SILVER
SPRING, Md., July 26,
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 approved Palforzia [Peanut (Arachis
hypogaea) Allergen Powder-dnfp] to include initiation of
treatment, up-dosing and maintenance in individuals ages 1 through
3 years with a confirmed diagnosis of peanut allergy to mitigate
allergic reactions, including anaphylaxis, that may occur with
accidental exposure to peanuts. Palforzia has been approved since
January 2020 for initiation of
treatment in individuals ages 4 through 17 years with a confirmed
diagnosis of peanut allergy with up-dosing and maintenance in
individuals 4 years of age and older. Those who take Palforzia must
continue to avoid peanuts in their diets. A Risk Evaluation and
Mitigation Strategy (REMS) is in place for Palforzia to mitigate
the risk of anaphylaxis associated with Palforzia, which includes
elements to assure safe use., which includes elements to assure
safe use.
- Today the FDA released findings from a sampling assignment that
collected and tested both domestic and imported fresh basil,
cilantro, and parsley. The assignment sought to estimate the
prevalence of Cyclospora cayetanensis, Salmonella spp., and Shiga
toxin-producing Escherichia coli (STEC) in these herbs as part of
the FDA's ongoing effort to help proactively ensure food
safety.
- Today, the FDA issued a Safety Alert, warning consumers not to
use Optimized Plant Mediated Solutions (OPMS) Black Liquid
Kratom.
- On Thursday, the FDA announced the issuance of warning letters
to 80 brick and mortar retailers in 15 different states for selling
unauthorized e-cigarette products popular with youth, including Elf
Bar and Lost Mary. Additionally, the FDA also announced the filing
of complaints for civil money penalties against eight other
retailers who failed to take action after being previously warned
about selling unauthorized e-cigarettes.
- On Thursday, the FDA issued a public health alert advising
consumers to throw away and not buy the El Servidor brand ground
cinnamon product listed in the alert due to it containing elevated
levels of lead.
"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."
- On Thursday, the FDA issued a Safety Alert advising restaurants
and retailers not to serve or sell and consumers not to eat certain
oysters from Recompense Cove, Freeport,
Maine potentially contaminated with Campylobacter.
- On Thursday, the FDA published the Digital Health Center of
Excellence blog: A Lifecycle Management Approach toward Delivering
Safe, Effective AI-enabled Health Care. The blog explores issues in
the context of AI in health care settings. As global interest in AI
in health care soars, it's crucial to ensure the safety and
effectiveness of AI-enabled medical devices, as well as their
trustworthiness, fairness, and performance. The blog focuses on the
potential of Lifecycle Management concepts to address the unique
challenges of generative AI in health care, toward helping to
ensure these systems meet real-world needs while managing their
inherent risks across the software lifecycle.
- On Wednesday, the FDA published a Spotlight on CDER Science
featuring CDER researcher conducted among adult asthma patients to
determine how the similarity, proximity, and frequency of exposure
to a disease awareness communication and prescription drug
television advertisement impact consumer perception and
understanding of the benefits and risks of a prescription drug.
Consumers sometimes conflate the information in disease awareness
communications with information presented in prescription drug
promotional materials. Knowing which advertising features cause
conflation is important because it offers an opportunity for
pharmaceutical companies to consider these features when developing
prescription drug advertising and disease awareness
communications.
- On Wednesday, the FDA announced the virtual Medical Device
Sterilization Town Hall: Sterilization Short Topics and Open
Q&A that will be held on August 7,
2024, from 2-3 p.m.
EST. During this town hall, the FDA will discuss
topics including bioburden, bacterial endotoxin, and packaging
integrity testing for sterile medical devices. We will also host an
open question and answer session. Please submit questions to
MedicalDeviceSterilization@fda.hhs.gov by 4 p.m. EST on
Wednesday, July 31, 2024.
Registration is not required to attend.
- On Wednesday, the FDA posted a new web page dedicated
exclusively to monitoring the research on microplastics and
nanoplastics in the food supply, explaining what is known about
their health effects, and describing ways in which the FDA is
working to advance the science.
- On Tuesday, the FDA updated the advisory for illnesses linked
to Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies to
report additional illnesses. As of July 22,
2024, a total of 74 illnesses have been reported from 28
states. Sixty-two (62) of the 74 people have reported seeking
medical care, 38 have been hospitalized, and there are two
potentially associated deaths under investigation. All Diamond
Shruumz-brand products have been recalled and should not be sold.
Consumers should not purchase any Diamond Shruumz-brand
products.
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