US FDA to Launch Cosmetic Allergens Survey for Consumers

by | Feb 6, 2019 | Cosmetics, U.S. Regulatory | 0 comments

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.