CSPI, Waxman Back GAO's Call for Tighter Supplement Regs

WASHINGTONA recently released report by the Government Accounting Office (GAO) concluded dietary supplements and foods with added dietary ingredients, such as vitamins and herbs, are a big business with too loose regulation and oversight from FDA, which it said is limited in its resources and authority to detect concerns and remove products from the market. The Center for Science in the Public Interest (CSPI) and Rep. Henry Waxman (D-Calif.) each made statements supporting GAO's findings and calling for stricter regulation and oversight of dietary supplements.

In its report, GAO stated: "FDA has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and information about moderate and mild adverse events reported to industry. Additionally, FDA dedicates relatively few resources to oversight activities, such as providing guidance to industry regarding notification requirements for products containing new dietary ingredients (NDIs)." It further contended a lack of mandatory recall authority and the burden of proving significant or unreasonable risk for specific ingredients hinders FDA's ability to remove products from market.

"This report highlights significant gaps in FDAs ability to ensure the safety of dietary supplements," said Waxman, chairman of the House Energy and Commerce Committee. "Because of limitations on FDAs authority and its lack of resources, consumers dont have the assurance they should that all supplements are safe."

CSPI's legal affairs director, Bruce Silverglade, agreed with GAO and Waxman, saying, "The supplement industry operates in a gray area where the loopholes loom larger than the law. Congress should close those loopholes by requiring that ingredients be reviewed for safety and effectiveness and that cautionary information appear on product labels."

However, the Council for Responsible Nutrition took a different approach to the GAO report. Steve Mister, president and CEO of CRN, said his organization is pleased that the new GAO report demonstrates that the industry has come a long way since the original 2000 GAO report on dietary supplements was released. "We are gratified that this latest report recognizes that dietary supplements are extensively regulated by the Food and Drug Administration (FDA)," he said. "We are also appreciative that the report refers to several of the regulatory improvements institutedand fought for by responsible industryincluding the issuance by FDA of Good Manufacturing Practices (GMPs) specific to dietary supplements and passage of a law mandating that serious adverse events are reported to FDA. These kinds of improvements in industry regulation are the cornerstone of producing safe, high-quality dietary supplements used by more than 150 million Americans each year.

Further, Mister noted CRN agrees that some recommendations in the report, especially increased funding, would strengthen FDA's abilities in dietary supplement regulation. However, he argued any extra funding and resources "should be focused on enforcing the current laws and regulations to help ensure that all companies demonstrate a commitment to protecting consumers and producing beneficial supplement products." As for NDIs, he said CRN welcomes guidance on this from FDA and has called on the agency to be more transparent and issue such guidance. "The industry could potentially support registration of products assuming the details are not inappropriately burdensome and would not prevent beneficial products from being brought to market," he said. "But regulations are only as strong as enforcement, and it is time for FDA to focus its energy and resources on inspections and enforcement actions directed at the small minority of companies that are giving those in the majority a black eye."

Mister also opposed GAO's recommendation the mandatory adverse event reports (AERs) law expand to include any adverse event.

David Seckman, executive director and CEO of the Natural Products Association (NPA), agreed with Mister's stance on AERs that reporting should be limited to incidents that are serious. "If the FDAs resources are already stretched, as the report indicates, then adding to this burden by mandating that any complaint be dealt with by the agency does not make sense," Seckman said. He further stated, "There is little scientific data regarding underreporting of adverse events and the data that are cited are not specific to dietary supplements, but represent all FDA-regulated products, including pharmaceuticals, a category that accounts for more than 460,000 reports annually."

Seckman also took issue with the report's assertion FDA does not have enough information on supplements. "The dietary supplement industry has cooperated by registering all manufacturing facilities under bioterrorism regulations that went into effect more than five years ago," he noted. "Additionally, the NPA is currently working with the government to create a database of all dietary supplement labels to augment this information."

Both CRN and NPA were interviewed by GAO for this dietary supplement report. The report can be found on the GAO Web site, here.

For an advanced analysis of the FDA GMP rule, the Natural Products Association along with Virgo Publishing, are offering a 2-day workshop on the Final FDA GMP Rule for Dietary Supplements, April  27 28, 2009,  in Secaucus, N.J.  Visit SupplySideShow.com/East for more details.