Joanne S. Hawana

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  • University of Maryland School of Law (JD, cum laude)
  • University of Medicine and Dentistry of New Jersey, Graduate School of Biomedical Sciences (MS, Molecular Genetics & Microbiology)
  • College of William & Mary (BS, Biology)

Bar Admissions

  • District of Columbia
  • Maryland

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US Federal and State actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. Joanne assists clients in understanding the interplay of FDA’s regulations with other Federal or State laws, like the Federal Trade Commission’s requirements for truthful advertising that apply to many categories of FDA-regulated products. Her clients include privately held and publicly traded companies, individual entrepreneurs and inventors, patient advocacy groups, and individual investors as well as investment funds.  

Her strategic counseling and compliance support work reaches into all aspects of FDA-regulated companies’ operations, including:   

  • Determining regulatory status of novel products like mobile health systems and point-of-care diagnostics;
  • Pre-market and post-market requirements for various regulated products;
  • Restrictions on advertising and sampling, including for controlled substances; 
  • State licensing schemes for prescription drug manufacturers and distributors;
  • Federal track-and-trace obligations for all members of the prescription drug supply chain, from manufacturers to pharmacies;
  • Compliance with drug compounding regulations, both State and Federal;
  • Review and approval of various types of policies and procedures for facilities that manufacture or distribute regulated products;
  • Advising on or drafting clients’ written submissions to FDA requests for comments or rule-making activities;    
  • Requirements for importing and exporting regulated products; 
  • Counseling on cosmetic product claims in order to avoid high-risk areas; and 
  • Food safety and labeling advice for human and animal food, including dietary supplements and “functional foods,” as well as alcoholic beverage products. 

Joanne frequently works with clients to develop and implement their responses to common FDA actions, such as warning letters and inspectional reports (the “Form 483”). She also advises companies on how to conduct voluntary product recalls and how to communicate those recall activities to FDA, consumers, and other stakeholders. In recent years, she has been providing ongoing counseling to clients on the impact of sweeping changes to the U.S. food safety system that are being ushered in by the FDA Food Safety Modernization Act, including foreign supplier verification requirements and preventive controls for registered food facilities. 

Joanne also assists Mintz Levin Corporate Teams by performing regulatory due diligence as part of potential mergers, acquisitions, loans, and other financing agreements that involve FDA-regulated companies.  She frequently works in conjunction with the Firm’s Intellectual Property attorneys to ensure that patent and regulatory activities are strategically aligned. Potential marketing exclusivities granted under various FDA authorities are often critical data points for Corporate and IP Teams to be aware of during negotiations and transactions, and Joanne analyzes factors that may support a period of exclusivity and puts the information into context for other members involved in a deal. 

Although the day-to-day work for clients may be different, the common thread that she enjoys most is helping companies (both start-up and established) bring their products to market – without heightened risks of enforcement actions as a result of non-compliance with sometimes-opaque regulatory requirements.

Prior to joining Mintz Levin, Joanne was an attorney in the food and drug practice in the DC office of another law firm. She had internship experiences during law school at the Biotechnology Industry Organization and the business incubator-focused Maryland Intellectual Property Legal Resource Center. She also spent a summer as a National Institutes of Health Fellow. Before attending law school, Joanne was assistant managing editor of a biomedical research trade publication, and prior to that she was a lab scientist studying the regulation of gene expression and the molecular basis of cancer.

Joanne is a contributor to the Mintz Levin Health Law & Policy Matters blog and an editor of the Consumer Product Matters blog

Professional and Community Involvement

  • Member, Food and Drug Law Institute (FDLI)
  • Member, FDLI Publications Advisory Board Member
  • American Bar Association (ABA), and ABA Health Law Section
  • Member, American Health Lawyers Association (AHLA), and AHLA Life Sciences Practice Group
  • Past Chair, FDLI Primer Committee and FDLI Update Magazine Editorial Advisory Board 

Recognitions & Awards

  • William P. Cunningham Award for Achievement and Service to the School of Law, University of Maryland (2007) 
  • Manuscripts Editor, The Journal of Health Care Law and Policy (Vol. 10)

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