The Truth About Nutrition Supplements
Quality and Safety Concerns
Concerns about quality and safety have swirled around dietary supplements ever since the 1700s, when the first snake-oil salesmen peddled elixirs with outrageous, unsupported claims; they're one reason the FDA was created, back in the 1930s.Government Rules for Supplements
But from the beginning, the rules for supplements have been far less stringent than those for conventional drugs. Unlike pharmaceutical companies, dietary-supplement manufacturers don't need FDA approval to sell their products, and they certainly don't need to conduct expensive clinical trials. Worse, makers aren't even required by the government to report any "adverse events" -- FDA-speak for unwelcome side effects such as blotchy skin, heart palpitations, and organ damage.
As a result, the FDA is unable to compile convincing evidence against a bad product in order to ban it. Even when anecdotal evidence does pile up, such information is sometimes too weak to effect a change, explains Marvin Lipman, MD, chief medical advisor for Consumers Union, publisher of Consumer Reports. "You need clinical data to prove that ingredient X caused side effect Y. But because supplements are poorly studied at best, that's tough."How Safe Is Kava?
Here's an example: Kava, an herb found in the South Pacific, whose root has sedative properties. "After it became popular for stress reduction, some manufacturers started including stems and other parts of the plant in their formulas, presumably to save money," explains Gurley. Unfortunately, these parts contain a toxic compound that can cause liver damage. The FDA issued a safety warning in 2002 but didn't remove kava from the market or restrict its sale. Why? Because there's no proof that anyone in the U.S. has died from liver damage directly caused by kava stems.
Even if deaths do occur, the FDA may still find itself impotent in a courtroom. Take ephedra, an amphetamine-like stimulant, which was linked to as many as 155 deaths and more than 16,000 adverse events before the FDA got it banned in 2004. Often packed into weight-loss and energy-boosting products, ephedra can raise heart rate and blood pressure and trigger seizures, heart attacks, and strokes. Yet last year, a federal judge in Utah ruled that despite the seeming mountain of anti-ephedra evidence, the FDA hadn't proved that the herb was dangerous in small quantities. (The ban is now in bureaucratic limbo as the FDA figures out its next move.)
Although headlines often focus on concerns about herbal supplements, everyday vitamins and minerals aren't problem-free. "The most common issue is that a product won't contain or deliver all the ingredients it promises," says Tod Cooperman, MD, president of ConsumerLab.com, an independent supplement-testing service. And what's missing may cause harm: At least one vitamin B complex tested by Consumer Lab.com provided less than the RDA for folic acid -- a deficiency of which can cause birth defects such as spina bifida.
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