Deadline for PFOA and PFOS Approaches in California

Delsie Braganza

Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to help clients understand the Canadian and US requirements, set targets to achieve compliance, and attain their goals to get products to market.

Delsie is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all regulatory compliance reviews and submissions made to Health Canada and the US FDA.

Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).

When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

Jennifer Porter, BA Psychology, MBA – President & CEO

Having started at Focal Point Research in 2011, Jenn has been fully engaged in the company and since day one, has leveraged her MBA and interest in the regulated products industries to grow her passion for the business and services offered.

Jenn has excelled at building on initial conversations with a variety of companies from all industries seeking regulatory and quality assurance services. She has developed strong relationships with each client, offering each one a unique opportunity to have the Focal Point Research team help them develop successful strategies and bring products to market, while ensuring their compliance needs are being fulfilled.

Jenn has not only been a leader internally, but a key contact for all clients and in 2021, Jenn was the obvious choice to lead Focal Point Research into the future as the successor to company founder, Rob Fichtner.

Jennifer balances her career by honouring her wanderlust, spending her leisure time golfing, and enjoying the outdoors with her loving dog.

In 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) published their notice of intent to list perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) to the state’s Proposition 65. While the two chemicals had been listed on Proposition 65 in November 10, 2017, implementation will be effective November 10, 2018.

PFOA and PFOS are synthetic compounds that do not occur naturally in the environment and are fully fluorinated. PFOA and PFOS are not ingredients intended for cosmetic products, however they are identified in some cosmetics and sunscreens as contaminants of polytetrafluoroethylene (PTFE) – a known cosmetic ingredient.

The State of California had identified and produced sufficient information that the chemicals cause reproductive toxicity to the human body. This was determined from clinical studies on rats and mice as well as epidemiological data from general human populations. In addition, PFOA and PFOS have been found to be persistent in the environment where they have been shown to be toxic for use and consumption. Moreover, the U.S. state of Michigan had recently declared a state of emergency due to alarming levels of PFOA and PFOS found in local drinking water – linking the compounds to serious health issues.

In the past, PFOA and PFOS were widely used in industrial application for their oil- and water-resistant properties in addition to their use in certain waterproof sunscreens. However, after concerns by the U.S. Environmental Protection Agency (EPA), their production and use had begun to decline. Regardless, the Independent Cosmetic Manufacturers and Distributors (ICMAD) has cautioned the cosmetics and personal care products industry as these compounds could make manufacturers vulnerable to lawsuits. ICMAD suggests that companies that are manufacturing, distributing or selling products in California to determine if their products contains PFOA and/or PFOS and to prepare a warning label accordingly if present. It should be noted that the OEHHA has not set permissible use levels for these two chemicals yet.

For more information, please do not hesitate to contact Focal Point Research Inc. We are leading U.S. regulatory and FDA consultants for Cosmetics, and other personal care products.

Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

Deadline for PFOA and PFOS Approaches in California

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