Natural Supplements Can be Dangerously Contaminated, or Not Even Have the Specified Ingredients
By C. Michael White
More than two-thirds of Americans take dietary supplements. The vast majority of consumers — 84 percent — are confident the products are safe and effective.
They should not be so trusting.
I'm a professor of pharmacy practice at the University of Connecticut. As described in my new article in the Annals of Pharmacotherapy, consumers take real risks if they use diet supplements not independently verified by reputable outside labs.
What Are the Risks?
Heavy metals, which are known to cause cancer, dementia and brittle bones, contaminate many diet supplements. One study of 121 products revealed 5 percent of them surpassed the safe daily consumption limit for arsenic. Two percent had excess lead, cadmium and aluminum; and 1 percent had too much mercury. In June 2019, the Food and Drug Administration seized 300,000 dietary supplement bottles because their pills contained excessive lead levels.
Bacterial and fungal contamination in dietary supplements is not uncommon. In one assessment, researchers found bacteria in all 138 products they investigated. Toxic fungi were also in many of the supplements, and counts for numerous products exceeded the acceptable limits set by the United States Pharmacopeia. Fungal contamination of diet supplements has been linked to serious liver, intestinal and appendix damage.
From 2017-18, dozens were hospitalized with salmonella poisoning after ingesting kratom, a highly addictive natural opioid. Thirty-seven of the kratom products studied were contaminated.
Some dietary supplements contain drugs, yet the manufacturers don't disclose that information to consumers. Frequently, the concealed drugs are experimental and, in some cases, removed from the market because they're dangerous. Hundreds of weight-loss, sexual-dysfunction and muscle-building products are adulterated with inferior or harmful substances.
Sometimes, the herb you think you're buying contains little to no active ingredient. Occasionally, another herb is substituted.
The consequences for consumers are considerable. When manufacturers replaced the herb Stephania tetrandra with the herb Aristolochia fangchi in 2000, more than 100 patients developed severe kidney damage; 18 more got kidney or bladder cancer. Although the herb is now banned by the U.S., a 2014 investigation found Aristolochia fangchi in 20 percent of the Chinese herbal products sold on the internet.
In an assessment of CBD products, only 12.5 percent of vaporization liquids, 25 percent of tinctures and 45 percent of oils contained the promised amount of CBD. In most cases they held far less. A few CBD products had enough THC to put the user in legal jeopardy of marijuana possession.
Embarrassed by a New York Attorney General's Office investigation suggesting widespread and fraudulent under-dosing of active ingredients in dietary supplements, CVS pharmacies analyzed 1,400 products that it previously sold in its stores. Seven percent, or about 100 products, failed, resulting in updates to the supplement facts panel or removal of the product from shelves.
What Should Consumers Do?
The Dietary Supplement Health and Education Act of 1994 allows manufacturers to sell dietary supplements without providing proof of their quality to the FDA. Instead, it's up to the FDA to prove a product is unsafe and take it off the market. That's an incredibly tall order, and woefully inadequate. But it's unlikely to change.
In the meantime, I recommend that consumers should not purchase supplements without verification from one of three highly regarded independent laboratories: the aforementioned United States Pharmacopeia, the National Science Foundation and ConsumerLabs.com. The United States Pharmacopeia is an organization that sets reference and quality standards for prescription medication and food in the U.S.; the National Science Foundation is a governmental scientific body that sponsors basic science research; and ConsumerLabs.com is a company started to verify product quality for consumers that are paying members. These laboratories conduct an initial analysis and then perform periodic unannounced assessments of the products; those with the appropriate amount of active ingredient, and without contamination or adulteration, can put the United States Pharmacopeia, National Science Foundation and ConsumerLabs.com seals on their bottles. CVS announced that all products sold at its stores going forward will need to provide the company proof of quality. Other major retailers should follow suit.
In the meantime, I recommend that consumers should not purchase supplements without verification from one of three highly regarded independent laboratories: the aforementioned United States Pharmacopeia, NSF International and ConsumerLabs.com. The United States Pharmacopeia is an organization that sets reference and quality standards for prescription medication and food in the U.S.; the NSF International is an independent group that assesses safety and risk for food, water and consumer products; and ConsumerLabs.com is a company started to verify product quality for consumers that are paying members. These laboratories conduct an initial analysis and then perform periodic unannounced assessments of the products; those with the appropriate amount of active ingredient, and without contamination or adulteration, can put the United States Pharmacopeia, NSF and ConsumerLabs.com seals on their bottles. CVS announced that all products sold at its stores going forward will need to provide the company proof of quality. Other major retailers should follow suit.
Some manufacturers conduct quality testing and post certificates of analysis on their websites. But the autonomy of the laboratory, and its standards, are often not known. Sometimes, labs may select an inappropriate testing method, intentionally or unintentionally. Sometimes they perform the test incorrectly, or simply make up results.
Because the FDA can't fully protect you from quality issues in dietary supplements — at least not right now — you must protect yourself. Even if a celebrity or "health guru" recommends a product, that doesn't mean it's high-quality. Before you put any supplement into your body, demand proof.
Correction: An earlier version of this article stated that the organization that tests consumer products for safety is the National Science Foundation. It has been corrected to clarify that NSF International is the organization who conducts the testing.
Reposted with permission from The Conversation.
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Where Does the Deficiency Begin?<p>Nobody knows exactly how much vitamin D a person actually needs. The question of when a deficiency starts is correspondingly controversial. However, vitamin D is becoming increasingly popular.Not only is the pseudo-scientific literature on the "sun vitamin" experiencing an upswing, but the number of published studies has also increased enormously in recent years. For example, in 2019 <a href="https://academic.oup.com/edrv/article/40/4/1109/5126915" target="_blank">a study found that</a> Vitamin D is responsible for keeping the skeleton functional and is associated with cardiovascular diseases, type 2 diabetes and various types of cancer. <br></p>
An All-Rounder<p>Vitamin D levels in the body rise and fall according to sun exposure. If sufficient UV rays reach the skin, the body is able to produce the vitamin itself. However, the human body only derives an estimated 10 to 20 percent of its daily requirement from food.</p><p>The vitamin D that we synthesize from sunlight or food is not biologically active at first. Before the kidneys can produce the biologically active form of the vitamin, known as calcitriol, and release it into the blood, some metabolic processes must take place beforehand.</p><p>In addition, many organs have receptors to which the precursor of calcitriol binds. Further, this substance is also present in blood.</p><p>From this precursor, the organs then produce calcitriol themselves, which the body then uses for countless other processes in the body. This form of vitamin D thus regulates insulin secretion, inhibits tumor growth, and promotes the formation of red blood cells as well as the survival and activity of macrophages, which are important for the <a href="https://www.mdpi.com/2072-6643/5/7/2502/htm" target="_blank">immune system.</a></p>
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Association Versus Intervention Studies<p>Many studies on the vitamin are association or observational studies. "By definition, these studies cannot prove the causal relationship, but only point to mere correlations," said Fassnacht. The physician tries to illustrate this with an example:</p><p>"Imagine two groups of 80-year-olds. One group is spry, active and does sports. If you compare them with another group living in nursing homes, the difference in vitamin D levels will be dramatic. Life expectancy would also be extremely different."</p><p>But to try to explain the difference in fitness by vitamin D status alone is far too simplistic. "Vitamin D levels are a good measure of how sick someone is. But not more," says Fassnacht. </p><p>According to Fassnacht, none of the intervention studies carried out to date -- that specifically examined the effect of vitamin D on various diseases -- has been able to confirm the previous association and laboratory studies or the presumed positive effect of vitamin D.</p>
Further Research Is Needed<p>"If a coronavirus infection is suspected, it is therefore absolutely necessary to check the vitamin D status and quickly correct any possible deficit," said the recommendation of the paper published by the University of Hohenheim.</p><p>"Studies are underway to see whether vitamin D helps in COVID-19 infection, but I personally do not believe that this is really the case," says endocrinologist Fassnacht. Nevertheless, he says it is of course useful to carry out these studies.<br></p><p>"I don't want to rule out that there are actually subgroups of people who benefit from an additional vitamin D dose," he says. After all, this has been proven to be the case with a severe deficit.</p><p>In view of the study situation, Fassnacht does not think much of preventive, nationwide vitamin D substitutes. "My belief that the vitamin helps somewhere is very low. But, of course, I can be wrong."</p>
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