Longtime supplement industry adversary Sen. Richard Durbin (D-IL) has proposed an amendment that would require manufacturers to register with FDA. The amendment would attach to the Senate FDA Reauthorization for User Fees bill—scheduled for a vote the afternoon of May 24—and would mandate specific information be supplied to FDA, including a description, list of ingredients and label (copy) for each supplement, updated for each new, reformulated or discontinued product. Closely related to the first provision in his legislation (The Dietary Supplement Labeling Act of 2011; S. 1310) introduced last year, the amendment is co-sponsored by Sen. Richard Blumenthal (D-CT), who also sponsored last year's provision.
In talking to fellow Senators about the amendment, Durbin seemed to focus on energy drinks. He displayed a large poster of a young woman who passed away after consuming energy drinks; her family was in the Senate audience. Last month, Durbin asked FDA to investigate energy drinks and to define what is a beverage vs. a liquid dietary supplement. In his latest address to the Senate, Durbin said more emergency room visits are being linked to energy drink consumption, and energy drinks are conventional foods “escaping regulation” by claiming to be dietary supplements. He noted most dietary supplements are safe and used by millions of Americans without incident, but said government has to do more to protect consumers.
"Many people would be surprised to learn that, in spite of the popular use of dietary supplements today, the FDA does not know how many are being sold in the United States," Durbin said. "If a dietary supplement ingredient presented serious health concerns, the FDA would likely not have enough information to track down the product containing that harmful ingredient. Requiring manufacturers to provide basic information about their product to the FDA and to consumers is common sense.”
The American Herbal Products Association (AHPA) urged its members to call on their Senators to oppose this bill—Sens. Orrin Hatch (R-UT), Tom Harkin (D-IA) and Mike Enzi (R-WY) all vocally opposed this amendment. AHPA argued the amendment "places an unnecessary product registration burden on supplement companies, including small businesses."
In entering the amendment on the Senate floor today, Durbin said it was a straight-forward idea that was originally proposed by the Government Accountability Office (GAO) in its 2009 report. He also said FDA responded to the GAO report confirming it would be helpful information to have. Durbin also said unlike the testing and approvals required for prescription and over-the-counter (OTC) drugs, dietary supplements have much less disclosure, less transparency and far less regulation. "We are not requiring testing or assertions of safety, just simply that they register," he said about his amendment. "Does that sounds like onerous, heavy-handed, big government overregulation?"
With his time at the podium, Hatch argued it would be a case of overregulation. He said instead of urging FDA to use its existing authority—all recent agency commissioners have said DSHEA (the Dietary Supplement Health and Education Act of 1994) provides ample authority to FDA—Durbin's amendment serves to punish all responsible companies with its overreaching mandates. He added the amendment would pile more work on an underfunded agency struggling to keep its head above water with it core responsibilities. "It took over 10 years to get GMPs (good manufacturing practices) completed by FDA," he said. "Now adding other regulations to this industry is just plain not right." He urged fellow Senators to vote against this amendment.
Harkin also had the floor for a few minutes and noted under DSHEA manufacturers already are required to list all their ingredients on the label; when a product is reformulated, the label must be changed to reflect this. "We added this to DSHEA for consumer protection," he said, noting Durbin is a consumer protection champion. He further added dietary supplement companies already have to register biennially (every two years), under the recently passed Food Safety Modernization Act (FSMA). Also, there is a voluntary program for supplement companies to submit their labeling to the NIH's Office of Dietary Supplements (ODS).
Durbin said only 7,500 labels have been submitted to the voluntary program, while there were 75,000 supplements on the market in 2008. "Good actors share with NIH; bad ones don't," he said emphasizing that only 10 percent of supplements participate in this voluntary program. He noted many supplements come into the U.S. market from foreign countries, such as China. "Would you like to know they've at least registered in the U.S.?" he asked. "I bet 99 percent of Americans thought they already did that."
Enzi also had a chance to speak to the Senate, and he focused on what effect, or lack thereof, all this required information would have. Consumers are the ones who need information on companies and products, he argued, but the information will go to FDA and no further. Even if this information were supplied to consumers, would they care? "They already don't pay attention to the label, which includes ingredients," he said. The right way to approach this issue, he offered, is to hold Health Committee hearings and work together to find common ground. Such an approach would actually get something done, he promised, calling Durbin's amendment "a little premature."
All debate on amendments to the User Fee Bill, including Durbin's amendment, is scheduled to end at 2pm May 24, and a vote on the amendments is expected shortly thereafter.
From
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