FDA Finds Nearly 800 Supplements with Unapproved Ingredients

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A study of US Food & Drug Administration data has found that nearly 800 over-the-counter supplements contained unapproved ingredients1.

Many supplements for erectile dysfunction were found to contain sildenafil or tadalafil. Since the herbal supplements have little or no impact on ED, manufacturers include small amounts of actual drugs to convince purchasers that the supplements are helping. (See our article on Herbal Remedies for ED.)

Unlisted ingredients and contaminants can cause serious adverse health effects . One study found that dietary supplement use was associated with 23,000 emergency department visits and 2,000 hospitalizations in the United States each year2.

Previous studies have found that up to 50% of herbal supplements do not even contain the supposed main ingredient. Since 2015, the FDA has released public warnings on more than 160 ED supplements and “male enhancement” products found to contain dangerous ingredients and contaminants.

Most herbal supplements are produced in 3rd-world countries, and packaged for distribution under various brand names in the United States. Growers often use chemical pesticides, and there is no testing for contamination.

More than 50% of American adults use dietary supplements, a $35 billion industry.

References

  1. Tucker, J; Fisched, T. Upjohn, L. “Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings.” JAMA Network Open. Oct 2018.
    <https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496>
  2. Geller, AI; Shehab, N; Weidle, NJ. “Emergency department visits for adverse events related to dietary supplements.” New England Journal of Medicine. Oct 2015. 373:1531-1540 DOI: 10.1056/NEJMsa1504267/
    <https://www.nejm.org/doi/full/10.1056/nejmsa1504267>

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