FDA禁用Ppa的计划又朝前推进(上)
WASHINGTON (Reuters Health) - Moving ahead with plans to remove a once popular diet aid and cold medicine ingredient from the US market, the US Food and Drug Administration (FDA) offered several makers of phenylpropanolamine, or PPA, on Tuesday an opportunity for a hearing prior to the withdrawal of their products.
In November, the FDA declared its intentions to ban PPA after two studies and a committee of expert advisors to the agency concluded that the ingredient found in a number of over-the-counter diet aids and cold medicines might cause strokes in young, healthy people.
Retailers nationwide already have voluntarily pulled several brands of those products, and a number of the larger manufacturers of cold medications have agreed to substitute ingredients. But there is no alternative to the over-the-counter diet aids, and as a result, not all manufacturers have joined the bandwagon.
These manufacturers argue that the studies were flawed and that the actual risk does not outweigh the benefits, considering the prevalence of obesity among the American populace.
"When we received the FDA advisory, each individual company made its own decision," a spokesperson for the Consumer Healthcare Products Association (CHPA) told Reuters Health. CHPA is the nation's largest representative of over-the-counter and dietary supplement makers, and the sponsor of the largest study to find a link between PPA and stroke., 百拇医药
In November, the FDA declared its intentions to ban PPA after two studies and a committee of expert advisors to the agency concluded that the ingredient found in a number of over-the-counter diet aids and cold medicines might cause strokes in young, healthy people.
Retailers nationwide already have voluntarily pulled several brands of those products, and a number of the larger manufacturers of cold medications have agreed to substitute ingredients. But there is no alternative to the over-the-counter diet aids, and as a result, not all manufacturers have joined the bandwagon.
These manufacturers argue that the studies were flawed and that the actual risk does not outweigh the benefits, considering the prevalence of obesity among the American populace.
"When we received the FDA advisory, each individual company made its own decision," a spokesperson for the Consumer Healthcare Products Association (CHPA) told Reuters Health. CHPA is the nation's largest representative of over-the-counter and dietary supplement makers, and the sponsor of the largest study to find a link between PPA and stroke., 百拇医药