Despite Warnings, Many Supplements Still Contain Undeclared Ingredients

Despite FDA warnings, unapproved, potentially dangerous active pharmaceutical ingredients continue to be identified within dietary supplements, according to a recent report.

The unapproved ingredients were most prominently identified in supplements labeled for sexual enhancement or weight loss.

More than 50% of adults in the US have reported consuming dietary supplements, according to the study authors. However, warnings from the FDA of potential undeclared, unapproved pharmaceutical ingredients have not been comprehensively analyzed for recent years.

In order to investigate and summarize trends of unapproved ingredients in relation to FDA warnings from 2007 through 2016, the researchers conducted a quality improvement study using data extracted from the FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database from 2007 to 2016.

Overall, they found that 776 adulterated dietary supplements were identified by the FDA (from 146 different dietary supplement companies) from 2007 through 2016. Of these, 353 were marked for sexual enhancement, 217 for weight loss, and 92 for muscle building, with 157 containing more than 1 unapproved ingredient. The most common adulterants were sildenafil for sexual enhancement supplements (166 of 353), sibutramine for weight loss supplements (269 of 317), and synthetic steroids or steroid-like ingredients for muscle building supplements (82 of 92).

Further, 28 products were named in 2 or 3 warnings issued more than 6 months apart. Of these, 19 were found to contain new unapproved ingredients in the second or third warning.

“The active pharmaceutical ingredients identified in dietary supplements are present at unknown concentrations and have not been characterized as safe and effective by the FDA, making them unapproved drugs. These products have the potential to cause severe adverse health effects owing to accidental misuse, overuse, or interaction with other medications, underlying health conditions, or other drugs within the same dietary supplement. As the dietary supplement industry continues to grow in the United States, it is essential to further address this significant public health issue.”

—Michael Potts

Reference:

Tucker J, Fischer T, Upjohn L, et al.

Unapproved pharmaceutical ingredients included in dietary supplements associated with us food and drug administration warnings [published online October 12, 2018]. JAMA Network Open. doi:10.1001/jamanetworkopen.2018.3337.