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Researchers warn of hazards of inadequately regulated dietary supplements

Posted 15 Jan 2024

After a review of several databases, researchers with Touro College of Pharmacy and Nova Southeastern University’s College of Pharmacy have identified a total of 79,071 reported adverse events related to the use of dietary supplements. The events were reported to U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) between 2004 and 2021. Their searches for adverse-event reports included the use of vitamin E (vitamin derivative), beta-sitosterol (plant sterol) yohimbine, kava kava, kratom, garcinia cambogia, herbal products, and OxyElite Pro (marketed for weight loss).

Key points made in their paper include:

  • Vitamin E supplementation has documented interaction with several routine medications.
  • Over a thousand adverse events regarding the use of a prostate support supplement called Super Beta Prostate containing beta-sitosterol were reported to CFSAN in the past two decades. Most of the reports involved finding blood in the urine.
  • Poison centers have received hundreds of reports of adverse events, some leading to hospitalizations linked to yohimbine use.
  • Kava kava has been linked to various symptoms and liver damage, in some cases leading to fatalities.
  • Kratom side effects include weight loss, dry mouth, liver damage, chills, change in urine, constipation, nausea, and vomiting. Poison control centers in the U.S. have received reports of spontaneous seizures, spikes in high blood pressure, and death among kratom users.
  • More than a thousand garcinia cambogia-related adverse events were documented from 2004 to 2021, with symptoms ranging from headache, nausea, and vomiting to liver injury or failure, and kidney disorders.

The researchers concluded:

Having only touched the surface of regulation, the FDA is in dire need of reform to control dietary supplements and prevent adverse effects through advancements in studies of efficacy and safety in addition to labeling updates emphasizing the potential harm stemming from use of these products. It is, therefore, highly recommended that this public health gap be closed by the FDA requiring safety and efficacy proof prior to marketing for supplements, as is done with most other health-related products. By implementing the same rigorous procedure of prescription medication review prior to marketing including preclinical research followed by clinical research and thorough FDA examination preceding approval and post-marketing monitoring, the significance in adverse events can be vastly reduced.

Li W, Wertheimer A.
Narrative review: The FDA’s perfunctory approach of dietary supplement regulations giving rise to copious reports of adverse events.

Innovations in Pharmacy, 14(1), 2023 DOI: https://doi.org/10.24926/iip.v14i1.4989

https://pubs.lib.umn.edu/index.php/innovations/article/view/4989

Abstract

Background: The Food and Drug Administration (FDA) originated from the passage of the 1906 Pure Food and Drugs act aimed to rein in the long-standing abuse in the consumer product marketplace. The act was passed to prohibit interstate commerce of misbranded and adulterated foods, drinks, drugs. Thus, promoting the FDA’s mission to protect the public health by regulating human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and tobacco to ensure safety, efficacy, and security. Progressing further in 1994, the Dietary Supplement Health and Education Act (DSHEA) was established designating specific label requirements, providing regulatory framework, and authorizing the FDA to promulgate good manufacturing practices for dietary supplements.  This act defined and classified “dietary supplements” and “dietary ingredients” as food requiring all over the counter products (OTC) products to consist of labeling that is easy to understand and meets the FDA quality, effectiveness, and safety standards. However, under the umbrella of OTC products, the FDA fell short in its regulation of the expansive dietary supplement market. The objective of this study is to discern how the lack of efficacy in the FDA’s regulations of OTC dietary supplements inevitably inspired more harm than benefit.

Methods: This review comprised of case studies including young adolescents and adult consumers who experienced adverse events from the use of dietary supplements. Products which showed highest prevalence in adverse event reports through the Food and Drug Administration CFSAN Adverse Event Reporting System (CAERS) included but not limited to; Vitamin E (vitamin derivative), Beta-sitosterol (plant sterol) Yohimbine, Kava Kava Kratom, Garcinia Cambogia, (herbal products) and OxyElite Pro (marketed weight loss product). The primary endpoint was evaluating the FDA’s regulations on dietary supplement safety protocols. The secondary endpoint was assessing the actions of the FDA in response to these case events.

Results: Overall, between 2004 to 2021, a total of 79,071 adverse events related to the use of dietary supplements were reported to the Center for Food Safety and Applied Nutrition. Vitamin E products for example, marketed for decades for their antioxidant benefits in turn have shown significant evidence of toxicity and an increased risk of bleeding outweighing its potential benefit. The FDA’s response was simply implementing a label guideline update, yet this update had evidence of minimal effect as the number of cases gradually continued to increase. Likewise, herbal products such as Kava Kava, Yohimbine, Kratom, and Garcinia Cambogia, in addition to weight regulating products, such as OxyElite Pro and HydroxyCut, have been linked to organ failure, hepatic, renal, cardiac toxicity, and death respectively. The FDA merely responded through instating public consumer warnings of their effects with consumption and limited recalls of certain products.

Conclusion: With the easy accessibility of these products, the general public is more inclined to its use without proper guidance and monitoring from their healthcare team, posing as a major concern for possible interactions, contraindications and unfavorable outcomes. With proper implementation of stringent regulations post findings from increased studies on efficacy and safety, cases of adverse events could have been reduced significantly or averted completely. The FDA’s minimalistic efforts consisting of only post-marketing monitoring and retrospective actions of label modifying have time and time again shown flaws as seen in the growing series of reports. By emending the over-the-counter supplement review process to reflect that of prescription medication, the magnitude of adverse events can be diminished. The process should include preclinical research in addition to clinical research, FDA thorough examination of data prior approval and post marketing surveillance.

 

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