On December 18, 2023, the U.S. FDA officially launched the Cosmetics Direct portal* for the submission of cosmetic product listings and facility registrations. As the SRC team has begun submitting filings in the new portal, we have found it to be working well and to be a user-friendly platform. FDA has also issued a final [...]
Consumer product labels are subject to a multitude of state and federal requirements. Creating a compliant consumer product label can be challenging. Whether your product is marketed in the U.S. or Canada, SRC has you covered! SRC will work with your company to ensure your consumer product labels are compliant with the following requirements: U.S. [...]
On September 29, 2023, EPA published a draft guidance and corresponding test method to allow the addition of planktonic Legionella pneumophila claims for cooling tower water. These documents have been released for public comment only and are not yet able to be used to support claims. EPA is accepting comments on the docket for 60 [...]
On September 28, 2023, EPA finalized the rule for Recordkeeping and Reporting Requirements of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA). This rule requires reporting of information on uses, production volume, disposal, exposure, and hazards of PFAS manufactured or imported since January 1, 2011. Reporting will be submitted electronically through [...]
UPDATE: On 11/09/2023, FDA released a notice that enforcement for product listing and facility registration requirements under MoCRA will be delayed by 6 months, making the new compliance deadline 07/01/2024. This update comes following delays to the release of the Cosmetic Direct platform. As new cosmetic product regulation compliance deadlines are quickly approaching, SRC Senior [...]
Effective June 28, 2023, all antimicrobial notifications submitted to the Antimicrobials Division (AD) prior to October 1, 2022 have been closed out by the Environmental Protection Agency (EPA). The Agency announcement, released on June 29, 2023, followed months of discussion between AD and the antimicrobial industry about how to best address the growing backlog of [...]
In response to recent simultaneous outbreaks of Marburg virus in Tanzania and Equatorial Guinea the United States EPA has engaged the Emerging viral Pathogens Policy (EVP). The Ministry of Health and Social Welfare for Equatorial Guinea first announced the outbreak on February 7, 2023. Since the announcement, 15 cases and 11 deaths have been confirmed [...]
What is MoCRA? The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 was signed into law by President Biden on December 29, 2022 as part of the 2023 Consolidated Appropriations Act , H.R. 2617. This Act significantly increases the U.S. Food & Drug Administration (FDA)’s oversight of cosmetic and personal care products from the 1938 [...]
In addition to compliance assistance with the new Food & Drug Administration (FDA) Modernization of Cosmetics Regulation Act (MoCRA) of 2022, SRC offers compliance support for cosmetic ingredient disclosure and reporting requirements for the California Safe Cosmetics Act of 2005 (CSCA) (and the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) (Senate [...]
SRC monitors industry trends through frequent communication with regulating agencies, and review of warning letters and enforcement actions. From our monitoring of FDA Warning Letters, we have noticed some recent trends in FDA enforcement and interpretation of the regulations of over-the-counter drugs. Bob MacDonald, SRC’s VP of Regulatory Services provides a breakdown of these trends. [...]