Venable's Food and Drug Law Practice is driven to help clients resolve their most difficult regulatory challenges across the broad spectrum of FDA’s jurisdiction, including food and dietary supplements, medical products, and consumer products.
Our team operates at the intersection of the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), an advantage that very few law firms can provide. With decades of marketplace experience, we assist clients at all stages of the product life cycle—from product development and regulatory approval/clearance to advertising, marketing, and distribution. We offer counsel on regulatory strategy, product formulation, regulatory approval, labeling, good manufacturing practices, claim substantiation, recall issues, and a wide range of matters across all FDA product centers.
Navigating the FDA is complicated, particularly where FDA and FTC regulations overlap. In the area of advertising and product dissemination, we regularly address and overcome FTC-related questions pertaining to the assessment of scientific burden and advertising claims. In addition, our attorneys routinely represent clients in disputes pertaining to National Advertising Division (NAD) and Electronic Retailing Self-Regulation Program (ERSP) matters.
Venable's successful advocacy in these matters relies on a deep understanding of the statutes and regulations under which the FDA operates. Our attorneys bring in-the-trenches knowledge of the FDA's "regulatory culture." Members of our legal team include practitioners with significant prior experience in senior positions at FDA and many are among the most highly regarded thought leaders in their legal specialties.
Regulatory Matters
Venable has extensive experience in representing clients in matters before the FDA. Our attorneys handle everything from early research and development to product application review and approval and post-market enforcement actions. We also regularly represent clients in seeking to shape FDA policy by, for example, submitting comments on proposed regulations and guidance documents or helping shape legislative changes to the Food, Drug & Cosmetic Act or the Public Health Service Act.
Litigation
Venable offers a formidable defense when there is a challenge to a product or advertising claim. Whether it is an individual, class action suit, or government agency inquiry, we have successfully resolved many food and drug industry-related disputes. Our litigators regularly manage the complicated class actions, parallel civil and administrative proceedings, and the nationwide and multidistrict litigation that can arise when doing business in the food and drug industry.
We have also represented major pharmaceutical companies in litigation against FDA involving product approvals and brand protection. These cases typically involve emergency injunction proceedings, an area in which we have significant experience.
Industry Focus
- Animal and pet food
- Biologics
- Biosimilars
- Controlled substances
- Cosmetics
- Current good manufacturing practices (cGMPs)
- Dietary supplements and herbals
- Drug Supply Chain Security Act
- Drugs
- Food and beverage
- Generic drugs
- GxP compliance
- Human subject protections
- Human tissues and tissue-based products
- Imports and exports
- International market access
- Medical devices
- Medical food and beverage products
- Over-the-counter (OTC) drugs
- Proposition 65
- USDA
