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MaryJoy Ballantyne is a member of the firm’s Food and Drug practice group, resident in the D.C. office. Her practice focuses on food & drug law, with an emphasis on food, dietary supplements, cosmetics, OTCs, and animal products.
Ms. Ballantyne advises major food companies on a broad range of U.S. regulatory and compliance issues, including facility registration requirements, product formulation, ingredient status (food additive, GRAS), CGMP compliance, labeling, advertising, imports, exports, recalls, and regulatory reporting requirements. She also advises food and dietary supplement companies on strategies for minimizing the risk of consumer fraud/class action litigation. Ms. Ballantyne reviews and analyzes product claims and marketing materials for FDA and FTC regulatory compliance.
Ms. Ballantyne also advises cosmetic and over-the-counter drug companies on U.S. regulatory and compliance matters, including registration, CGMP, labeling, and state reporting requirements.
Ms. Ballantyne advises animal food and drug companies on compliance with state and federal requirements for feed ingredients, feed, and drug products. Ms. Ballantyne assists animal research laboratories and pharmaceutical companies on matters arising under USDA’s Animal Welfare Act and the federal Freedom of Information Act.
Representative Matters
- Advise major conventional food and dietary supplement companies on preparing for and managing state and federal regulatory facility inspections and other regulatory enforcement actions. Assist companies in drafting CGMP SOPs and responses to state and federal enforcement actions.
- Advise major food and dietary supplement companies on strategies for minimizing risk of consumer fraud/class action litigation. Provide regulatory strategic advice to clients involved in consumer fraud/class action litigation.
- Review and analyze label claims and product marketing materials of major food and dietary supplement companies for compliance with FDA and FTC requirements.
- Advise major food and dietary supplement companies in strengthening CGMP compliance.
- Provided regulatory advice and due diligence to a multi-billion dollar dietary supplement company for a corporate acquisition.
Previous Experience
Prior to law school, Ms.Ballantyne worked for several years conducting basic science research in the fields of biochemistry, molecular biology, infectious diseases, and neurobiology at Cornell University and University of Utah School of Medicine. Following her years in the basic sciences, she was a Fixed Income research assistant in JP Morgan’s NY office and a policy analyst at the Institute of Medicine of the National Academy of Sciences in Washington, DC.
Memberships and Affiliations
- American Bar Association
- American Intellectual Property Law Association
Publications and Speeches
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