FDA Extends Screening To Low Value Imports
One of the Food and Drug Administration’s (FDA) many responsibilities is to screen imports that fall under its jurisdiction. While low-value shipments have been exempt from their screening requirements in the past, that is no longer the case. We’ll dive into the new changes and what they mean for importers.
Why Did the FDA Change Their Regulations?
Low-value shipments regulated by the FDA have been exempt from screening under the Section 321 “de minimis” rule. This specifically applies to items that are valued at $800 or less.
Low-value imports that were exempt from FDA screening include:
- Cosmetics
- Dinnerware
- Radiation-emitting devices (non-medical)
- Biological samples
- Many foods
On July 9th, Customs and Border Protection (CBP) informed the trade community the FDA was revoking the exemption. CBP and the FDA have emphasized that even smaller shipments can be a threat to the health and safety of U.S. citizens.
As a result, removing the exemption allows the FDA to provide better oversight and protection of the U.S. supply chain.
The FDA has also been concerned about regulation of the “gray market” for obesity medicines. Many of these medicines are from China and use ingredients that aren’t registered with the FDA.
Another reason for the change is due to the advancement of the FDA’s technology. They now have the systems in place to electronically review all shipments that enter the country.
How Will FDA’s New Screening Regulations Affect Importers?
Since low-value imports were exempt from FDA screening, importers didn’t need to follow the typical requirements to get these goods into the country.
Now that de minimis no longer applies to low-value shipments, the FDA requires the same level of compliance for all imported products under their jurisdiction.
This means importers must follow the applicable guidelines for their FDA-regulated products, no matter the value of the shipment. The Prior Notice (PN) the FDA requires for food and feed products will remain in effect.
How We Can Help Importers
There are all kinds of red tape that comes along with importing. It can be difficult for importers to navigate their way through these requirements, especially when they change.
Here at R+L Global Logistics, we help importers by staying up-to-date on regulatory changes. We also offer an extensive logistics networks that we use to get importers into the country and transported domestically.