Study Uncovers Alarming 89% Inaccuracy Rate in Dietary Supplement Labels
What you're putting into your body is often a mystery. A staggering number of dietary supplement labels were found to be misleading, and a concerning 12% of these products were discovered to contain ingredients that the FDA explicitly prohibits.
A team of experts sheds light on a troubling tendency in the world of sports supplements in a new study released on Monday. Their studies reveal that many of these items' labels give deceptive information, hiding the genuine composition of these highly sought-after supplements. The investigation has brought to light a troubling fact that has long been hidden from public view. It indicates a wide disparity between the information on athletic supplement labels and the actual content of these goods.
With so many alternatives and claims on the market, customers have depended primarily on the information offered on product labels to make educated decisions. This research, however, reveals a disappointing truth: many of these labels do not correctly depict the genuine nature of the supplements they cover, and some can have the potential for negative outcomes.
A recently published study, unveiled on Monday, has shed light on a significant issue within the sport supplement industry. It has come to light that a notable proportion of sport supplement labels are found to be misleading consumers by providing inaccurate information regarding the actual contents of the product.
Furthermore, a considerable proportion of sports and dietary supplements may exhibit misleading practices in accurately labeling their constituent components, as highlighted in a research letter recently published in the JAMA Network Open.
The study's findings revealed that a significant majority, specifically 89%, of the dietary supplements under examination exhibited inaccuracies in labeling the ingredients contained within the products. Furthermore, it was discovered that a proportion, amounting to up to 12%, of these supplements consisted of ingredients that the Food and Drug Administration explicitly prohibits.
These supplements are marketed as incorporating up to five novel botanical ingredients derived from plants traditionally utilized for medicinal purposes. The purported aim of these supplements is to enhance overall well-being and optimize physical performance during workouts. The findings revealed that most supplements containing botanical ingredients exhibited misrepresentation in terms of their actual contents compared to the information provided on the label. Certain levels of the ingredients exceeded the listed amount by as much as 330%, while a notable 40% of the products lacked any botanical components whatsoever.
When considering the quality and accuracy of supplements, it is important to acknowledge the significant variability. Unlike prescription drugs, the supplement industry operates without regulation from the FDA, contributing to this variability. Consequently, manufacturers of dietary supplements are not required to substantiate the safety or effectiveness of their products, nor are they subject to the rigorous standards imposed by clinical trials.
Pieter Cohen, a clinician-researcher at Cambridge Health Alliance and Harvard Medical School in Cambridge, Massachusetts, and colleagues ordered 57 sports supplements to analyze their contents.
According to Cohen, it can be inferred that customers lack a comprehensive understanding of the actual contents and associated risks of the supplements they put in their bodies, primarily due to the absence of human safety testing conducted on the ingredients. He stated that the screening process was limited to specific additives. There is a potential for the presence of additional ingredients in these products that may pose a risk, which has not yet been identified.
The ingredients utilized can vary, encompassing starch, flour, or even placebos, which enhance the visual appearance of powders by creating a fuller texture. Cohen's most disconcerting revelation entailed unearthing a disquieting statistic: a notable 12% of the assessed supplements were found to harbor stimulants that have been officially proscribed by the Food and Drug Administration (FDA). According to Cohen, the combination of stimulants and exercise can potentially induce significant health complications. Exploring Further: The Regulatory Framework of Dietary Supplements" I am concerned about the potential health risks associated with the consumption of high doses of stimulants, such as high blood pressure, heart attacks, arrhythmias (abnormal heart rhythm), and cerebral hemorrhage," expressed Cohen.
The oversight of dietary supplements by the FDA is notably limited, particularly in guaranteeing their efficacy and safety. Existing regulations mandate that supplement manufacturers bear the responsibility of ensuring the quality and safety of their products. However, it is important to note that the Food and Drug Administration (FDA) does not conduct product testing or grant approval for claims stated on product labels. Regulatory authorities are authorized to intervene solely in instances where substantial and pervasive evidence indicates that dietary supplements pose a risk to consumer well-being or engage in deceptive practices regarding their constituents.
According to Cohen, despite the preceding circumstances, the Food and Drug Administration encounters significant challenges in effectively monitoring and addressing the issue of mislabeled and fraudulent products. According to Cohen, the challenge lies in the inability to effectively remove these products from store shelves, as manufacturers can easily circumvent the issue by introducing new brands, reprinting labels, and continuing to sell their merchandise.
The study acknowledges the limited sample size and the potential variability of results across different batches. Nevertheless, Cohen asserts that utilizing these supplements does not justify the associated risks. Merely having the ingredients accurately listed on the label does not necessarily guarantee the product's safety. The ingredients in question have not undergone the FDA approval process. The specimens were discovered within the confines of various plant species. "That is precisely why they are marketable as dietary supplements." It is strongly advised to consult with your healthcare professional regarding any possible risks or adverse effects associated with dietary supplements before their consumption. Additionally, relying exclusively on products certified by reputable third-party organizations such as the U.S. Pharmacopeia (USP) or the National Sanitation Foundation (NSF) is recommended.
In 2004, the Food and Drug Administration (FDA) implemented a ban on the commercial distribution of herbal supplements containing ephedrine alkaloids. This decision was made due to the recognition that these products posed an unreasonable threat of causing harm or illness to individuals who consumed them.
Ephedrine alkaloids, commonly referred to as ephedra, are stimulant compounds derived from Ephedra sinica and various other botanical sources. These substances have gained recognition for their purported ability to augment energy levels and improve athletic prowess. Following the discontinuation of ephedra, instances of poisonings in the United States have experienced a significant decline, with no documented fatalities associated with ephedra reported since 2008.
FDA inspections have revealed a recurring issue wherein supplement manufacturers frequently fall short in adhering to fundamental manufacturing standards. These standards encompass crucial aspects such as establishing the final product's identity, purity, and composition.
The analysis revealed that approximately 40 percent of the 57 supplements purchased online (although it should be noted that this sample size is relatively small) did not exhibit any detectable quantity of the specified ingredient.
According to the report by Cohen and colleagues, a mere 11 percent of the products examined were found to possess accurate labeling.
A significant proportion, specifically forty percent, exhibited an absence of any discernible quantity of the intended ingredient. Instances were found where products purported to contain the specified ingredient. However, the concentration levels varied significantly, ranging from negligible amounts to exceeding threefold the quantity indicated on the packaging.
An advised portion of a supplement was found to have a mass more than three times that of one of the stimulants listed on the product label, even though the amounts may vary across different batches within the same brand.
The investigation discovered four illegal stimulants in herbal sports supplements, 4-dimethylamylamine, which has never been permitted in any nation, and three medicines previously sold in Europe: deterenol, oxilofrine, and octodrine.
According to Cohen, these stimulants often increase strain on the heart by raising blood pressure, causing the heart's muscles to contract more forcefully or raising the heart rate.
A fifth unapproved medication, termed omberacetam and exclusively accessible in Russia, was discovered in the supplements and is said to enhance brain function.
Clinical practitioners should warn consumers that supplements claiming botanical substances with alleged stimulant or anabolic properties may not be appropriately labeled and may include FDA-prohibited medications in light of these results.
Cohen advises picking supplements approved by either the NSF or the U.S. Pharmacopeia, which are represented by the letters NSF in a blue circle within an oval.
According to Cohen, this certification "doesn't mean that ingredient's going to help your workout," but it gives you peace of mind knowing you're receiving what's on the label.
Similar advice is provided by the Council for Responsible Nutrition, which suggests purchasing goods from well-known merchants. He said, "Buy them from brands you trust."
While the study's revelations may appear astonishing, they are not entirely unexpected when one delves into the regulatory frameworks governing dietary supplements in the United States and other nations like Australia.
The Therapeutic Goods Administration (TGA), Australia's drug regulator, has been diligently intensifying its efforts to address the issue of supplements. This proactive approach is driven by the potential risks associated with these products, such as their potential to interfere with prescription medications or trigger severe allergic reactions.
In recent times, as of late 2020, the Therapeutic Goods Administration (TGA) has implemented a regulatory shift in categorizing high-risk sports supplements as medicines, as opposed to their previous classification as 'sports foods.' This significant change comes in response to a series of unfortunate incidents resulting in multiple fatalities.
However, regulatory bodies in the pharmaceutical industry are currently faced with the challenge of keeping pace with a rapidly evolving market. According to Cohen, there has been a significant proliferation of novel ingredients in dietary supplements over the past few years. He approximates that the United States market alone boasts an impressive array of over 75,000 distinct dietary supplement products.
During his Ask Me Anything (AMA) interview, Cohen expressed that in the present era, there is a notable influx of novel innovations and newly introduced ingredients in the realm of dietary supplements.
Once more, due to the absence of pre-market evaluation by the FDA, these products are susceptible to presenting unforeseen hazards when made available for purchase in physical retail outlets or online platforms.