The Polypharmacy Network

Polypharmacy Prevention
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Dietary Supplements
By: Demetria Antimisarias PharmD

Dietary supplemenrts are an easy to access resource for treating health problems. Fortunately, if you have vitamin D deficiency and are concerned about osteoporosis, you can purchase calcium and vitamin D supplements without obtaining a prescription. This means that as a consumer, people must work diligently to understand what the products contain, what their benefits are, what happens if too much is taken, what the long term and short-term effects might be and where to source information. [1-5]

Challenges with dietary supplements supply chain in the United States

Unlike prescription and over the counter medications, over the counter dietary supplements in the United States are not subject to FDA regulation. For prescription and over the counter medications, the FDA consistently spot checks quality assurance and manufacturing processes as well as ingredients to ensure that what is on the label is what is in the product container.

With herbal dietary supplements in the United States (we are stating the United States because we are not aware of policies and regulations in other countries), technically, the product inside the container is not necessarily the same product or the same strength, as listed on the label. The reason is that they are not subject to the same FDA regulation as prescription medications and over the counter medications. The FDA regulates dietary supplements under a different set of regulations called the “Dietary Supplement Health and Education Act of 1994 (DSHEA)”. This regulation places the responsibility for safety and labeling on the firms doing the manufacturing.

Please see the FDA website for more information: FDA.gov / Food and DietarySupplements ↗

What this means is that raw ingredients can come from sources around the world with inconsistent surveillance of content and strength. The potential for problems in manufacturing is heightened with herbal and dietary supplements such as that experienced with the highlighted valsartan case in this article.

One common example of tainted dietary supplements is sexual enhancement products. The FDA website has a special webpage highlighting the problem which can be found here: FDA.gov / Tainted Sexual Enhancement Products ↗

When you click on any of the reports you; will read that FDA laboratory analysis found these products contained actual sildenafil (the active ingredient in Viagra®) instead of the herbal product advertised on the label. Sildenafil can cause sudden cardiac death and be potentially very dangerous for persons taking nitrates and with underlying cardiovascular disease.

Here is one example: FDA.gov / Public Notification: Platinum Rhino 25000 contains hidden drug ingredient ↗

Lastly, dietary supplements should be sourced by reputable and high-quality manufacturers. The more you can know about the manufacturer, the better.

The USP (United States Pharmacopeia) verified dietary supplements (USP emblem on bottle) means the manufacturer voluntarily agrees for quality assurance spot checks to ensure product inside container is what is listed on the label.

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  1. Felix, T.M., K.D. Karpa, and P.R. Lewis, Adverse Effects of Common Drugs: Dietary Supplements. FP Essent, 2015. 436: p. 31-40.
  2. Wang, C.Z., J. Moss, and C.S. Yuan, Commonly Used Dietary Supplements on Coagulation Function during Surgery. Medicines (Basel), 2015. 2(3): p. 157-185.
  3. Yu, S. and I. Paetau-Robinson, Dietary supplements of vitamins E and C and beta-carotene reduce oxidative stress in cats with renal insufficiency. Vet Res Commun, 2006. 30(4): p. 403-13.
  4. Montgomery, A.E., et al., Evaluation of Point-of-Care Resources for Dietary Supplement Information. J Evid Based Integr Med, 2018. 23: p. 2515690X18764844.
  5. Shields, K.M., C.E. McQueen, and P.J. Bryant, National survey of dietary supplement resources at drug information centers. J Am Pharm Assoc (2003), 2004. 44(1): p. 36-40.