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FDA tightens import controls on obesity drug ingredients amid safety concerns

FDA tightens import controls on obesity drug ingredients amid safety concerns

The Food and Drug Administration (FDA) in the USA has intensified its scrutiny of imports containing GLP-1 drug ingredients, widely used in treatments for weight loss and diabetes, following increasing concerns over safety and quality. Rising demand for obesity medicines from companies such as Novo Nordisk and Eli Lilly has spurred a flood of cheaper or unregulated alternatives, some of which have been linked to inaccurate dosing, unapproved formulations and serious side effects.

Under a newly issued import alert, the FDA now has the authority to detain shipments at USA ports without physical inspection, blocking potentially unsafe products before they enter the supply chain. Importers will be required to provide clear evidence of quality before their consignments are released.

An FDA review of 48 overseas manufacturing facilities found that around 21 per cent failed to comply with regulatory standards. To balance enforcement with efficiency, the agency has also introduced a “green list” of vetted suppliers — covering manufacturers in countries such as Belgium, Canada, China and India — whose shipments will not be subject to automatic detention.

More news about: drug discovery & development | Published by Darshana | September - 06 - 2025 | 287

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