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There is not a well-established pharmacovigilance policy for herbal supplements, especially those for sexual dysfunction, weight loss, and recreational experiences. For example, the FDA reports that one-third of sexual enhancement products have been adulterated with pharmaceutical drugs (Bhagavathula et al., 2016). In consequence, the public is at risk for adverse reactions such as headaches, nausea, abnormal vision, and even death. Unfortunately, herbs remain to be inadequately monitored while the demand for these supplements continues to grow.
One possible solution is to create a separate set of regulations for products advertised as sexual dysfunction, weight loss, and recreational experience herbal supplements. For these herbs to be approved for consumer consumption, they must fulfill the following qualifications. First, the herbs must be safe according to the Botanical Safety Handbook, and if it is classified with possible adverse reactions from clinical trials or case reports, those adverse effects must be labeled on the container (Botanical Safety Handbook, n.d.). If the herb is not listed in the Botanical Safety Handbook, then the herb must be researched through Medline Plus for its safety (U.S. National Library of Medicine, n.d.). Once confirmed to be safe, then the herbs must go through DNA-barcoding for its final check. If they are the authentic herb, then the product can be approved for the market. Through these multiple qualifications, the goal is to create more steps to eliminate those who are in the market solely for monetary gain and do not have the time or patience to go through numerous approval stages sell their supplements to consumers.
However, there is an additional cost a company would have to set aside to afford this DNA testing. Depending on the financial status of merchant, paying $256 for 500 reactions with a Phire DNA extraction kit may or may not be costly (Molina et al., 2018). In addition, even with these rules, it is possible for sellers to rebrand their products to avoid these regulations. Ultimately, this policy will not be able to completely remove dangerous supplements from the market, but at least it can minimize the amount. For instance, a study in the Netherlands concluded that almost 75% of sexual enhancement herbal products contain experimental drugs (Bhagavathula et al., 2016). As a result, most of these supplements are imposters. The least this policy could do is lower this astronomical number to at least 50-25%. Overall, though it may remove adulterated herbs from the market, it may also remove genuine small businesses if they do not have the available funds or research expertise to determine the safety of their product.
The paper by Bhagavathula et al. highlights a serious issue regarding sexual enhancement supplements, they are assumed to be safe until deaths occur (Bhagavathula et al., 2016). As a result, the above policy implements pre-market checks in hopes of eliminating as many potentially dangerous products as possible. One solution they suggested was creating a global database with confirmed adulterated products along with their analytical methods to speed up the process of identifying product violations. As a whole, Bhagavathula et al. suggest heavier pharmacovigilance regulations and give examples of the harmful effects caused by adulterated ingredients, but they do not go into detail about what these regulations should include or possible pre-market procedures. I personally would like to know solutions or changes that need to be made to different regulations throughout the world, or at least in the U.S., to fully understand why the current regulations are failing, and why it is so easy to sell hazardous materials to the public. Beyond the scope of the paper, I would also like to know if there has been lobbying by major companies to prevent the FDA from executing stricter regulations for herbal products.
In the end, the weight-loss, sexual dysfunction, and recreational herbal supplements market is blossoming. For instance, in the U.S., approximately 15% of adults have taken weight-loss supplements (Barrea et al., 2019). In addition, recreational herbs such as cannabis have been employed by 11% of the adult U.S. population. However, this has created a market full of businesses waiting to take advantage of consumers for their own fortune. For example, synthetic cannabinoid products have infiltrated the market. Unfortunately, up to 17% of U.S. college students have used this synthetic toxin, which can cause adverse reactions such as respiratory difficulties, tachycardia, acute renal failure, psychosis, and cognitive impairment (Cohen & Weinstein, 2018). Ultimately, through these policy measures, the incident of illegitimate herbs can decrease. Perhaps there should be programs in school or college discussing the dangers of adulterated herbs, what to look out for, and the importance of seeking reliable sellers to purchase these products.
References
Barrea, L., Altieri, B., Polese, B., De Conno, B., Muscogiuri, G., Colao, A., Savastano, S., & Obesity Programs of Nutrition, Education, Research and Assessment (OPERA) Group (2019). Nutritionist and obesity: brief overview on efficacy, safety, and drug interactions of the main weight-loss dietary supplements. International journal of obesity
supplements, 9(1), 32–49. https://doi.org/10.1038/s41367-019-0007-3
Bhagavathula, A. S., Elnour, A. A., & Shehab, A. (2016). Pharmacovigilance on sexual
enhancing herbal supplements. Saudi Pharmaceutical Journal,24(1), 115-118.
Botanical Safety Handbook. American Herbal Products Association. (n.d.). Retrieved February 22, 2023, from https://www.ahpa.org/store_category.asp?id=11
Cohen, K., & Weinstein, A. M. (2018). Synthetic and Non-synthetic Cannabinoid Drugs and Their Adverse Effects-A Review From Public Health Prospective. Frontiers in public health, 6, 162. https://doi.org/10.3389/fpubh.2018.00162
Molina, J., Sherpa, C., Ng, J., Sonam, T., & Stuhr, N. (2018). DNA Barcoding of Online Herbal
Supplements: Crowd-sourcing Pharmacovigilance in High School. Open life sciences, 13,
48–55. https://doi.org/10.1515/biol-2018-0007
U.S. National Library of Medicine. (n.d.). Herbs and Supplements. MedlinePlus. Retrieved February 22, 2023, from https://medlineplus.gov/druginfo/herb_All.html
