Mr. Young has practiced food and drug law for more than 35 years. He joined Kleinfeld, Kaplan & Becker in 2003. Previously, he was a partner with Wald, Harkrader & Ross, and then Piper Rudnick, LLP, all in Washington, DC. He has counseled and represented domestic and foreign manufacturers and distributors with respect to compliance and defence of matters under the statutes enforced by the Food and Drug Administration, the Consumer Product Safety Commission, the Federal Trade Commission, the Drug Enforcement Administration and the Environmental Protection Agency.

Mr. Young has extensive expertise in all matters relating to the administration of the Federal Food, Drug, and Cosmetic Act and related laws. He represents food. drug and dietary supplement product and ingredient manufacturers, developers and distributors. Mr. Young has represented various trade associations before the Food and Drug Administration and he currently serves as General Counsel to the American Herbal Products Association (AHPA).

Mr. Young also represents companies in proceedings before the Federal Trade Commission with respect to advertising substantiation and compliance with the Federal Trade Commission Act. Representations of record include Nature’s Way, Pharmavite, LLC, Seasilver, Inc., and Pinnacle Marketing Concepts (CortiSlim). He similarly represents advertisers before the National Advertising Division of the Council of Better Business Bureaus.

Mr. Young’s environmental litigation experience includes his role as one of the defense counsel in the nine month trial of New York State’s punitive damage claim in the Love Canal Landfill governmental litigation, United States v. Hooker Chemical & Plastics Corp., 850 F. Supp. 993 (W.D.N.Y. 1994). He also represented Hooker with respect to the 102nd Street Landfill litigation and remediation and the Niagara Falls Army Chemical Warfare Plant litigation. He presently represents a major national defense contractor with respect to the remediation of a chemical weapons manufacturing facility.

Mr. Young helped form and serves pro bono as General Counsel to the National Association of Free Clinics, the non-profit association of free clinics.

  • Counseled dietary supplement manufacturer in the substantiation of claims for new product and successfully defended those claims when challenged on product introduction
  • Represented Seasilver, Inc. through US District Court appointed receiver to help keep dietary supplement company alive after Federal Trade Commission TRO shutdown by bring company into compliance and negotiated Consent Decree that provided company opportunity to stay in business
  • Represented one of the defendants in the FTC’s action against the makers and marketers of Corti-Slim dietary supplement for weight loss and negotiated a Consent Decree on terms favorable to this defendant
  • Represented Nature’s Way in an FTC investigation of flu claims made for a dietary supplement with the result that FTC recognized that claims regarding mitigation of symptoms and duration of flu were substantiated by competent and reliable scientific evidence
  • GRAS notification for Hi-DHA Tuna Oil
  • Counseled American Herbal Products Association on comments to FDA Structure Function Claims rule with result that a number of OTC drug prohibited claims were deemed by FDA to be acceptable for dietary supplements
  • Represented pharmaceutical distributor trade association in staying a final FDA rule regarding pharmaceutical distribution for four years.  Final rule later declared invalid

2008 American Herbal Products Association Herbal Hero Award.

Best Lawyers in America (FDA Law) 2012-2019

FDLI Distinguished Service and Leadership Award 2017

Tony Young to speak at Supply Side East May 4, 10:30 AM Meadowlands Exposition Center, Secaucus, NJ

Tainted Products and Supply Chain Obligations

The dietary supplement industry is a regulated industry, but general dietary supplement enforcement remains a low priority at FDA because the safety of dietary supplements is generally not in question. Brick and mortar and electronic retailers are important gatekeepers that stand between dietary supplement manufacturers and distributors and consumers. Retailers can play an important role in assuring that products with claims that are “too good to be true” and that raise potential safety issues or are just plain illegal are thoroughly screened. FDA’s actions regarding tainted products show that retailers and others in the supply chain should apply their knowledge and experience to assure the integrity of the products they sell. Hard questions and careful review of responses can help protect retailers from potential liability and help keep manufacturers responsible.

Co-Author, Dietary Supplement Health and Education Act – A Legislative History and Analysis, Food and Drug Law Institute (1996)