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FDA Regulatory


FDA Regulatory

Following are some illustrative examples of our experience:

  • 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)