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Description:

Industry attorney, MarcUllman, will review what you need to be aware of when it comes to the legal and regulatory landscape for promoting bone and joint health products. From the FDA authorized health claim for calcium, to FDA and FTC’s enforcement activities against products claiming “miracle arthritis” cures, Ullman will discuss how to properly formulate your claims in accordance with FDA requirements and back them up with the substantiation needed to satisfy the FTC.  

Dr. Barry Ritz will examine the science behind traditional and emerging dietary therapies for the management of osteoarthritis, including potential sources of conflict within the literature, such as variations in product form, the progression of disease, and industry (and medical) bias. Additionally, Ritz will discuss: bone and joint physiology; the use of calcium, vitamin D and minerals to support bone structure and prevent osteoporosis; scientific literature on the use of glucosamine alone and in combination with chondroitin for joint functionality and the treatment of osteoarthritis; variations in product form, including clinical results with glucosamine HCl vs. sulfate; and emerging supplements for maintaining joint functionality and the treatment of inflammation and associated symptoms.

Speakers:

Barry W. Ritz, Ph.D., is an active researcher in the emerging field of nutritional immunology. Ritz currently holds a research faculty position as an instructor at Drexel University in Philadelphia, Pa., and serves as a consultant on technical and regulatory matters to a number of leading companies in the dietary supplement, functional food and wellness industries. He is involved in a number of professional organizations, including the American Society for Nutritional Sciences, and has been a member of the dietary supplement industry for more than nine years. His research interests in nutrition science are varied, including the evaluation of immunomodulatory nutraceuticals, bioactive peptides as functional foods and the influence of nutritional status on the innate immune response to influenza infection. Ritz has presented his research at national and international meetings, has numerous publications in scientific journals and recently completed a chapter on the use of nutraceuticals for immune restoration in the elderly. He has been featured on a number of radio shows and in print, most recently interviewed by Cooking Light Magazine.

Marc Ullman, a partner at New York-based Ullman, Shapiro & Ullman, LLP, represents clients in legal matters relating FDA and DEA matters, regulatory issues, FTC proceedings and litigation. His practice includes representation relating to FDA compliance, including labels, labeling, claims and good manufacturing practices as well as a number of complex proceedings with the FDA relating to the agency’s powers under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Ullman has also worked with the firm’s clients on the successful preparation of material for submission to the FDA in support of New Dietary Ingredient notifications. In addition, he has counseled numerous firm clients in matters relating to compliance with FTC substantiation requirements as well as representing clients in FTC investigations of advertising practices. He has been specializing in Food & Drug law since 1997, when he joined Bass & Ullman as counsel to that firm after spending the first 10 years of his career with a boutique practice career specializing in white-collar criminal defense matters. Marc writes a blog that posts on the NPI Center addressing industry issues and inviting discussion from colleagues. He is a frequent speaker at Natural Products Expo East and East, SupplySide East and West and the Natural Products Association’s annual trade show. He also serves as chair of the Legal Advisory Council of the Natural Products Foundation.

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