Looking at Vitamins
Posted on October 17th, 2006 by garyPosted in Vitamins
Vitamins are taken by seven out of ten Americans with the hopes of improving something. Whether it is their health, performance, longevity, skin, outlook, sex or hair vitamins promise a benefit. Most of us believe that a government agency like the Food and Drug Administration is keeping a watchful eye on the 20 billion dollar supplement industry. But it is not and nearly 30% of multivitamins on the market had contamination problems or ingredient shortfalls.
The federal regulators who would normal regulate poor-quality supplements were restricted by the 1994 legislation passed by President Clinton. This Dietary Supplement Health and Education Act (DSHEA) was intended to make supplements including vitamins, minerals and herbs more widely available by classifying them not as drugs but as foods. This allows supplements not only to not do what they promise but to also not even be safe. In 2004 alone, more than 24,000 toxic exposures to supplements were reported. Other studies show that some supplements contain potentially dangerous contaminants such as lead, mercury, pesticides, mold and bacteria.
Consumer advocates say this regulation helped created a marketplace that fails to protect consumers. People have always assumed since they are vitamins, minerals or herbs they are naturally occurring and safe which is not always the case. Concerns about quality and safety have always been an issue around dietary supplements. But from the beginning the rules for supplements have been far less stringent than those for conventional drugs. Unlike pharmaceutical companies, dietary supplement manufactures do not need FDA approval to sell their products and do not need to conduct extensive expensive clinical trials. Makers are not even required to report any adverse effects. Since supplements are not studied it is difficult for the FDA to compile enough evidence to ban a bad product. Even when evidence is gathered, sometimes the information is too weak to effect a change.
For example, kava an herb found in the South Pacific has roots that have sedative properties. When it became popular for stress reduction, some manufacturers started using stems and other parts of the plant in the production. This was done to save money. Unfortunately these parts contain a toxic compound that can cause liver damage. The FDA issued a safety warning in 2002 but did not remove it from the market or restrict its sale. They could not since there was no proof anyone in the US had died from liver damage directly caused by kava stems.
But even when there is death- the FDA is restricted. When ephedra, an amphetamine-like stimulant was linked to as many as 155 deaths and more than 16,000 adverse events the FDA banned it in 2004. Ephedra can raise heart rate and blood pressure and trigger seizures, heart attacks and strokes. It was packed into weight-loss and energy-boosting products. Yet last year, a federal judge in Utah ruled that despite the evidence the FDA did not prove the herb was dangerous in small quantities. The ban is now in limbo as the FDA figures out its next move.
Although headlines often focus on herbal supplement concerns, everyday vitamins and minerals are not free of problems. The most common issue is that they will not deliver all the ingredients they promise and that vital ingredients may be missing. Some medical experts say vitamins and supplements should be regulated more like drugs with mandatory pre-market testing and FDA approval for safety and effectiveness before sales. But many consumers do not want their access to them restricted.
FDA regulated drugs are not exactly risk free either. In fact with so many adverse effects of medication, supplements are often chosen by patients as the safer option. Products like Ephedra are the exception. About 150 million Americans are using safe supplements. If supplements had to undergo extensive clinical testing the prices would rise so the manufacturer could recoup their research costs. Some manufacturers would have to stop productions.
There are many good, reliable supplements on the market that have been produced by reputable manufactures. The FDA should be given more power to take products off the market. Two bills pending now in Congress could provide resolutions. The first would require manufacturers to forward all serious safety reports to the Secretary of Health and Human Services so that unsafe products could be banned more quickly. The other would require the FDA to budget more money to regulate supplements.
To protect yourself, if you take a lot of supplements, subscribe to an independent testing service. The Natural Medicines Comprehensive Database or Consumer Lab.com keeps taps on brands. Or if you prefer, look for supplements that carry the USP (United State Pharmacopeia seal. This non profit public-health organization charges a fee to conduct independent product testing. This seal ensures the product you are buying contains what the label says it does, that it is free of contaminants, it will be properly absorbed by the body and it was made using safe manufacturing processes.
You should also get educated and learn about the supplements you are taking. The Center for Food Safety and Applied Nutrition has a lot of information on products of most concern. The more complex a product is the more likely for it to have problems. Ingredients to avoid include: aristolochic acid (a potent carcinogen that may cause kidney failure); bitter orange (may raise blood pressure and may increase risk of heart trouble especially when mixed with caffeine); chaparral, germander, skullcap and kava (all may cause liver damage); and lobelia (may cause rapid heartbeat, low blood pressure and dizziness).
If you experience any side effects you believe may have been caused by the supplement, file an adverse event report with the FDA.
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