Hidden Drugs and Steroids Found in More Than 170 Supplements Since 2008
YONKERS, NY — A new investigation in the September issue of Consumer Reports and available online at www.ConsumerReportsHealth.org describes a striking lack of government oversight for the bustling $26.7 billion dietary supplement market and identifies a "dirty dozen" list of supplement ingredients that have been linked by clinical research or case reports to serious adverse events, such as cancer, coma, heart problems, kidney damage, liver damage, or death.
Working with experts from the Natural Medicines Comprehensive Database, an independent research group, Consumer Reports identified 12 supplement ingredients linked to serious adverse events by clinical research or case reports. Other factors were also evaluated, including evidence of effectiveness for their purported uses, and the extent to which the ingredients are readily available, either alone or in combination products. The dozen are aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe. Surprisingly, the Food and Drug Administration (FDA) has warned about at least eight of these, some as long ago as 1993; those eight supplements include chaparral, colloidal silver, comfrey, country mallow, germanium, kava, lobelia, and yohimbe. But warnings have not prevented retailers from selling supplements containing these ingredients.
More than half of the adult population in the U.S. have taken supplements for a variety of reasons—to stay healthy, lose weight, gain an edge in sports, or to improve their performance in the bedroom. What consumers may not realize is that the supplement manufacturers routinely, and legally, sell their products without first having to demonstrate that they are safe and effective. The Consumer Reports investigation states that the FDA has not made full use of even the meager authority granted it by the industry-friendly 1994 Dietary Supplement Health and Education Act (DSHEA). The FDA has only once used its power to ban a supplement ingredient (ephedrine alkaloids) outright.
"Supplements are marketed with very seductive and sometimes overblown sales pitches for increasing your performance in the bedroom, slimming down, or boosting your athletic prowess. And consumers are easily lulled into believing that supplements can do no harm because they're 'natural.' However, some natural ingredients can be hazardous, and on top of that the FDA has repeatedly found hazardous ingredients, including synthetic prescription drugs, in supplements," said Nancy Metcalf, senior program editor, Consumer Reports.
The report notes that, because of inadequate quality control and inspection, supplements contaminated with heavy metals, pesticides, or prescription drugs have been sold to unsuspecting consumers. The FDA says hidden drugs or steroids have been found in more than 170 products marketed as supplements since 2008. As evidence of the agency's inability to properly regulate the supplements industry, Consumer Reports notes that the FDA has yet to inspect a single supplement factory in China, which has become a major supplier of raw supplement ingredients.
Consumer Reports' investigation also notes that the FDA and Congress have recently taken some action to strengthen the agency's oversight, such as passing a long overdue law that went into effect in December 2007 requiring supplement companies to report serious adverse events. The FDA said it received 1,359 reports of serious adverse effects from manufacturers and 602 from consumers and health professionals from 2008 through 2009. Consumer Reports believes that this law is a good step but much more needs to be done to keep consumers safe. In the meantime, here are some steps consumers can take to make sure the supplements they use are safe and beneficial.
* Consult your doctor or pharmacist. Even helpful products can be harmful, for example, if you're pregnant or nursing, have a chronic disease, taking a medication that interacts adversely with the supplement, or are about to undergo elective surgery.
* Beware of these categories. Supplements for weight loss, sexual enhancement, and bodybuilding have been problematic, the FDA said, because some contain steroids and prescription drugs.
* Look for the "USP Verified" mark. It indicates that the supplement manufacturer has voluntarily asked U.S. Pharmacopeia, a trusted nonprofit, private standard-setting authority, to verify the quality, purity and potency of its raw ingredients or finished products. USP posts a list of verified products on its website at www.uspverified.org.
* Don't assume more is better. It's possible to overdose even on beneficial vitamins and minerals. Avoid any product that claims to contain "megadoses."
* Report problems. Let your doctor know if you experience any symptoms after you start taking a supplement. And if you end up with a serious side effect, ask your doctor or pharmacist to report it to the FDA, or do it yourself at www.fda.gov/medwatch or by calling 800-332-1088.
* Research in the right places. Be skeptical about claims made for supplements in ads, on TV and by sales staff. If a claim sounds too good to be true, it probably is. Consumer Reports provides several online links for assessing supplements at www.ConsumerReportsHealth.org.
Working with experts from the Natural Medicines Comprehensive Database, an independent research group, we identified a group of ingredients (out of nearly 1,100 in the database) linked to serious adverse events by clinical research or case reports. To come up with our dozen finalists, we also considered factors such as whether the ingredients were effective for their purported uses and how readily available they were to consumers. We then shopped for them online and in stores near our Yonkers, N.Y., headquarters and easily found all of them for sale in June 2010.
The dozen are aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe. The FDA has warned about at least eight of them, some as long ago as 1993.
Why are they still for sale? Two national retailers we contacted about specific supplements said they carried them because the FDA has not banned them. The agency has "the authority to immediately remove them from the market, and we would follow the FDA recommendation," said a spokeswoman for the Vitamin Shoppe chain.
Most of the products we bought had warning labels, but not all did. A bottle of silver we purchased was labeled "perfectly safe," with an asterisked note that said the FDA had not evaluated the claim. In fact, the FDA issued a consumer advisory about silver (including colloidal silver) in 2009, with good reason: Sold for its supposed immune system "support," it can permanently turn skin bluish-gray.
Janis Dowd, 56, of Bartlesville, Okla., says she started taking colloidal silver in 2000 after reading online that it would keep her Lyme disease from returning. She says her skin changed color so gradually that she didn't notice, but others did. "They kept saying, 'You look a little blue.'"
Laser treatments have erased almost all the discoloration from Dowd's face and neck, but she said it's not feasible to treat the rest of her body.
Under the DSHEA, it is difficult for the FDA to put together strong enough evidence to order products off the market. To date, it has banned only one ingredient, ephedrine alkaloids. That effort dragged on for a decade, during which ephedra weight-loss products were implicated in thousands of adverse events, including deaths. Instead of attempting any more outright bans, the agency issued warnings, detained imported products, and asked companies to recall products it considered unsafe.
Release Date: 08/03/2010
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