FDA Roundup: November 5, 2024

News provided by

Nov 05, 2024, 17:40 ET

SILVER SPRING, Md., Nov. 5, 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 published "Catching Up with Califf: One Health - Optimal Public Health Outcomes for Humans and Animals in Our Shared Environment," by FDA Commissioner Robert M. Califf, M.D. Dr. Califf discusses One Health and the FDA's mission to collaborate across disciplines and sectors to promote the health of humans and animals; and taking into account agricultural and environmental issues, using science, technology, and innovation to better understand and define policies that involve these intersections. The blog also provides details on FDA Center for Veterinary Medicine's upcoming Symposium: "Paws, Claws, Hooves, Fins, and Feet—Advancements through a One Health Approach."
On Monday, the FDA published the Supplement to the 2022 Food Code. The Supplement updates the 2022 Food Code with recommendations made by regulatory officials, industry, academia, and consumers at the 2023 Biennial Meeting of the Conference for Food Protection. The Food Code and its Supplement provide government and industry with practical, science-based controls for reducing the risk of foodborne illness in retail and foodservice establishments of all types. The Food Code and the Supplement are joint projects by the FDA, the Centers for Disease Control and Prevention, and the United States Department of Agriculture – Food Safety and Inspection Service.
On Monday, the FDA, in collaboration with the Environmental Protection Agency (EPA), announced the registration of the first antimicrobial treatment for pathogen reduction in pre-harvest agricultural water—a landmark achievement in enhancing food safety. This product effectively combats foodborne pathogens such as E. coli and Salmonella in water used to grow crops. It is the first label amendment approved under a revised efficacy protocol–designed by the FDA and EPA–to ensure robust treatment options are available for agricultural use.
On Monday, the FDA authorized marketing of LumiThera, Inc.'s Valeda Light Delivery System to help improve vision in certain dry age-related macular degeneration (AMD) patients. According to data on AMD prevalence estimates analyzed by the CDC, in 2019 an estimated 19.8 million Americans aged 40 years and older were living with some type (dry or wet) of AMD.

"Today's action brings to market the first therapeutic option for adult patients with dry AMD," said Malvina Eydelman, M.D., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices at the FDA's Center for Devices and Radiological Health. "This authorization reinforces FDA's commitment to assuring access to innovative, safe and effective medical devices to treat high-prevalence, degenerative conditions."

The Valeda Light Delivery System uses three light emitting diodes that generate light at different wavelengths to provide treatment to the patient's eye. Treatment with the device after approximately two years can provide an average improvement in vision equivalent to around one line on an eye chart.

On Friday, the FDA Office of Criminal Investigations arrested a Massachusetts spa owner, Rebecca Fadanelli, for allegedly performing thousands of illegal injections of counterfeit Botox, Sculptra and Juvederm on clients for over three years. If you or a family member believe you received services involving a counterfeit drug or counterfeit device from Fadanelli and/or Skin Beaute Med Spa in Randolph and South Easton, Mass. between 2021 through and including to the present date, please complete the questionnaire located on the FDA's website here.

Additional Resources:

FDA Newsroom

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.

SOURCE U.S. Food and Drug Administration