SILVER
SPRING, Md., July 30,
2024 /PRNewswire/ -- Today, the U.S. Food
and Drug Administration is providing an at-a-glance summary of news
from around the agency:
- Today, the FDA is announcing the fiscal year (FY) 2025 user fee
rates for importers approved to participate in the Voluntary
Qualified Importer Program (VQIP) and accreditation and
certification bodies interested in participating in the Accredited
Third-Party Certification Program (TPP). The user fee rates are
authorized by the FDA Food Safety Modernization Act (FSMA) and
allow the agency to assess and collect fees to cover the FDA's cost
of administering these programs.
- Today, the FDA issued a public health alert advising consumers
to throw away and not buy nine additional ground cinnamon products
due to the presence of elevated levels of lead. Please see our
previous alerts on ground cinnamon products, March 6, 2024 alert, and July 25, 2024 alert, for a list of additional
ground cinnamon products previously recommended for recall.
"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."
- Today, the FDA officially opened the CDRH Center Director
vacancy following the retirement of former CDRH Director
Jeff Shuren. The post will remain
open until August 27 as the agency
conducts a national search for the next director to lead the
Center. The Center Director is responsible for fulfilling CDRH's
mission to protect and promote the public health and to help ensure
that patients and providers have timely and continued access to
safe, effective, and high-quality medical devices and safe
radiation-emitting products. This position is being filled under a
streamlined hiring authority, Title 21, Section 3072 of the 21st
Century Cures Act.
- 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. The test is
used for CRC screening in individuals at average risk for the
disease who are 45 years of age or older. Patients with positive
test results should have a colonoscopy since the test is not a
replacement for diagnostic colonoscopy or for surveillance
colonoscopy in high-risk individuals. Shield has limited detection
(55%-65%) of Stage I colorectal cancer and 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
that affect both men and women. This is the latest example of the
FDA's ongoing commitment to expanding colorectal cancer screening
options for patients.
Additional Resources:
Media Contact: FDA Office of Media Affairs,
301-796-4540
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration