Stricter Guidelines for Supplements
The Inspector General's office of the Department of Health and Human Services has just issued a draft report calling for tougher regulations on the sale and use of dietary supplements.
The report said that current federal regulations do a poor job of protecting the public from risks associated with dietary supplement use. Approximately 60 percent of Americans have used such supplements, the report notes.
The report specifically mentioned that dietary supplement manufacturers do not have to undergo stringent FDA testing procedures before being marketed, and manufacturers do not have to report adverse health effects experienced by consumers of their products. Instead, the FDA relies on voluntary information provided by the manufacturers themselves.
The report referenced a previous FDA study that estimated the agency learns of only 1 percent of all "adverse events" involving dietary supplements. More than three-quarters of the products mentioned in adverse event reports do not have adequate labeling, and 71 percent do not specify where the product was manufactured.
The Inspector General's office said the current regulatory system "cannot serve as an adequate safety valve" for protecting consumers. It called for immediate regulatory action to impose the same manufacturing and marketing standards on dietary supplements as exist on other food and consumer products.
As a perfect example of this imperfect system, the FDA has just issued a consumer alert regarding aristolochic acid, an herbal extract linked to permanent kidney damage and urinary tract cancers. It is found in many folk medicines and diet aids.
The FDA recently called on supplement manufacturers to closely monitor any of their products that contain aristolochic acids, and to report any adverse reactions to the agency. But they felt that more aggressive action was warranted.
As a result, they issued a national consumer alert, which advised anyone who has taken any herbal products containing aristolochic acids to contact their healthcare provider immediately. "Even if these products have not been used recently," it warns, "consumers should still inform their healthcare provider about which product they took, so that an appropriate evaluation may be conducted."
Problems with dietary supplements can be compounded because patients often do not inform their doctors that they are using them.
In a study presented at the annual meeting of the American Academy of Family Physicians, Dr. Margaret Planta reported that 60 percent of the patients she interviewed at a low-income county health clinic reported using herbal remedies or dietary supplements. But more than half (53 percent) said they had not informed their physician. Furthermore, nearly 20 percent of the patients who reported using such product said that they had no intention of telling their physician about their use of the products.
In a related study, Dr. John Metz of the University of Pennsylvania reported at a recent meeting of the American Society of Clinical Oncology that cancer patients tend to divulge their use of alternative therapies only when directly questioned by their physician. After interviewing 196 cancer patients, just 13 (7 percent) said they were using an alternative or unconventional therapy. Yet, more than a third of the patients (34 percent) admitted using vitamins, herbal supplements, shark cartilage, guided imagery or meditation when asked directly about these therapies.
Even in a best-case scenario, it will be years before a meaningful, industry-wide system is implemented that will guarantee the safety and effectiveness of all dietary supplements on the market. And even then, these supplements will still not undergo the stringent review and approval procedures that the Food and Drug Administration applies to medicinal drugs.
Therefore, consumers themselves must take the initiative to ensure the quality and safety of what they are purchasing. Talk to your pharmacist, read the labels, and most importantly of all, let your physician know that you are taking such supplements. While most herbal products are safe if taken in the appropriate doses, they can skew the results of certain diagnostic tests and possibly interact with other medicines being taken.
A growing number of research studies are now underway which are testing the safety and effectiveness of at least the most popular herbal products. For example, four herbal products-aloe vera, ginseng, kava kava, and milk thistle-have been recommended by the National Cancer Institute for substantially increased testing because of their widespread use by the public. NCI also cited indole-3-carbinol, a substance found in cruciferous vegetables such as broccoli, as a compound requiring additional study.
But many more herbal products must be subjected to similar scrutiny. And definitive results from these and other studies are still years away. Therefore, in the interim, the old adage still applies-buyer beware.
SOURCES:
Office of the Inspector General, U.S. Department of Health and Human Services (http://www.hhs.gov)
U.S. Food and Drug Administration (http://www.fda.gov)
American Society of Clinical Oncology (http://www.asco.org)
American Academy of Family Physicians (http://www.aafp.org)