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Navigating Regulatory Requirements for Ingredients in These Times of Transition: Moving Forward With ODIs as Industry Awaits NDI Final Guidance

Available: On Demand

The timing of FDA's release of final guidance on New Dietary Ingredient (NDI) notifications is anyone's guess, and industry experts have observed that the current executive administration introduces more uncertainty to this already unknown timeline. What can responsible industry do in the mean time?

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary ingredients marketed in the United States before Oct. 15, 1994 are not NDIs, and therefore are not subject to NDI notification requirements. FDA’s Office of Dietary Supplement Programs (ODSP) has indicated its willingness to proceed in meaningful and appropriate ways to work with industry to develop a list of Pre-DSHEA Dietary Ingredients, or “Old Dietary Ingredients” (ODIs). In fact, the agency is holding a stakeholder public meeting on Oct. 3 to address this issue.

On the heels of the Oct. 3 FDA public meeting, the Council for Responsible Nutrition (CRN) and Informa will host an expert discussion on the direction of this initiative, including what transpired during the public meeting. Webinar presenters will address questions, such as:

  • Will FDA develop a publicly available official ODI list?
  • What evidence will FDA require to show an ingredient was marketed before Oct. 15, 1994?
  • What is a reasonable standard of evidence, considering over two decades have passed since DSHEA was enacted?
  • How will this evidence translate to old ingredients being used with present-day methods?
  • What value is old evidence, such as a magazine ad for an herbal supplement, if the ad does not include details on the plant part and extraction method?
  • Who will review the evidence and make decisions?
  • What process will FDA use to review and add ingredients to the pre-DSHEA list? Who should be involved?
  • How will FDA include information from the trade association lists?
  • What if an ingredient is "old" but does not end up on the pre-DSHEA list?
  • And more

Register for this webinar for an opportunity to ask additional questions.

Speakers:

Andrea Wong, Ph.D. Andrea Wong, Ph.D.
Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition (CRN)

Dr. Wong is an integral part of CRN’s science and regulatory affairs department, responding to emerging scientific and regulatory issues as well as advocating for science-based nutrition. Her regulatory expertise includes a working knowledge of international health claims, preparation of technical submissions to international regulatory agencies, and designing regulatory strategies for marketing products in global jurisdictions. Prior to joining CRN, she worked as a senior scientific and regulatory consultant for the highly respected consulting firm Intertek Cantox, formerly Cantox Health and Sciences International, in Ontario. Dr. Wong has been published in scientific journals, including Regulatory Toxicology and Pharmacology. Dr. Wong earned her bachelor’s of science in life sciences from Queen’s University in Kingston, Ontario, and her doctorate from the University of Toronto, Ontario.

Vasilios Frankos, M.S., Ph.D. Vasilios Frankos, Ph.D.
Senior Corporate Advisor, Product Science, Safety & Compliance, Herbalife

Dr. Frankos serves as senior corporate advisor product science, safety and compliance, Herbalife. He is responsible for ensuring all products sold by Herbalife are safe, meet regulatory safety requirements and that all claims are scientifically supported. He ensures Herbalife’s product development activities support the company’s product portfolio strategy.

He retired from the U.S. Food and Drug Administration in 2010, where he served as the Director, Division of Dietary Supplements programs. He was the lead scientist for dietary supplements for FDA and was responsible for the full implementation of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

While at FDA, he also served as Special Assistant for Dietary Supplement Science Review, Staff Science Advisor in the Office of the Commissioner, and as a Senior Toxicologist in the Center for Food Safety and Applied Nutrition (CFSAN).

Before joining the FDA, Frankos was a principal consultant with ENVIRON Corp. for over 18 years.

He holds a doctorate in pharmacology and toxicology from the University of Maryland pharmacy School; a master’s in molecular biology and a bachelor’s in biology from University of Maryland.

Jessica P. O'Connell Jessica P. O'Connell
Special Counsel, Covington & Burling LLP

Jessica P. O’Connell is Special Counsel in Covington & Burling’s Food and Drug practice group in Washington. She advises companies and trade associations on complying with U.S. regulatory requirements enforced by FDA, USDA, FTC, and state regulators for the manufacture and sale of foods, dietary supplements, cosmetics, over the counter (OTC) drugs and animal products, and the import and export of all FDA and USDA-regulated products. Before joining Covington, she was an Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, O’Connell counseled various components of FDA and HHS on legal issues primarily related to foods, dietary supplements and cosmetics, including the implementation of the Food Safety Modernization Act (FSMA) and nutrition labeling initiatives, and on a wide range of import and export issues. O’Connell received a bachelor’s degree in biology and physics from University of Virginia, a master’s of public health from Johns Hopkins University, and a juris doctor from Georgetown University Law Center.

Ashish R. Talati Ashish R. Talati
Partner, Amin Talati & Upadhye

Ashish R. Talati is a partner and chair of the food and drug practice at Amin Talati & Upadhye. Talati helps clients safely navigate the minefield of U.S. food, beverage, dietary supplement, drug, cosmetic, and medical device regulations. Mr. Talati primarily counsels clients on matters of regulatory compliance, helps them anticipate and address regulatory issues in their business operations and strategic planning, and advocates on their behalf before FDA, FTC, Customs, USDA, DEA, and other federal agencies, and in court. Considered a creative and strategic partner by his clients, Talati works with companies all over the globe and is a trusted advisor at every step of the product life cycle, including product formulation, safety and efficacy studies, product launch, and ongoing marketing and sales. Talati has written extensively on topics related to new dietary ingredients (NDI) and has successfully filed many NDI notifications with FDA. Mr. Talati is widely regarded as one of the leading food and dietary supplement attorneys in the country.

Cara Welch Cara Welch, Ph.D.
Senior Advisor, Office of Dietary Supplement Programs, FDA

Cara Welch, Ph.D., came to the Food and Drug Administration in 2014 as a chemist and is currently the Senior Advisor for the Office of Dietary Supplement Programs. In this role, Dr. Welch works on new policies and programs involving regulatory compliance matters for the dietary supplement industry. Welch utilizes her background to provide guidance on research throughout the center applicable to dietary supplements and serves as an expert witness on regulations regarding dietary supplement ingredients, labeling, and manufacturing.

Prior to FDA, Dr. Welch was the senior vice president of scientific and regulatory affairs at the Natural Products Association (NPA). While there, she was responsible for implementing policies in response to government initiatives in the regulatory arena; advising association members on regulatory, safety, nutrition and health issues; and overseeing the association’s certification programs. Welch earned her doctorate in medicinal chemistry from Rutgers University working with traditional medicinal African plants.