FDA Roundup: September 10, 2024

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Sep 10, 2024, 14:54 ET

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:

FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
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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.

SOURCE U.S. Food and Drug Administration