FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan

no smokiing no vaping

Today, we’re also announcing that we’ve sent letters to more than 40 companies seeking information about whether more than 50 products – including a variety of flavored e-cigarette products – are being illegally marketed and outside the agency’s current compliance policy. Some of these companies may be attempting to capitalize on the troubling popularity of products like JUUL among kids by illegally selling similar products and outside of the compliance policy. We also need to determine if any of these products may be counterfeit knockoffs. If tobacco products are being unlawfully marketed and sold outside the FDA’s compliance policy, we’ll take action. We simply cannot tolerate this behavior and will take additional action as needed.

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FDA Adds Boxed Warning for Increased Risk of Death with Gout Medicine Uloric (Febuxostat)

Doctor is warning against side effects of medicine

Uloric was FDA-approved in 2009 to treat a type of arthritis called gout in adults. Gout happens when a naturally occurring substance in the body called uric acid builds up and causes sudden attacks of redness, swelling, and pain in one or more joints. Uloric works by lowering uric acid levels in the blood. Gout is a chronic disease that affects approximately 8.3 million adults in the U.S.1 The number of medicines to treat gout is limited and there is an unmet need for treatments for this disease.

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FDA Authorizes First Interoperable Insulin Pump Intended to Allow Patients to Customize Treatment Through their Individual Diabetes Management Devices

“Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We’ve heard from the patient community that having the ability to customize their own diabetes management devices is important to them. Advances in digital health make more tailored approaches to diabetes care possible,” said FDA Commissioner Scott Gottlieb, M.D. “The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently. Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology. We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies.

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FDA Warns Patients and Doctors About Recall of Home-use Test Strips Used with Device to Monitor Blood Thinner Warfarin, Not Authorized for Sale in U.S.

“Monitoring warfarin dosing is a critical part of using the drug properly to prevent and treat blood clots. Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That’s why it’s so concerning that this distributor continued to sell these test strips in the U.S. even though domestic sales had been stopped due to safety concerns. To reduce risks to patients, we’re warning health care providers and the public about the dangers associated with this product,” said FDA Commissioner Scott Gottlieb, M.D. “Distributing products that are not labeled or authorized for sale in the United States raises significant concerns for us in view of the serious safety issues with these test strip devices, and our work on this matter is not finished. Our top priority is the immediate safety of patients, and we’re taking steps to ensure the products that this company distributed are removed from the market.”

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The Food and Drug Administration (FDA) Just Approved a Diagnostic Test to Assist Healthcare Providers in Measuring Nutrients in Breast Milk

rawpixel.com photo

The FDA reviewed data submitted by the sponsor of 112 samples of human milk to analyze the performance of the device. For the study, the sponsor tested the same 112 samples in the machine and compared them to the expected true values obtained by independent methods; both systems provided similar results for each test. The data showed that the Miris Human Milk Analyzer test was effective at determining levels of protein, fat and carbohydrate in the milk. There may be conditions that limit the information available from the Miris Human Milk Analyzer. For example, certain medications that a nursing mother may be taking could interfere with the test’s ability to accurately measure nutrient levels in breast milk.

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