Hidden Drug Ingredients, Recalls & Distributor Responsibility
Distributors are responsible for the products they sell
FDA just posted six warning letters involving unapproved drugs and hidden-drug safety concerns. There is a lot to learn here, including repeat alerts, distributor responsibility, and disease claims translated from Chinese product labels.
In five of these letters, FDA reviewed the companies’ websites following an earlier alert, such as a recall, about products previously flagged for hidden drug ingredients. This suggests FDA likely searched for the drug-spiked products, and when it found them after the alerts, it looked deeper with more testing or cited website claims, which led to the letters. If these companies had acted on the alerts and removed the product from commerce, they may have avoided these letters.
For example, FDA warned about a drug-spiked product called Tawon Liar three times over the past few years! This is kind of insane, as one drug-spiked warning is too much, and three times is very sad! The most recent FDA warning was in May, and then FDA found this company to be selling it several months later.
In this warning letter, FDA cited disease claims written in Chinese on the label. I always get so excited when I see references to translated disease claims, as this is somewhat uncommon. Reviewing the English copy alone would miss this part of the compliance picture, so understanding claims, even the foreign language claims, is important. Those letters cite treatment claims supporting unapproved-drug violations and separately raise concerns about products with earlier hidden-drug findings.
From one of the warning letters. “It is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients”
The letters don’t prove these sellers held previously recalled lots. But prior alerts and recalls are good reasons to investigate your inventory and suppliers, especially when you carry a large catalog.
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