The Food and Drug Administration (FDA) of the United States announced on Tuesday (July 15) that it will review all imported products under its regulation, regardless of quantity or value, after federal enforcement agencies recently revoked tariff exemptions for small goods.
According to Reuters, the FDA’s latest announcement may strengthen its supervision over the “gray market” of obesity drugs. A report by Reuters in June cited import data and posts on social media, stating that Americans have been importing cheap active pharmaceutical ingredients from China for “research purposes.”
Research from the Partnership for Safe Medicines, a public health organization, shows that the transportation of such active pharmaceutical ingredients from unregistered entities in China saw a sharp 44% increase in January compared to the previous month. This data does not include parcels valued below $800 that were exempt from tariffs.
In an industry notice, the FDA stated that previously the government allowed the import of products valued at $800 or below without undergoing comprehensive FDA review, but under the updated regulations, this exemption will be revoked.
The health regulatory agency expects that the new regulations, which took effect on July 9, will strengthen supervision of the U.S. supply chain and help identify repeat offenders.
These changes will allow the FDA to review all relevant e-commerce products, such as those that can be ordered online and imported.
The new rules will apply to all FDA-regulated products, including drugs, food, beverages, dietary supplements, cosmetics, medical devices, and biological samples.
The FDA noted in its announcement that small packages will be required to adhere to the same standards as larger cargo.
President Trump signed an executive order after taking office, canceling the “de minimis” policy for goods originating from China and Hong Kong. The “De Minimis” policy was initially introduced to promote international trade. Due to the convenience of this policy, it facilitated the smuggling of fentanyl ingredients from China and the trend of importing cheap clothing, toys, and furniture from China through online platforms such as Temu, Shein, and Amazon Haul, which has become the subject of criticism from both parties.