Posted 5/6/2014 4:25 PM (GMT 0)
I saw this online and was wondering what you all thought:
"Part of the problem with these herbal supplements is that many consumers think that they are safe because someone must be regulating them. And they also think that the claims made by Big Herbal must be factual because someone must be regulating them. Except, in the USA, regulation barely exists. The Dietary Supplement Health and Education Act (DSHEA), passed by the US Congress in 1994, specifically removed supplements from being regulated like pharmaceuticals. According to the US Food and Drug Administration (FDA), “the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.”
In other words, the supplement manufacturer doesn’t really have to prove anything to anyone before marketing the product. A pharmaceutical company has to spend tens or hundreds of million of dollars in clinical trials to show safety, efficacy, shelf life, interactions with other drugs, and then wait several years to gain FDA clearance to bring the drug to patients. Because Big Herbal doesn’t have to pay that huge cost to prove that those supplements are safe and that they actually work, the profit margin of supplements is probably quite a bit higher than pharmaceuticals.
In a recent article in the Archives of Internal Medicine (a respected peer-reviewed journal), DM Marcus and AP Grollman stated that “Even when the agency [FDA] identifies an unsafe product, it lacks authority to mandate its removal from the market because it must meet the very high legal requirement to demonstrate a ‘significant or unreasonable’ risk. That is why it took FDA more than 10 years to remove from the market ephedra-containing herbal weight-loss products that had caused hundreds of deaths and thousands of adverse events.”