FDA Reclassifies OTC Laxative Products
The US Food and Drug Administration has reclassified five widely-used ingredients in over-the-counter laxative products from Category I (safe and effective) to Category III (more data needed).
The five ingredients - phenolphthalein, bisacodyl, aloe, cascara sagrada and senna - were first put onto the market many years ago and a non-government review panel concluded in 1975 that they should be considered "safe and effective." They were subsequently put into Category I in 1985. In the USA, around 40 products contain at least one of these ingredients.
The FDA has stopped short of banning the products because the risks are unproven and intermittent use is not likely to cause a problem. The agency did caution that people should not ignore the warnings on packs of these products and not use them repeatedly for long periods of time.
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