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Certain fruit juices contain too much antimony (a chemical that may cause cancer or damage the reproductive system).
The Children’s Wireless Protection Act, 02/26/2010.
Even educated people don’t want to read long, complicated materials–except possibly the most highly motivated people, and even they want to get the meat of the matter, not the extraneous information. And, also remember that most medications in this country are taken by the elderly, and even those who are highly educated may not be able to read or concentrate as well as they did when they were younger.
Clearly, the focus of the 510(k) process has been on letting companies change devices in the name of innovation, not based on public health standards or problems. As a result, devices are being sold that are so different from previous “substantially equivalent” devices that the FDA has no idea whether the product is safe or effective, and in many cases these innovative devices are either not as safe as other products on the market, or not as effective. This costs the medical system (and individuals) billions of dollars each year.