Practice Areas: State Regulatory & Business Compliance

Benjamin L. England & Associates provides representation and counsel to domestic and foreign members of the food, drug, cosmetic, medical device, tobacco, and alcohol community. While the federal government through FDA, USDA, and TTB largely regulates these commodities, the states have their own enforcement agencies that also investigate and verify compliance. Additionally, the states may include extra requirements, such as permitting requirements for pet foods and California’s Proposition 65.

Beyond the federal and state governments, private organizations seek to self-regulate their communities, such as the Natural Products Association (NPA), the U.S. Pharmacopeial Convention (USP), the Personal Care Products Council, and the Council for Fair Business Practices.  These organizations frequently have hearings when it is alleged that a company is not satisfying its legal and regulatory obligations. If the company does not satisfy the self-regulatory authority, the authority threatens to notify the relevant government agencies. We help companies understand the allegations and respond to the self-regulators to seek a favorable outcome.