US FDA to Launch Cosmetic Allergens Survey for Consumers

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.

A Food and Drug Administration (FDA) Release outlines the launch of a web-based survey to gain consumer insight on allergens in cosmetics such as fragrances, hair products, makeup, nail products, and skin care products. Pending Office of Management and Budget (OMB) approval, it is the first survey conducted by the FDA on consumer sensitivities of cosmetics since 1975.

According to a Federal Register Notice, the purpose of this survey is to gather consumer information with the intent of making decisions regarding the purchasing of specific products or avoiding certain cosmetic ingredients altogether. Thorough labelling of cosmetic products is crucial to avoid leaving customers in the dark about potentially allergenic ingredients.

The European Union (EU) is far more proactive in clear labelling of cosmetic allergens than the US or Canada, who do not mandate full allergen labelling under the Food, Drug, and Cosmetic Act or Canada’s Food and Drug Act. Many cosmetic allergens can be masked by generic terms such as “fragrance,” or “parfum.” One example of the regulation difference between the EU and the US is demonstrated by the regulation of Methylisothiazolinone (MI), a chemical which has been associated with an increase in contact dermatitis. In the EU, only a miniscule amount of this product is allowed in rinse-off products, where as the US has not implemented any such restriction. Canada has recently joined the EU in restricting its use, amending the Cosmetic Ingredient Hotlist in June 2018 to prohibit MI in leave-on cosmetics, and reduce its maximum allowed concentration to 0.0015% in rinse-off products.

In order to move forward in launching the survey, a public consultation on the contents of the survey are held for 60 days following FDA Release. This provides the public with the ability to ensure that all relevant information is being collected. After OMB approval, the survey is planned to be conducted sometime in 2019 and may bring about stricter cosmetic labelling regulations in the US.

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

US FDA to Launch Cosmetic Allergens Survey for Consumers

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