Dietary supplements are not regulated the same way as medications. This lack of oversight puts consumers' health at risk.
Consumer Reports / Jeneen Interlandi / July 27, 2016 / Additional reporting by Laurie Tarkan and Rachel Rabkin Peachman
Calvin Jimmy Lee-White was tiny. He was born on Oct. 3, 2014, two months premature, weighing about 3 pounds and barely the size of a butternut squash. There are standards of care for treating infants that fragile, and as an attorney for the baby’s family later acknowledged, doctors at Yale-New Haven Hospital in Connecticut followed them. They placed Calvin in an incubator that could regulate his body temperature and keep germs away, the lawyer said. And they administered surfactant drugs, which help promote crucial lung development in premature infants. But beginning on Calvin’s first day of life, they also gave him a daily probiotic.
Probiotics are powders, liquids, or pills made up of live bacteria thought to help maintain the body’s natural balance of gut microorganisms. Some neonatal intensive care units (NICUs) have been giving them to preemies in recent years based on evidence that they can help ward off deadly intestinal disease.
Some doctors are concerned about that trend. Because probiotics can be classified as dietary supplements, they don’t have to be held to the same regulatory standards as prescription or even over-the-counter drugs. Manufacturers don’t have to secure Food and Drug Administration approval to sell their products, and their facilities aren’t policed the same way as pharmaceutical companies.
But the NICU at Yale-New Haven chose what looked to be a safe product. It was made by a large, seemingly reputable company, marketed specifically for infants and children, and available at drugstores across the country.
Calvin struggled anyway. His abdomen developed bulges, and surgery revealed that his intestines were overrun by a rare fungus. The infection spread quickly from his gut to his blood vessels, where it caused multiple blockages, and then into his aorta, where it caused a clot.
Unproven Treatments
The Lee-White family filed a lawsuit against both Solgar and Yale-New Haven Hospital, claiming that their baby had been repeatedly poisoned and that no one had warned them about the risks associated with probiotics.
“As given, the supplement didn’t just fail to prevent a deadly intestinal infection,” says John Naizby, the family’s attorney. “The supplement actually caused a deadly intestinal infection.” Solgar told Consumer Reports via email that it conducted a thorough investigation in cooperation with the FDA and the Centers for Disease Control and Prevention (CDC) and found no contaminants at any point in its own supply chain. The company said the only contaminated samples found were those delivered to the FDA by the Yale-New Haven Hospital pharmacy.
The hospital declined to comment for this article. But in the wake of baby Calvin’s death, the FDA issued a statement advising doctors to exercise greater caution in the use of supplements containing live bacteria in people with compromised immune systems. Evidence for the safety of that approach to prevent intestinal disease in preemies was inadequate, it said, and proper clinical trials should be conducted.
The problem stretches well beyond one tainted probiotic. Dietary supplements—vitamins, minerals, herbs, botanicals, and a growing list of other “natural” substances—have migrated from the vitamin aisle into the mainstream medical establishment. Hospitals are not only including supplements in their formularies (their lists of approved medication), they’re also opening their own specialty supplement shops on-site and online. Some doctors are doing the same. According to a Gallup survey of 200 physicians, 94 percent now recommend vitamins or minerals to some of their patients; 45 percent have recommended herbal supplements as well. And 7 percent are not only recommending supplements but actually selling them in their offices.
Consumers are buying those products in droves. According to the Nutrition Business Journal, supplement sales have increased by 81 percent in the past decade. The uptick is easy to understand: Supplements are easier to get than prescription drugs, and they carry the aura of being more natural and thus safer. Their labels often promise to address health issues for which there are few easy solutions. Want a smaller waistline? There’s garcinia cambogia for that. Bigger muscles? Try creatine. Better sex? Yohimbe. How about giving your brain a boost? Omega-3 fatty acids. Or your energy level? Ginseng.
It’s tough to say what portion of those products pose a risk to consumers. A 2013 report from the Government Accountability Office (GAO) found that from 2008 through 2011, the FDA received 6,307 reports of health problems from dietary supplements, including 92 deaths, hundreds of life-threatening conditions, and more than 1,000 serious injuries or illnesses. The GAO suggests that due to underreporting, the real number of incidents may be far greater.
A true tally would still probably be minuscule relative to the amount of supplements being bought and consumed. But there’s no reliable way to tell whether any given supplement is safe. And the fact remains that dietary supplements—which your doctor may recommend and may sit right alongside trusted over-the-counter medications or just across from the prescription drug counter—aren’t being regulated the same way as drugs.
“Not only are the advertised ingredients of some supplements potentially dangerous,” says Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School who has studied supplements extensively and written many papers on the issue, “but because of the way they’re regulated, you often have no idea what you’re actually ingesting.”
The answer is that the probiotic was contaminated. The FDA tested unopened containers from the same batch of probiotic given to Calvin and discovered the same fungus that had infected his intestines. Certain lots of the product—ABC Dophilus Powder, made by the supplement manufacturer Solgar—were recalled from pharmacies and drugstores across the U.S.
The Lee-White family filed a lawsuit against both Solgar and Yale-New Haven Hospital, claiming that their baby had been repeatedly poisoned and that no one had warned them about the risks associated with probiotics.
“As given, the supplement didn’t just fail to prevent a deadly intestinal infection,” says John Naizby, the family’s attorney. “The supplement actually caused a deadly intestinal infection.” Solgar told Consumer Reports via email that it conducted a thorough investigation in cooperation with the FDA and the Centers for Disease Control and Prevention (CDC) and found no contaminants at any point in its own supply chain. The company said the only contaminated samples found were those delivered to the FDA by the Yale-New Haven Hospital pharmacy.
The hospital declined to comment for this article. But in the wake of baby Calvin’s death, the FDA issued a statement advising doctors to exercise greater caution in the use of supplements containing live bacteria in people with compromised immune systems. Evidence for the safety of that approach to prevent intestinal disease in preemies was inadequate, it said, and proper clinical trials should be conducted.
The problem stretches well beyond one tainted probiotic. Dietary supplements—vitamins, minerals, herbs, botanicals, and a growing list of other “natural” substances—have migrated from the vitamin aisle into the mainstream medical establishment. Hospitals are not only including supplements in their formularies (their lists of approved medication), they’re also opening their own specialty supplement shops on-site and online. Some doctors are doing the same. According to a Gallup survey of 200 physicians, 94 percent now recommend vitamins or minerals to some of their patients; 45 percent have recommended herbal supplements as well. And 7 percent are not only recommending supplements but actually selling them in their offices.
Consumers are buying those products in droves. According to the Nutrition Business Journal, supplement sales have increased by 81 percent in the past decade. The uptick is easy to understand: Supplements are easier to get than prescription drugs, and they carry the aura of being more natural and thus safer. Their labels often promise to address health issues for which there are few easy solutions. Want a smaller waistline? There’s garcinia cambogia for that. Bigger muscles? Try creatine. Better sex? Yohimbe. How about giving your brain a boost? Omega-3 fatty acids. Or your energy level? Ginseng.
It’s tough to say what portion of those products pose a risk to consumers. A 2013 report from the Government Accountability Office (GAO) found that from 2008 through 2011, the FDA received 6,307 reports of health problems from dietary supplements, including 92 deaths, hundreds of life-threatening conditions, and more than 1,000 serious injuries or illnesses. The GAO suggests that due to underreporting, the real number of incidents may be far greater.
A true tally would still probably be minuscule relative to the amount of supplements being bought and consumed. But there’s no reliable way to tell whether any given supplement is safe. And the fact remains that dietary supplements—which your doctor may recommend and may sit right alongside trusted over-the-counter medications or just across from the prescription drug counter—aren’t being regulated the same way as drugs.
“Not only are the advertised ingredients of some supplements potentially dangerous,” says Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School who has studied supplements extensively and written many papers on the issue, “but because of the way they’re regulated, you often have no idea what you’re actually ingesting.”
Consumers Are in the Dark
Dietary supplements are subject to far less stringent regulations than over-the-counter and prescription medication. The FDA classifies them differently from drugs. So the companies that make and sell them aren’t required to prove that they’re safe for their intended use before selling them, or that they work as advertised, or even that their packages contain what the labels say they do.
And because of those lax policies, supplements that make their way into retail stores, doctors’ offices, and hospitals can pose a number of potential problems. They can be ineffective, contaminated with microbes or heavy metals, dangerously mislabeled, or intentionally spiked with illegal or prescription drugs. They can also cause harmful side effects by themselves and interact with prescription medication in ways that make those drugs less effective.
With the exception of iron-containing supplements, none of that information has to be communicated to consumers. Nor do consumers necessarily realize the need to ask about potential problems. According to a 2015 nationally representative Consumer Reports survey, almost half of American adults think that supplement makers test their products for efficacy, and more than half believe that manufacturers prove their products are safe before selling them.
“You see these products in drugstores or in doctors’ offices, and you assume they’re as tried and true as any other medication being sold at those places,” says Paul Offit, M.D., an infectious disease specialist at the Children’s Hospital of Philadelphia, who has written a book about the supplement industry. “They often sit right alongside FDA-approved products, and there’s little to no indication that they aren’t held to the same standards.”
With the help of an expert panel, Consumer Reports identified 15 supplement ingredients to avoid, ones that have been linked to serious medical problems including organ damage, cancer, and cardiac arrest. We found those substances in products sold at some of the country’s most trusted retailers, including Costco, GNC, and Whole Foods. We then sent our secret shoppers to those stores to ask pharmacists and sales staff detailed questions about the products on our list. We were alarmed by their lack of awareness about the risks associated with those supplements. Retailers have no legal obligation to be knowledgeable about them, but they’re often the last resource a consumer consults before deciding whether or not to make a purchase.
And because of those lax policies, supplements that make their way into retail stores, doctors’ offices, and hospitals can pose a number of potential problems. They can be ineffective, contaminated with microbes or heavy metals, dangerously mislabeled, or intentionally spiked with illegal or prescription drugs. They can also cause harmful side effects by themselves and interact with prescription medication in ways that make those drugs less effective.
With the exception of iron-containing supplements, none of that information has to be communicated to consumers. Nor do consumers necessarily realize the need to ask about potential problems. According to a 2015 nationally representative Consumer Reports survey, almost half of American adults think that supplement makers test their products for efficacy, and more than half believe that manufacturers prove their products are safe before selling them.
“You see these products in drugstores or in doctors’ offices, and you assume they’re as tried and true as any other medication being sold at those places,” says Paul Offit, M.D., an infectious disease specialist at the Children’s Hospital of Philadelphia, who has written a book about the supplement industry. “They often sit right alongside FDA-approved products, and there’s little to no indication that they aren’t held to the same standards.”
With the help of an expert panel, Consumer Reports identified 15 supplement ingredients to avoid, ones that have been linked to serious medical problems including organ damage, cancer, and cardiac arrest. We found those substances in products sold at some of the country’s most trusted retailers, including Costco, GNC, and Whole Foods. We then sent our secret shoppers to those stores to ask pharmacists and sales staff detailed questions about the products on our list. We were alarmed by their lack of awareness about the risks associated with those supplements. Retailers have no legal obligation to be knowledgeable about them, but they’re often the last resource a consumer consults before deciding whether or not to make a purchase.
Continue reading the article at: http://www.consumerreports.org/vitamins-supplements/supplements-can-make-you-sick/?
