MaryJoy Ballantyne combines her technical and policy background with expertise in all aspects of food (human and animal), cosmetic, and OTC law at both the state and federal level to help companies and trade associations navigate ever-changing regulatory and litigation risks.
Ms. Ballantyne helps clients assess and obtain authorizations of food and dietary ingredients, create competitive yet low-risk labeling and marketing strategies, and respond strategically to regulatory and competitor challenges. Ms. Ballantyne helps clients understand the nuances of clean label claims such as “natural,” “organic,” “healthy,” “non-GMO,” “locally sourced,” “no artificial . . .” She also conducts substantiation assessments for claims and advertising campaigns, relying on her experience with scientific and clinical studies, and counsels clients on designing clinical programs to support marketing claims. On behalf of her clients, Ms. Ballantyne has submitted numerous technical documents to FDA and USDA, including comments on FSMA, dietary fiber, added sugar, and the federal bioengineered food disclosure standard.
Ms. Ballantyne has considerable experience with food safety requirements, including HACCP, dietary supplement CGMPs, good laboratory practices (GLPs), and FDA’s Food Safety Modernization Act (FSMA). She is certified through the Food Safety Preventive Controls Alliance (FSPCA) as a Preventive Controls Qualified Individual (PCQI). Clients rely on her in-depth knowledge of FSMA for practical strategies for implementing the PC requirements for human and animal food, the Foreign Supplier Verification Program, Sanitary Transportation, and Food Defense and responding to related FDA inspections. With an in-house perspective on quality and manufacturing compliance, Ms. Ballantyne assists clients in strengthening CGMPs and quality systems, implementing procedures and quality agreements, successfully closing out challenging inspections, responding to 483s and warning letters, and effectively advocating in person at FDA.
Ms. Ballantyne also advises clients on USDA requirements, including nutrition programs, the National Organic Program, the federal bioengineered disclosure standard, the Food Safety Inspection Service, the Animal and Plant Health Inspection Service, exports, and imports, including imports under the Lacey Act.
At the state level, Ms. Ballantyne advises and assists clients, including grocery and meal kit retailers, on their obligations under good retail practices (GRP), FDAs Food Code, California’s Proposition 65 and applicable safe harbors, the Pasteurized Milk Ordinance (PMO), state weights and measures requirements (including slack fill risk assessments), and local taxes targeting foods.
Using her broad knowledge of state and federal requirements for foods, cosmetics, and OTCs, Ms. Ballantyne supports corporate transactions and litigation matters, enabling clients to accurately assess the value and liabilities of potential transactions or develop technical-based litigation strategies. Ms. Ballantyne also advocates alongside clients on Capitol Hill and at the White House, providing valuable insight directly to legislators and policy makers on regulatory impacts and legal implications of pending or existing law.