Continued Risk of Dietary Supplements Adulterated With Approved and Unapproved Drugs: Assessment of the US Food and Drug Administration's Tainted Supplements Database 2007 Through 2021

Abstract

The US Food and Drug Administration created the Tainted Dietary Supplement Database in 2007 to identify dietary supplements adulterated with active pharmaceutical ingredients (APIs). This article compares the determination of API adulteration in dietary supplements from the 10-year time period of 2007 through 2016 to the most recent 5-year period of 2017 through 2021. From 2007 through 2021, 1068 unique products were found to be adulterated with APIs. Sexual enhancement and weight loss dietary supplements are the most common products adulterated with APIs. Phosphodiesterase-5 inhibitors are commonly included in sexual enhancement dietary supplements and a single product can include up to 5 APIs. Sibutramine, a drug removed from the market due to cardiovascular adverse events, is the most included adulterant API in weight loss products, although sibutramine analogues, phenolphthalein (which was removed from the US market because of cancer risk), and fluoxetine were also included. While muscle-building dietary supplements were commonly adulterated before 2016, since 2017 no additional adulterated products have been identified. The lack of disclosure of APIs in dietary supplements, circumventing the normal procedure with clinician oversight of prescription drug use, and the use of APIs that are banned by the Food and Drug Administration or used in combinations that were never studied are important health risks for consumers.

Keywords: Food and Drug Administration; adulteration; clinical pharmacology (CPH); dietary supplement safety; drug-food interactions.