Food, Beverage & Dietary Supplement
Kendall PC draws on decades of experience in food, beverage, and dietary supplement law to help our clients achieve their business objectives while managing regulatory and litigation risks. Our team of attorneys provides a full range of services to assist our clients in all aspects of product development, safety, labeling, and promotion considerations.
Kendall PC’s experienced team comprises leading litigation, regulatory and corporate attorneys who advise food, beverage, and dietary supplement companies on the broad range of issues that may arise from product conception through promotion. Additionally, our team of attorneys counsels clients on commercial transactions negotiations and drafting and the formation, acquisitions, merger, and sale of corporate entities.
Contact Kendall PC today online or at (484) 414-4093. We serve food, beverage, and dietary supplement companies of all sizes and stages of development throughout the United States and across the globe.
Litigation
Clients look to Kendall PC to resolve disputes in the smartest, most cost-effective, and expeditious manner. Kendall PC’s litigation team combines business practicality with creative litigation strategies. We work to preserve our clients’ interests, assets, and reputations quickly and efficiently. As seasoned trial attorneys, we have vast experience helping highly regulated businesses navigate the extraordinary challenges, complexities, and financial risks of such litigation. Kendall PC has a depth of experience and mastery of scientific and technical issues. Our cross-practice litigation team combines subject-matter expertise to provide comprehensive guidance in the most complex and high-stakes disputes, including:
- RICO actions
- Medical monitoring actions
- Breach of commercial contracts
- Fraud and misrepresentation
- Partnership and shareholder disputes
- Licensing disputes
- Consumer class action and other consumer-related litigation
- Development, production, sale, and distribution disputes
Mass Tort and Toxic Tort Defense
The mass tort and toxic tort defense team of attorneys at Kendall PC has significant experience managing mass tort litigation. We have served as national coordinating counsel in state and federal courts throughout the country. Our team of attorneys has a demonstrated track record including successful exclusions of general causation experts via Daubert hearings and trials, defending petitions to create Multidistrict Litigation (MDL) in nationwide products liability actions, conducting expert discovery, and mapping strategies to obtain important early substantive motion victories for our clients.
Regulatory Counsel
Kendall PC’s regulatory attorneys are highly experienced in counseling food, beverage, and dietary supplement clients on the numerous regulatory frameworks that apply to the myriad of products within these industries. We are highly experienced in emerging regulatory issues and developments, including proposals and challenges pursuant to the Food Safety and Modernization Act and FDA’s implementing regulations. Our firm is well-positioned to assist our clients in meeting the legal and regulatory requirements set by state and federal agencies including the U.S. Food and Drug Administration (FDA), United States Department of Agriculture (USDA), and Federal Trade Commission (FTC) throughout the product lifecycle from initial concept to registration to manufacturing post-market commercialization endeavors.
We regularly advise clients on regulatory and compliance matters, including:
- Regulatory category and related health benefit claim assessments for conventional food, dietary supplement, medical food, or food for special dietary use products
- Premarket applications
- GRAS determinations
- Food and color additive approvals
- New dietary ingredient analyses
- Assessments of food biotechnology and nanotechnology
- Product labeling, packaging, and warnings
- Health-benefit and health claims
- Retailer and distributor compliance
- Corporate compliance matters
- Environmental compliance
- U.S. FDA compliance matters
- Facility registration
- Healthcare law matters
- Warning Letters
- Recall, correction, removal, and supply chain issues
- Export and import matters
- Manufacturing processes
Government Investigations
Kendall PC handles investigations involving a range of law enforcement agencies, including the U.S. attorney’s offices, DOJ, and state attorneys general. We have extensive experience in defending food, beverage, and dietary supplement companies in government investigations into alleged violations under the Federal Food, Drug and Cosmetic Act, the Anti-Kickback Statute, and state and federal False Claims Acts, among others. We handle complex multiagency government investigations, including managing parallel investigations by federal and state government entities and settlement and corporate integrity agreement (CIA) discussions and negotiations.
Our government investigations team of attorneys counsels clients on the following government investigation matters:
- Suspensions and debarments
- Anti-Kickback Statute
- FDA Form 483 and Warning Letter Responses
- Foreign Corrupt Practices Act, UK Bribery Act, and other fraud and corruption matters investigations
- False Claims Act investigations
- Deferred prosecution agreements
- US federal and state government civil investigative demands and administrative subpoenas
- Corporate Integrity Agreement (CIA) negotiations
- US healthcare program matters
Commercial Contracting
Kendall PC’s commercial contracting practice combines legal knowledge with deep sector experience to cover the full spectrum of commercial and business law issues companies must address on a daily basis with a myriad of relationships and contracts that bind them to their suppliers, customers, licensors, distributors, and other strategic partners. These complexities are intensified by the regulatory obligations that impact every facet of operations within the food, beverage, and dietary supplement sector. Kendall PC understands the complex legal and business issues impacting companies operating in these areas, and we have a depth of experience to help clients meet their business objectives.
We provide support to business entities in their commercial contracting needs, including:
- Licensing and permits
- Supply and manufacturing
- Commercial transactions
- Real estate transactions
- Manufacturing and supply transactions
- Logistics and warehousing transactions
- Master service
- Intellectual property agreements
- Software as a service (SaaS)
- Product development transactions
Business Startup, Formation, and Corporate Governance
Kendall PC conducts due diligence reviews for food, beverage, and dietary supplement companies engaging in acquisitions, mergers, licensing deals, and investments. Our business startup, formation, and corporate governance and regulatory teams work together to identify and evaluate the myriad of issues, including those specific to proposed FDA-regulated entities and/or products, that may affect the proposed transactions. We are also able to provide business startup and formation and corporate governance services to emerging entities in the food, beverage, and dietary supplement space.
Contact Kendall PC Today
To learn more about how our team of seasoned attorneys can help your food, beverage, or dietary supplement company, contact Kendall PC today online or at (484) 414-4093. We serve companies of all sizes and stages of development throughout the United States and across the globe.
