The rumors surrounding the imminent publishing of a final rule for GMPs may just be true. According to Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT, the final GMP regulation was to be sent from the Office of Management and Budget (OMB) to FDA on Monday, April 30th. It will take 30 days from this date to publish the regulation. Given this calculation, Mr. Israelsen said he expects FDA to publish the final rule in late May or early June. “We will not know until the regulation comes out, but if there has been a dramatic watering down of the regulation by OMB, it is possible that this rule may be inadequate as a governing standard to assure quality, product safety and manufacturing integrity,” Mr. Israelsen commented. As a result, he believes the industry might find itself in the unusual position of wanting and needing to argue for a more rigorous standard. Additionally, the industry might have to develop the means to set up more robust standards, as well as communicate this to consumers and other interested parties. He said, “Who would have thought that we might find ourselves in this position?”