In this video, David Lennarz, President of Business Development and Operations at Registrar Corp., discusses the FDA’s new MoCRA adverse event regulations. The updated rules aim to enhance consumer safety and transparency in the cosmetics industry.

Lennarz explains that cosmetics labels must now include information for reporting adverse events, such as skin reactions. Brands are required to provide contact details like a QR code, email address, or URL, allowing consumers to notify the manufacturer directly. This process helps companies quickly assess the severity of the issue and determine if it needs to be reported to the FDA.

Previously, cosmetic brands were not obligated to include contact information on their product labels for reporting such events. With MoCRA, the responsibility shifts to manufacturers to monitor product safety actively and respond to consumer concerns. Although consumers can still report directly to the FDA, the new rules place more accountability on the brands.

Lennarz also addresses other changes brought by MoCRA, including the mandatory registration of manufacturing facilities and listing of cosmetic products with their ingredients. This shift from a voluntary system to a mandatory one enables the FDA to oversee product safety more effectively and conduct facility inspections when necessary. These changes mark a crucial step forward in protecting consumers and ensuring industry transparency.

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