Upcoming Deadlines July 1, 2024 Product listings and facility registrations for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) must be completed by July 1, 2024. These filings can be made online in the FDA Cosmetics Direct portal. FDA has released a user guide to assist responsible parties in signing up and [...]
What are Nitrosamines? Nitrosamines are impurities that may be found in some drug products. These impurities are not expected to be harmful at low levels, but may increase the risk of cancer when ingested at higher levels over a long period of time. The FDA has set guidelines for over-the-counter (OTC) drug monograph and pharmaceutical [...]
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 [...]
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 [...]
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 [...]
On March 24, 2023, the US Food and Drug Administration (FDA) announced its 2023 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). The Monograph Drug Facility (MDF) fee has increased by $1,975 from $24,178 last year and the Contract Manufacturing Organization (CMO) fee has increased by $1,316 from [...]
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. [...]
UPDATE: The Maine Board of Pesticide Control has now set up a dedicated portal for submission of additional CSFs to ensure a secure method of transmitting these documents. Registrants should no longer email CSFs to Maine. Any CSF that was previously emailed to Maine does not need be resubmitted. In the below article, bolded red [...]
Legislation enacted by California, Illinois, Oregon, and Washington requires labels for disposable wipes to contain specific symbols and statements to clearly indicate they are not flushable. The intent of such legislation is to help consumers easily identify the difference between flushable and non-flushable wipes, ultimately protecting water quality and public wastewater systems. According to [...]
On March 26, 2021, the US Food and Drug Administration (FDA) announced its 2021 fees for OTC monograph drug facilities under the Over-the-Counter Monograph Drug User Fee Program (OMUFA). This fee assessment was authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act which added a new provision to the Federal Food, Drug and [...]