New U.S. Customs Rule Ends Duty-Free Mail Shipments, Impacting Access to Canadian Prescription Drugs
A U.S. Department of Homeland Security order effective October 22 removes the de minimis exemption for mail shipments valued at $800 or less. This change ends duty-free treatment and requires formal customs clearance, significantly increasing costs for Americans who rely on Canadian pharmacies for affordable prescription drugs.
A new regulation from the U.S. Department of Homeland Security, effective Oct. 22, eliminates the "de minimis exemption" for international mail shipments arriving in the United States with a stated value of $800 or less. Under the previous rules, these small-value packages were exempt from tariffs and investigations, allowing them to bypass formal customs processes. The new order mandates that such shipments now undergo full customs clearance and are subject to duties.
The policy shift has immediate consequences for patients who import medication from Canada. Diamantina Cavazos, a project manager based in Dallas, currently pays approximately $10 per week for Xifaxan through an online Canadian pharmacy. Following the implementation of the new rule, her cost is projected to rise to about $1,100 per week because she cannot get the drug covered by her U.S. insurer. Without insurance, the retail price for brand-name Xifaxan 550 mg in the U.S. ranges from $59 to $65 per tablet, averaging between $2,800 and $3,800 for a typical 42-tablet course. In contrast, the same medication generally costs between $11.30 and $17.50 per pill in Canada.
Xifaxan is patented by a subsidiary of Bausch Health, an international pharmaceutical company headquartered in Laval, Quebec. Although the initial patents expired in 2024, regulatory extensions were granted until 2029 due to new formulations developed for treating encephalopathy.
The origin of this trade measure traces back to February 2025, when President Donald Trump issued a presidential order declaring a national emergency regarding illicit drugs crossing the Northern Border. This order included suspending duty-free de minimis treatment for low-value packages as part of efforts to curb flows of substances like fentanyl. However, the policy has evolved into a broader trade measure affecting all small international mail packages, including personal importations of prescription medications.
Canada Post has warned that all postal shipments up to US$800 in value destined for the U.S. now require duties to be assessed and prepaid before crossing the border. Tim Smith, general manager of the Canadian International Pharmacy Association (CIPA), noted that member pharmacies have been shipping products to the U.S. for 25 years to assist individuals needing low-cost drugs not covered by their health-care insurance.
While the policy was intended to tackle illicit drug imports, its impact on fentanyl smuggling is expected to be non-existent. Instead, the unplanned consequence deprives millions of U.S. patients of access to low-cost essential pharmaceuticals, creating an impending deadline that could abruptly cut off their prescription supply.