Published: Tuesday, August 24, 2010, 7:00 AM
Brie Zeltner, The Plain Dealer
Warning: may cause low blood pressure, heart rhythm disorders, fainting, liver damage, kidney damage, rapid heart rate. A nightmare list of side effects for a new erectile dysfunction drug? Nope, it's worse.
These are the possible dangers of taking 12 supplements that are readily available in stores and on the Internet and are purported to help conditions from upset stomach to cancer and heart disease. Many of the supplements, identified by Consumer Reports in its September cover story, have no warning labels.
And that is the crux of the problem: In an effort to protect access to herbal remedies, consumers are left vulnerable to harm by inadequate regulation of the supplement industry. The 12 supplements identified by Consumer Reports represent a tiny portion of the vast supplement market, but they are perfect examples of an ineffective system that forces consumers to act as detectives in order to remain safe.
The Food and Drug Administration regulates dietary supplements under a set of rules laid out in the 1994 Dietary Supplement Health and Education Act. Under these rules, the open market is the testing ground for the safety of supplements: manufacturers are responsible for developing safe products, and the FDA takes action when needed if adverse events crop up.
Representatives of the supplement industry argue that the system has produced a safe marketplace.
"The FDA has the authority to remove products from the market that it believes to be hazardous to consumers," says Duffy MacKay, a naturopathic physician and vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, or CRN, a trade association representing supplement manufacturers.
This happens only rarely, though. The most recent example was ephedra, a weight-loss stimulant banned in 2004 after it was linked to heart attack, stroke, suicide risk and death. More frequently, the FDA notifies the public through consumer warnings.
Eight of the 12 supplements identified by Consumer Reports have been the subject of FDA warnings in the past, some as far back as the early 1990s. Three of them, colloidal silver, kava and yohimbe, are the most widely available.
Colloidal silver, which has been marketed as a natural antibiotic and anti-fungal agent, can cause a permanent bluish skin discoloration when taken in large doses, as well as neurological problems and kidney damage.
Kava, a plant in the pepper family, has been used in many cultures as a nausea remedy and for relaxation purposes. It was widely used in the 1990s for anxiety, until it was linked to cases of liver damage and liver failure. It was subsequently banned in Canada, Germany, France and the United Kingdom.
Yohimbe, an evergreen tree native to Africa, yields the chemical yohimbine from its bark. A drug version of yohimbine has been used to treat erectile dysfunction, and the herb has also been marketed as an aphrodisiac. Normal doses can cause high blood pressure and a rapid heart rate, and high doses can lead to death.
It's hard to know what's in supplements
Vitamin Shoppe, which sells store brands of the three supplements, says there is no need for alarm.
"I think you'd really have to take an excessive amount that is not recommended on the label [to cause harm]," says Susan McLachlan, spokeswoman for the retail supplement chain. "You really have to go over and above to have that happen."
But because of poor enforcement of quality manufacturing standards in the supplement industry, it's currently impossible to tell with any certainty how much of each ingredient is in these products.
Richard Creger, a pharmacist at University Hospitals Case Medical Center who counsels cancer and bone marrow transplant patients, asks all of his patients to stay off supplements during treatment.
"You really aren't sure what these people are getting," he says. "There's no regulation -- so when you look at [a product] and it says there's 700 milligrams of herb in it, you don't know if there's really 700, or if it's 100, or 1,000. You don't know if there's fungus or yeast or bad bacteria in there. You don't know if there are heavy metals like lead and zinc in them, because there's actually no control."
Dr. Carolyn Nemec, a family practice physician at the Cleveland Clinic who specializes in women's health, agrees. She fields daily questions from women about weight-loss supplements, including yohimbe.
"Unfortunately we just don't have a lot of good studies on these products because frankly there isn't a lot of money in it for the pharmaceutical companies," she says.
MacKay of CRN says the FDA and the supplement industry are making moves to improve quality and reporting. In 2007, the Dietary and Supplement Non-Prescription Drug Consumer Act made it mandatory for supplement and over-the-counter-drug manufacturers to report all serious adverse events to the FDA. Regulations regarding Current Good Manufacturing Practices now require domestic and foreign companies producing supplements sold in the United States to adhere to standards of quality, consistency, purity, strength and composition.
An example of poor policing
Regulations are useless without adequate enforcement, and for now, the supplement marketplace is poorly policed.
Take the example of Miracle Mineral Solutions, or MMS, an oral liquid marketed as a lifesaving scientific breakthrough. On July 30, the FDA warned consumers to stop drinking the solution, which turns into a potent bleach when mixed with citrus juice per the instructions on the product.
The agency has received several health reports from consumers who have experienced severe nausea, vomiting and life-threatening low blood pressure from dehydration after using MMS.
The manufacturers claim that the product, which contains 28 percent sodium chlorite, can cure cancer, AIDS, hepatitis, malaria, tuberculosis and acne -- claims that the FDA has repeatedly warned the company to remove from its website.
What is even more shocking than these unsupported and outlandish claims is that one month after the FDA's warning, you can still easily buy a product that instructs you to prepare and drink industrial-strength bleach in the name of good health.
Caveat emptor, indeed.
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