Fiscal Year 2025 User Fees for VQIP and TPP Programs
Today, the FDA announced the fiscal year (FY) 2025 user fee rates for:
- Importers approved to participate in the Voluntary Qualified Importer Program (VQIP)
- Accreditation and certification bodies interested in the Accredited Third-Party Certification Program (TPP)
These fees are authorized by the FDA Food Safety Modernization Act (FSMA) and allow the FDA to assess and collect fees to cover the costs of administering these programs.
Public Health Alert: Elevated Lead Levels in Ground Cinnamon
The FDA issued a public health alert advising consumers to throw away and not buy nine additional ground cinnamon products due to elevated lead levels. For previous alerts on ground cinnamon products, refer to:
- March 6, 2024 Alert
- July 25, 2024 Alert
“We appreciate the continued work of our state partners to help us monitor lead in ground cinnamon in the market,” said Jim Jones, Deputy Commissioner for Human Foods. “Reducing dietary exposure to lead and other heavy metals among babies and young children is one of the top priorities of the human foods program and something we will continue to work on through the Closer to Zero initiative.”
CDRH Center Director Vacancy
The FDA has officially opened the CDRH Center Director vacancy following the retirement of former Director Jeff Shuren. The position will remain open until August 27 as the agency conducts a national search for the next director. The Center Director will:
- Fulfill CDRH’s mission to protect and promote public health
- Ensure timely and continued access to safe, effective, and high-quality medical devices and radiation-emitting products
This position is being filled under a streamlined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act.
Approval of Guardant Health’s Colorectal Cancer Screening Test
On Friday, the FDA approved the Guardant Health, Inc. Shield, a test intended to screen for colorectal cancer (CRC) using blood collected in the Guardant Shield Blood Collection Kit. This test is for individuals aged 45 and older who are at average risk for CRC.
Key Details:
- Positive test results should be followed by a colonoscopy
- Limited detection: 55%-65% of Stage I colorectal cancer
- Does not detect: 87% of precancerous lesions
According to the American Cancer Society, CRC is the second leading cause of cancer-related death among cancers affecting both men and women. This approval is part of the FDA’s ongoing commitment to expanding colorectal cancer screening options.
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Read the full FDA article here.