Durbin’s bill, the Dietary Supplement Labeling Act, requires regulators to compile a list of dietary supplement ingredients and proprietary blends of ingredients that are judged to be capable of causing potentially serious adverse events, drug interactions or risks to subgroups such as child or pregnant or breastfeeding women. In addition, the bill would expand registration requires by mandating manufacturers to submit a list of all the products they make at a given facility and their ingredients. New products or reformulations would require new registrations.
“While I understand his continuing concerns with his respect to energy drinks and stimulants, we feel his proposal does not address his concerns,” Loren Israelsen, executive director of the United Natural Products Alliance told NutraIngredients-USA.
“We think that Sen. Durbin’s initiative is completely, totally misguided,” said John Shaw, executive director of the Natural Products Association. In addition, Shaw said the timing of Durbin’s speech in the Senate was something of a slap in the face. NPA members had visited Sen. Durbin's office on Tuesday as part of the organization's annual lobbying day.
“We find it shocking that on the same day he spoke on the Senate floor he had members of the Natural Products Association, who employ thousands of people in Illinois, in his office talking to his staff about his concerns,” he said.
Energy drinks in crosshairs
Although Durbin’s bill pertains to all supplements, he has been on the record about his particular concerns regarding energy drinks, their caffeine levels and the practice of marketing them to young consumers. On several occasions he and Sen. Richard Blumenthal, D-CN, have requested that FDA investigate the energy drinks question.
“I think he misunderstands the dynamics of the energy drinks market. There has been a significant shift of brands going from dietary supplement labeling to food labeling,” Israelsen said. “His bill would not capture some of the products he’s concerned about.”
Israelsen said that if the concern is whether consumers are using caffeine inappropriately, then education is the best place to start. And, he noted, FDA has responded to Durbin on at least two occasions saying that the caffeine levels contained in most energy drinks are not out of line with other sources of caffeine in the American diet, and that the consensus among health authorities is that up to 400 mg of daily caffeine intake poses no special risk to the average adult.
“The reason there has been a dietary supplement to food shift is probably because for dietary supplements there is a serious adverse event reporting requirement that does not exist for foods. Which means, for that reason and some others, dietary supplements are more rigorously regulated than foods,” Israelsen said.
Monster Beverage Company is among the prominent players in the energy drinks category to announce that it was rebranding its products as beverages and removing their dietary supplement labeling. The company’s stated intent was to “get out from under the cloud” of dietary supplements.
“His bill has a dietary supplement focus. What he will end up creating is a migration of products to a sector that is in some respects not as highly regulated as dietary supplements. I don’t think that is his intention,” Isrealsen said.
GAO report
Isrealsen also noted the interesting timing of Durbin’s announcement, coming as it does on the heels of the release of a report he requested from the General Accounting Office on FDA’s handling of serious adverse event reports. The GAO report found that from 2008 to 2011, FDA received 6,307 AERs associated with dietary supplements. The report noted that not all AERs are submitted along the proper channel, and estimated an additional 1,000 AERs that were submitted to various poison control centers. The number of AERs, then, can be seen as minuscule in comparison to the hundreds of millions of supplement servings consumed during the same period.