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Everyone has seen the ads or the products on the shelves.
A dietary supplement that promises to make skinny consumers, without dieting or exercise. Or the one who will be bulkheads and turn them into the envy of other weightlifters at the gym. Not to mention the one to make them perform better in the bedroom.
Their labels say they are safe and all-natural. But are they?
Many of these products contain unapproved and unregulated pharmaceutically active ingredients, according to a study published Friday in JAMA Network Open. The authors wrote that the substances represent "a serious public health concern."
Researchers from the California Department of Public Health found that from 2007 to 2016, 776 products marketed as dietary supplements are hidden active ingredients that are unsafe or unstudied. Among them, dapoxetine, an antidepressant that is not approved in the United States, and sibutramine, which was included in some weight-loss supplements in the US market because of cardiovascular risks.
"It's mind-boggling to imagine what's happening here," said Dr. Pieter Cohen, associate professor of medicine at the Cambridge Health Alliance in Massachusetts. Cohen was not involved in the study but wrote a commentary published alongside the research.
The California researchers based their findings on an analysis of a food and drug administration database that identified "tainted" supplements. "The study lays a foundation for ongoing enforcement, by the FDA and other partner agencies, to import, distribution, and sales of adulterated dietary supplements," spokesman spokesman Corey Egel said in an email.
Being tainted or adulterated means that the product contains active ingredients not listed on the label that fly under the FDA's radar.
Dietary supplements are not classified by the FDA as drugs. They are instead considered foods. They include vitamins, minerals and botanicals. They are not intended to treat or prevent diseases and are not subject to premarket safety.
The FDA database tracked problems that emerged during "post-market surveillance" – for instance, adverse-events reports and consumer complaints – when bottles were already in consumers' medicine cabinets. These issues draw FDA warning letters and agency requests for voluntary recalls by the manufacturer.
With an estimated 50 percent of Americans consuming some type of supplement, the researchers note that the $ 35 billion industry is a big business.
But Duffy MacKay, Senior Vice President for Scientific and Regulatory Affairs at the Supplementary Industry Council for Responsible Nutrition, noted that with between 50,000 and 80,000 supplement labels on the market, 776 tainted products is serious but not widespread.
Of the adulterated products, nearly 46 percent were for sexual performance, 41 percent were for weight loss and 12 percent were for building muscle. Ingredients like Sildenafil, the active drug in Viagra, and Ephedrine, a stimulant banned from diet pills since 2004, were found in supplements. Anabolic steroids, or ingredients like them, were in 73 of the muscle-building supplements.
Nearly a fifth of these supplements contained more than one unapproved ingredient.
"Adulterated dietary supplements have the potential to cause adverse health effects both on their own and also in individual medications," the authors wrote.
Cohen agreed, noting that a patient with heart disease may be affected by erectile dysfunction medications because they could interact with other medications and dangerously lower the patient's blood pressure.
Instead, that patient turns to over-the-counter supplements that are marketed as all-natural, thinking this product will not pose the risks. "And that's very worrisome," said Cohen.
The study authors wrote that these adulterated dietary supplements "are consumed under the presumption of safety and have the potential to cause dangerous consequences in cases of misuse or overdose."
Cohen suggests that they have a single ingredient, because they probably will have a lower likelihood of containing secret, harmful ingredients. And never trust a supplement that definitively says it can improve your health.
That advice was echoed by MacKay, from the supplement industry's trade group, who said outrageous claims about weight loss or body building are red flags.
These products are sold by shady retailers and have ridiculous names like Ball Refill or Weekend Prince, he said.
"There is such a difference between these and the other products," he added, "that they are marketed to a base that may be OK with this kind of illegal stuff." , who are "gym rats" and people who want Viagra without a prescription.
But prior research conducted by Cohen and cited in this study. It should be pointed out in the postmarketing surveillance system, especially the inability of physicians and consumers to identify an adulterated product to the cause of a health problem or to know that such things should be reported to the FDA.
"In fact," the researchers wrote, "Poison Control Centers Received More FDA Did Over a 3-year-period."
There is little FDA can or will do bad. Recalls are not like food recalls, Cohen said. With supplements, the FDA can only notify a company that its products have unapproved ingredients. It's up to the company to conduct a voluntary recall.
"The recollection process itself has completely broken down as far as I can tell," Cohen said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
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