This post is the first in a series on recurring FDA Import Alert patterns by industry. This installment covers food and dietary supplement cases; the next covers medical devices. Read more:: Trapped in Customs: The Hidden Triggers Behind FDA Import Alerts for Medical Devices Three days after his container cleared Busan and reached the Port of LA, the exporter got a frantic call from his U.S. buyer. Customs wouldn't release the shipment. The paperwork from FDA mentioned someth

You can no longer approach the FDA without an eSTAR. To launch a medical device in the U.S., entering the FDA’s gateway is an absolute necessity. For most companies, the preferred route is the 510(k), or Premarket Notification process. While primarily designed for Class II (moderate-risk) devices, it also applies to certain low-risk or high-risk devices depending on their unique technical characteristics. In fact, the vast majority of medical devices entering the U.S. market

Companies looking to enter the U.S. cosmetics market should pay close attention to the latest news from the FDA regarding MoCRA...

An Amazon seller, let's call her A, once updated a single line on her cosmetic product label and suddenly her listing was deactivated. It...

Have you ever had a seemingly perfect product unexpectedly delayed or detained at customs? One of the most common reasons for this is a...