On September 19, 2025, the FDA issued Import Alert 66-80, which authorizes field staff to detain without physical examination shipments of GLP-1 active pharmaceutical ingredients (APIs) from manufacturers not included on its newly established “Green List.”[1]
This action follows FDA’s September 5th announcement of the Green List initiative to curb illegal imports of semaglutide, tirzepatide, and other corresponding APIs.[2] Together, the Green List and Import Alert form FDA’s most aggressive enforcement measures to date against GLP-1 imports.
The FDA’s Green List
FDA announced the creation of a “Green List” on September 5, 2025, intended to prevent the entry of unsafe GLP-1 APIs into the U.S. markets. This List identifies foreign manufacturers that FDA has inspected or evaluated and found to be in apparent compliance with current good manufacturing practice (cGMP) standards. GLP-1 APIs from any other source are automatically subject to detention without physical examination.
FDA Import Alerts
An Import Alert is a tool used by FDA to flag products with a history of violations so that field offices are on notice of potential risk. Once a product is placed on import alert, FDA staff may hold incoming shipments without conducting physical testing or inspection—a process known as detention without physical examination—or “DWPE”, as mentioned above. This mechanism enables the agency to quickly block potentially unsafe or noncompliant products from entering U.S. market.
The FDA has broad authority under federal law to regulate the importation of drugs and APIs, including the power to issue DWPEs. Import Alerts are tailored to risk, and once issued, importers bear the burden of demonstrating that their products meet FDA’s quality and safety standards before release.
FDA’s Reasoning
The FDA explained that these enforcement measures were necessary because the recent semaglutide and tirzepatide shortage had resulted in increased compounding by pharmacies using APIs from overseas suppliers of questionable quality. The agency highlighted risks including dosing errors, contamination, and the use of unapproved salt forms in compounded versions, some of which resulted in adverse events requiring hospitalizations.[3]
This followed previous statements by the FDA concerning unapproved GLP-1 drugs used for weight loss, including concerns with compounded versions of the drug, fraudulent compounded GLP-1 drugs, and versions sold falsely for research purposes or not for human consumption.[4]
Import Alert 66-80 now ties enforcement to the Green List by authorizing detention without physical examination of GLP-1 API shipments from non-listed firms. Manufacturers may petition FDA for inclusion on the Green List, but this requires providing robust evidence of compliance with cGMP standards, including Certificates of Analysis, process validation, and detailed manufacturing records.
Key Provisions of Import Alert 66-80
The FDA’s Import Alert 66-80 included several provisions that will squarely impact pharmacies and API importers, alike.
- Enforcement Authority: FDA divisions may now detain GLP-1 API shipments if the manufacturer does not appear on the Green List.
- Targeted APIs: Import Alert 66-80 applies to GLP-1 receptor agonist bulk drug substances, including semaglutide, tirzepatide, liraglutide, exenatide, dulaglutide, and related peptides.
- Green List: Agency has specified that requests for removal from DWPE (i.e., placement on the Green List) should include information to adequately demonstrate that the requestor has in place appropriate measures to overcome the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.
Detention of Goods at the Border
What is a detention?
If FDA or U.S. Customs and Border Protection (CBP) determines that a product offered for import appears to violate federal regulations, the shipment may be detained prior to entry for further review. In such cases, FDA issues a Notice of Detention and Hearing to the responsible parties, outlining the alleged violations and setting a deadline for submission of evidence to rebut the agency’s findings.
Typically, the notice is directed to the shipment’s owner or consignee, though the importer of record may also provide information on the firm’s behalf. Legal counsel or another designated representative may respond, provided the responsible party has authorized that representation in writing directly to FDA.
What is the correct strategy for addressing a detention?
To address a detention, importers must act promptly. The FDA generally allows 10 business days (or up to 20 calendar days) to submit evidence of compliance or request corrective actions, such as relabeling or reconditioning. Failure to respond within the deadline usually results in a refusal of admission, which is final and cannot be appealed. Timely engagement with the FDA is, therefore, critical to avoid such outcomes.
A refusal of admission is FDA’s final determination that a shipment violates U.S. law. Once refused, the importer must either export or destroy the goods within 90 days under FDA and/or CBP oversight. Products commonly refused include those found to be adulterated, misbranded, containing unapproved ingredients, or violative of a third party’s intellectual property rights. Importers that fail to comply risk liquidated damages under their customs bond, which can be as much as three-times the then current commercial – not declared – values of the goods. This can lead to very large amounts being owed to CBP.
If a case reaches the liquidated damages stage, it is important to work with experienced legal counsel who can petition CBP for mitigation (i.e., reduction) of liquidated damages, under certain circumstances. This can result in significant monetary savings for a client.
How Frier Levitt Can Help
At Frier Levitt, we understand the challenges of operating in a fast-evolving regulatory environment. Our team works closely with businesses to resolve any import compliance issues related to FDA-regulated goods. This includes importation of food, drugs, biologics, dietary supplements and medical devices. By combining deep regulatory knowledge with practical industry insight, we provide tailored guidance that helps clients reduce risk, protect their brands, and conduct their business with clarity and confidence in this highly regulated and changing environment. Contact us for assistance.
[1] U.S. Food & Drug Admin., Import Alert 66-80: Detention Without Physical Examination of GLP-1 Bulk Drug Substances (Sept. 19, 2025)
[2] https://www.fda.gov/news-events/press-announcements/fda-launches-green-list-protect-americans-illegal-imported-glp-1-drug-ingredients
[3] Id.
[4] https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
Senior Associate
