Shari E. Gottesman is a Senior Associate with Fuerst Ittleman. Her practice is focused on regulatory and marketing issues concerning the product development, manufacture, distribution and promotion of foods, dietary supplements, over-the-counter drugs (OTCs), homeopathic preparations, medical foods, medical devices, weight loss products and programs, exercise equipment, cosmetic as well as many consumer products and their subsequent advertising appearing in all forms of media. Each of these practice areas involves a complex scheme of regulations promulgated by multiple federal and state agencies, including the United States Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the United States Department of Agriculture’s (USDA) National Organic Program (NOP), and Ms. Gottesman is well experienced in guiding her clients towards compliance. In addition to federal and state agencies, her practice includes representing clients in matters concerning self-regulatory bodies such as the National Advertising Division (NAD) of the Council of Better Business Bureaus (CBBB) and the National Advertising Review Council’s (NARC) Electronic Retailing Self-Regulation Program (ERSP).
Ms. Gottesman started her legal career as in-house counsel at Overseas Military Sales Group, the world's leading automotive marketer to the U.S. military with locations in over 30 countries. It was there where she partnered with the marketing team to review all the advertising originating from over 100 separate sales locations. Eventually Ms. Gottesman broadened her product span by becoming in-house Regulatory Compliance Counsel for the retail shopping channel HSN and its internet counterpart, HSN.com. As the primary attorney responsible for products that fell under the regulations of the FDA, USDA, Environmental Protection Agency (EPA), CPSC (Consumer Products Safety Commission) or were otherwise highly scrutinized by the FTC, Ms. Gottesman gained a diverse knowledge of the world of health and nutrition products and deep understanding how to work with the companies that manufactured and marketed those products. Later, Ms. Gottesman served as Assistant General Counsel and Director of Regulatory Compliance for Garden of Life, an emerging leader in the field of dietary supplements and nutrition and sustainability. Throughout these roles, Ms. Gottesman was responsible for each of the legal issues that accompany product development and marketing campaigns including:
- Formulation and labeling concerns for cosmetics, food, dietary supplements and medical foods
- Regulatory strategies for functional food and dietary supplements
- Reviewing and Revising Product Labels,
- Reviewing Websites and Writing Website Policies
- Advising on General Product Advertising including the use of :
- Health claims
- Qualified Health Claims
- Structure/Function Claims
- Nutrient Content Claims
- the term “Organic
- “Structure/function” claims notifications
- Claim Substantiation
- Responding to Regulatory Inquiry required regulatory submissions;
- Adverse Event Reporting and Product Recalls;
- Determining the Need for 510(k) Premarket Notifications for Medical Devices
- Determining the Need for New Dietary Ingredient (NDI) Notifications for Supplements
- Reviewing Sweepstakes Terms and Promotional Campaigns
- Advising on the use of Social Networking, Online Communities and Other Forms of Digital Media as a Marketing Tools
In addition Ms. Gottesman provided regular training seminars on the topics of FDA and FTC law. Not only does she bring to Fuerst Ittleman her capability in these areas, she brings her experience as in-house counsel to highly regulated companies and her special understanding of the needs of a corporate client.
Ms. Gottesman is a native New Yorker who currently resides in Broward County, Florida with her husband and two children.
Position:
Senior Associate
Office Location:
Miami
1001 Brickell Bay Drive
Suite 2002
Miami, FL 33131
Phone:
305.350.5690
Email:
sgottesman@fuerstlaw.com
Practice Areas:
Food, Drug and Cosmetic Law
Advertising and Marketing Law
Ecommerce and Privacy Law
Sweepstakes and Promotions Law
General Corporate Law
Contracts Law
New Media Law
Education:
Touro College Jacob D. Fuchsberg Law Center
Central Islip, New York
J.D., 2000
University of Hartford
West Hartford, Connecticut
B.A., 1993
Admitted:
New York 2003
Maryland 2003
