Marc S. UllmanOf Counsel
Marc S. Ullman represents clients in matters relating to all aspects of Food and Drug Administration and Drug Enforcement Administration matters, regulatory issues, Federal Trade Commission proceedings and litigation. He practiced with one of New York’s leading white collar criminal defense firms for ten years, where he represented clients in both 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 as well as counseling clients on general litigation related issues. He has represented clients in adversarial proceedings involving the FTC, including the negotiation of consent decrees and litigation regarding the adequacy of substantiation of advertising claims. Marc has appeared/testified on behalf of clients before the Food and Drug Administration’s Food Advisory Committee and at the FDA’s April 4, 2000 hearing concerning the impact of the First Amendment to the United States Constitution on FDA’s regulation of health claims concerning diseases and has counseled clients in connection with matters under investigation by the United States Congress.
Marc’s practice 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 of clients at the heart of the pet food/melamine, StarCaps 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 and other matters at various events, including Virgo Publications’ Natural Products Industry Supply Side East and West Trade Shows, the Natural Products Expo East and Expo West Trade Shows and the National Nutritional Foods Association’s annual Market Place Convention. 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 in October 2002 and is the author of the Marc Ullman FYI Blog on the NPI Community website.
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.
The Health Services Practice Group has been listed in the prestigious Legal 500. The practice also has been included in the Chambers USA directory in the Healthcare category.
926 RXR Plaza
Uniondale, NY 11556-0926
George Washington University National Law Center, J.D.
State University of New York at Albany, B.A.