Understanding the Dangers of Nutraceuticals and Dietary Supplements
Although these compounds are marketed as health products, a lack of regulation complicates patient safety and comprehensive research on the formulations.
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- Throughout the past few decades, the healthcare industry has seen the emergence of a new class of treatments: nutraceuticals. A cross between nutrition and pharmaceuticals, the term nutraceutical was coined by Stephen DeFelice, MD, in 1989.
This class of compounds is a formulated nutrient that can prevent or treat a condition. Despite differing industry definitions, nutraceuticals and dietary supplements are often lumped into one category and sold alongside over-the-counter medications.
However, unlike over-the-counter pharmaceuticals, these products are poorly regulated, without independent pre-market evaluations from the United States Food and Drug Administration (FDA). As a result, nutraceuticals and nutritional supplements have been linked to heterogeneous outcomes.
The wellness industry's proliferation of nutraceuticals and dietary supplements has threatened consumer health. According to an article in the Scientific American, the global nutraceuticals market was valued at $400 billion in 2021.
Companies must understand the regulatory implications before making broad claims about supplements or food ingredients. Beyond that, healthcare providers and public health experts must know the potential dangers of nutraceutical and dietary supplement advertising, use, and insufficient regulation.
In this article, PharmaNewsIntelligence explores nutraceuticals, dietary supplements, and how regulatory ambiguity can impact the healthcare landscape and consumer or patient health.
What Are Nutraceuticals?
Understanding what nutraceuticals are and how they differ from dietary supplements — despite the terms being used interchangeably — is critical to explaining the potential benefits and risks associated with these compounds.
Nutraceuticals may include vitamins, minerals, amino acids, herbs, and botanicals that can be consumed as pills, capsules, tablets, or liquids. The products can consist of a single or combination of probiotics, prebiotics, food supplements, protein supplements, functional foods, or herbal supplements. The Expert Review of Clinical Pharmacology defines nutraceuticals as a phytocomplex derived from plant products and secondary metabolites from animal products.
The most common nutraceuticals are derived from fruits and vegetables. Often, nutraceuticals have antioxidant or anti-inflammatory properties that can minimize or manage chronic diseases, including cardiovascular disease, diabetes, cancer, and osteoporosis.
While nutraceutical is not defined by US law, the term has been used across the healthcare and wellness industry to identify products derived from food that can promote human health beyond fulfilling dietary needs.
“A nutraceutical is a food or part of a food such as a dietary supplement that has a medical or health benefit including the prevention and treatment of disease,” DeFelice told Health E-Insights.
Although nutraceutical products are often lumped with dietary supplements, the primary difference is that nutraceuticals must provide additional health benefits, such as managing or preventing a condition. Beyond that, nutraceutical research involves understanding the product’s safety, efficacy, and toxicity.
According to the Annual Review of Pharmacology and Toxicology, the most commonly used dietary supplements are multivitamins, mineral supplements, calcium, and omega-3 or fish oil. But researchers explain in Nutrients that identifying a nutraceutical among dietary supplements starts with acknowledging an epidemiological target that the nutraceutical addresses beyond nutrient deficiencies.
Once the target is identified, in-depth safety and efficacy studies should be used to provide evidence-based data before the product is applied in healthcare settings.
The Role of Nutraceuticals in the Pharmaceutical Industry
The intersection of the pharma and nutraceutical industries can be a vital starting point for integrating nutraceuticals into the healthcare industry using evidence-based, effective strategies. Nutraceuticals may be incorporated into the pharmaceutical sector through drug development, complementary and alternative therapies, or research and development (R&D).
According to a 2022 article in Nutrients, some nutraceutical products, such as omega-3s, aloe vera, seaweed, wheatgrass, ginseng, and echinacea, have clinical trial data supporting their incorporation into treatment plans.
Nutraceuticals can play multiple roles in the healthcare and pharmaceutical industries, with applications in preventative healthcare, supplementation, managing chronic diseases such as hypertension, atherosclerosis, obesity, functional foods, R&D, and more. Some researchers theorize that nutraceutical integration into healthcare can delay the use of pharmaceuticals to manage disease.
However, there is not enough data to support the claims made by all dietary supplements to classify them as a nutraceutical.
“The main issue regarding the proper and effective use of nutraceuticals in prevention and therapy is linked to the lack of clinical data substantiating in full their efficacy, which prevents the obtainment and use on the label of a health claim,” noted researchers in Expert Review of Clinical Pharmacology.
Nutraceutical and Dietary Supplement Regulations
According to an article in the Annual Review of Pharmacology and Toxicology, more than 70% of people in the United States consume dietary supplements daily as the industry grows.
However, one of the significant challenges of dietary supplements is the need for more regulation of these products. Although the FDA monitors and regulates food and pharmaceutical products, the administration does not closely monitor nutraceuticals and dietary supplements.
Unlike food and pharmaceutical products, the FDA does not approve or regulate dietary supplements before they come to market. Based on authority from the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA can only monitor nutraceutical products and dietary supplements post-marketing, which often means following reports of adverse events.
“Despite widespread consumption, there is limited evidence of health benefits related to nutraceutical or supplement use in well-nourished adults. In contrast, a small number of these products have the potential to produce significant toxicity. In addition, patients often do not disclose supplement use to their physicians. Therefore, the risk of adverse drug-supplement interactions is significant,” scientists in the Annual Review of Pharmacology and Toxicology wrote.
Current regulatory guidelines prohibit dietary supplement manufacturers from claiming that their products can cure or prevent illness; however, these companies can make claims about improving general health. One caveat is that they must disclose that the FDA has not evaluated the product and cannot be used to diagnose, treat, cure, or prevent illnesses.
Nutraceutical regulation follows the same laissez-faire regulations in place for dietary supplements, and thus, additional research and understanding are necessary to incorporate nutraceuticals into the healthcare sector.
Risks of Nutraceuticals
While healthcare providers may recommend some dietary supplement usage, research suggests that 75% of people who use nutritional supplements do so of their own volition. The opaque regulatory landscape surrounding nutraceutical products makes it difficult for consumers to identify which products may have a beneficial impact.
The Annual Review of Pharmacology and Toxicology notes that appropriate micronutrient levels are critical for good health and proper organ function; however, most people in developed nations get enough of these nutrients from foods, eliminating the need for additional vitamin and mineral supplements.
For individuals who do not have vitamin deficiency, supplements have not been proven to benefit healthcare. In fact, in some cases, excess consumption can result in toxicity. Although water-soluble vitamin toxicity is rare, some cases of photosensitivity and neurotoxicity have been reported with the overconsumption of B6 vitamins.
Fat-soluble vitamins are more likely to result in toxicity due to overconsumption. For example, excessive consumption of vitamin E has been linked to antiplatelet action that causes bleeding, diarrhea, fatigue, blurred vision, and gonadal dysfunction.
Omega-3 fatty acids are another common dietary supplement often used to improve heart health. Omega-3 fatty acids, or fish oils, cannot be synthesized by humans and must be ingested through diet.
A 1971 study of populations from the west coast of Greenland linked a diet rich in polyunsaturated omega-3 fatty acids to lower total lipids, plasma cholesterol, plasma triglycerides, and pre-beta lipoproteins. This supplement’s anti-inflammatory properties have also been thought to have cardioprotective properties. However, clinical trials evaluating the benefits of omega-3 fatty acids on heart health have been inconclusive, with conflicting results.
The confusion about dietary supplements and nutraceutical products is exacerbated by the fact that they are often sold alongside other over-the-counter pharmaceutical products. Nutraceutical products have been linked to roughly 23,000 emergency department visits and 2,000 hospitalizations annually despite the potential for benefits.
An article published in the New England Journal of Medicine evaluated emergency department visits in 63 emergency departments across the US between 2004 and 2013. Based on a sample population of 3,667 cases, the researchers estimated that over 23,000 adverse events that cause emergency department visits are related to dietary supplements. Approximately 2,154 hospitalizations result from these emergency department visits yearly.
A lack of regulation and unmonitored claims have left consumers susceptible. For example, Rainbow Light manufactured a prenatal vitamin and advertised it as metal-free; however, an investigation by an independent lab found lead, arsenic, and cadmium in the vitamins. The company settled the lawsuit in 2019 for $1.75 million.
Many other cases echo the concerns listed above. To better understand the role of nutraceuticals, conducting more research and enforcing more comprehensive regulatory guidelines to gather accurate data safely is vital.
