Wiley provides compliance assistance regarding federal and state laws governing the manufacture, distribution, and sale of consumer products. We counsel clients on regulatory compliance matters arising under laws administered by relevant federal agencies including the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS), U.S. Customs and Border Protection (CBP), Consumer Product Safety Commission (CPSC), U.S. Department of Transportation (DOT), the Federal Aviation Administration (FAA), U.S. Department of Energy (DOE), and the Federal Trade Commission (FTC). We also provide strategic advice in regulatory compliance issues arising at the state level, including California’s Proposition 65 and various recycling laws for electronics and batteries.

Wiley conducts compliance audits and assists clients with internal evaluations to spot and correct compliance problems before they are discovered by regulatory authorities. We support clients in conducting post-inspection compliance evaluations and root cause analyses, and assist with identifying appropriate corrective actions. We are known for our practical expertise in helping clients implement corrective actions through developing and refining Standard Operating Procedures and designing training programs to prevent future compliance failures.

In addition, we have over 50 years of collective experience representing clients in enforcement matters before federal and state agencies involved in the regulation of consumer products such as pesticides, chemicals, electronics, industrial equipment, food, batteries, and other household products. We routinely assist clients in responding to requests for information, notices of violation, and stop sale orders, and we negotiate settlement agreements and consent orders under various enforcement programs involving compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), the Resource Conservation and Recovery Act (RCRA), the Clean Air Act (CAA), the Hazardous Materials Transportation Act (HMTA), the Pension Protection Act (PPA), and laws and regulations relating to export controls.

Representative Experience:

  • Serving as on-site regulatory compliance officer for major pesticide manufacturer during conduct of internal compliance review and corrective action program involving several environmental statutes.
  • Assisting major consumer products company with root cause investigation and compliance review arising from recalls involving pet food.
  • Assisting chemical company in designing new compliance programs for chemical exports.
  • Developing training programs for pesticide manufacturer for compliance with FIFRA.
  • Negotiating the successful settlement of a federal-level EPA enforcement action against a company for violations of FIFRA.
  • Negotiating the successful settlement of an FAA enforcement action involving alleged violations of air transport restrictions for hazardous materials.
  • Advising companies on how to respond to FDA inspections and requests for information.
  • Negotiating with the FDA to favorably resolve active or threatened enforcement actions.

Contact Us

Tracy Heinzman
202.719.7106 | theinzman@wiley.law

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