Hatch Takes Issue with GAOs Report on Dietary Supplements

Says Government's Conclusions Overly Broad, Misleading

WASHINGTON – Sen. Orrin Hatch (R-Utah) took issue this week with the Government Accountability Office's testimony on dietary supplements, saying it takes a few bad apples and uses them to tarnish a whole industry.

"One company that makes misleading statements about its dietary supplement products is one too many," Hatch said following yesterday's hearing on the issue. "Where I take issue with the GAO is that it highlighted several products from a few rogue companies – several out of thousands of products – and used them to tar an entire industry. That is misleading at best and totally irresponsible at worst."

In his statement on dietary supplements to the Senate Aging Committee, Hatch refuted many of the assertions in the GAO testimony and arguments made by critics of the nutritional supplement industry.

A sample of critics' claims and Hatch's answers follow:

Claim 1)

• "Deceptive marketing and dangerous advice pose a risk to the health of the elderly and perhaps other consumers," Greg Kurtz, head of the GAO's Forensic Audits and Special Investigations. "Aggressive marketers are providing customers with unsubstantiated claims that their products can treat and cure disease."

Answer 1)

• "To pick three products when there are hundreds of thousands of products doesn't tell us a whole lot," Hatch told the Salt Lake Tribune. "There are some bad actors in the industry. We try to ferret them out and get rid of them."
• "False health claims about these products – on the Internet, in newspaper ads or on product labels are illegal today. So is selling contaminated dietary supplements," Hatch told members of the Aging Committee. "Companies engaging in these types of activities are breaking the law and, therefore, should be taken off the market immediately. That power is granted through current law, so amending that law is not necessary. What is necessary is providing the Food and Drug Administration the funding it needs to properly enforce and implement current law."
• "Most members of the dietary supplement industry are providing consumers not only with safe products, but also accurate information about their use," the senator continued.

Claim 2)

• "The GAO advises expanding current FDA authority over dietary supplements to ensure safety of the consumer," Tina Tusztynski of Chicago Health Living Examiner reported.

Answer 2)

• Hatch noted at the hearing that he and Sen. Tom Harkin (D-Iowa) are the authors of the 1994 Dietary Supplement Health Education Act (DSHEA), which enabled the FDA to regulate dietary supplements as foods and empowered the agency to remove potentially harmful products from the market.
• Moreover, it directed manufacturers to submit marketing safety information about any new ingredients in their products to the FDA at least 75 days prior to putting those products on the market, and it authorized Good Manufacturing Practice (GMP) Standards "so that the FDA could ensure products were being manufactured in compliance with the law." Finally, DSHEA required all ingredients in dietary supplements to be listed on the label and that "all claims be truthful and not misleading."
• "One of my biggest frustrations was, that once DSHEA was signed into law, it took the FDA many years to implement the GMP standards …," Hatch told the committee. "It is clear the FDA has much higher priorities than dietary supplements. Moreover the FDA has not asked for additional funding for supplement enforcement, which I believe is an indicator these products are not the safety concerns some would allege from the cases highlighted at this hearing."

Claim 3)

• "The Food and Drug Administration needs greater authority, more cooperation from other agencies and must do more scientific research to help make the U.S. food supply safer, the General Accountability Office said on Monday." (Reuters, 5/24/10)

Answer 3)

• "It also is important to note that previous FDA commissioners – Dr. Jane Henney, Dr. Mark McClellan, Dr. Lester Crawford and Dr. Andy von Eschenbach – have all stated in Senate hearings and in my meetings with them that, through DSHEA, they had the power necessary to regulate dietary supplements," Hatch said. "Moreover, current FDA Commissioner Dr. Margaret Hamburg has assured me that she will work with me to ensure these laws are enforced."
• Hatch further noted that during the Aging Committee hearing on dietary supplements, FDA Deputy Commissioner Joshua Sharfstein stated that DSHEA strikes the appropriate balance between risk and accessibility.

To help the FDA better regulate supplements, Hatch and Harkin this week introduced the Dietary Supplement Full Implementation Act of 2010 (S.3414) – legislation to give the agency the funding it needs to do its job and fully enforce DSHEA.

"We don't need to create new and entirely unnecessary enforcement laws and bureaucracies, which would restrict the ability of over 150 million Americans to use dietary supplements," Hatch told members of the press this week. "What we need to do is ensure that the Food and Drug Administration is properly implementing and enforcing existing dietary supplement laws. That's precisely what this common sense legislation that Senator Harkin and I have introduced will do."