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Blog

New FDA Challenge to Develop Traceability in Food Safety Efforts

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 […]

British Insomnia Device Hits US Markets

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 […]

Nevada Water Bottle Company Must Stop Production for Failure to Comply

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, […]

FDA Seizes Dietary Supplements with Kratom

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 […]

New FDA Commissioner to Remove More Toxic Chemicals in Food

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 […]

How the FDA and NAFTA Work Together

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 […]

Food and Beverage FDA Regulations

The Food and Drug Administration (FDA) has strict regulations to ensure the safety of food and beverages. These regulations typically refer to the safety of facilities, imports, exports, and the manufacturing of food and beverage items. At UReg FDA, we want to guide you through these regulations to save you time, money, and significant issues […]

Don’t Believe These FSVP Fables

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, […]

Fundamentals of FDA Registration

The Food and Drug Administration (FDA) of the United States regulates a wide range of products in addition to food and drugs. Though food may be the biggest, the FDA also regulates cosmetics, dietary supplements, homeopathic remedies, medical equipment, tobacco products, vaccines, blood and biologics, animal and veterinary foods, medications and supplements, and radiation-emitting products. […]