Regulators and Physicians Raise Alarms About Dangerous Ingredients in Many Herbal Remedies
From WSJ.com:
When Dan Gerkey was trying to get into better shape a few years ago, he tried out a dietary supplement from a local store that promised to help build his strength. At first, the stuff worked. But after several weeks the police officer, who lives in Fraser, Mich., started feeling exhausted, and his wife noticed a yellowish tinge in his eyes.
Soon, Mr. Gerkey’s skin also yellowed, and it itched so fiercely that taking a shower or pulling on his socks became agonizing. Eventually, a liver specialist at Henry Ford Health System in Detroit figured out the pills’ ingredients list included the name of a steroid, which he linked to the liver damage that was the main cause of Mr. Gerkey’s symptoms. Mr. Gerkey, 40, ended up losing 35 pounds before he recovered.
“I was shocked,” says Mr. Gerkey, who says he had avoided buying supplements online because of worries about what they might contain. The pills “seemed legitimate to me,” sold in a sealed bottle at a shop selling supplements that he’d visited before. Now, he won’t even take vitamins.
Extreme cases like Mr. Gerkey’s are unusual. But dietary supplements have long raised safety worries, with high-profile examples including ephedra, the herbal weight-loss treatment pulled from the U.S. market in 2004 after it was tied to heart problems and strokes. Some doctors continue to be concerned about evidence of side effects from such herbal ingredients, including research highlighting possible concerns about kava and comfrey. And the issue is drawing new attention after recent reports from the Food and Drug Administration about allegedly natural supplements illegally containing performance-enhancing drugs and undeclared pharmaceuticals.
For consumers, the upshot can be confusion and alarm. But people can reduce the risk that the supplements they take will endanger their health using a growing number of online information resources and certification programs, and some common-sense tactics. “Consumers need to be their own advocate, and read and understand what they are taking,” says Linda Katz, interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
Nearly two-thirds of American adults take dietary supplements, a broad category that includes vitamins, minerals and herbal products, according to the Council for Responsible Nutrition, an industry trade group. The most commonly used include multivitamins, calcium and omega-3, the group says. Allegedly natural over-the-counter treatments that promise to melt pounds, build muscle or boost energy are also widely used.
Most supplements are consumed without raising safety concerns. Still, the products are much less closely scrutinized than drugs, which are tested extensively and must win FDA approval before going on the market. Supplements that are made from products that were on the U.S. market before 1994—as most commonplace ones are—can be sold without being reviewed by the FDA beforehand. Companies that include newer substances are supposed to inform the agency before they go on the market, but don’t have to wait for approval.
Consumer advocates have long called for tougher rules. Officials at the Council for Responsible Nutrition say no new laws are needed, citing new FDA manufacturing standards for supplements, which are now being phased in, as well as a requirement for supplement makers to tell the FDA when they get reports of serious side effects, which took effect at the end of 2007.
A Senate Judiciary subcommittee plans a hearing this month focused on dietary-supplement safety. FDA officials say they are boosting their enforcement efforts, but it is a challenge to oversee the large and fast-growing supplement industry. “We do the best we can with the resources we have available,” says Janet Woodcock, the head of the FDA’s drug center. “Consumers have to be vigilant as well.”
Chuck Haugh, a mailing-equipment salesman in Lincoln, Neb., says he didn’t pay much attention at first when his teenaged son started taking dietary supplements as part of a new workout regimen last spring. But within a few weeks, Mr. Haugh and his wife say they noticed the then-high-school senior seemed far more irritable than usual, with a hair-trigger temper. Mr. Haugh says he secretly examined the muscle-building products he found in the teenager’s gym bag and mentioned their ingredients to a sports dietician he knew.
Mr. Haugh says his friend warned that the products, which had been purchased locally without a prescription, might contain substances that could put stress on his son’s liver, among other concerns. A blood test, connected to a pharmaceutical the teen was also taking, showed he had elevated liver enzymes, an early sign of potential liver damage. The supplements might not have been to blame, but the boy quit taking the products and returned to normal, his father says. “It was just scary,” says Mr. Haugh.
A 2007 survey of U.S. weight-loss and athletic supplements by the British lab HFL Sport Science, a unit of Quotient Bioresearch Ltd., found the undisclosed presence of steroids in at least trace amounts in 25% of the 52 samples analyzed. The survey didn’t include companies using HFL’s certification service. Anabolic steroids are controlled substances, and they are not supposed to be sold in dietary supplements. Some forms can be prescribed by a doctor as drugs.
Last year, an article in the journal Gastroenterology, on a national effort spearheaded by the National Institute of Diabetes and Digestive and Kidney Diseases to track drug-induced liver injuries, said that 9% of the 300 cases then recorded were potentially tied to dietary supplements, including some widely used weight-loss and herbal products.
Mr. Gerkey’s doctor, Stuart Gordon, published last month in the Journal of Clinical Gastroenterology an account of Mr. Gerkey’s history and two other liver-damage cases that the authors tied to supplements that appeared to be laced with steroids. Zhen-Zhou Feng, a co-author of the article, says he has already encountered another patient who appeared to have the same problem. “It’s out there, it’s just not being recognized” by most doctors, says Dr. Gordon, partly because they don’t always know that their patients are taking supplements.
Since last December, the FDA has issued warnings about more than 70 weight-loss supplements that included potentially dangerous ingredients. The ingredients included prescription drugs, and the agency said the side effects could include seizure, heart attack and stroke. In July, the FDA warned consumers to avoid bodybuilding supplements that claimed to contain steroid-like ingredients, but actually included steroids. The agency, which issued a general warning but also named some specific brand names, said it had received reports of men with serious liver injuries, stroke, kidney failure and pulmonary embolism potentially linked to such products.
An FDA spokesman said the agency can’t comment on supplement makers’ intent. But Ed Wyszumiala, general manager of dietary supplement programs for NSF International, a nonprofit organization in Ann Arbor, Mich., that certifies supplements’ safety, says the drugs and steroids likely get into the products through a combination of deliberate spiking and inadvertent contamination.
Andrew Shao, a vice president at the Council for Responsible Nutrition, says safety problems are a “rare occurrence,” but “there are some issues, we recognize that.” In the Gastroenterology publication, the share of liver problems tied to supplements may appear larger because the study didn’t include cases caused by acetaminophen, or Tylenol, he says. He questioned the HFL survey, which he called a “marketing tactic”; an HFL official said it was meant to “show there was reason for concern.” Mr. Shao says his group welcomes the FDA’s ramped-up enforcement efforts, and “consumers need to be savvy as well.”
People who want to take a supplement should talk to a doctor, says Travis Tygart, chief executive of the U.S. Anti-Doping Agency, a nonprofit that oversees drug-testing of American Olympic hopefuls and some other top athletes. He says he advises athletes that they take all supplements at their own risk.
Along with talking to a physician, people can do their own research. Many herbs have been tested in major studies and shown no benefits. Some have been linked to side effects, even without the presence of undisclosed drugs. A 2007 article by a National Institutes of Health researcher in the journal Clinics in Liver Disease listed comfrey, chaparral and kava among other herbs potentially tied to liver damage.
Before they take a supplement, consumers should also check for potential interactions between any herb, vitamin or mineral and their prescriptions. They should also be particularly sensitive if they have existing health issues. For instance, those with heart conditions should be careful about supplements that act as stimulants, which can involve ingredients such as bitter orange and guarana, in addition to caffeine.
For information on evidence, side effects and interactions, try the National Library of Medicine’s medlineplus.gov, under “Drugs and Supplements.” The NIH has more information at nccam.nih.gov and dietary-supplements.info.nih.gov, which has fact sheets and a research database. Subscriptions at www.naturaldatabaseconsumer.com include effectiveness ratings.
Consumers can also search for specific supplements before taking them at www.fda.gov, to see if they’ve been included in safety warnings. Some other tactics are common sense, like being suspicious of those that boast dramatic curative effects. Products that brag of steroid-like effects may actually contain versions of the drugs, and consumers should be careful with products that claim to be “herbal” versions of prescriptions.
Consumers should closely read the ingredients. Potentially dangerous substances often won’t be disclosed. But sometimes they are—if you know what to look for. One step is to look for drugs banned for top athletes, or variations on those names. The World Anti-Doping Agency list is at www.wada-ama.org under “Resources for Athletes.” Certain suffixes in chemical names are common for steroids or tweaked versions of them. Among them are -one, -ene, -iol and -bol, though these can also appear in the names of legitimate ingredients. Some products also use versions of steroid names in their brands, like “tren” to connote trenbolone.
But consumers shouldn’t necessarily feel secure just because a product doesn’t set off warning bells. Kicker Vencill, 31, a former competitive swimmer who is now a lifeguard living in Santa Monica, Calif., flunked an athletic drug test several years ago and claimed it was due to a dietary supplement. The Court of Arbitration for Sport ruled that, as Mr. Vencill argued, a multivitamin that he took contained banned steroids, it was the supplement that caused him to fail the test, and that he didn’t know the capsules contained drugs. But he was still suspended from competition for two years.
“The last one that I thought would be the culprit was the multivitamin,” Mr. Vencill says. A spokesman for Ultimate Nutrition Inc., which made the multivitamin, had no comment.
Several services test supplements for safety and purity. They generally charge supplement makers, and they don’t always disclose when paying clients’ products fail. Nonetheless, the certifications are “useful,” and can provide evidence of a product’s reliability, says Paul Coates, director of the NIH’s Office of Dietary Supplements.
Professional sports organizations including the National Football League and Major League Baseball urge players to take only supplements reviewed by NSF, which lists products certified for athletic use at nsf.org under “certified for sport.” Other organizations checking supplements are HFL, which has a program called Informed-Choice,with products listed at www.informed-choice.org, the U.S. Pharmacopeia, at www.usp.org, and ConsumerLab.com LLC, which charges consumers for its reports. ConsumerLab also does some checks without being paid by the manufacturers.
Finally, people should watch carefully for any symptoms that start after they take a new supplement. Among the warning signs cited by the FDA in its public-health advisory on products that may contain steroids are nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellow corneas and skin, and discolored urine. Most of those are signs of liver or heart problems.
SUPPLEMENTAL INFORMATION
If you are thinking of taking a dietary supplement, talk to your doctor. In addition, here are some resources for your own research.
SOURCES ON HERBS and VITAMINS
To check the research into effectiveness and safety of herbal products, try the National Library of Medicine’s Medline Plus at medlineplus.gov, under Drugs & Supplements: http://www.nlm.nih.gov/medlineplus/druginformation.html
You can also go to two other National Institutes of Health sites, one for the National Center for Complementary and Alternative Medicine (http://nccam.nih.gov/) and one for the Office of Dietary Supplements (http://dietary-supplements.info.nih.gov/).
The Centers for Disease Control and Prevention offers background on vitamins here: http://www.cdc.gov/nutrition/everyone/basics/vitamins/
There’s a paid subscription service at www.naturaldatabaseconsumer.com.
The supplements industry backs a site called Life Supplemented at www.lifesupplemented.org.
For a safety-oriented focus, here’s a Consumers Union report: http://www.consumerreports.org/health/natural-health/dietary-supplements-to-avoid-1-08/overview/risky-supplements-ov.htm
SOURCES ON PRODUCTS
If you are looking into a specific brand, here are some places to check.
You can start with the FDA’s site, at www.fda.gov, where you can search to see if your product has been the subject of a warning letter or consumer alert. Another federal agency web site that may be worth checking is the Federal Trade Commission’s, at www.ftc.gov. Look under Internet Fraud and Safety, then click on Health.
You can look at the prohibited-substance list of the World Anti-Doping Agency at www.wada-ama.org, under “Resources for Athletes.”
Certification services can provide some outside verification that a product is safe. Here are their Web sites.
The U.S. Pharmacopeia’s list is at: http://www.usp.org/audiences/consumers/#Dietary
NSF International lists those it has certified for sport at nsf.org. Click on “NSF Banned Substances Program.”
HFL Sport Science’s list is at www.informed-choice.org
ConsumerLab.com LLC charges for access to its reports, at www.ConsumerLab.com.
MEDICAL JOURNAL ARTICLES
For medical-journal publications mentioned in this article, here are links to their abstracts:
Article in Gastroenterology about drug-induced liver injury:Article in Clinics in Liver Disease about herbs and liver injury Article in the Journal of Clinical Gastroenterology about three cases of liver damaged linked to supplements containing steroids
