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The U.S. Food Safety Modernisation Act (FSMA) is the most significant update to U.S. food safety laws in over 70 years. Its focus is clear: shifting from responding to food safety problems to preventing them. Companies that manufacture, process, pack, or store food for U.S. consumption must implement robust Food [...]
Socio Platforms Inc. is offering investment opportunities in its diversified tech portfolio, encompassing Fintech, HR Tech, Ratings, and Ad Network sectors. This approach provides investors with exposure to multiple high-growth industries under one umbrella. Investment Model: Revenue-Based Growth Socio Platforms Inc. employs a revenue-based investment model, allowing investors to participate [...]
Any company manufacturing shelf-stable, canned, or bottled food and beverage products for the U.S. market must comply with FDA Food Canning Establishment (FCE) Registration and Scheduled Process (SID) Submission requirements. These regulations apply specifically to low-acid and acidified foods such as juices, pickles, sauces, soups, canned vegetables, bottled drinks, and [...]
The U.S. dietary supplements and nutraceuticals market is one of the largest in the world, but gaining entry requires strict compliance with U.S. Food and Drug Administration (FDA) regulations. Companies manufacturing or distributing dietary supplements, vitamins, minerals, herbal products, protein powders, or fortified beverages must meet specific FDA requirements before [...]
For companies developing innovative food products, beverages, nutraceuticals, or functional ingredients, U.S. market entry often requires regulatory approval of food ingredients. The U.S. Food and Drug Administration (FDA) regulates additives and novel ingredients to ensure consumer safety. Two main pathways exist: Generally Recognized As Safe (GRAS) submissions and Food Additive [...]
The U.S. Food Safety Modernization Act (FSMA) introduced the Foreign Supplier Verification Program (FSVP) to ensure that imported foods meet the same safety standards as those produced domestically. Under this regulation, U.S. importers must verify that their foreign suppliers are manufacturing, processing, packing, and storing food in full compliance with [...]
Every company manufacturing, importing, or distributing FDA-regulated products must be prepared for inspections and audits. Whether you operate in food, beverages, dietary supplements, cosmetics, or medical devices, an FDA inspection can happen at any time. Being unprepared may result in Form 483 observations, warning letters, import holds, or even suspension [...]
In the highly regulated U.S. market, product recalls and enforcement actions can significantly impact a company’s reputation, finances, and consumer trust. Whether involving food, dietary supplements, cosmetics, or medical devices, recalls are often initiated due to safety concerns, mislabeling, contamination, or non-compliance with FDA regulations. Having a proactive recall and [...]
Achieving U.S. FDA compliance is only the first step maintaining it requires constant attention. FDA regulations are dynamic, with frequent updates to labeling rules, safety standards, registration requirements, and inspection protocols. Businesses that fail to keep up with these changes risk losing market access, facing enforcement actions, or damaging their [...]
Foreign companies manufacturing, repackaging, relabeling, or importing FDA-regulated products into the United States are required to appoint a U.S. Agent. The U.S. Agent serves as the official liaison between the company and the FDA, ensuring that regulatory communications, inspection notices, and emergency matters are handled efficiently and accurately. At XPRO [...]