Sen. Durbin speech teases dietary supplement listing billSen. Durbin speech teases dietary supplement listing bill
The majority of Americans take a dietary supplement, yet FDA “can’t even tell us how many dietary supplements are sold in America,” Sen. Dick Durbin said Tuesday. Durbin aims to change that, and more, with a dietary supplement bill that's going to be introduced this week in Congress.
April 26, 2022
U.S. Sen. Dick Durbin (D-Illinois) said Tuesday he and a colleague planned to introduce a bipartisan bill requiring manufacturers of dietary supplement products list their products with FDA.
In a speech on the floor of the U.S. Senate and broadcast via C-SPAN, Durbin said he and Sen. Mike Braun (R-Indiana) would introduce a bill this week.
Under the bill, manufacturers would be required to provide FDA certain information, including the names of their products, ingredients in them and an electronic copy of the label, Durbin said.
“All of this information would be available to consumers … Americans have the right to know,” he said. “If there’s a problem with a supplement, the FDA can quickly check the database to see what other products might contain the same ingredients and warn innocent consumers.”
“Dietary supplement makers that refuse to register with the FDA would see their products misbranded, and FDA should be given the appropriate authority to take action against them,” he added.
While 70% of Americans take a dietary supplement—including Durbin, who said he takes a multivitamin—FDA “can’t even tell us how many dietary supplements are sold in America,” the senator remarked. The agency has estimated the U.S. contains between 50,000 and 80,000 dietary supplement products.
That’s “a gap of 30,000 products,” he pointed out.
“What’s going on here?” Durbin asked. “They don’t even know how many products are being sold, let alone what they are or what’s in them.”
Durbin spoke just days after his former colleague, Republican Sen. Orrin Hatch of Utah, died. Hatch and former Sen. Tom Harkin (D-Iowa) spearheaded passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Since the law was enacted, the industry has grown from $4 billion a year in sales to over $50 billion, Durbin remarked.
He shared a story of a woman in Michigan who used heroin for a decade and decided to become clean after her sister overdosed and died. The woman tried tianeptine, which Durbin said has been dubbed “‘gas station heroin’ because you can buy it easily at gas stations across America.”
“She became hooked and dangerously ill, ending up in the hospital with a dangerous infection called sepsis,” Durbin said. “One doctor said to her, ‘I don’t know if I can save your limbs, but I’ll try.’ Another doctor told her she came within a day or two of dying.”
The woman survived.
“In the midst of a deadly opioid epidemic and a Covid pandemic, some unscrupulous characters are hustling to make a buck off of people’s pain by selling them an unregulated product that might make them sick or even kill them,” Durbin said. “And the Food and Drug Administration lacks the basic knowledge, the basic information it needs, to go after the people who are peddling these dangerous, life-threatening products.”
He described his bill as a “common-sense, bipartisan compromise that will protect consumers’ health and save lives.”
“As long as that dietary supplement is not dangerous to you or to Americans, as long as we know that it’s for sale, who made it, what’s in it, I think that basic information is what the government should gather,” Durbin said. “The vast majority of these supplements will not harm people, and the dietary supplement manufacturers know that, and that’s why they’re supporting our effort.”
However, the supplement industry is far from united on this issue.
As profiled in a recent episode of “Short Legal Briefs,” industry trade groups are deeply divided on whether mandatory product listing is a good idea. Some have said FDA’s legislative proposal will improve transparency and help the agency—and retailers—remove potentially dangerous supplements from the market. Others have countered FDA already has ample access to product-specific information and could use mandatory product listing to restrict access to legitimate dietary supplement products.
Dan Fabricant, president and CEO of the Natural Products Association (NPA), is among the critics of mandatory product listing. He described Durbin’s bill as establishing “premarket approval for dietary supplements.”
“The FDA has several tools at its disposal, including mandatory facility registration, with associated penalties for failure to comply,” Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs from 2011 to 2014, said in a press release following Durbin’s speech. “The FDA already has access to information regarding who is making dietary supplements, what products are made at which facilities, when new ingredients are introduced into commerce, and whether any products are associated with serious adverse events.”
He concluded, “The Durbin-Braun approach will hurt consumers and needlessly damage the industry.”
On the other hand, the Council for Responsible Nutrition (CRN) supports Durbin’s bill, as the senator mentioned in his speech. Steve Mister, president and CEO of CRN, has denied mandatory product listing amounts to premarket approval and has said it should be like getting a birth certificate rather than a driver’s license.
Durbin, meanwhile, juxtaposed the support he’s received from industry on mandatory product listing with the opposition he faced many years ago when he advocated for a bill requiring manufacturers report to FDA adverse events associated with their dietary supplement products.
“I went into vitamin stores in the state of Illinois and saw my picture on every cash register. I was enemy No. 1 because I asked that dangerous supplements report to the government if somebody gets sick when they took them,” he reflected. “I proposed that change about 10 years ago, and the dietary supplement industry hated me. They fought me tooth and nail. They hated my idea like the devil hates holy water.”
Eventually, a law was enacted by Congress: The Dietary Supplement and Nonprescription Drug Consumer Protection Act, signed in 2006 by President George W. Bush.
Commenting on mandatory product listing, Durbin said, “Responsible dietary supplement manufacturers should welcome this because the people who are abusing the market and endangering consumers are giving them a bad name.”
FDA declined to comment on pending legislation. But in its FY23 budget justification to Congress, FDA proposed requiring dietary supplement products be listed with the agency.
Mandatory listing, an FDA spokesperson said, “would allow the FDA to know when new products are introduced, quickly identify illegal products, improve transparency and promote risk-based regulation.”
Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA), expressed his gratitude to Durbin and Braun for working to update DSHEA.
"It is fitting that attention is being placed on DSHEA following the passing of former Senator Orrin Hatch, the author of DSHEA, a testament to his legacy," Melville said in a press release.
Melville described mandatory product listing as "an important component of modernizing DSHEA," yet he said "more needs to be done to enhance quality, ensure safety, and provide the transparency and predictability needed to promote innovation in the dietary supplement industry."
"We look forward to continuing to work with the bill sponsors on our shared commitment to provide greater oversight of products that 77 percent of Americans have used over the past calendar year," he added.
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