FDA to screen all imports, exemptions for low-value shipments revoked

The U.S. Food and Drug Administration said on Tuesday it will now review all imports of the products it regulates regardless of their quantity or value, after a federal law enforcement agency recently rescinded an exemption for small shipments.

Under the updated regulations, exemptions that previously allowed import of some product shipments valued at $800 or less without a full screening by the FDA will be revoked, it said in an industry notice.

The health regulator expects the new regulations, which kicked in from July 9, will improve its oversight of the U.S. supply chain and help identify any repeat offenders.

These changes will allow the FDA to review all electronically transmitted products, such as those ordered online and offered for import.

The new rules will apply to all FDA-regulated products, including medicines, food, beverages, dietary supplements, cosmetics, medical devices and biological samples.

Smaller parcels will have to comply with the same standards as bulky shipments, the notice said.

This could increase the agency's oversight of the so-called "gray market" for obesity medicines. Americans have been bringing in cheap active ingredients from China "for research purposes", according to a Reuters report from June that cited import data and social media postings.

Shipments of such active ingredients from Chinese entities not registered with the FDA jumped 44% in January from the previous month, according to research by a public health group called Partnership for Safe Medicines.

Packages valued at less than $800 that enter the U.S. under the exemption were not included in the data.