The US Food and Drug Administration (FDA) has established a “green list” import alert to protect the US market from potentially hazardous glucagon-like peptide-1 (GLP-1) active pharmaceutical ingredients (APIs), such as semaglutide and tirzepatide, from unverified foreign sources.
Demand for the APIs, used in weight-loss and diabetes treatments, has been booming, leading to concerns about adulterated ingredients and counterfeits.
Under the new policy, introduced on 5 September 2025, APIs from FDA-inspected or evaluated facilities will be included on the green list, highlighting firms and products that have met compliance criteria and are not subject to automatic seizure at US ports.
All other imported APIs will be subject to detention without physical examination (DWPE) until proof of compliance is presented.
Of the 48 foreign manufacturing sites reviewed, 21% failed to meet FDA compliance standards, prompting their exclusion from the green list. Sources from Belgium, Canada, China and India, among others, were found to meet the criteria.
“Americans should be confident that the prescription drugs they take are safe,” said FDA Commissioner Marty Makary.
George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research, added that “targeting illegal foreign GLP-1 active ingredients at the border is a critical part of this work”.
The FDA flagged specific risks tied to compounded versions of semaglutide and tirzepatide, including dosing mistakes, use of unapproved salt forms and adverse events, some which have led to hospitalisation.
Potential price hikes, supply chain disruptions
Analysts note that the FDA’s action has a direct impact on companies involved in pharmaceutical compounding and importing. While the measure is designed to protect public health, smaller compounding pharmacies that have previously relied on cheaper, unverified foreign APIs may face disruptions to their supply chains.
These smaller companies will now need to source ingredients from FDA-approved manufacturers on the green list, which may raise costs and affect their ability to compete on price with larger licensed drug companies.
Industry observers also point out that the move indirectly protects major pharmaceutical companies such as Novo Nordisk and Eli Lilly, whose patented products were facing competition from these cheaper compounded versions.
Trade experts suggest that wider tariff policies would add to these challenges. While the Trump administration has recently announced tariff exemptions for certain pharmaceutical compounds from “aligned partners”, a broader policy of reciprocal tariffs could increase the cost of importing even compliant APIs.
However, on 25 September, US President Donald Trump announced on Truth Social that he would introduce a new round of 100% tariffs on imported brand drugs from 1 October. He added that the tariffs would not apply to pharmaceutical companies that build manufacturing plants in the US.
Pharmaceutical companies are now under pressure to absorb higher costs or pass them on to consumers, a situation that could worsen shortages and fuel further price rises.