November 7, 2018
“Gathering information about consumer experiences with cosmetic products, especially adverse reactions such as irritated skin or an allergic reaction, is critical to the FDA’s ability to effectively conduct surveillance and oversight of these products in the U.S. marketplace,” said FDA Commissioner Scott Gottlieb, M.D. “As part of the FDA’s ongoing efforts to learn more about allergens in cosmetics, we’re announcing today our proposed plans to conduct a survey to collect information that will improve our current understanding of adverse events associated with allergens in cosmetics. To help ensure we are collecting all relevant information, as a first step, we are asking for public input on the survey. The information that the FDA collects through this survey is an important step in advancing a process for reducing exposure to allergens in vulnerable individuals.”
The U.S. Food and Drug Administration is planning to conduct a web-based consumer survey about allergens in cosmetics, including fragrances, hair products, makeup, nail products and skin care products. To conduct the survey, the FDA must obtain approval from the Office of Management and Budget (OMB). As a first step toward obtaining that approval, the FDA has published a notice in the Federal Register seeking public comment on the survey. The people invited to participate in the survey will be selected to be representative of U.S. adults.
The survey will help the agency better understand consumer perceptions and awareness regarding allergens in cosmetics as well as consumer decisions about whether to purchase specific products or to avoid certain ingredients, when to contact a health care professional, and when to report an adverse event. The FDA also encourages people to report their cosmetic-related adverse events to their state’s consumer complaint coordinator or to Medwatch, the FDA’s adverse event reporting program. If OMB approval is received, the FDA expects to begin conducting the new consumer survey in 2019.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.