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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. 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.

Capabilities

Experience

  • Obtained the release of various food, dietary supplement, drug, medical device, and cosmetic imports detained by FDA.°
  • Counseled various Class I and Class II facemask, IVD test kit, and hand sanitizer manufacturers through bringing products to market under traditional routes and under COVID-19 enforcement discretion and EUA routes.°
  • Conducted formulation and label compliance reviews of food, dietary supplement, medical device, OTC drug, and cosmetic products.°
  • Counseled several clients on product recalls, including food distributors, OTC drug manufacturers, and an alcoholic beverage manufacturer.°
  • Advised a major beverage company on compliance with FDA requirements applicable to a unique color additive.°
  • Supported a private equity firm’s purchase of a multimillion-dollar niche cosmetic company through due diligence compliance work and an assessment of the potential for future adverse legislation and regulations.°
  • Drafted and submitted comments to FDA on a proposed prescription drug rule on behalf of a major healthcare nonprofit, resulting in several significant changes in the final rule.°
  • Counseled a large pharmaceutical manufacturer on FDA, DEA, and state registration and licensing requirements with respect to a proposed complex prescription drug manufacturing operation.°

°The above representations were handled by Mr. Scandalios prior to his joining Greenberg Traurig, LLP.

  • Regulatory Counsel, U.S. Food and Drug Administration, 2014-2019
    • Office of Regulatory Affairs, Division of Operational Policy, 2015-2019
    • Center for Tobacco Products, Office of Compliance and Enforcement, 2014-2015
  • Attorney Advisor, Social Security Administration, 2012-2014
  • Regulatory Affairs Certification: U.S. Drugs and Devices
  • Law Clerk Intern, U.S. Department of Justice, Civil Division, Torts Branch, 2012
  • Judicial Intern, Chambers of Judge Robert E. Jones, U.S. District Court for the District of Oregon, 2011
  • Intern, International Trade Centre (joint UN/WTO agency), Office of Export Strategy, 2010
  • Intern, Office of Congressman Peter DeFazio (OR), 2009

Recognition & Leadership

  • FDA Award (individual and group), 2014-2019
  • Pro bono Honor Roll, D.C. Bar Association, 2013, 2014
  • Member, Food and Drug Law Institute, 2014 – Present
    • Member, Food and Drug Law Journal Editorial Advisory Board, 2021
    • Member, Publications Peer Review Committee, 2019-2021
  • Member, American Bar Association, 2012 – Present
    • Chair, Administrative Law and Regulatory Practice Committee, Young Lawyers Division,   2015 – 2017
  • Member, Customs and International Trade Bar Association, 2015-Present

Credentials

Education
  • J.D., Washington University in St. Louis School of Law
    • Senior Editor, Washington University Jurisprudence Review
  • B.A., University of Oregon, Robert D. Clark Honors College
Admissions
  • District of Columbia
Languages
  • Spanish, Conversational