unnecessary recalls, develop effective corrective action plans, and defend penalty investigations and enforcement actions.

Ms. Gillice's experience includes representing manufacturers, importers, and online and traditional retailers of various consumer products, including household appliances, home furnishings, heating and cooling equipment, lighting products, toys and other children's products, computer equipment, lithium-ion batteries, packaging, pharmaceutical drugs, and connected (IoT) products.

In addition, Ms. Gillice counsels pharmaceutical manufacturers, wholesale distributors, hospitals, and other healthcare clients on regulatory compliance and enforcement issues involving the Controlled Substances Act (CSA) and its implementing regulations. She also advises companies on business procedures relating to DEA registration, recordkeeping, reporting, and security. Immediately prior to joining the firm in 2016, Ms. Gillice served as a senior attorney at DEA, Office of Chief Counsel, Diversion and Regulatory Litigation Section, where she represented the federal government in administrative litigation against wholesale distributors, pharmacies, and practitioners for alleged violations of the CSA.

Experience

  • Advise companies on CPSC reporting obligations and other regulatory requirements.
  • Develop effective recalls in the US and as part of coordinated global corrective action plans.
  • Defend CPSC late reporting and post-recall sale investigations.
  • Assist companies with notices of import violations, FOIA requests, and consumer reports filed on CPSC's Safer Products database.
  • Counsel companies in developing and enhancing internal compliance policies and procedures.

Perspectives

Regulatory Compliance and Communications with the CPSC
Instructor, Product Safety Professional Certification Program, Saint Louis University, Chaifetz School of Business
Going "Direct to Consumer" Without Going Direct(ly) to Court—Best Practices for Using E-Commerce While Reducing Legal and Regulatory Risks
The New Norm? Selling Products Online During the Time of COVID-19
Panelist, ICPHSO 2020 Virtual Product Safety Training Workshop
DEA Proposes Regulatory Changes to Facilitate Marijuana Production and Distribution for Research
Advisory
Culture, Communication and Regulatory Compliance
Product Safety Professional Certification Program, Saint Louis University, Chaifetz School of Business
More

Recognition

The Legal 500 US
Product Liability and Mass Tort Defense: Pharmaceuticals and Medical Devices (2017)
Product Liability, Mass Tort and Class Action: Consumer Products (including tobacco) (2017)

Credentials

Education
  • JD, American University Washington College of Law, 1997
  • BS, Syracuse University, 1992, cum laude
Admissions
  • District of Columbia
Overview

Email Disclaimer