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If you are an importer of low-value food and cosmetic shipments into the United States, you must read this blog. Effective August 29, 2025, the De Minimis exception, which has been in place by the Food and Drug Administration (FDA) for these products for 30 years, has ended. This means that every shipment, whether one with a few bars of chocolate or a single bottle of supplements, is no longer
The Food and Drug Administration (FDA) is a federal agency that regulates food, drugs, cosmetics, medical devices (including those that emit radiation), vaccinations, and veterinary products in the United States. If you intend to import any food product that falls under their purview, you must file an FDA prior notice to obtain customs clearance. While this pre-screening process has set guidelines and timelines, there may be instances where importers need to
If you have ever had a meal, used a cosmetic product, or taken medication in America, there is a high likelihood that all of the above have been regulated by the Food and Drug Administration (FDA). The FDA has only one goal: promoting and protecting public health. America is the largest importer of food in the world. According to the U.S. Department of Agriculture, the U.S. imported $194 billion worth of
Understanding FDA Prior Notice Every country has its own indigenous food, ingredients, packaging processes, and regulatory mandates for maintaining safety standards. When importing food or drug items from another country, the native country must consider the potential health and safety risks that these differences could likely cause the citizens. Every importer of such items in the USA must, thus, notify the FDA, or the US Food and Drug Association, about
Importing goods into the United States involves navigating through a multitude of regulatory processes. As food safety and security have become paramount concerns, the Food and Drug Administration (FDA) plays a pivotal role in safeguarding the public from potential threats and emergencies. One critical aspect of this process is complying with the Food and Drug Administration’s (FDA) Prior Notice requirements. This comprehensive guide explores the intricacies of FDA Prior Notice
On September 24, 2013, the UDI rule otherwise known as the Unique Device Identification system was published by the Food and Drug Administration (FDA). The system was set up to more effectively and efficiently identify medical devices sold in the United States throughout the manufacturing journey to distribution and use. The goal of the new UDI system is to enhance the safety of patients, modernize post-market surveillance of devices and
On May 15th, 2023 the U.S. Customs and Border Protection Agency announced an update to the SE CATAIR process. Under the new regulations, importers and their authorized agents may make Port of Entry (POE) Changes using the Cargo Release Update Transaction. Importers and their agents filing entries with the U.S. Food and Drug Administration through the Automated Commercial Environment (ACE) are now allowed to make certain changes (using the Update
Importing cosmetics into the United States using entry type 86 can be very lucrative even though the process can have many pitfalls. One of the biggest challenges that importers face is that many countries define cosmetics and drugs differently from the United States. For instance, in some countries, sunscreens are deemed cosmetics and are under cosmetics regulations while they are regulated as drugs in the United States. Given that cosmetics
The Voluntary Qualified Importer Program (VQIP) is a fee-based voluntary program that provides expedited import and review of animal and human foods into the US for participating importers. The scheme will benefit both importers and consumers in a variety of ways. Participating importers can usually import their products into the US with greater predictability and speed and avoid unforeseen delays at the port of entry. Consumers stand to gain from