Comprehensive Legal Guidance for Complex FDA Regulations

Our Food and Drug practice provides strategic legal counsel to manufacturers, distributors, and innovators navigating the intricate regulatory landscape governing food, pharmaceuticals, medical devices, dietary supplements, cosmetics, and biotechnology products. We guide clients through every stage of the product lifecycle—from development and market entry to compliance, enforcement actions, and beyond.

With deep expertise in FDA regulations and related federal agencies, we help companies bring products to market efficiently while maintaining rigorous compliance standards. Our team understands that in today's rapidly evolving regulatory environment, businesses need counsel that can anticipate challenges, mitigate risks, and capitalize on opportunities within the complex framework of food and drug law.

Core Practice Areas

Product Development & Market Authorization We assist clients in obtaining necessary approvals and clearances for new products, including GRAS (Generally Recognized as Safe) determinations, food additive petitions, new drug applications (NDAs), medical device submissions, and dietary supplement notifications. Our counsel ensures compliance from conception through commercialization.

Regulatory Compliance & Risk Management Our comprehensive compliance programs help clients navigate FDA inspections, implement robust quality assurance systems, and develop effective adverse event reporting protocols. We provide ongoing guidance on current Good Manufacturing Practices (cGMP), food safety modernization requirements, and evolving regulatory standards.

Labeling, Claims & Marketing We counsel clients on compliant product labeling, health claims, nutrient content claims, and advertising strategies. Our team ensures marketing materials meet FDA and FTC requirements while maximizing commercial impact and minimizing regulatory risk.

Enforcement Defense & Crisis Response When regulatory challenges arise, we provide vigorous defense against FDA enforcement actions, warning letters, and import alerts. Our crisis response team helps clients manage product recalls, contamination events, and public health emergencies with strategic communication and swift regulatory response.

International Trade & Global Compliance As businesses expand globally, we guide clients through international regulatory frameworks, including EU regulations, export/import requirements, and foreign supplier verification programs. Our international perspective helps clients achieve compliance across multiple jurisdictions.

Industries We Serve

• Food & Beverage

  Conventional foods, functional foods, alternative proteins, food additives, and packaging materials

• Pharmaceuticals

  Prescription drugs, over-the-counter medications, biologics, compounding pharmacies

• Medical Devices

  Class I-III devices, software as medical devices (SaMD), combination products

• Dietary Supplements

  Vitamins, minerals, botanicals, sports nutrition, weight management products

• Cosmetics & Personal Care

  Color additives, ingredient safety, claims substantiation

• Agriculture & Veterinary

  Animal feeds, veterinary drugs, pesticide residues, bioengineered foods

• Cannabis & Hemp

  CBD products, hemp-derived ingredients, state-federal compliance coordination

• Emerging Technologies

  Novel foods, artificial intelligence in healthcare, precision medicine, biotechnology

Why Choose Our Food & Drug Practice

Our attorneys bring together legal expertise with scientific knowledge, including team members with advanced degrees in chemistry, biology, and food science. This unique combination allows us to understand not only the legal implications of regulatory requirements but also the underlying scientific principles that drive FDA decision-making.

We maintain active relationships with key FDA personnel and stay current with emerging policy trends through participation in industry organizations, advisory committees, and regulatory conferences. This insight enables us to provide proactive counsel that anticipates regulatory developments and positions our clients for success.

Our multidisciplinary approach integrates food and drug regulatory counsel with related practice areas including intellectual property, litigation, corporate transactions, and international trade. This comprehensive perspective ensures our clients receive coordinated legal support across all aspects of their business operations.