Tyler Scandalios counsels clients in the food, medical device, dietary supplement, drug, and cosmetic industries on compliance with Food, Drug, and Cosmetic Act (FDCA) laws, regulations and policies. He advises clients on proactive regulatory compliance and regulatory paths to market; counsels clients through US Food and Drug Administration (FDA) investigative and enforcement actions, including recalls, information requests and import detentions; advises clients on developing compliant labels, labeling and advertising; performs FDA regulatory due diligence in connection with commercial transactions; and represents clients before the FDA.
Before entering private practice, Mr. Scandalios served as regulatory counsel in the FDA’s Office of Regulatory Affairs. In his five-and-a-half years with the agency, he developed and drafted regulations and guidance; advised on the interpretation and application of the FDCA and relevant policies; and reviewed evidence of violations to recommend for or against enforcement. Prior to joining Arnold & Porter, Mr. Scandalios was an associate in the healthcare and FDA practice of another law firm in Washington, DC.
Experience
- Multiple manufacturers in conducting formulation, label, and marketing compliance reviews of FDA-regulated products (including foods, dietary supplements, medical devices, drugs (both OTC and prescription), and cosmetics).
- Companies regarding methods for bringing FDA-regulated products to market under traditional routes and under COVID-19 enforcement discretion and EUA routes, and on meeting post-market regulatory requirements.
- Potential investors or purchasers in conducting regulatory due diligence for acquisitions of FDA-regulated companies.
- Manufacturers and distributors of FDA-regulated products regarding product recalls.
- Manufacturers and importers in obtaining the release of various food, dietary supplement, drug, medical device, and cosmetic imports detained by FDA, and petitioning for removal from FDA import alert.
- Companies in drafting comments on proposed FDA regulations and guidance.
- Drug and device manufacturers and distributors on FDA and state drug and device licensing requirements.
Perspectives
Credentials
- J.D., Washington University School of Law, 2012
- B.A., Economics, University of Oregon, Robert D. Clark Honors College, 2009, Departmental Honors in Economics
- District of Columbia
- Regulatory Counsel, US Food & Drug Administration (2014–2019)
- Attorney Advisor, US Social Security Administration (2012–2014)
- Member, Food and Drug Law Journal Editorial Advisory Board (2021–Present)