"I am concerned that continuing promises have been made without results," Congressman Frank Pallone said in a letter to the Secretary for Health Tommy Thompson this week.
Referring to promises for GMP regulations, Pallone criticised the FDA's failure to release the regulations when originally stated.
"For over nine years, the industry and the public have anxiously awaited promulgation and implementation of the Good Manufacturing Practices (GMP) regulations. In previous years, you have stated before the Energy and Commerce Committee that the GMPs were to be issued within months, however, they were not forthcoming. During the hearing last week, you specifically promised that these regulations were to be released within days."
The letter followed a hearing earlier this month on the President's 2004 Health and Human Services budget, when issues including the status of the Good Manufacturing Practices (GMPs) regulations for the dietary supplement industry were raised.
"The FDA owes a duty to the public and the industry to improve enforcement efforts regarding unproven health claims for dietary supplements that claim to diagnose, prevent, treat or cure any disease or condition. Instead of using its authority over supplements and working with the industry, the FDA has failed to implement appropriate enforcement action to rid the market of unscrupulous players that give the industry a bad name."
Pallone's letter continued: "I urge you to exercise your leadership and authority to require FDA to act in a timely and responsible fashion. If the FDA believes additional funding is necessary to carry out its responsibilities under the Act, Congress will consider the reasons for this need when addressing the FY 2004 budget. "
The Congressman also requested that a dietary supplement ombudsman is appointed within the FDA Ombudsman's Office. This representative would be responsible for providing guidance on many of the questions the industry and the public have with regard to dietary supplements. According to Pallone, this would help improve accountability within the FDA.