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Looking for a late-afternoon energy boost, a woman purchases a highly marketed energy bar. Little does she realize that the energy bar contains excessive amounts of vitamin K that could interfere with the blood-clotting medication she is taking.
The label has no warnings.
This is just one example of what, experts say, is the serious and potentially dangerous lack of standards that currently exists in the over-the-counter dietary supplement market. Federal law requires manufacturers of dietary supplements to ensure that the products they market are "safe". But no real government or industry standards are in place to protect consumers from potential dangers, not to mention products that are less-than-efficacious, according to consumer advocacy groups. The U.S. Food and Drug Administration does not review and approve supplement ingredients prior to their marketing.
"Currently, consumers have no clear basis for determining product quality," said Larry Augsburger, Ph.D., past president of the American Association of Pharmaceutical Scientists. He stressed that consumers need to do considerable research before they purchase any supplement.
"You have to do your homework and use common sense. That includes getting in touch with manufacturers and asking questions," says Ara DerMarderosian, Ph.D., professor of pharmacognosy at the University of the Sciences in Philadelphia.
What questions should you ask?
How can you tell which supplements are effective and right for you? Here are some recommendations on what you should know before you buy:
- Could the supplement interact negatively with one or more of your prescription medications? Because some vitamins and herbs interact negatively with drugs, it's important to inform your doctor about all supplements you're taking, says Augsburger, a professor at the University of Maryland School of Pharmacy. For example, the FDA issued a warning that St. John's wort decreases the effectiveness of HIV drugs such as indinavir.
- Could the supplement affect you during or after surgery? Some supplements can effect how fast or slow your blood clots, your heart rate or blood pressure and other factors that could be vital if you are going to have surgery. Tell your doctor about the vitamins, minerals, herbals or any other supplements you are taking.
- Are the potentially beneficial ingredients easily absorbed into your body? If pills are not formulated properly or are compressed too tightly during the manufacturing process, your body may excrete them before they dissolve, Augsburger says. Augsburger cited a recent study showing that two of nine commercial products containing melatonin (a sleep aid) did not disintegrate after more than 20 hours.
- Do you really need to take this supplement? Ask yourself why you want to take a supplement and whether you need it if you can get the same nutrients from the foods you eat, says Stephen Barrett, a retired psychiatrist and board member of the National Council Against Health Fraud and founder of Quackwatch.com. "There's a certain amount of gambling involved in terms of whether the product might be useful or whether it's even in the bottle," says Barrett.
- Has this supplement been scientifically tested? Do some research to find if the product has been tested on human subjects. Make sure the references you read are from professional journals like The New England Journal of Medicine.
Other important concerns
- Be wary of advertisements and labels on supplements. Labels often have little or no precautionary information, such as what you should do if you take too much. And, what supplement makers can say about their untested products is not much different than what drug manufacturers are permitted to say about their regulated medications. "We have a lot of marketing and a lot of hype. I don't know if we have enough science," Augsburger says.
- Seek answers from supplement manufacturers, who should be willing to send you studies on the stability and effectiveness of their products, information on active ingredients and proof that they are using the correct part of the plant, says DerMarderosian.
Supplement regulations
Dietary supplements must comply with food Good Manufacturing Practice (GMP) regulations. These FDA regulations are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.
Until manufacturers are required to follow drug GMPs, you may want to buy herbal products made in Europe, suggests DerMarderosian, where manufacturers must adhere to strict guidelines that not only standardize the herbal extracts according to chemical or biochemical markers but also set limits on contaminants and require that the ingredients be stable over time.
As herbs and dietary supplements become more popular, researchers are increasingly testing them to find out if they really work. In 1998, test results published by the American Medical Association found that three of the seven remedies tested, including the herb Garcinia cambogia (touted as a diet pill), were no more effective than a placebo, an inactive substance given to some clinical trial participants as if it were the actual supplement.
Supplements can carry the Seal of Approved Quality from ConsumerLab.com, an independent company that tests for the correct ingredients, absorption and purity, says company President Tod Cooperman, M.D. Of the more than 100 dietary supplements tested by ConsumerLab.com, roughly one-third have failed. "What that tells us is good quality is certainly achievable, just not enough companies are achieving it," says Cooperman.
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External Sources
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ConsumerLab
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Quackwatch
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U.S. Food and Drug Administration
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This article was reviewed and updated June 2007.
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