MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

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 compared API adulterations in dietary supplements from the 10-year time period of 2007 through 2016 to the most recent 5-year period of 2017 through 2021. Its findings are alarming:

  • 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.
  • 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.
  • Sibutramine analogues, phenolphthalein (which was removed from the US market because of cancer risk), and fluoxetine were also included.
  • Muscle-building dietary supplements were commonly adulterated before 2016, but since 2017 no additional adulterated products have been identified.

The authors concluded that 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.

The problem of adulterated supplements is by no means new. A similar review published 4 years ago already warned that “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.”

These papers relate to the US where supplement use is highly prevalent. The harm done by adulterated products is thus huge. If we focus on Chinese or Ayurvedic supplements, the problem might even be more serious. In 2002, my own review concluded that adulteration of Chinese herbal medicines with synthetic drugs is a potentially serious problem which needs to be addressed by adequate regulatory measures. Twenty years later, we seem to be still waiting for effective regulations that protect the consumer.

Progress in medicine, they say, is made funeral by funeral!

 

5 Responses to Dietary Supplements Adulterated With Approved and Unapproved Drugs

  • Last paragraph, second sentence

    The arm done..
    should be
    The harm done

  • Yellow journalism again. The fact of the matter is that the vast majority of these problems are in weight loss and sexual enhancement supplements, a subsection of nutritional supplementation that is notoriously suspicious. For this subsection, most natural medicine advocates would agree with you, but your headline doesn’t convey this message.

    How convenient for you and how purposefully yellow.

    • Oh Dana, what a fool you are!
      Here is the title of the original paper:
      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

  • In the veterinary world, CBD supplementation seems to be the flavor of the day despite evidence of activation of the cytochrome p450 pathway in the liver of dogs and less than impressive clinical application results.

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6678684/

    https://www.vetsmall.theclinics.com/article/S0195-5616(18)30087-1/references

    So despite underwhelming evidence of effectiveness of CBD for any veterinary malady and also some evidence to support the potential to induce liver damage, CBD products (without analysis) are being widely marketed and sold as medications for companion animals using the deceitful language that the supplement industry uses to skirt regulation.

    Here in the US this company https://www.ellevetsciences.com/ seems to be the most recommended by members of the veterinary profession despite the extraordinary claims and paucity of evidence presented by the company on its website: here is an example of the extraordinary rhetoric:

    “The next step was answering the question, “Does this product actually work?”. After reaching out to multiple veterinary schools to see if there was interest in conducting a clinical trial with two unknown people, with a brand new company and a product that had never been tried, the partnership with Cornell and Dr. Joe Wakshlag was formed.

    The rest is history. Dr. Joe led the astoundingly successful first-ever clinical trial on dogs with joint discomfort, the first pharmacokinetic study, the first safety study, and the first published paper, which is now the most downloaded paper from the publisher of all time. The study was conducted in 2017 and to date, no other company has been able to prove efficacy. We are now 30 R&D projects deep and are making original discoveries which lead to making better and better products for dogs and cats.”

    I don’t think the “rest is history”, I think the rest is going to be needed to try to prove some unsubstantiated claims.

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