On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. …
FDA Guides on General Wellness and Low Risk Devices
On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current position on low risk devices and general wellness products. This guidance document directs the Center for Devices and Radiological Health …
Court Issues Injunction after FDA Warning Letter Issues Persist
On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its products until the company meets certain U.S. Food & Drug Administration (“FDA”) regulations and mandated standards (Current Good Manufacturing Practices …
Overview of FDA’s Final Menu and Vending Labeling Rules
Menu and Vending Labeling Rules On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring that calorie counts be listed on menus and menu boards in certain restaurants and vending machines (menu and vending labeling …
FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place
On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District of Michigan against Scotty’s Incorporated, a manufacturer of ready-to-eat sandwiches. The FDA alleges that Scotty’s violated the Hazard Analysis and …
USDA Organic Labeling
The United States Department of Agriculture (USDA) oversees the National Organic Program and organic labeling in the United States. The National Organic Program is a regulatory program housed within USDA Agricultural Marketing Service, which sets standards for organically produced agricultural …
FDA Food Allergen Labeling
When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product does not contain any ingredients that would cause them to have an adverse reaction. Milk, eggs, fish, shellfish, nuts, wheat, …
FDA Imports: Foods and Cosmetics
Do you ever wonder how your favorite exotic cheese, foreign cookies, or champagne make it to the United States? As it turns out, importing food and cosmetics into the United States is not as simple as putting it in boxes …
FDA Approval Required for Company Enjoined from Marketing Products
On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As …
Court Finds FDA Exceeded Authority in Device Reclassification
On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA had “short circuited” its procedural requirements, pertaining to device reclassification and formal rulemaking, when it reevaluated a medical device being …