We provide strategic counseling on FDA-regulated products, including foods, drugs, medical devices, cosmetics, veterinary products and tobacco products. Given the FDA’s immense size and its expansive administrative reach, regulated entities often have questions about navigating the agency. Our lawyers have the extensive knowledge needed to effectively work with the FDA, share best practices, and assist clients in navigating through a wide range of agency matters, including imports and exports, alternative food development, and product labeling, among others.
In addition to understanding the FDA’s functionality, we have experience with responding to compliance concerns and litigation involving the agency. Our focus is to provide insight and practical advice to help clients achieve their goals while adhering to applicable laws and regulations.
Following are some illustrative examples of our experience:
- Successfully removing companies from FDA’s Import Alerts, or FDA “Red Lists.”
- Helping companies coordinate with FDA during the entry process to avoid import refusals and address shipment holds.
- Helping companies successfully submit premarket approval applications for newly deemed tobacco products.
- Advising companies on compliance with FDA’s regulations for a variety of issues, such as product labeling and age restrictions, for newly deemed tobacco products.
- Obtaining a stay pending review of FDA’s denial of a premarket tobacco application. Wages & White Lion Investments, LLC v. FDA, 16 F. 4th 1130 (5th Cir. Oct. 26, 2021)