Cosmetics manufacturers and distributors are now required to report serious adverse reactions to their products, following updated requirements from the US Food and Drug Administration.<\/p>\n\n\n\n
The Modernization of Cosmetics Regulation Act<\/u><\/a> (MoCRA) went into effect on Dec. 29, 2023, requiring the manufacturers, packers and distributors of cosmetic goods to file reports of serious adverse events related to their products within 15 business days. Under former FDA regulations, reporting these reactions was fully voluntary.<\/p>\n\n\n\n A \u201cserious adverse event\u201d is defined by the FDA<\/u><\/a> as a reaction to a product that results in a person\u2019s death, near-death experience, hospitalization, disability, birth defect, infection, significant disfigurement or surgical or medical intervention to prevent said complications.<\/p>\n\n\n\n Dr. Linda Katz, director of the FDA\u2019s Office of Cosmetics and Colors, said Tuesday that approximately one quarter of previously reported adverse events due to cosmetic products would be categorized as serious.<\/p>\n\n\n\n \u201cIf you look at, in general, the amount of adverse events that we get for cosmetics, they range,\u201d she said, per CNN<\/u><\/a>. \u201cThey\u2019re about a little over 5,000 total per year. Not all of those are serious. In fact, it used to be that, when we\u2019d look at them, about 25% would meet a definition previously of \u2018serious.\u2019\u201d<\/p>\n\n\n\n Under MoCRA, responsible parties must report any instances of serious adverse events to the FDA within 15 days. The required report includes a form the responsible party must fill out, as well as a copy of the product\u2019s retail label. If the responsible party receives additional information about the serious adverse event within one year of filing their report, they must submit that new information in an additional FDA report within 15 days.<\/p>\n\n\n\n One purpose of MoCRA is to enable the FDA to gather better data on public health, according to Dr. Namandj\u00e9 Bumpus, Chief Scientist of the FDA.<\/p>\n\n\n\n \u201cThe serious adverse event reporting is really a key provision because it allows us to just understand a lot more about what\u2019s out there and what people are experiencing,\u201d Bumpus said, per CNN. \u201cSo these data will be beneficial to us and really help us advance public health as far as our regulation of cosmetics.\u201d<\/p>\n\n\n\n MoCRA will also help the FDA study cosmetics with per- and polyfluoroalkyl substances (PFAS), also known as \u201cforever chemicals,\u201d which the FDA<\/u><\/a> has linked to serious adverse health effects.<\/p>\n\n\n\n Although all drugs and pharmaceuticals must receive FDA approval before being sold in the U.S., cosmetics do not fall under those same requirements. According to the FDA<\/u><\/a>, color additives are the only product that must receive approval before they go on the market. However, the FDA can take action against a product if they find it violates the law.<\/p>\n\n\n\n To check whether a specific product or ingredient has been reviewed by the FDA, consult the Cosmetics Products & Ingredients<\/u><\/a> page on the FDA website. Additional information on labeling guides<\/u><\/a> and cosmetics laws and regulations<\/u><\/a> are also available on the site.<\/p>\n\n\n\n