Objectives of the Presentation:
- To learn about FDA's Biotechnology policy
- To learn about FDA's Biotechnology Consultation program
- To comply with new state GMO labeling laws that recently took effect
- To understand worldwide GMO labeling requirements
- To review the new U.S. July 2016 legislation, the Compromise GMO labeling
- To understand the changing nature of GMO labeling requirements and how U.S. companies are responding
Why Should you Attend:
Public and scientific opinion on GMOs in the US is controversial and GMO labeling requirements have been a subject of much debate in the country. On July 1, 2016 Vermont enacted mandatory GMO product labeling and in July 2016 U.S. federal legislation was passed to require the labeling of foods that contain genetically engineered ingredients. This webinar will cover those two new pieces of legislation.
Genetically Modified Organisms (GMOs) in food products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. The United States does not have any federal legislation that is specific to genetically modified organisms (GMOs). Rather, GMOs are regulated pursuant to health, safety, and environmental legislation governing conventional food products although the FDA has a Biotechnology Policy and a Biotechnology Consultation program. The U.S. is the world's leading producer of genetically modified (GM) crops. In 2012, of the 170.3 million hectares of biotech crops globally, the United States accounted for 69.5 million, over 40% of the total. (Source: Library of Congress)
- Regulatory status of GMO's in the USA
- FDA's Position on GMO's
- FDA Biotechnology Policy
- FDA Biotechnology Consultation Program
- State initiatives: GMO Labeling, Including the Vermont GMO Labeling Act
- Worldwide GMO labeling regulations
- Proposed legislation: Safe and Accurate Food Labeling Act of 2015
- New 2016 Compromise GMO Labeling Bill
Regulatory Consultant ,
EAS Consulting Group & NS Consulting
Norma Skolnik works as a regulatory consultant to FDA regulated companies and to firms who wish to launch products in the U.S.A. Norma has over 35 years of U.S. regulatory experience, starting in the pharmaceutical industry. She was the Associate Director of Regulatory Affairs at Lederle Laboratories in Pearl River, N.Y. and then became Associate Director of Regulatory Affairs at Lederle Consumer Health where she helped launch Centrum and Caltrate dietary supplements. When Lederle was acquired by Wyeth, she became Associate Director of Regulatory Affairs there, acquiring more experience in the Dietary Supplement and OTC drug fields. She joined Warner-Lambert Consumer Health division in 1998 and became Assistant Director of Adams Regulatory Affairs. In 2002 she was promoted to Director of Regulatory Affairs for the Adams division. Adams was acquired by Cadbury-Schweppes in 2003 and she served as Cadbury Adams' Director of Regulatory Affairs for the Americas from 2003 until her retirement in 2008.
Norma earned a Bachelor's degree in Biology from the University of Cincinnati and holds a Master's degree from Pratt Institute in Brooklyn, New York. She's also done graduate work at Columbia University and Montclair State University.
- Labeling managers & Associates
- Product Safety managers
- Compliance Specialists
- Marketing managers and anyone involved in planning to market or label GMO food products in the U.S.A.