FDA Cracks Down on Imported Obesity Drug Ingredients Amid Safety Fears

The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, which are used for weight loss and diabetes, following fears that many of the items may be adulterated and pose a safety risk.

The news comes amid the FDA’s crackdown on unapproved compounded drugs, which had been filling the gap during shortages of patented treatments.

Soaring demand for Novo Nordisk and Eli Lilly’s obesity drugs has fueled a booming global market for cheaper, and sometimes counterfeit, versions.

According to the health regulator, there are serious concerns with compounded weight-loss drugs, including dosing errors, use of unapproved salt forms, and dangerous side effects, with some requiring hospitalization.

JP reports:

As part of its heightened scrutiny, the FDA sent an import alert on Friday authorizing detention without physical examination (DWPE) at U.S. ports. This will allow the agency to seize shipments that appear to be non-compliant with federal requirements, without inspecting them on arrival.

Importers must now provide proof of quality and compliance before their goods are released.

The FDA evaluated 48 manufacturing sites outside the U.S. and found that 21% of them were non-compliant.

The regulator will also maintain a separate “green list” — identifying firms or products that have resolved compliance concerns and are not subject to automatic detention at the border.

Under the “green list”, the agency identified sources in Belgium, Canada, China, and India, among others, that met its criteria and are excluded from DWPE.