Marc S. Ullman represents clients in matters relating to all aspects of Food and Drug Administration (FDA) regulatory issues with a focus on the dietary supplement/natural products industry; FDA proceedings and litigation concerning consumer protection compliance; and response to enforcement actions concerning advertising practices, privacy, and cyber security. Previously, he practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in federal and state prosecutions, as well as numerous related civil matters and other litigations.

Marc’s practice as part of the firm’s Health Services Practice Group includes representation of clients on issues relating to FDA compliance, including labels, labeling, claims, and good manufacturing practices. He has also represented clients in a number of complex adversarial proceedings with the FDA relating to the scope of the agency’s powers under the Dietary Supplement Health and Education Act of 1994 and its ability to seek remedies such as consumer restitution. He counsels clients on general litigation issues and most recently on complex legal issues of concern to the emerging hemp trade in the U.S. He has represented clients in adversarial proceedings involving the FTC, including the negotiation of consent decrees and litigation regarding the adequate substantiation of advertising claims. Marc has appeared and testified on behalf of clients before the FDA’s Food Advisory Committee and at FDA’s 2000 hearing concerning the impact of the First Amendment to the U.S. Constitution on the agency’s regulation of health claims concerning diseases. He has also counseled clients in connection with matters under investigation by the U.S. Congress.

Marc’s expertise includes guiding clients through FDA’s New Dietary Ingredient Notification (NDI) Process and counseling on issues involved in achieving status as Generally Recognized as Safe (GRAS) as a prerequisite for ingredient use in food products. His work in these areas includes counseling on the first GRAS assessment for Stevia leading to the first legal importation of this ingredient as a sweetener. He also provides counsel to clients dealing with serious recall situations. His work has included representation at the heart of the pet food/melamine, StarCaps product, and pistachio recalls providing advice in dealing with the FDA, insurance companies, potential consumer claims, media contacts and general crisis management.

In addition, Marc speaks frequently on these topics and other matters at various events, including the Natural Products Industry’s SupplySide East and SupplyWest Trade Shows and the Natural Products Expo East and Expo West Trade Shows. He has also presented and moderated a panel discussion entitled, Crisis Management and Risk Reduction on several occasions, including at the Metropolitan Association for Food Protection’s annual meeting. Marc is an instructor at a well-known training seminar on good manufacturing practices for dietary supplements offered several times a year across the country and has spoken at a number of the annual meetings of the New York State Bar Association.

Education

George Washington University National Law Center, J.D.

State University of New York at Albany, B.A.

News & Publications

• Investigating Quality Incidents
  August 20 | 2024
• Ullman Publishes Article on FDA Siloing
  June 24 | 2024
• Ullman Publishes Article Regarding FDA Warning Letters to Amazon
  March 29 | 2024

Marc is on the Board of Directors of the Natural Products Association (NPA) East, a nonprofit trade organization serving the natural and organic foods, vitamins, supplements, and cosmetics industries and a member of the Southwest College of Naturopathic Medicine Master of Science in Nutrition Business Leadership Advisory Council.

The Health Services Practice Group has been listed in the prestigious Legal 500. Since 2016, the Health Services Practice Group has been recognized in the Chambers USA directory.