Operating at the intersection of the FDA and FTC

Venable's food and drug practice operates at the intersection of the FDA and the FTC, an advantage that very few law firms can provide. We have decades of marketplace experience and we assist clients at all stages of the product lifecycle – from product development and regulatory approval/clearance to advertising, marketing and distribution. Our food and drug team includes lawyers with significant prior experience in senior positions at FDA.

We counsel clients on product formulation, regulatory approval, labeling, good manufacturing practices, claim substantiation, recall issues and a wide range of matters across all FDA product centers. Venable’s successful representation of clients in FDA matters is due to 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."

Navigating the FDA is quite 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 NAD and ERSP matters.

Regulatory matters

Venable has extensive experience in representing clients in matters before the FDA. Our attorneys handle everything from product application review and approval to enforcement actions. We also regularly represent clients in seeking to shape agency policy by, for example, submitting comments on proposed regulations and guidance documents.

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, as well as the nationwide and multidistrict litigation that occurs 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.