FDA updates regulations on toys and childcare articles
Comprehensive updates address gaps and enhance safety measures
The Food and Drug Administration’s (FDA) Center for Cosmetics and Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) unveiled a series of significant updates to the regulatory policies governing toys and childcare articles (TCCA) on Wednesday, Dec. 20.
The agency acknowledged the status of the implementation of existing TCCA product authorization guidelines, initially introduced through FDA Circular No. 2015 to 002 in 2015.
It noted that over the years, gaps in the system were identified, prompting the need for a comprehensive overhaul.
These gaps include upgrading the application system to align with the latest FDA online platforms, updating labeling requirements, rationalizing certification procedures for exempted products, and revising product safety standards applicable to TCCA products.
To address these issues, the FDA, through CCHUHSRR, is undertaking the development and update of the existing FDA circular.
It said that the proposed changes will be shared with stakeholders through official channels after consultation.
Moreover, the FDA provided updates on the licensing application procedures, revealing a shift toward the utilization of the FDA eServices Portal System as a common application platform for regulatory services.
By 2024, the agency highlighted that the licensing application procedures, among other services, will migrate to this digital platform, incorporating features to align with the "Ease of Doing Business and Efficient Government Service Delivery Act of 2018."
In line with prioritizing child safety, the FDA is developing a policy on safety reporting for TCCA products.
The agency said that this initiative aims to establish a robust reporting system for TCCA-related injuries, clarify the roles and responsibilities of establishments in the supply chain, facilitate preventive measures, and raise public awareness of children's safety.
The FDA is also actively engaged in research initiatives, specifically focusing on the testing of phthalates in TCCA products on the market.
The results of this study will inform updates to existing restrictions, enhancing safety measures for TCCA products, it stated.
Furthermore, in a call to action, the FDA emphasized the importance of industry stakeholders' cooperation to ensure compliance with regulatory standards.
“The agency also calls upon the public to support the initiatives of the FDA, in order to ultimately foster an environment conducive to the well-being and development of children,” the FDA said.