GMPs form part of the 1994 Dietary Supplement Health and Education Act, and are the final piece of the puzzle before this law governing the supplements industry is fully implemented.
The long, 12-year wait has been a source of frustration to the industry, which Steve Mister, president and CEO of the Council for Responsible Nutrition, said "wants to do the right thing. The absence of GMPs has opened the entire act up to criticism from some quarters in the past. Although it was announced last October that the GMPs were with the Office of Management and Budget, the final step in the law-making process that usually takes 90 days, the latest word was that they would be published in December 2006. The two letters seen by NutraIngredients-USA.com were sent to The Honorable Michael O Leavitt, secretary of health and human services. One was signed by member of Congress Ed Towns, and the other by eight members - Mary Bono, Mike Ferguson, Pete Sessions, Chris Cannon, Chip Pickering, Marsha Blackburn, Fred Upton and CA Dutch Ruppersberger. "It is our view that finalizing GMPs is an essential element of an effective regulatory program for dietary supplements and would be another important step in this administration's effort to more aggressively implement DSHEA," they wrote. Mister told NutraIngredients-USA.com that the letters are "extremely encouraging, as it is important that Congress keeps up the pressure to ensure FDA realises this is a priority". In March the CRN held a lobbying day on Capitol Hill, at which it stressed the need for final GMPs. "Congress has the ability to nudge the agency in the direction it needs to go," said Mister. Reputable dietary supplement companies already adhere to good manufacturing practices, and Mister said that members of his organization make products to standards that are already in excess of what will be required by the GMPs. But he said that the publication of GMPs in their final form will "level the playing field so everyone is playing the same game." What is more, it will give consumers in dietary supplements to know that all products must conform to the same standards. However so long has the delay been that it is easy to be sceptical of any new deadline. Of the announcement that they would be unveiled in December, Michael McGuffin, president of the American Herbal Products Association, said: "This is not the first time that we have been told that the final rule would be completed by December - but the year keeps changing.He questioned whether the time may be coming to evaluate a self-regulatory approach, "in the absence of timely completion of this important rulemaking". For his part, Mister said he hopes the letters will mean the GMPs will be forthcoming before the end of 2006 at least - although it would be better if they were brought forward.