FDA Compliance Won’t Protect You From CBP Enforcement
Why is FDA approval not enough to avoid customs issues for import shipments? FDA compliance alone may not safeguard shipments from customs issues because customs jurisdiction covers everything crossing the border, including technical requirements unrelated to FDA...
Tariff Refunds Are Triggering New Customs Audits
Why are tariff refunds creating deeper scrutiny for importers now? Tariff refunds have become a significant issue as customs lost a Supreme Court case regarding the IEPA tariffs. The court ordered refunds, but not all importers were part of the lawsuit. Customs has...
Registration Season is Coming! FDA has announced the Medical Device User Fees for Fiscal Year 2027
On July 30, 2026, the U.S. Food and Drug Administration (FDA) issued a Federal Register notice announcing medical device user fees and annual establishment registration fees for Fiscal Year 2027 (FY 2027), effective October 1, 2026, through September 30, 2027. All...
FDA Registration Renewal Season Opens October 1
Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is...
Bi-Annual Food Facility Registration Renewals
Between October 1 and December 31 this year, all FDA-registered facilities must renew their registrations. Food facilities are not charged a fee by FDA at renewal. However, FDA does require that any facility involved in the manufacturing, processing,...
Understanding Voluntary Disclosures in FDA and Customs
What are the circumstances where a company is obligated to tell the government about safety-related issues related to their products according to the Food and Drug Administration (FDA)? Companies are obligated to report safety-related issues to the FDA when there is a...
Customs Post-Entry Audits Explained: CF-28s, CF-29s, and What Happens After Clearance
Why isn't a shipment fully cleared once it passes through customs? When a shipment enters the United States, it is initially released to the importer on a conditional basis. This means that while the goods may be in the importer's possession, the release is not final....
First FDA-Regulated Import? The Mistakes That Get Shipments Stopped
What are the common starting problems for companies importing FDA-regulated products for the first time? Problems often begin at the inception of the transaction between the importer and the foreign supplier. Many issues arise from the purchase order stage, where...
TrumpRx.gov Explained: Why FDA and Customs Are Cracking Down on Drug Imports
What is TrumpRX.gov and why is it significant compared to other programs? TrumpRX.gov is a website created by the Trump administration that allows consumers to research pharmaceuticals, compare prices with and without insurance, and find participating pharmacies for...
FDA’s ‘No Artificial Colors’ Shift: When Enforcement Changes but the Law Doesn’t
What is the significance of color additives in FDA regulations for various products? Color additives are substances regulated by the FDA that can change, add, or affect the color of foods, cosmetics, drugs, and more. They can be derived from natural sources like...