06.01.07
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 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 this month.
As this issue went to press, Senator Orrin Hatch’s (R-UT) office issued a press release stating that OMB had given final clearance for GMP regulations for dietary supplements. “GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Senator Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”
Commenting on what the final regulation might look like, Mr. Israelsen said, “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.” 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.
As this issue went to press, Senator Orrin Hatch’s (R-UT) office issued a press release stating that OMB had given final clearance for GMP regulations for dietary supplements. “GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Senator Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”
Commenting on what the final regulation might look like, Mr. Israelsen said, “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.” 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.