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California’s Proposition 65: Recent Developments in Litigation, Regulation and Compliance

Available: On Demand

INSIDER Premium Series

December 6th 2016

Co-sponsored by:
CRN Informa

CRN Member Price:

*Discount subject to verification. Registrants that use the CRN member discount and are not members will be charged the additional $50 towards full registration.

Non-CRN Member Price:

California's Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, requires businesses to warn residents about significant exposures to chemicals that cause cancer, birth defects or other reproductive harm. The Office of Environmental Health Hazard Assessment (OEHHA), the agency charged with implementing Proposition 65, maintains and updates a list of these chemicals – a list that includes nearly 900 chemicals and continues to grow. This webinar will provide an overview of recent and potential Proposition 65 developments to assist dietary supplement and food companies with compliance and help mitigate the risk of litigation.

Under Proposition 65, companies doing business in California must provide a "clear and reasonable" warning to consumers about exposures to listed chemicals, unless the exposures do not exceed warning threshold levels. Because Proposition 65 is enforced primarily through private litigation, having a strong compliance plan in place reduces the risk of costly and time-consuming lawsuits. However, OEHHA recently adopted changes to its clear and reasonable warning regulations and continues add additional chemicals to the list. Further, pending litigation and possible regulatory changes may significantly lower the warning threshold for lead, which is perhaps the most ubiquitous and frequently litigated chemical on the Proposition 65 list. This webinar will assist companies in identifying current and future liability and litigation risks, discuss the future of Proposition 65, and provide companies with practical tips for compliance.

Participants will learn about:

  • The current litigation and regulatory environment, including recent changes to the clear and reasonable warning regulations
  • Potential changes to the safe harbor for lead following Environmental Law Foundation v. Beech-Nut
  • New chemicals listings on the horizon
  • Compliance considerations for companies

Moderated by:

Rend Al-Mondhiry, Esq.
Associate General Counsel, CRN

Rend Al-Mondhiry is Associate General Counsel at the Council for Responsible Nutrition (CRN) in Washington, DC. At CRN she provides legal counsel and advice to CRN’s staff and members in the areas of legislation, regulatory compliance and advocacy, and international policy development with respect to dietary supplements and nutrition issues. She also advises the association on a variety of general business matters, including contract drafting, negotiation and review, non-profit and association governance issues, and general corporate matters affecting CRN, CRN-International, and the CRN Foundation. Previously, Ms. Al-Mondhiry worked as state legislative counsel for the Consumer Healthcare Products Association (CHPA) where she provided testimony and comments on legislative and regulatory proposals, drafted legislation and regulatory language and served as a policy expert in the area of food and drug law. Ms. Al-Mondhiry received her BA from The George Washington University and her JD from Pennsylvania State University, Dickinson School of Law.


Trent H. Norris
Senior Partner
Arnold & Porter LLP

Trenton H. Norris litigates complex scientific disputes in the areas of consumer protection, product safety, and environmental law. His clients are consumer product manufacturers, distributors, and retailers facing challenges from plaintiffs’ lawyers, the FTC, state attorneys general, and local district attorneys. In his 23 years of practice, Mr. Norris has represented over a thousand companies, including over a hundred dietary supplement companies, in lawsuits and regulatory matters concerning state consumer protection and toxics laws, with a particular focus on California Proposition 65. Mr. Norris regularly advises trade associations in this area and is a registered lobbyist in California. Mr. Norris is listed in Chambers USA for both Environmental and Food & Beverages Regulatory and Litigation and in Best Lawyers for Environmental Law. He received his law degree magna cum laude from Harvard Law School, where he was an editor of the Harvard Law Review.

Paul Bolar Paul Bolar
Vice President, Regulatory Affairs
Pharmavite LLC

Paul Bolar is Vice President of Regulatory Affairs for Pharmavite LLC, a major manufacturer of dietary supplements and maker of Nature Made® supplements, based in Los Angeles. Since joining Pharmavite in 1974, Mr. Bolar has held a number of positions, including oversight of quality control, quality assurance and regulatory affairs operations. In his current role, Mr. Bolar is responsible for guiding the company in domestic and international regulatory matters.

Mr. Bolar currently serves on the Board and the Executive Committee of the Council for Responsible Nutrition (CRN). He also served for many years as the chairman/co-chair of the CRN Regulatory Affairs Committee where he was actively involved in developing and representing industry positions on dietary supplement GMPs and other regulatory issues. Mr. Bolar is a graduate of UCLA with a bachelor’s degree in biochemistry.

James Coughlin James R. Coughlin, Ph.D., CFS
President & Founder
Coughlin & Associates: Consultants in Food/Nutritional/Chemical Toxicology & Safety

Dr. James R. Coughlin received his M.S. in Food Science and Technology, Ph.D. in Agricultural and Environmental Chemistry and postdoctoral training in Environmental Toxicology at the University of California, Davis. He is a Certified Food Scientist. He worked at Armour Foods, General Foods and Kraft General Foods for 12 years before undertaking independent consulting in 1991. He served as President of the Paris-based Association for Science and Information on Coffee and has been an ASIC Board member for the last decade. He was elected three times as Chair of the Institute of Food Technologists’ Toxicology and Safety Evaluation Division and has served for over a decade as IFT’s Codex Subject Expert on Food Contaminants. He specializes in safety evaluation and risk assessment of food additives/contaminants, California Proposition 65, health and regulatory issues for functional foods and supplements, and safety and regulatory issues surrounding coffee/caffeine, meats and other major food products and ingredients.

Anthony Cortez Anthony J. Cortez
Greenberg Traurig, LLP

Anthony Cortez is a regulatory attorney and business litigator with a focus on the representation of national consumer product companies and other businesses in compliance, commercial litigation, and government enforcement matters. Throughout California and nationally, Mr. Cortez advises and defends clients in legal, regulatory, and administrative proceedings involving numerous industries including food, drug, supplement, cosmetic, apparel, and industrial products, among others.

He is regularly involved in complex and high-dollar value litigation involving federal and state consumer protection and environmental laws, including CA’s Proposition 65, false adverting law, FTC regulations, and other labeling or marketing laws. He has handled matters involving the FTC, FDA, the CA Office of Environmental Health Hazard Assessment (OEHHA), the CA Department of Pesticide Regulation (DPR), and the CA Department of Toxic Substances Control (DTSC).

*All registration fees are non-refundable
*Content and speakers are subject to change