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 …
Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter
On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary …
Permanent Injunction Sought after Cheese Manufacturer Fails to Respond to FDA Warning Letter
On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) filed a Complaint for Permanent Injunction against a Michigan Cheese Manufacturer and its owners under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332. The FDA seeks …
FDA Seeks Permanent Injunction against Oregon Dietary Supplement Company
On October 21, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it is seeking a permanent injunction against James G. Cole, a dietary supplement manufacturer based in Oregon, along with the company’s president, James G. Cole, and general …
FDA Publishes Overview of Regulatory Requirements for Food Businesses
On June 19, 2013, as part of Small Business Week, the U.S. Food and Drug Administration (FDA) published “How to Start a Food Business” on its website. The article provides a brief overview of the requirements that a food business …
Marshals Seize Supplements with Undeclared Drug Ingredients
On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be …
FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA
On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree of permanent injunction with Jonlly Fruits, Inc. (“Company”) and its President, Bartolo Pérez Román. Jonlly Fruits is a frozen fruit, …
FDA Proposes New Unique Identifier System for Medical Devices
On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve …
FDA Expands Use of Device to Detect both Viral and Bacterial Causes of Respiratory Infection
On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is …
FDA Explains its Regulation of Bottled Water
Recently, the U.S. Food and Drug Administration (“FDA”) published “Food Facts”, a document providing the public with information concerning the Agency’s regulation of bottled water. Found here, the document details how the Agency works in conjunction with the Environmental Protection …