The Attorneys of Ullman, Shapiro & Ullman, LLP
For comprehensive service and reliable advice across the range of regulatory compliance, enforcement and litigation issues that food, dietary supplement, drug and cosmetic companies are likely to encounter, contact a lawyer at Ullman, Shapiro & Ullman. We represent clients nationwide and around the world engaged in such facets of the industry as manufacturing, importing, distributing and advertising.
Steven Shapiro has over 30 years of experience in food and drug regulatory matters and regularly counsels clients in the areas of food and drug law relating to the manufacture and marketing of foods, dietary supplements, over-the-counter drugs, and cosmetics. Steven concentrates on areas of interest to the natural products industry and spends much of his time advising companies on the intricacies of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), as they concern the marketing of dietary supplements.
Steven has also assisted clients in matters relating to enforcement by the Food and Drug Administration (FDA), including the handling of FDA inspections, responses to Warning Letters, and injunctions and seizure actions. He is a contributor to many natural product industry trade magazines and a frequent lecturer on topics of concern to the natural products industry at various tradeshows for the Food and Drug Law Institute and the New York State Bar Association, Food and Drug Law Section.
In addition, Steven has extensive experience in the review of advertising and marketing materials, as well as the representation of companies in investigations initiated by the Federal Trade Commission (FTC) and the various state Attorneys General. He has also represented companies in matters arising from the Drug Enforcement Administration’s control of List I chemicals, and the U.S. Customs Service’s control of imports into the United States.
His litigation practice includes involvement in several cases concerning interpretations of the Food and Drug Act, which have resulted in judicial precedents. He also handles general litigation matters for a number of the firm’s clients.
Marc S. Ullman
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.
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.