Zachary G. Maciejewski

Associate

+1 317 237 1000

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Overview

Zac Maciejewski helps clients navigate the complexities of FDA regulatory concerns as they look to market new food, beverage, dietary supplement and cosmetic products.

Regulatory and Transactional

Zac partners with clients to address complex licensing, permitting and regulatory needs and helps them navigate the intricacies of state and federal licensing entities. He also works with companies looking to import and export food and beverage products internationally, helping them understand compliance requirements and interface with U.S. and foreign export authorities.

Zac drafts supply agreements, contract manufacturing agreements and product development agreements, focusing on issues related to food safety, marketing, regulatory compliance, intellectual property, indemnification, import/export, inspections and recalls. He helps clients draft Food Safety Modernization Act (FSMA) compliance programs for animal feed and human food manufacturing facilities.

When a deal is on the line, Zac counsels food and agribusiness clients in due diligence and agreement drafting, coordinating with M&A counsel and providing insights on food regulatory issues that may impact a food or animal feed transaction.

Marketing and Advertising

As clients launch new food, beverage, dietary supplement and cosmetic products, Zac assists with product classification, counsels on feasibility for market entry, and advises on best practices to help clients advertise and market products in compliance with industry regulations. He focuses on understanding a client’s goals, objectives and risk tolerance, and he leverages his knowledge of the product life cycle to provide practical guidance. When companies take their products to market, Zac helps them navigate Federal Trade Commission (FTC) standards for substantiating marketing claims as well as requirements from the National Advertising Division of the Better Business Bureau and state and local regulators.

Prior Experience

As a 2019 summer associate with our firm, Zac worked closely with pharmaceutical investor-initiated agreements and asset purchase agreements related to medical device company acquisitions. He also served as a legal extern for Eskenazi Health, analyzing the hospital’s cyber liability insurance policy and authoring documentation regarding the hospital’s compliance with HIPAA and OCR encryption regulations. During a general counsel internship with the Indiana State Board of Education, Zac co-authored Indiana Administrative Code regulations concerning at-risk students and dropout recovery services.