Advising on regulated products and navigating the regulators
We provide market-leading counsel to companies working in regulated products such as foods, beverages, alcohol, and dietary supplements. We have extensive experience interacting with the Food and Drug Administration, U.S. Department of Agriculture, Federal Trade Commission, Environmental Protection Agency, Alcohol and Tobacco Tax and Trade Bureau, state and local authorities.
In a complex highly regulated industry, companies need a strategic legal partner with extensive sector and regulatory experience rather than simple black-letter legal analysis. We provide this informed perspective, advising on regulations, compliance and strategy from commercial, risk management and litigation standpoints.
Our approach draws on long experience in tracking, analyzing and interacting with the FDA, USDA, FTC, EPA, TTB and other federal and state agencies. We also bring experience in navigating regulatory gray areas. These often relate to innovations that don’t fall clearly within existing regulations but where compliance must be demonstrated.
We advise national and international food companies, growers, suppliers, processors, importers, distributors, retailers and biotech firms, alongside startups and niche players. We work for direct-to-consumer and e-commerce platforms including online ordering, meal delivery and food apps.
“We provide this informed perspective, advising on regulations, compliance and strategy from commercial, risk management and litigation standpoints.”
Our support extends across the product lifecycle. This includes R&D, formulation and design, product labeling and label claims, regulatory submissions, compliance, facility permitting and registrations, food and product safety, marketing and social media, supply chain agreements, cross-border sales, import/export, product recalls, regulatory inspections and investigations, false advertising litigation, and product liability implications.
We also provide strategic advice in sustainability and ESG, global consumer markets, supply chains, health and safety, hazard analysis and critical control points (HACCP), and the Food Safety Modernization Act (FSMA) and its specific rules including Produce Safety, Preventive Controls , Traceability, and Foreign Supplier Verification. We regularly advise on label, marketing, and advertising claims, benefit statements and nutrient content claims, health claims, organic, and third-party certification.
As thought leaders, we keep informed of new and emerging trends, and lead industry conversations on risks and opportunities. Topics includes innovation and disruption in regulated products, e-commerce, industry and regulators moving at different speeds, the evolving litigation landscape, and consumer appetites for ‘cleaner and greener’ products and the regulatory response.
Awards and recognition
- Ranked for Food and Beverage: Regulatory & Litigation
- Ranked for Cannabis Law by Legal 500
- Ranked for Cannabis Law by Chambers USA
- Stefanie Fogel: 2020 Cannabis Law Trailblazer by the National Law Journal
- Maggie Craig: 2022 Cannabis Law Trailblazer by the National Law Journal
- Regulatory advice and label claims risk assessment for a multinational food company’s infant foods, toddler foods/follow-on formulas, cereal bars, and dietary supplements, including on a variety of FDA regulations concerning use of vignettes, structure function claims, disease claims, nutrient content claims, “natural” claims, gluten free claims, and other product benefit statements.
- Regulatory advice and risk analysis for yogurt products regarding compliance with FDA regulations and use of such terms as “fresh”.
- Regulatory advice and risk analysis for a company providing organic food kits, including various USDA regulatory implications, organic claims, CGMPs, HACCP, and food facility requirements.
- Regulatory advice regarding country-of-origin labeling and Tariff Act implications for imported frozen vegetable products.
- Regulatory advice and risk analysis for an international sweetener manufacturer regarding packaging and labeling compliance under FDA regulations for stevia product.
- Regulatory advice and analysis for a national restaurant chain regarding menu labeling laws and compliance with USDA regulations for meat, poultry, and organic claims.
- Representation of an international sugar manufacturer in addressing over 15 potential recalls and development of a food safety and compliance program, and serving as national counsel overseeing contamination and mislabeling claims.
- Representation of a peanut butter manufacturer in addressing regulatory and compliance concerns as well as legislative efforts relating to labeling of consumer product.
- Representation of a food and beverage manufacturer in consumer fraud class action regarding probiotic fruit beverage products, resulting in extremely favorable injunction-only terms and no damages paid by defendant.
- Advising an importer of German butter regarding supplier contract considerations and provisions relevant to FDA compliance