Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings | Complementary and Alternative Medicine | JAMA Network Open | JAMA Network
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    5 Comments for this article
    Supplement ingredients
    Ben Garcia |
    Great article. Where does a reader find the specific names of the supplements and their manufacturers that were identified as including unapproved ingredients? Surely people would like that information to see if they are taking something that has been banned.
    Squandered medical science
    ARS |
    The focus of this article is further profit of the pharmaceutical industry by proving otc products should be regulated. No point otherwise
    Pharmaceutical fraud
    Frederick Rivara, MD, MPH | University of Washington
    I was very surprised when I saw this study. These companies are committing fraud on the public. Will the FDA step up their efforts to better protect the public?
    CONFLICT OF INTEREST: Editor in Chief, JAMA Network Open
    renal toxicity
    Kunal Malhotra, MD | University of Missouri
    This study is very important from renal point of view. When seeing a patient with decreased GFR, we should ask history of supplements since these unapproved ingredients can lead to Acute Kidney Injury and Chronic Kidney disease. This is specially true for those with pre-existing renal disease. The first step should be to stop all supplements.

    Kunal Malhotra, MD, FASN, FNKF
    Illegal drugs are not dietary supplements
    Haley Chitty | American Herbal Products Association (AHPA)
    The American Herbal Products Association (AHPA) and its members share concerns about health risks presented by unapproved drugs masquerading as dietary supplements.

    However, the article does not make a clear distinction between unlawful, misbranded drugs and legal dietary supplements. Put simply, these products are illegal under current U.S. law and those who knowingly manufacture and distribute them are criminals.

    This is in stark contrast to the regulated dietary supplement industry which is committed to consumer safety. AHPA and its members fully support strict enforcement of all laws and regulations, including those that prohibit illegal, undeclared drugs from being
    sold in any product.

    Since 2011, AHPA has worked to keep consumers informed about illegal products that contain undeclared drug ingredients through our Keep Supplements Clean website. The website lists recalls and health advisories posted by FDA, and by international regulatory organizations in other countries including Canada, Australia, and the United Kingdom. The fact that this is an international concern demonstrates that the U.S. legal and regulatory structure for dietary supplements is not to blame for this issue.

    It is important for consumers to know the difference between these products and I encourage you to help educate your readers to make this distinction in future articles by refraining from identifying these fraudulent products as dietary supplements.
    CONFLICT OF INTEREST: AHPA is a non-profit association for herbal product companies
    Original Investigation
    Public Health
    October 12, 2018

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

    Author Affiliations
    • 1Food and Drug Branch, California Department of Public Health, Sacramento
    • 2California Epidemiologic Investigation Service (Cal EIS) Fellowship Program, Sacramento
    JAMA Netw Open. 2018;1(6):e183337. doi:10.1001/jamanetworkopen.2018.3337
    Key Points español 中文 (chinese)

    Question  What are the trends across adulterated dietary supplements associated with a warning released by the US Food and Drug Administration from 2007 through 2016?

    Findings  In this quality improvement study, analysis of the US Food and Drug Administration warnings from 2007 through 2016 showed that unapproved pharmaceutical ingredients were identified in 776 dietary supplements, and these products were commonly marketed for sexual enhancement, weight loss, or muscle building. The most common adulterants were sildenafil for sexual enhancement supplements, sibutramine for weight loss supplements, and synthetic steroids or steroid-like ingredients for muscle building supplements, with 157 products (20.2%) containing more than 1 unapproved ingredient.

    Meaning  Potentially harmful active pharmaceuticals continue to be identified in over-the-counter dietary supplements.


    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.