Daniel J. Manelli

Areas of Practice
  • Food and Drug Administration
  • Legislation
  • Environmental Law
  • Federal Trade Commission
  • Consumer Product Safety
Contact Info
  • Phone: Office Mgr. (202) 261-1034
  • Fax: (202) 204-8587
  • Email: Office Mgr. at ljcardea@mdslaw.com

Mr. Manelli (Of Counsel), after nine years as a partner at Graham & James LLP, established Manelli Selter PLLC. His practice is focused on regulatory matters involving the U.S. Food and Drug Administration (FDA), trade association law and legislation. He has also represented clients before the Environmental Protection Agency, the Consumer Product Safety Commission and the Federal Trade Commission.
His FDA practice has included advising clients on the regulation of medical devices, drugs, cosmetics and food additives, including preparation of premarket approval applications and supplements; investigational exemptions for clinical testing of unapproved products, including presentations to institutional review boards; establishment registration and product listing requirements; compliance with FDA regulations concerning import and export of regulated products; evaluation of formulae, labeling and advertising; compliance with FDA “current good manufacturing practices” (GMP) regulations; response to FDA inspection, deficiency notices, warning letters, injunctions and seizure actions; negotiation and supervision of product recalls; and proposed FDA referrals to the Department of Justice for criminal prosecution.

Mr. Manelli has had substantial experience in licensing and manufacturing contracts involving FDA regulated products, including the sale of ownership or referencing rights to FDA marketing approvals.

Prior to entering private practice, Mr. Manelli was Vice President, Legal Affairs, for the Non-Prescription Drug Manufacturers Association, a national trade association.

He is presently counsel to the Contact Lens Manufacturers Association and the Dental Implant Manufacturers Association.

Mr. Manelli has had extensive legislative experience. He was formerly Chief Counsel to the Special Subcommittee on Investigations of the U.S. House of Representatives’ Committee on Energy and Commerce. In that capacity, he was engaged in legislative oversight activities involving the operations of most of the major federal regulatory agencies, including the Food and Drug Administration, Federal Trade Commission, Consumer Products Safety Commission, Federal Communications Commission, and the Securities and Exchange Commission.

He has represented clients in both state and federal legislative matters; activity has included drafting legislation, preparation of testimony, appearance as a witness before Congressional committees, the formation and operation of political action committees, and compliance with applicable State and Federal lobbying regulations. Federal legislative representation utilizes contacts and experience developed during his ten years on Capitol Hill.

Mr. Manelli has authored and co-authored several law review articles on various regulatory issues. He is a member of the District of Columbia Bar.