US Edition
US FDA tightens control over obesity drug ingredient imports amid safety concerns
The FDA's green list covers 21% non-compliant foreign manufacturing sites to prevent unsafe compounded GLP-1 drugs for diabetes and weight loss from entering the market.
- On Friday, September 5, 2025, the U.S. FDA established a green list import alert to block unverified GLP-1 drug ingredients from entering the U.S. market.
- This measure addresses safety issues and limited availability of authorized GLP-1 medications, such as those containing semaglutide and tirzepatide, amid rising use of unapproved compounded alternatives.
- The FDA inspected 48 manufacturing facilities located outside the United States, identifying 21% as failing to meet compliance standards, while firms from countries including Belgium, Canada, China, and India that satisfied requirements were placed on a green list and exempted from automatic border detention.
- FDA Commissioner Marty Makary emphasized that the agency is committed to ensuring the safety of prescription medications by enhancing oversight of imported APIs and intensifying efforts to prevent illegal drug imports.
- Legislators called on the FDA and Customs to issue import alerts and intensify enforcement against unsafe GLP-1 drugs being brought into the U.S. from China, emphasizing the need to safeguard consumers and the drug supply.
55 Articles
55 Articles
FDA Tightens Grip On Safe Weight Loss Drugs, WHO Adds Them To Essential Medicines List - Novo Nordisk (NYSE:NVO), Eli Lilly (NYSE:LLY)
The U.S. Food and Drug Administration on Friday established a "green list" import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market. Certain GLP-1 drugs, including Novo Nordisk A/S’ (NYSE:NVO) semaglutide and Eli Lilly and Co.’s (NYSE:LLY) tirzepatide, are FDA-approved for specific uses such as treating type 2 diabetes an…
FDA's green list cracks down on illegal imported drug ingredients
The Food and Drug Administration is cracking down on ingredients from potentially from unverified foreign sources and that could be used in GLP-1 drugs that include Wegovy, Ozembic and Mounjaro.
InsideNoVA.com
FDA Creates 'Green List' of GLP-1 Drug Ingredients Approved for Entry in the U.S.
FRIDAY, Sept. 5, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has created a "green list" import alert to stop unapproved and unverified glucagon-like peptide 1 (GLP-1) drug ingredients from entering the United States.
FDA Tightens Control Over Obesity Drug Ingredient Imports Amid Safety Concerns
The U.S. Food and Drug Administration is tightening oversight of imports of GLP-1 drug ingredients, used for weight loss and diabetes, amid concerns that many of the items may be adulterated and pose a safety risk.The move comes as the FDA cracks down on unapproved compounded drugs, which had filled the gap during shortages of patented treatments. Soaring demand for Novo Nordisk and Eli Lilly’s obesity drugs has fueled a booming global market fo…
FDA Tightens Grip On Safe Weight Loss Drugs, WHO Adds Them To Essential Medicines List
The U.S. Food and Drug Administration on Friday established a "green list" import alert to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the U.S. market. Certain GLP-1 drugs, including Novo…
Coverage Details
Bias Distribution
- 35% of the sources are Center, 35% of the sources lean Right
Factuality
To view factuality data please Upgrade to Premium
