Dem reaches out for support on regulation on dietary supplements

Durbin said he plans to reintroduce the Dietary Supplement Labeling Act, which would require companies to give the FDA the name of each supplement they produce, along with a description, a list of ingredients and a copy of the label.

“Try to get past the cash register at your local gas station without running into a 5-Hour Energy drink or Monster Energy drink,” he said. “Over the years the types of dietary supplements sold have evolved from some very basic formulas such as simple vitamin C and calcium supplements to include products with potentially serious side effects.”

Dietary supplements are not subject to Food and Drug Administration (FDA) approval, but Congress passed legislation in 2006 that requires the regulator to collect consumer complaints of illnesses, medical complications and death.

From 2008 to 2011, the FDA received more than 6,300 “adverse event reports” about dietary supplements, according to a study by the Government Accountability Office (GAO).

Since October, the FDA has received 52 injury reports that name Monster Energy or 5-Hour Energy, including nine deaths, according to a New York Times report. The reports are not evidence that a product was at fault.

{mosads}A spokesman for Monster Energy told the Times that it has decided to market its products as beverages, instead of as dietary supplements, because of the blowback it has received.

“Monster Energy drinks could equally satisfy the regulatory requirements” for either category, Michael Sitrick, with Monster Energy, told the newspaper. Rockstar brand energy drinks made the same shift in January. Although the change subjects them to tougher reporting requirements, the FDA says it doesn’t have specific regulations for energy drinks and being classified as a beverage means no longer having to submit accident reports to the FDA.

GAO suggested that the FDA work more closely with national poison control centers in order to spot patterns with the various supplements. The report says that poison control centers received nearly 3,000 adverse event reports from 2008 to 2010 — 1,000 more than the FDA was sent during the same period.

“As you can imagine, when somebody feels sick after using a supplement, they don’t usually call the [FDA]; they call a local hospital or the poison control centers, which are all across America,” Durbin said.

But the GAO report notes that talks between the FDA and the American Association of Poison Control Centers have broken down over data costs. Even after a hefty discount, giving the FDA access to the raw data could cost nearly $1 million per year — more than double the agency’s budget for researching and regulating dietary supplements.

Although the FDA laments that AER data does not provide the entire picture — someone may have preexisting conditions or taken another medication that caused an adverse reaction — GAO said tapping into a broader amount of poison control data and increasing the effort to educate consumers about the existence of AERs would help the agency develop better patterns of illness.

All that Durbin is arguing for, he says, is more transparency to help people make smart choices about what they consume.

“I can guarantee you that at some website somewhere they are saying, ‘Here comes Durbin again. He is going to take your vitamin pills away. He is going to make it so you need a prescription to take vitamin C.’ Not the case at all,” he said. “People using dietary supplements have the right to know if there is a risk associated with the product.”


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