Our Food, Drug, and Medical Devices 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 and 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 and 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, and 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 and 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 and 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, Drugs, and Medical Devices Practice

Regulatory and litigation under one roof. A label claim can draw an FDA warning letter, a state attorney general inquiry, and a consumer class action at the same time. We coordinate positions across all three so that something said to a regulator doesn’t undermine the defense of a private suit.

Experienced with the people who test your claims. When a case turns on ingredient function, testing, or consumer perception, we retain qualified outside scientific and survey experts and manage them as part of the defense.

Practical across industries. We work with manufacturers, importers, distributors, and brand owners in food and beverage, dietary supplements, cosmetics, and healthcare products, and we connect this practice with our healthcare, corporate, and litigation teams.

Some of our focus areas:

• Food & Beverage Consumer & Regulatory Defense

• Importing Food into the U.S.

• Foreign Cosmetics Producers and U.S. Importers

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