WASHINGTON -- Public health officials in Texas, citing "advice" from the Bush administration, have suspended enforcement of a new state regulation designed to protect athletes and other users of dietary supplements. The Texas regulation centers on supplements that contain ephedrine, a powerful stimulant that is suspected of causing at least 80 deaths nationally. The new rule requires the labels on those products to provide a toll-free number for reporting suspected side effects to the U.S. Food and Drug Administration. The state would be the first in the nation to impose such a requirement on the $16.8 billion-a-year dietary supplement industry, exempt from federal prescription drug regulations. Attempts to enact similar regulations in other states have failed in the face of strong industry opposition. Calls for the stricter controls of the supplements in Texas followed several deaths there. The new rule was supposed to take effect Sept. 1. But in the last week, noting Bush administration concerns, Texas health officials have instructed staff to allow the sale of supplements without the required labeling information for at least 60 days. [continues 556 words]
Health: Agency Director Works With Manufacturer To Bring Back Lotronex Despite Fatalities. WASHINGTON-- Senior Food and Drug Administration officials are planning how to bring back to market a pill for a common bowel disorder despite new evidence that the risk of a life-threatening complication is far higher than thought when the drug was withdrawn in November, government documents show. The FDA began reconsidering the withdrawal amid an outcry from patients who say they benefited from the prescription drug, called Lotronex. In early clinical studies, as many as 1 in 5 participants showed improvements that doctors attributed to Lotronex. [continues 2322 words]
