Nutritional Supplements: Buyers Be Aware
Nutritional Supplements: Buyers Be Aware
"My neighbosr tried this stuff, and she feels great. Doesn't that prove that it works?"
By: Eva Briggs, M.D.
It's not a drug. It's an all-natural nutritional supplement. So it must be safe, right?
Wrong. That nutritional supplement probably hasn't been tested to determine whether it's safe or effective. It's regulated by the Dietary Supplement Health Education and Supplement Act of 1994, and as long as it doesn't make any drug claims, there is no need for the manufacturer to systematically test whether it works or not.
But the label says that it supports the cardiovascular system. And everyone in my family has had a heart attack. So won't it protect me?
If the label said that it prevented heart disease, then that would be a drug claim, and the product would have to be regulated as a drug. But a statement of support is permitted for a nutritional supplement. Then it should help my father with those chest pains he's been having, right?
Supporting the cardiovascular system doesn't mean a supplement can treat heart disease.
I'm confused. If this supplement can't prevent or treat any disease, why doesn't it say so?
There's a disclaimer somewhere on the label, in fine print. It reads something like "This product has not been evaluated by the FDA for prevention, treatment, or mitigation of any disease."
The words "nutritional supplement" mean that it must supply something that the body needs, such as an essential nutrient, right?
No, under the law, substances that are categorized as nutritional supplements may include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. The category is so broad that even some hormones are marketed to consumers as dietary supplements!
But it's natural. It must be safe and pure.
Not necessarily. Nutritional supplements don't need to be tested for safety before marketing. Even if a manufacturer receives a report that one of its supplements caused an adverse reaction, the manufacturer is not required to report that to the FDA. And the burden of proof falls to the FDA to demonstrate that a product is dangerous. Only substances that are regulated as drugs need to present safety data before they can be sold.
Whoever heard of a natural product harming someone?
Chinese herbal preparations containing an herb called Aristolochia fangi caused an outbreak of urinary tract cancers in Belgium. It's now banned in several European countries, but has been found in products sold in the United States. Germander is associated with acute hepatitis, comfrey is associated with blockage of liver veins, and ephedra is associated with deaths from cardiovascular causes. Supplements are not tested for purity, or for the accuracy of their labels. A 1998 study by the California Department of Health found that 32 percent of Asian patent medicines sold in that state contained undeclared pharmaceuticals or heavy metals. And in June of 2004, an Illinois nurse filed suit against the manufacturer of a salve called Cansema, which claimed to target skin cancer without affecting normal skin. The woman's face was severely burned and disfigured because the product actually contained dangerous corrosive ingredients substances that were not listed on the label.
My neighbor tried this stuff, and she feels great. Doesn't that prove that it works?
That's called anecdotal evidence, and it's not enough to demonstrate that a product acts as claimed. I'll save that subject for a later column. In the meantime, be cautious with supplements. Under current regulations, it's not possible to know whether a supplement is safe, effective, or pure. Buyer beware.
Eva Briggs, M.D., a graduate of S.U.N.Y. Health Science Center at Syracuse and the family practice residency of St. Joseph's Hospital in Syracuse, is a family physician in private practice in Marcellus. She can be reached at 673-9926.
"My neighbosr tried this stuff, and she feels great. Doesn't that prove that it works?"
By: Eva Briggs, M.D.
It's not a drug. It's an all-natural nutritional supplement. So it must be safe, right?
Wrong. That nutritional supplement probably hasn't been tested to determine whether it's safe or effective. It's regulated by the Dietary Supplement Health Education and Supplement Act of 1994, and as long as it doesn't make any drug claims, there is no need for the manufacturer to systematically test whether it works or not.
But the label says that it supports the cardiovascular system. And everyone in my family has had a heart attack. So won't it protect me?
If the label said that it prevented heart disease, then that would be a drug claim, and the product would have to be regulated as a drug. But a statement of support is permitted for a nutritional supplement. Then it should help my father with those chest pains he's been having, right?
Supporting the cardiovascular system doesn't mean a supplement can treat heart disease.
I'm confused. If this supplement can't prevent or treat any disease, why doesn't it say so?
There's a disclaimer somewhere on the label, in fine print. It reads something like "This product has not been evaluated by the FDA for prevention, treatment, or mitigation of any disease."
The words "nutritional supplement" mean that it must supply something that the body needs, such as an essential nutrient, right?
No, under the law, substances that are categorized as nutritional supplements may include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. The category is so broad that even some hormones are marketed to consumers as dietary supplements!
But it's natural. It must be safe and pure.
Not necessarily. Nutritional supplements don't need to be tested for safety before marketing. Even if a manufacturer receives a report that one of its supplements caused an adverse reaction, the manufacturer is not required to report that to the FDA. And the burden of proof falls to the FDA to demonstrate that a product is dangerous. Only substances that are regulated as drugs need to present safety data before they can be sold.
Whoever heard of a natural product harming someone?
Chinese herbal preparations containing an herb called Aristolochia fangi caused an outbreak of urinary tract cancers in Belgium. It's now banned in several European countries, but has been found in products sold in the United States. Germander is associated with acute hepatitis, comfrey is associated with blockage of liver veins, and ephedra is associated with deaths from cardiovascular causes. Supplements are not tested for purity, or for the accuracy of their labels. A 1998 study by the California Department of Health found that 32 percent of Asian patent medicines sold in that state contained undeclared pharmaceuticals or heavy metals. And in June of 2004, an Illinois nurse filed suit against the manufacturer of a salve called Cansema, which claimed to target skin cancer without affecting normal skin. The woman's face was severely burned and disfigured because the product actually contained dangerous corrosive ingredients substances that were not listed on the label.
My neighbor tried this stuff, and she feels great. Doesn't that prove that it works?
That's called anecdotal evidence, and it's not enough to demonstrate that a product acts as claimed. I'll save that subject for a later column. In the meantime, be cautious with supplements. Under current regulations, it's not possible to know whether a supplement is safe, effective, or pure. Buyer beware.
Eva Briggs, M.D., a graduate of S.U.N.Y. Health Science Center at Syracuse and the family practice residency of St. Joseph's Hospital in Syracuse, is a family physician in private practice in Marcellus. She can be reached at 673-9926.
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