Tyler Scandalios counsels clients in the food, dietary supplement, medical device, drug, and cosmetic industries on compliance with Food, Drug, and Cosmetic (FD&C) Act laws, regulations, and policies. He advises clients on proactive regulatory compliance and regulatory paths to market; counsels clients through FDA investigative and enforcement actions, including recalls, information requests, and import detentions; advises clients on developing compliant labels, labeling, and advertising; and has represented clients before the FDA.
Prior to private practice, Tyler served as Regulatory Counsel at the FDA in its Office of Regulatory Affairs and in its Center for Tobacco Products. In his five years with the agency, he developed and drafted regulations and guidance; advised on the interpretation and application of the FD&C Act and relevant policies; and reviewed evidence of violations and recommended for or against enforcement.
Articles in the National Law Review database by Tyler M. Scandalios