Senators Urge OMB to Move Forward on GMP Regulations
WASHINGTON--Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) have asked the Office of Management and Budget (OMB) to expedite its review of FDA's proposed regulations of Good Manufacturing Practices (GMPs) for the dietary supplement industry. In a Jan. 19 letter, the senators wrote that it has been more than six years since the Dietary Supplement Health and Education Act (DSHEA) was signed into law, making these regulations long overdue. "Consumer protection demands that there be GMP standards specifically for dietary supplements as well," they wrote. Hatch and Harkin supported the need for immediacy by referring to a letter submitted Nov. 29 by various industry trade groups asking the Food and Drug Administration (FDA) to implement regulations for ephedra. FDA designated GMPs for supplements a "must do" last fall, and it passed its regulations on to OMB on Nov. 8. However, according to media reports and the White House itself, the new administration could significantly impede the office's review of the GMPs, which Hatch and Harkin seemed to want to avoid via this letter. For additional information, visit www.whitehouse.gov/omb.