Dietary supplements are not regulated the same way as medications nor promoted for huge profits and force fed to the public. This lack of greed in the market helps consumers!
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. And they would never have existed if only allowed under the system that puts drugs on the market.
Some doctors are concerned about that trend. There are less kickbacks that they can benefit from. 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.
On Oct. 11, at just 8 days old, baby Calvin died. Government officials then launched a mournful investigation. Where did the fungus come from? And how did it get into this premature baby’s tiny body?
Unproven Treatments
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 could have grossly mishandled the supplement but will not comment.
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 scare campaign stretches well beyond one 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 but articles keep the scare campaign going with innuendo and damn little data. 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. A fraction of that for prescription drugs. 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. And we Americans are thankful for that!
“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.”
More on Dietary Supplements
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.
The Real Story of Snake OilA Powerful Industry Is Born
Our modern love of dietary supplements began in 1970 when Linus Pauling, the chemist and two-time Nobel Prize winner, declared that taking 3,000 mg of vitamin C every day could abolish the common cold. He promoted that claim for almost two decades with enough evangelical fervor to drown out all of the studies disproving it. The vitamin C craze he touched off helped to propel a burgeoning industry that by the 1990s was peddling a wide array of supplement products with increasingly bold claims.
When the FDA stepped in to regulate, the industry fought back. Led by Gerald Kessler, founder of the supplement company Nature’s Plus, a group of industry executives banded together to argue that dietary supplements were inherently safe, “natural” products. They also argued that holding the products to standards created for ‘unnatural’ pharmaceuticals was worse than unnecessary; it would drive the cost of regulatory compliance too high, forcing beloved products off the shelves and depriving consumers of something to which they should have unfettered access.
Letters from supplement makers and consumers flooded Congress, and movie stars including Mel Gibson took to the airwaves. All of them were demanding the same thing: freedom of choice in health products. “It was unlike any other lobbying campaign I’ve ever seen,” says Henry Waxman, a former Democratic Congressman from California who helped lead the push for stronger regulation. “People believed what they were being told because it fed into their view that doctors, pharmaceutical companies, and the FDA wanted to block alternative medicines that could keep people healthy. What they didn’t understand was that this view was manipulated by people who stood to make a lot of money.”
Banking on Too Little Oversight
The industry’s campaign resulted in the Dietary Supplement Health and Education Act (DSHEA) of 1994. Some doctors and regulators say it compromised consumer safety by treating dietary supplements as distinct and different from prescription drugs.
Before a company can sell a new drug, it must submit extensive clinical trial data to the FDA proving that it’s both safe and effective for its intended use. Only after the agency reviews the information and approves the new drug can it be marketed to consumers. The process can take years and cost upward of $2 billion.
Under DSHEA, dietary supplements are held to a different standard. “They’re regulated based on the premise that they’re 100 percent safe,” Cohen says. Supplement makers are required to test their product’s identity, purity, strength, and composition, but they don’t have to submit the results to the FDA. They also have to notify the agency of new ingredients. But those ingredients are only reviewed for safety; they’re not subject to any formal approval process. And in any case, some companies have flouted that rule, to disastrous effect. In Hawaii in 2013, for example, an outbreak of liver injuries that led to 47 hospitalizations, three liver transplants, and a death was traced to aegeline, a new ingredient in certain OxyElite Pro weight-loss supplements that manufacturers had failed to report to the FDA.
Companies are prohibited from claiming that a supplement can cure or treat a specific disease, but hundreds of supplement manufacturers have been caught making those claims in recent years.
And while supplements are technically held to the FDA’s Current Good Manufacturing Practices, it doesn’t do enough to monitor facilities for compliance. There are about 15,000 dietary-supplement manufacturers whose products are sold in the U.S., according to a 2015 study in the journal Drug Testing and Analysis. Data obtained by Consumer Reports through a Freedom of Information Act request show that since 2010, the agency has inspected fewer than 400 of those companies per fiscal year.
Part of the problem is a lack of resources. Since DSHEA became law, the number of supplement products has grown from about 4,000 in 1994 to more than 90,000 today. The FDA’s budget to monitor supplements hasn’t grown in tandem. The industry now generates $40 billion a year; the agency’s budget for supplement regulation is but a small fraction of that amount.
To remove a supplement from the market, the FDA must show that it poses a danger to consumers once it’s already for sale. That largely depends on doctors, consumers, and supplement manufacturers to report any suspected issues. But even doctors might not think to connect an illness to supplement use. And if they do, they might not think to call the FDA. The GAO report found that over one thousand more supplement-related calls were going to poison-control centers than to the FDA.
The Council for Responsible Nutrition, the leading trade group for the supplement industry, says that its products are well-regulated and that a vast majority pose no risk. “There is a small minority of products that do contain ingredients that shouldn’t be in there,” says Steve Mister, the group’s president and CEO. “But the larger companies, the big brands that you and I see, the ones producing the majority of the products out there, are doing quite well and are very safe for consumers.”
Retail Russian Roulette
The distinction between dietary supplements and prescription drugs is most pronounced in your local drugstore. Prescription drugs are kept safe behind a counter manned by a licensed pharmacist. Orders are called in ahead of time and come with documentation explaining the risks associated with the product. Supplements come with no such safeguards. You can pluck them off a drugstore shelf without thinking twice. Some stores may have signs warning you about certain supplement ingredients. But if you have specific questions, you might be out of luck. Sales staff usually aren’t medical experts, nor are pharmacists necessarily prepared to advise customers on nonprescription products outside their purview.
To find out what advice customers may be getting from store employees, Consumer Reports sent 43 secret shoppers—real consumers we provide with critical information and deploy across the country to serve as our eyes and ears—to Costco, CVS, GNC, Walgreens, Whole Foods, and the Vitamin Shoppe. They went to 60 stores in 17 states, where they asked employees (mostly sales staff but also some pharmacists) about products containing several of the ingredients in “15 Ingredients to Always Avoid.”
Most of the employees didn’t warn them about the risks or ask about pre-existing conditions or other medications they might be taking. Many gave information that was either misleading or flat-out wrong.
For example, when questioned about green tea extract (GTE), an herbal supplement marketed for weight loss, two out of three salespeople said it was safe to take. None warned that the herb has been found to alter the effectiveness of a long list of drugs, including certain antidepressants and anticlotting drugs. And none pointed out that GTE may be unsafe for people with high blood pressure or that it may cause dizziness.
Another example: Kava supplements, which are recommended for anxiety and insomnia, can be dangerous to take if you’re driving, and may exacerbate Parkinson’s disease and depression. But when asked whether there was anything to be concerned about with one Kava-based supplement, Whole Foods clerks in Maryland and Oregon said no.
Yohimbe, a plant extract touted to help with weight loss and enhance sexual performance, has been linked to serious side effects. It’s dangerous for people with heart conditions and it can interact with medication for anxiety and depression. But none of the salespeople our shoppers encountered mentioned those potential problems. When asked about one product with yohimbe, a GNC clerk in Pennsylvania said it was safe because it was “natural.”
Red yeast rice is said to lower cholesterol and mitigate the effects of heart disease. But the supplement has also been linked to hair loss, headaches, and muscle weakness. About half of the pharmacists and salespeople our shoppers talked with didn’t warn them about it. Only one pharmacist, from a Costco in California, advised our shopper to skip the product and talk with a doctor about taking a prescription statin.
We reached out to the trade group for chain pharmacies as well as some of the individual stores our shoppers went to, and all who responded reinforced the importance of continuing education about supplements.
The Right Role for Doctors?
Diane Van Kempen, a retired schoolteacher from Franklin Lakes, N.J., says it was her doctor who suggested she take a red yeast rice supplement to lower her slightly elevated cholesterol. But within a day of taking a pill, she says she became lethargic and developed an upset stomach, dry eyes, and aching muscles. Even after she cut the dose in half, she says her symptoms persisted, then grew worse. Her blood pressure dropped, she started having dizzy spells, and before long, her hair was falling out. “That’s when I stopped taking the supplement,” she says.
Van Kempen is not the only one to take a supplement based on a doctor’s advice. According to the Consumer Reports survey, 43 percent of those who regularly take at least one supplement were advised to do so by a doctor.
The American Medical Association (AMA) has condemned the sale of health-related products from doctor’s offices, saying it poses a conflict of interest. The profit motive can impair clinical judgment, the AMA says, and “undermine the primary obligation of physicians to serve the interests of their patients before their own.”
Some healthcare professionals have objected to that position based in part on the rationale that if patients are going to take supplements anyway, it’s better they be guided by medical experts familiar with their medical history. “Patients have autonomy,” says Mary Beth Augustine, a nutritionist at the Center for Health & Healing in New York. “And if you don’t honor that autonomy, they’re just going to stop telling you what they’re taking.”
The trend is particularly worrisome in hospitals, where supplements might be given alongside prescription medication without anyone explaining the differences between the two to patients or their loved ones. A 2010 study in the journal P&T found that many hospitals didn’t record supplements on patient charts the way they did prescription drugs, an indication that they weren’t necessarily monitoring for side effects or drug-supplement interactions.
Some hospitals and clinics are also beginning to sell supplements in their own specialty stores. Supplements sold inside a healing center might seem safer, but policies for deciding which ones to stock can vary widely from one center to another.
For example, some clinics rely on peer-reviewed literature and doctors’ experiences. “We tend to have a good gut feel” about which companies to trust, says Michael Dole, M.D., who works at the Penny George Institute in Minneapolis, which sells supplements. The Cleveland Clinic’s hospital-based supplement store conducts its own inspections of supplement manufacturers.
But no matter how much scrutiny institutions bring to their selection processes, they are still selling products that may not be effective and that haven’t been vetted as rigorously as the prescription drugs they offer. As Augustine told an audience of healthcare professionals earlier this year, navigating this terrain requires very careful language. “I’m never going to say to a patient that [a supplement] is safe,” she said. “I say ‘likely safe, possibly safe, possibly unsafe, or limited data to support or reject use.’ Am I being overly cautious? Yes.”
Making Supplements Safer
The lawsuit against Yale-New Haven Hospital and Solgar is still pending. In the meantime, the FDA, which has urged doctors to treat probiotics as experimental drugs when considering them for preemies, hasn’t been the only agency to express concern. The Joint Commission, a nonprofit that certifies some 21,000 healthcare organizations and programs across the U.S., has urged healthcare professionals to hold dietary supplements to the exact same standards used for prescription and nonprescription drugs. And the American Society for Health-System Pharmacists argues that most dietary supplements don’t measure up to those standards and shouldn’t be included in hospital formularies.
“The right thing to do is to tell patients the truth,” says Arthur Caplan, Ph.D., a bioethicist at NYU Langone Medical Center. “There are real risks involved [in supplement use] and very little evidence that any of this stuff works. Period.”
Ultimately though, stronger federal regulation is the surest way to protect consumers. “Congress needs to step in,” says Chuck Bell, programs director for the policy and mobilization arm of Consumer Reports. “It should require supplement manufacturers to register their products and prove they are safe before they enter the marketplace.”
Some people say that major changes are going to be a tough sell. “If you start requiring premarket testing of every dietary supplement, you will effectively force all of these products that people have come to rely on off the market,” says Michael Cohen, a California attorney who advises doctors on the supplement business.
Still, there are a few signs that change is already afoot. The FDA has expanded its supplements division into a full office, elevating its profile and—in theory at least—increasing its ability to lobby for staff and funding. And Joshua Sharfstein, M.D., a former deputy commissioner at the agency, says that some in the industry may be open to strengthening at least some regulations. “We may be just one crisis away from that,” he says.
Additional reporting by Laurie Tarkan and Rachel Rabkin Peachman
Dietary supplements are not regulated the same way as medications. Consumer Reports gives you a complete guide to supplement safety.