Manufacturers of over-the-counter (OTC) drugs: Get ready for change. The Over-the-Counter Drug Safety, Innovation, and Reform Act promises to modify the regulatory system that oversees most OTC medications—and the OTC Monograph system. Anyone who develops and produces an OTC drug for marketing and sale in More..
Thanks to the U.S. Food and Drug Administration’s new FSMA Subpart G rule for human/animal food, the receiver is liable for supplier preventive controls. And there are now 33 sections that outline exactly what receivers must do to comply with these new requirements. The 33 More..
Every year, millions of Americans get sick—and some even die—because of foodborne diseases, according to the Centers for Disease Control and Prevention. With the passage of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) is on a mission to prevent foodborne More..
Passage of the Food Safety Modernization Act (FSMA) gave the U.S. Food and Drug Administration (FDA) broader authority to manage product recalls and request records and information from product manufacturers. Additional funding in 2018 is expected to allow for even more sampling and product/facility inspections, More..
Strong and widespread pressure from industry groups, health advocates, and the general population has resulted in a long list of new labeling requirements for food products—and that includes genetically modified organisms (GMOs). Many of the new rules going into effect this year. But in some More..
Statistics on foodborne diseases are startling, to say the least: Each year, such illnesses are responsible for the hospitalization of approximately 128,000 people, as well as 3,000 deaths and 48 million illnesses, according to the Centers for Disease Control and Prevention (CDC). As shocking as More..
The Food & Drug Administration’s Food Safety Modernization Act (FSMA), which was signed into law by President Obama in 2011, was hailed as the “most sweeping overhaul of America’s food safety system since 1938.” The legislation gave the FDA authority to impose new rules to More..
If your business imports food products into the United States, you’ve got new rules to follow! The U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Programs (FSVP) final rule outlines the activities importers should perform to verify that food imported into the United States More..