Unlike pharmaceutical drugs, herbal supplements are not regulated by the Food and Drug Administration (FDA) and can only be recalled when there is substantive proof of harm or when contaminants are present that would change the regulatory status of the supplement.
In addition, in July 2019, Amazon sent a notice to its customers warning that some nutritional supplements recently sold on their site may have been fake. Adulteration using DNA barcoding has been found worldwide with a range of adulteration from 23–79% of tested supplements. investigated 44 over-the-counter supplements utilizing DNA barcoding and found that the ingredients listed on the tested product labels were not found in the products. Ī 2015 report released by the New York state’s attorney general revealed that store brand supplements did not contain the ingredients listed on the tested product labels up to 80% of the time. Over the past ten years herbal supplements that are marketed as adaptogens, to enhance immune function, reduce stress and anxiety have consistently been among the top selling supplements accounting for a high percent of the sales in the supplement market. Overall net profits from the sale of herbal supplements within the U.S. went up almost 9.4%, which represented the thirteenth straight year of sales increases. In 2018, the sales of herbal supplements in the U.S. Dietary supplements are used by 50 to 70% of adults in the United States of which herbal supplements are the most popular subset. The World Health Organization estimates that about 80% of the populations in Asian and African countries take herbal medicine as their only form of medication and treatment, while in Europe about 19% of adults use ‘Plant Food Supplements’. Additionally, many marketed herbal products are mixtures or parts of organic chemicals that come from any raw or processed part of a plant because these products come from plants consumers assume that they are healthy. Herbal medicines are thought to enhance and restore normal physiological functions by facilitating the body’s innate self-healing capabilities. Every year more consumers use over-the-counter herbal supplements for needs varying from digestive health and improved energy to relief from depression. Herbal remedies have existed for thousands of years and the demand for herbal supplements worldwide has increased significantly over the past few decades. Until such time it is crucial that consumers are informed that many of the supplements that they take may lack the standardization that would reduce the chance of contamination and lead to consistency from one pill to the next. The data, which demonstrates contamination and a lack of consistency, in conjunction with previous studies on supplement contamination, strengthen the case that the FDA should regulate over-the-counter herbal supplements the same way that they regulate food and drugs.
Although the majority of the fungi that were found in the supplements are generally not hazardous to human health, many of them could be problematic to sensitive groups, such as immunocompromised individuals. Approximately 60% of the supplements contained fungal isolates. Zinc was found in almost 90% of the supplements, nickel in about half of the supplements and lead in none of the supplements.
For all of the supplements tested there was high variability around the mean in antioxidant activity, phenolic concentrations and flavonoid concentrations, with coefficients of variation (CV) ranging from 0–120. The supplements were also analyzed for the presence of metals and fungal contaminants. Duplicate bottles of 29 herbal supplements were tested for consistency for antioxidant activity, phenolic concentration and flavonoid concentration under methanolic and water extraction. The purpose of the study was to determine consistency and contamination within and between bottles of common herbal supplements. Due to their frequency of use and the lack of regulation of herbal supplements by the Food and Drug Administration (FDA) it is important for the health and safety of consumers to know about consistency of supplements and any possible contamination by harmful products, such as heavy metals or microorganisms. In the United States the marketing of dietary supplements, of which the majority are herbal supplements, is currently a multibillion-dollar industry involving use from over half of the adult population.