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June, 2021 | UReg - FDA Registrations

Month

June 2021
This summer, the FDA issued a warning for Little Hatch’s products as they were linked to severe health concerns. In late May, the parent company Interstate Food products voluntarily recalled Little Hatch’s Jalapeno Cream Cheese. Another recall notice was given almost a week later for queso, and in mid-June, internal testing confirmed that the salsa...
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The SmartFuse, Intelligent Implants Ltd.’s new orthopedic implant, has been cleared for use by the Food and Drug Administration (FDA) through FDA device registration. The technology remotely stimulates and controls bone growth and monitors for clinical decisions that can be made instantaneously. The new device is clear for first use in patients who need lumbar...
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The Food and Drug Administration has launched an initiative to bring on change to the development of affordable, technology-based traceability tools to protect people and animals from contaminated food. This will allow rapid identification of food sources and assist them in removing contaminated products from the market as quickly as possible. Formally known as “The FDA...
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SleepCogni is now registered for medical use by the Food and Drug Administration (FDA). The device is data-supported, targeting those who suffer from insomnia, and aims to break cognitive cycles that prevent sleep. Preliminary analysis shows that the device does, in fact, reduce insomnia (as measured by Insomnia Severity Index) within seven days of use...
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The Food and Drug Administration recently announced that a Nevada-based water bottle company Real Water Inc. will need to stop operations until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) along with other requirements. The FD&C Act is a set of laws that oversees food safety, drugs, medical devices, and cosmetics, prohibiting...
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The Food and Drug Administration (FDA) has announced that United States Marshals have seized more than 207,000 units of dietary supplements and bulk dietary ingredients that either contain or are solely kratom. Kratom, a tropical tree native to SouthEast Asia, contains compounds that cause psychotropic mind-altering effects. While it is not fully illegal, it is...
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