(Newsworthy.news) – Updated guidance from the federal Food and Drug Administration (FDA) will now require manufacturers and dispensers of cosmetics to report “serious adverse events” that consumers experience from using their products.
On December 29, 2023, the federal agency made effective the Modernization of Cosmetics Regulation Act (MoCRA) to ensure that cosmetic manufacturing, packaging and distributing companies report major adverse reactions to products within 15 business days of receiving these complaints from consumers.
Previous cosmetics guidelines allowed for companies to file adverse reaction reports on a voluntary basis only. According to the 2023 update, the term “serious adverse event” is defined as a negative reaction to a product that leads to death or near-death, disability, birth defect, hospitalization, infection or requires major medical intervention to prevent serious issues.
The FDA’s Office of Cosmetics and Colors director, Dr. Linda Katz, explained to the media that up to one quarter of adverse reactions reported previously would fit the description of serious events.
Katz told CNN that the annual total of adverse reactions from cosmetics is slightly more than 5,000, not all of which are categorized as serious. She also noted that, in the past, roughly 25 percent of yearly complaints would have been deemed serious reactions under an earlier definition of the term.
The updated guidelines require a form to be completed by the “responsible person,” meaning the manufacturer, distributor or packer of the product. A copy of the product in question’s retail label must also be provided to the FDA.
Should more information about the incident be shared with the “responsible person” within a year of their filed report, a new report must be submitted to the FDA within 15 days of receiving new information.
FDA Chief Scientist Dr. Namandjé Bumpus emphasized the importance of MoCRA for enhancing data collection, improving public health and studying the chemicals used in cosmetics that have a known association with major health problems.
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