Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings

Abstract

Importance: Over half of adults in the United States report consuming dietary supplements. The US Food and Drug Administration (FDA) has warned of numerous dietary supplements containing undeclared, unapproved pharmaceutical ingredients. These FDA warnings have not been comprehensively analyzed for recent years.

Objective: To summarize trends across adulterated (containing unapproved ingredients) dietary supplements associated with a warning released by the FDA from 2007 through 2016.

Design, setting, and participants: In this quality improvement study, data were extracted from the FDA's Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database from 2007 through 2016. Data from each warning were recorded unless multiple warnings were issued for the same product within a 6-month period. Date, product name, company, hidden ingredient(s), product category, source of sample, and warning document type were recorded for each included warning. Data analysis was conducted from February 2017 to June 2017.

Results: From 2007 through 2016, 776 adulterated dietary supplements were identified by the FDA and 146 different dietary supplement companies were implicated. Most of these products were marketed for sexual enhancement (353 [45.5%]), weight loss (317 [40.9%]), or muscle building (92 [11.9%]), with 157 adulterated products (20.2%) containing more than 1 unapproved ingredient. The most common adulterants were sildenafil for sexual enhancement supplements (166 of 353 [47.0%]), sibutramine for weight loss supplements (269 of 317 [84.9%]), and synthetic steroids or steroid-like ingredients for muscle building supplements (82 of 92 [89.1%]). There were 28 products named in 2 or 3 warnings more than 6 months apart. Of these products, 19 (67.9%) were reported to contain new unapproved ingredients in the second or third warning, consistent with the assumption that the FDA found the product to be adulterated more than once. In recent years (2014-2016), 117 of 303 adulterated samples (38.6%) were identified through online sampling and 104 of 303 (34.3%) were identified through the examination of international mail shipments.

Conclusions and relevance: Active pharmaceuticals continue to be identified in dietary supplements, especially those marketed for sexual enhancement or weight loss, even after FDA warnings. The drug ingredients in these dietary supplements have the potential to cause serious adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other pharmaceuticals within the supplement.

Figure 1.. Products in the US Food and Drug Administration’s Tainted Supplements Database by Marketing Category, 2007 Through 2016

Data from the US Food and Drug Administration’s Tainted Products Marketed as Dietary Supplements_CDER (Center for Drug Evaluation and Research) database.

Figure 2.. Undeclared Ingredients Identified in 353 Sexual Enhancement Products From the US Food and Drug Administration’s Tainted Supplements Database, 2007 Through 2016

Data from the US Food and Drug Administration’s Tainted Products Marketed as Dietary Supplements_CDER (Center for Drug Evaluation and Research) database. PDE5 indicates phosphodiesterase-5.

Figure 3.. Undeclared Ingredients Identified in 317 Weight Loss Products From the US Food and Drug Administration’s Tainted Supplements Database, 2007 Through 2016

Data from the FDA’s Tainted Products Marketed as Dietary Supplements_CDER (Center for Drug Evaluation and Research) database.

Figure 4.. Warnings Associated With Products in the US Food and Drug Administration’s Tainted Supplements Database, 2007 Through 2016

Data from the US Food and Drug Administration’s Tainted Products Marketed as Dietary Supplements_CDER (Center for Drug Evaluation and Research) database.