Rob Portman, the head of the White House Office of Management and Budget, called Sen. Orrin Hatch, R-Utah, on Wednesday to notify the senator the regulations were complete. They likely won't be published for about five weeks.
"Finally!" Hatch said in a statement. "This is very good news."
Hatch co-authored the 1994 Dietary Supplement Health and Education Act. After passage of the act, the burden of showing a supplement was unsafe was placed on the Food and Drug Administration, rather than a company demonstrating that it was safe, as is the case with drugs.
Critics have said the law created an unregulated Wild West atmosphere in the industry.
The 1994 act mandated the Good Manufacturing Practices (GMPs), which set the bar for safe manufacturing of supplements and for inspectors to use when screening facilities.
"GMPs are crucial because they assure the public that the products they are buying live up to their labels," Hatch said.
Utah's booming supplement industry has been frustrated with the delays in issuing the standards. Loren Israelsen of the United Natural Products Alliance has not seen the guidelines, but says it is encouraging that they are nearing a public release and hopes they will be effective.
"We understand there are significant changes. I don't dare speculate what that means," Israelsen said.
The association has a seminar scheduled in July to educate companies on the guidelines.
"There's several key pieces. One is, let's get the regulation out. Two, I hope the regulation is practical, that it understands real-world issues, which means companies will say, 'OK, we can do this, let's do it,' " he said.


