04.01.09
he Government Accountability Office released a report in late January discussing the need for increased oversight and consumer understanding regarding dietary supplements. Emphasizing the need for improvements in how FDA monitors and regulates dietary supplements, the report also acknowledged that some progress has been made in terms of protecting the public from unsafe products (i.e., through GMPs, AERs, etc.). With regard to the former, the GAO suggested FDA provide more clarification surrounding ingredient documentation and marketing. It also underlined the importance of requiring more information from supplement companies in terms of who is selling what.
Not surprisingly, the Council for Responsible Nutrition (CRN), Washington, D.C., responded. So did consumer advocacy group Center for Science in the Public Interest (CSPI), Washington, D.C. The latter believes the GAO report underlines the concern that FDA does not have an accurate inventory of dietary supplement ingredients on store shelves. Further, CSPI says FDA doesn’t have a firm handle on the number and nature of serious adverse reactions to dietary supplements. For example, the organization pointed out, FDA doesn’t have a list of the names and locations of herbal supplement manufacturers. And several substances banned overseas are readily available on the Internet and in retail stores all over the U.S., even though CSPI claims they are variously linked to kidney damage, liver damage, seizures and death.
“When it comes to dietary supplements, it’s like the Wild West, and the bad guys know they don’t have to take the sheriff seriously,” said CSPI legal affairs director Bruce Silverglade. “Even when confronted with people dying from a dangerous substance like ephedra, the FDA has limited authority to get the product off the market.”
CRN president Steve Mister feels quite the opposite. “As industry report cards go, we are pleased to see that this one demonstrates that the industry has come a long way since the original 2000 GAO report on dietary supplements was released,” he said. “We are gratified that this latest report recognizes that dietary supplements are extensively regulated by FDA. We are also appreciative that the report refers to several of the regulatory improvements instituted—and fought for by responsible industry—including the issuance by FDA of GMPs specific to dietary supplements and passage of a law mandating that serious adverse events are reported to FDA.”
Mr. Mister also believes there are some recommendations in the report that CRN agrees could further strengthen FDA’s ability to protect consumers and bolster their confidence in these products. “Most importantly, we agree that FDA needs additional resources,” he said, adding, “We strongly believe, however, that these resources—including agency staff time and funding—should be focused on enforcing the current laws and regulations.”
Mr. Mister added that he also welcomes guidance from FDA on New Dietary Ingredients (NDIs) and could potentially support registration of products assuming the details are not inappropriately burdensome and would not prevent beneficial products from being brought to market. “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,” he commented.
As for adverse event reports, Mr. Mister disagreed with the logic behind the recommendation of submitting ALL adverse event reports, versus the important need to submit serious adverse event reports. “The agency is already overburdened and understaffed, and we are opposed to creating more bureaucratic paperwork that would not result in true benefits for consumer safety,” he explained. “The adverse event reporting law was carefully considered and supported by numerous stakeholders, including consumer groups, and there is no need to revise a law that only recently went into effect and appears to be working.”
Not surprisingly, the Council for Responsible Nutrition (CRN), Washington, D.C., responded. So did consumer advocacy group Center for Science in the Public Interest (CSPI), Washington, D.C. The latter believes the GAO report underlines the concern that FDA does not have an accurate inventory of dietary supplement ingredients on store shelves. Further, CSPI says FDA doesn’t have a firm handle on the number and nature of serious adverse reactions to dietary supplements. For example, the organization pointed out, FDA doesn’t have a list of the names and locations of herbal supplement manufacturers. And several substances banned overseas are readily available on the Internet and in retail stores all over the U.S., even though CSPI claims they are variously linked to kidney damage, liver damage, seizures and death.
“When it comes to dietary supplements, it’s like the Wild West, and the bad guys know they don’t have to take the sheriff seriously,” said CSPI legal affairs director Bruce Silverglade. “Even when confronted with people dying from a dangerous substance like ephedra, the FDA has limited authority to get the product off the market.”
CRN president Steve Mister feels quite the opposite. “As industry report cards go, we are pleased to see that this one demonstrates that the industry has come a long way since the original 2000 GAO report on dietary supplements was released,” he said. “We are gratified that this latest report recognizes that dietary supplements are extensively regulated by FDA. We are also appreciative that the report refers to several of the regulatory improvements instituted—and fought for by responsible industry—including the issuance by FDA of GMPs specific to dietary supplements and passage of a law mandating that serious adverse events are reported to FDA.”
Mr. Mister also believes there are some recommendations in the report that CRN agrees could further strengthen FDA’s ability to protect consumers and bolster their confidence in these products. “Most importantly, we agree that FDA needs additional resources,” he said, adding, “We strongly believe, however, that these resources—including agency staff time and funding—should be focused on enforcing the current laws and regulations.”
Mr. Mister added that he also welcomes guidance from FDA on New Dietary Ingredients (NDIs) and could potentially support registration of products assuming the details are not inappropriately burdensome and would not prevent beneficial products from being brought to market. “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,” he commented.
As for adverse event reports, Mr. Mister disagreed with the logic behind the recommendation of submitting ALL adverse event reports, versus the important need to submit serious adverse event reports. “The agency is already overburdened and understaffed, and we are opposed to creating more bureaucratic paperwork that would not result in true benefits for consumer safety,” he explained. “The adverse event reporting law was carefully considered and supported by numerous stakeholders, including consumer groups, and there is no need to revise a law that only recently went into effect and appears to be working.”