Beware of labels on weight-loss gadgets and over-the-counter supplements touting FDA approval, reports the Los Angeles Times. Such labels don’t necessarily mean a product is effective, or even safe. Consumers need to be aware that the FDA doesn’t evaluate all products with equal vigor, said Dr. William Maisel, a Harvard Medical School assistant professor and director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston, in the article. From the Times:
Strictly speaking, he says, the only products that the FDA actually “approves” are drugs and serious high-tech medical devices such as implantable defibrillators. Other products may be “listed” or “registered” with the agency, but that’s a big step down from actual approval; determining whether any particular product has actually gone through the right channels can be difficult.
The FDA doesn’t test dietary supplements, though a manufacturer who wants to make claims about a product’s ability to treat or prevent a disease must provide some evidence. Most supplements simply claim to “promote” health, which doesn’t require FDA approval. However, some companies defy the law, knowing that the FDA has limited enforcement staff, said Daniel Carpenter, a professor of government at Harvard University.
The level of FDA scrutiny applied to medical devices, which can include some exercise equipment, depends on how invasive the device is and whether it poses a potential danger to users. The Institute of Medicine is currently reviewing the FDA’s methods of approving medical devices, and plans to release a report in spring 2011.
Read the full article here.
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