11.01.03
The U.S. Senate Committee on Commerce, Science & Transportation held a full committee hearing on dietary supplements on October 28th in Washington, D.C. The hearing included testimony regarding the availability of dietary supplements to consumers of all ages, the marketing practices of the dietary supplement industry and the effectiveness of DSHEA in protecting consumers. The committee also examined whether the significant level of domestic consumption of dietary supplements could be exposing consumers to unexpected short- and long-term health risks. In his opening remarks, Senator John McCain (R-AZ) said, “While it is true that DSHEA has succeeded in freeing many safe and useful supplements from unnecessary regulation, it is equally true that the Act appears to have provided a safe haven for substances that many experts believe pose potentially serious health risks.”
Offering his testimony on behalf of the dietary supplement industry was David Seckman, CEO and executive director, National Nutritional Foods Association (NNFA), Washington, D.C., who pointed out, among other things, the lack of FDA’s implementation and enforcement of DSHEA. He said that while FDA Commissioner Mark McClellan has made progress in the implementation and enforcement of DSHEA, there is still a lot of work to be done. Mr. Seckman specifically discussed the issues of GMPs, performance-enhancing products, ephedra, truth in advertising and safety. In summary, he said, DSHEA provided more label information, increased FDA enforcement authority and mandated higher product standards, the result of which, Mr. Seckman said, is an increased ability by consumers to make informed personal health choices. He concluded by offering his recommendations for improving the effectiveness of DSHEA. First, he said, FDA should be given the resources it needs to fully implement and enforce DSHEA as outlined by bill S. 1538, “The DHSEA Full Implementation and Enforcement Act.” Second, Mr. Seckman recommended that FDA quickly finalize and begin enforcement of GMPs for dietary supplements. Lastly, Mr. Seckman said, “Stop seeking legislative solutions to regulatory problems when it comes to DSHEA. Changing DSHEA to give the FDA increased authority when it has not fully applied its current powers will simply perpetuate the current situation.”
In other news, the Senate has approved the $79.7 billion agricultural spending bill for fiscal year 2004, which includes dietary supplement-related amendments. The first amendment calls for an increase of $1 million in FDA’s budget to fully implement and enforce DSHEA and the second would give FDA an extra $250,000 to handle the ephedra situation. The first amendment was proposed by industry supporters Tom Harkin (D-IA) and Orrin Hatch (R-UT), as well as industry opponent Senator Richard Durbin (D-IL). However, the second amendment was introduced by Senator Durbin and cosponsored by Senators Harkin and Hatch.
Offering his testimony on behalf of the dietary supplement industry was David Seckman, CEO and executive director, National Nutritional Foods Association (NNFA), Washington, D.C., who pointed out, among other things, the lack of FDA’s implementation and enforcement of DSHEA. He said that while FDA Commissioner Mark McClellan has made progress in the implementation and enforcement of DSHEA, there is still a lot of work to be done. Mr. Seckman specifically discussed the issues of GMPs, performance-enhancing products, ephedra, truth in advertising and safety. In summary, he said, DSHEA provided more label information, increased FDA enforcement authority and mandated higher product standards, the result of which, Mr. Seckman said, is an increased ability by consumers to make informed personal health choices. He concluded by offering his recommendations for improving the effectiveness of DSHEA. First, he said, FDA should be given the resources it needs to fully implement and enforce DSHEA as outlined by bill S. 1538, “The DHSEA Full Implementation and Enforcement Act.” Second, Mr. Seckman recommended that FDA quickly finalize and begin enforcement of GMPs for dietary supplements. Lastly, Mr. Seckman said, “Stop seeking legislative solutions to regulatory problems when it comes to DSHEA. Changing DSHEA to give the FDA increased authority when it has not fully applied its current powers will simply perpetuate the current situation.”
In other news, the Senate has approved the $79.7 billion agricultural spending bill for fiscal year 2004, which includes dietary supplement-related amendments. The first amendment calls for an increase of $1 million in FDA’s budget to fully implement and enforce DSHEA and the second would give FDA an extra $250,000 to handle the ephedra situation. The first amendment was proposed by industry supporters Tom Harkin (D-IA) and Orrin Hatch (R-UT), as well as industry opponent Senator Richard Durbin (D-IL). However, the second amendment was introduced by Senator Durbin and cosponsored by Senators Harkin and Hatch.