Lauren Petrin

Lauren advises clients across the pharmaceutical, medical device, dietary supplement, food, and cosmetic industries on a wide range of regulatory and compliance matters. Her practice focuses on U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulatory counseling, product labeling and advertising compliance, import and export issues, and due diligence in corporate transactions.

She has counseled manufacturers, distributors, and importers on complex FDA regulatory frameworks, including claim substantiation, ingredient reviews, and state and federal licensing requirements. She has represented clients in responding to FDA import detentions, submitting public comments on proposed rulemakings, and preparing for engagement with federal agencies such as the Office of Management and Budget (OMB).

Lauren has notable experience advising clients on regulatory issues arising in mergers and acquisitions, particularly for companies in the health care and life sciences sectors. She has also negotiated a variety of clinical research agreements and supported clients in internal investigations and government enforcement matters related to the Federal Food, Drug, and Cosmetic Act (FDCA).

Her work includes engagements such as representing a major trade association in commenting on FDA’s proposed redefinition of “healthy” nutrient content claims, advising a global OTC drug manufacturer on label and formulation compliance, and coordinating due diligence for a $34 billion acquisition of a leading health care supply company.

Representative Matters

• Provided due diligence on mergers and acquisitions of FDA regulated entities.

• Counseled food companies on developing marketing claims to minimize regulatory and litigation risk and advising on the regulatory status of ingredients.

• Assisted client in developing a new over-the-counter drug product formulation, including conducting ingredient reviews, claims substantiation, and ensuring label compliance under FDA, FTC, and National Advertising Division (NAD) policies and guidance.
• Negotiated clinical trial agreements on behalf of a clinical research sponsor for numerous ongoing clinical research studies.
• Assisted in responding to a civil investigative demand issued to client regarding an investigation into the off-label promotion of a pharmaceutical product.
• Advised start-up pet food company on regulatory requirements related to manufacturing and distributing pet food products.

Professional Experience

• Associate, Private Law Practice (2024-2025)
• Associate, Private Law Practice (2021-2024)
• Summer Associate, Private Law Practice (2019)
• Intern, U.S. Food and Drug Administration (2018)
• Paralegal, Private Law Practice (2016-2017)

Affiliations

• Food & Drug Law Institute (FDLI)
  • Member, Planning Committee, New to FDA Law & Regulation Group (2025)