Regulatory Analysis
FDA regulatory intelligence, warning letter breakdowns, and actionable analysis for brands across all FDA-regulated categories.
FDA Has Sent Amazon Nine Warning Letters Since 2022. The Newest One Names Fulfillment by Amazon.
FDA has issued nine warning letters to Amazon.com since August 2022, every one alleging the same violation: unapproved new drugs introduced into interstate commerce. The June 2026 letter changes the theory — it ties the violation to Fulfillment by Amazon. Here is what that means for third-party sellers.
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FDA Sent 25 Telehealth Companies the Same Letter on the Same Day. The Violation Was Their Website Copy.
On June 8, 2026, FDA sent 25 telehealth companies warning letters over compounded semaglutide and tirzepatide. No inspection took place — FDA read their websites. Two specific marketing claims did most of the damage, and one of them appears in almost every direct-to-consumer health brand's copy.
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FSVP Warning Letters Hit a Three-Year High: 15 in Four Months and the One Mistake Every Importer Made
FDA issued 15 FSVP warning letters in the first four months of 2026, a 67% jump over the same period in 2024. Almost every recipient made the same mistake. Here is the pattern and what importers should do this week.
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30 FDA Warning Letters in a Day: Inside the GLP-1 Compounding Crackdown and the Case That Sent Three Patients to the ER
The FDA issued 30 warning letters to compounded GLP-1 telehealth companies on March 3, 2026. One documented ER visits from bacterial endotoxin contamination. A deep-dive into the violations—and what every compounding pharmacy must do now.
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