SILVER
SPRING, Md., Sept. 10,
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 posted a warning letter issued to Root
Bioscience Brands LLC, doing business as Naternal, for illegally
selling cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN)
products for people and pets. Naternal makes unproven claims their
products can treat multiple diseases in people including
Alzheimer's disease, substance use disorder, autism and high blood
pressure. Naternal also makes unproven claims their hemp extract
oil products for pets can treat conditions such as separation
anxiety, pain, arthritis and skin ailments. The Naternal products
that are the subject of the warning letter are unapproved new drugs
introduced or delivered for introduction into interstate commerce
in violation of sections 505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
The FDA requested a response from the company within 15 working
days stating how they will correct the violations.
- Today, the FDA announced it has commissioned an independent
literature review and initiated an internal bench laboratory study
to evaluate metals in tampons. The comprehensive review of the
published literature will provide a better understanding of the
data currently available regarding the presence of chemicals in
tampons and, importantly, any associated health effects of those
chemicals. The FDA's laboratory study will measure the amount of
metals that come out of tampons under conditions that more closely
mimic normal use. These initiatives will enable the FDA to complete
a risk assessment of metals contained in tampons, based on a
worst-case scenario of metal exposure. The FDA will communicate its
findings from the literature review and lab testing publicly when
they are available and have been peer reviewed. The FDA will also
continue monitoring these devices as part of its total product
lifecycle approach to medical devices.
- On Friday, the FDA issued a new advisory for the Outbreak
Investigation of Salmonella: Eggs. As of Sept. 6, 2024, a total of 65 people infected with
the outbreak strain of Salmonella have been reported from nine
states. The eggs were traced back to Milo's Poultry Farm LLC. The
FDA conducted an onsite inspection and collected samples at Milo's
Poultry Farms and the outbreak strain was detected in samples. In
response to this investigation, Milo's Poultry Farm LLC voluntarily
recalled all eggs supplied by their farm.
- On Friday, the FDA updated the list of medical devices that
incorporate Augment Reality (AR) and Virtual Reality (VR). With
this update, the FDA has authorized 69 medical devices that
incorporate AR/VR. The FDA has reviewed and authorized for
marketing a growing number of devices through 510(k) clearance and
granting of De Novo request with AR/VR across many different fields
of medicine—and expects this trend to continue. The FDA plans to
update this list on a periodic basis.
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