Key Takeaways:
It’s been a turbulent summer for global trade, with tariffs, shipping delays, and regulatory disruption hitting nearly all American businesses, including the beauty and wellness industry. In July, the U.S. Food and Drug Administration (FDA) issued a sweeping policy change that directly impacts any brand that relies on direct-to-consumer (DTC) e-commerce models and overseas suppliers.
As of July 9, all FDA-regulated imports—regardless of quantity or value—must undergo full review and screening. This includes cosmetics, skincare, dietary supplements, over-the-counter and prescription drugs, and food, among other categories.
The shift ends the long-standing “de minimis” exemption, which allowed shipments valued under $800 to bypass full FDA screening. Under the new policy, small parcels from international online retailers, express carriers, and fulfillment centers will face the same entry requirements as high-value imports. Importers must ensure all required FDA data elements are submitted correctly at the time of entry.
The FDA’s decision is part of a broader push to close regulatory loopholes in e-commerce imports. In recent years, low-value shipments have surged in volume, fueled by global platforms such as Shein, Temu, and AliExpress. The de minimis exemption has also played a significant role in the flourishing of K-beauty brands and retailers in the US market. K-beauty products, like sunscreen, that previously entered the United States duty-free will now face tariffs and duties, potentially leading to higher prices for consumers.
Between 2015 and 2024, the number of de minimis shipments entering the US skyrocketed from 134 million to over 1.36 billion annually, with U.S. Customs and Border Protection (CBP) now processing over 4 million such shipments daily.
Under the duty-free de minimis exemption, imports entering the US typically faced less stringent inspection compared to traditional imports. It was intended to streamline low-value shipments and reduce administrative burden. However, a press release issued by Homeland Security argued that the system was exploited to skirt import laws, avoid tariffs, and slip counterfeit or unsafe products into the country. The White House cited national security, public health, and economic concerns as reasons for ending the de minimis exemption.
On July 30, President Trump signed an executive order to close this regulatory loophole. Effective August 29, imported goods sent through means other than the international postal network that are valued at or under $800 and that would otherwise qualify for the de minimis exemption will be subject to all applicable duties. Packages sent through the international postal system will be charged either:
While long-standing exemptions for personal travel allowances and low-value gifts remain, the removal of the commercial de minimis benefit signals a major shift in US trade enforcement.
For the beauty sector, this means tighter oversight of imported skincare, cosmetics, and haircare, especially those sold online and shipped directly from overseas warehouses. Products without proper labeling, ingredient documentation, or manufacturing registration will face a much higher risk of being delayed or denied entry.
The One Big Beautiful Bill Act, signed earlier this year, permanently repeals the statutory basis for the de minimis exemption worldwide starting July 1, 2027. However, the administration is acting ahead of schedule, citing national emergencies related to illicit drug trafficking and “harmful trade loopholes.”
With all imports now subject to full screening, beauty brands must take proactive steps to ensure that all overseas manufacturers and suppliers are FDA-registered and compliant with the ever-changing US trade and cosmetics regulations. K-beauty brands, in particular, will face the most changes, now that the era of frictionless small-parcel imports is over. Regulatory scrutiny is increasing, and beauty brands need to stay up to date on the latest legislation to avoid disruptions.
