FDA Roundup: March 18, 2025
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On Tuesday, March 18, the United States District Court for the District of Maryland entered a consent decree of permanent injunction against Totally Cool, Inc., a Maryland-based manufacturer of ice cream and frozen desserts, and its CEO and owner, Michael J. Uhlfelder. On July 8, 2024, the FDA suspended Totally Cool’s food facility registration after an inspection of the firm revealed L. mono in the facility, as well as numerous failures of the firm to adhere to current good manufacturing practice for food safety, including sanitation requirements for employees and equipment. The consent decree prohibits Totally Cool and Mr. Uhlfelder from directly or indirectly receiving, preparing, processing, packing, holding, and/or distributing any article of food unless and until they meet certain requirements.
On Friday, the FDA issued a Letter to Health Care Providers to notify providers that we are aware that the United States is experiencing interruptions in the supply of hemodialysis bloodlines (also referred to as set, tubing, blood, with and without anti-regurgitation valve) because of recent supplier issues. The FDA has updated the medical device shortage list to include hemodialysis bloodlines (product code FJK). The disruption in availability of this device is expected to impact patient care and may require adjustments to the clinical management of patients requiring acute or chronic hemodialysis. The FDA expects the duration of this shortage to extend through early fall of 2025. The FDA is recommending health care providers experiencing delays in the supply of hemodialysis bloodlines consider strategies to conserve their use. Health care providers should use their clinical judgment in development and implementation of conservation strategies. The Letter to Health Care Providers includes important information about the hemodialysis bloodline shortage including:
- Additional information about hemodialysis bloodline products affected.
- Recommendations for health care providers.
- Actions that the FDA is taking to assess and mitigate the risk.
Instructions for reporting problems with a device.
- On Friday, the FDA announced the conditional approval of Felycin-CA1 (sirolimus delayed-release tablets) for the management of ventricular hypertrophy in cats with subclinical hypertrophic cardiomyopathy (HCM). This is the first product approved for use in cats with HCM for any indication. Cardiomyopathy is a disease of the heart muscle. HCM in cats causes thickening of the heart's left ventricle. It is the most common heart disease in cats and is one of the most common causes of death in cats. The drug is only available by prescription from a licensed veterinarian.
- On Friday, the FDA issued a safety alert warning consumers not to inhale or recreationally use any flavor of nitrous oxide in any size canister, tank, or charger. When inhaled, these products can result in serious adverse health effects, including death. For some individuals who regularly inhale nitrous oxide, this habit can lead to prolonged neurological effects, including spinal cord or brain damage, even after stopping use.
Related Information
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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.
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Source: U.S. Food and Drug Administration (FDA.gov)
