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FDA device registration
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,...
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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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Any Florida or Miami native knows how powerful hurricanes can be and the destruction a heavy hurricane season can bring. Long power outages and flood dangers pose a threat not only to your property but also to your food. Having a well-secured plan can help you and your family be well prepared for the risk...
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COVID-19 has been the main priority in the last year for the Food and Drug Administration (FDA). However, another critical role they are looking to bring more light to is preventing toxic chemicals from making their way into our food.  While President Biden has yet to nominate a new commissioner for the FDA, scientists and...
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While the FDA seeks to ensure food and medical device safety and quality, The North American Free Trade Agreement (NAFTA) safeguards the FDA’s ability to provide quality imports and exports throughout North America. NAFTA started in January of 1994, and is the agreement in place between Canada, the United States, and Mexico aimed to increase...
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Many U.S. importers are mandated by the Food and Drug Administration (FDA) to create Foreign Supplier Verification Systems (FSVPs) for all food products imported from overseas suppliers. Common misconceptions on when and how facilities can build FSVPs can lead to misconceptions. Failure to establish FSVPs will result in FDA intervention, including product detentions, importation prevention,...
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