By Sean Moloughney, Editor04.26.22
This article was last updated on May 2, 2022.
U.S. Senate Majority Whip Dick Durbin (D-IL) has introduced the Dietary Supplement Listing Act of 2022 (S. 4090) with Sen. Mike Braun (R-IN), aimed at requiring dietary supplement manufacturers to submit information about their products to FDA.
While introducing the proposal on the Senate floor on Apr. 26, Durbin argued that FDA and consumers are “flying blind” and should have basic information about what products are on the market, what’s in them, where they’re manufactured, etc.
“Seventy percent of people in America take a dietary supplement including me,” Durbin said. “I also believe that Americans who take vitamins, minerals, and herbs for their health and well-being have a right to know what’s in those supplements. Many people assume that if a product is sold in the United States of America, somebody has inspected it and it must be safe. Unfortunately, that’s not always true.”
FDA “has the authority to regulate dietary supplements and take dangerous products off the market, but it lacks information that it needs to use this authority effectively,” Durbin argued on the Senate floor.
Under the Dietary Supplement Health and Education Act (DSHEA) and the Food Safety Modernization Act (FSMA), supplement manufacturers must ensure safety of their products, register food facilities with FDA, and maintain current Good Manufacturing Practices (cGMPs), but there is no pre-market approval of products. However, FDA must be notified when a company introduces a New Dietary Ingredient (NDI) into commerce.
In his floor speech, Durbin said manufacturers “are not required to notify FDA what products they are selling, under what names, or what’s in them or where they are manufactured.”
The bill he and Braun are introducing would require dietary supplement manufacturers to provide “the names of their products, the ingredients they contain, an electronic copy of the label, a list of any health claims made, and more,” Durbin said.
Companies that refuse to comply “would be considered misbranded, and FDA should be given the appropriate authority to take action against them.”
The proposed bill responds to FDA’s request for more insight and regulatory authority over the dietary supplement industry.
In its FY2023 budget, the agency said it was seeking annual listing of individual dietary supplement products, including basic information about each unique product. “Additionally, the agency seeks to clarify its authorities over marketed dietary supplement products to better facilitate enforcement against unlawfully marketed products, allowing the FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers.”
A History of Opposition
Durbin acknowledged his adversarial relationship with the dietary supplement industry. For example, in 2013, he introduced the Dietary Supplement Labeling Act, which was met by fierce resistance that ultimately sank the bill.
“I’ve been down this road before,” he said, noting he worked “for years” to get adverse event reporting (AER) legislation passed with former Senator Orrin Hatch (R-UT), who died Apr. 23 and is regarded as a champion of the dietary supplement industry, having coauthored DSHEA.
“Eventually we worked out an agreement,” Durbin continued. “Adverse event reporting was required. Now I might argue that it never worked quite as we expected it to, but at least it was an effort to alert people that what sometimes looks like an innocent vitamin or mineral can be dangerous. And the notion that the government has already checked it out is just plain wrong.”
Saluting Change
Today though, he noted a “significant change” among the industry. "A strong majority of dietary supplement industry now supports responsible reporting requirements and stronger protections. Hats off to them,” Durbin said.
He noted support for the proposal from the Council for Responsible Nutrition, which has openly advocated for MPL.
[CRN President and CEO Steve Mister laid out his argument for MPL in this article.]
The legislation was also endorsed by the Pew Charitable Trusts, the American Medical Association, and U.S. Pharmacopeia.
[The Natural Products Association opposes the bill and offered its rebuttal in a letter to Durbin and Braun.]
“Responsible dietary supplement manufacturers should welcome this because the people who are abusing the market and endangering consumers are giving them a bad name,” said Durbin. “Our bill will give FDA information they need to protect Americans from dangerous products being sold as health supplements.”
He further called the proposal a “common sense, bipartisan compromise that will protect consumers’ health and save lives.”
“The bottom line is I’m willing to fight to protect every American’s right to buy safe dietary supplements. It may help them, it might not; that’s not my judgement. Each individual consumer should make that choice.”
However, the government should have basic information about products on the market, he added.
UNPA: 'A Positve Step Forward'
The United Natural Products Alliance (UNPA) said it “has consistently supported steps to assure the appropriate regulation of dietary supplements,” and sees the introduction of this bill as “a positive step forward.”
“We support the concept of mandatory product listing for supplements and we are reviewing the important details of the Durbin-Braun bill.”
UNPA noted its long history of working with Congress on dietary supplement law, “and we plan to continue our work with members of the Senate and House on this priority issue so that a bill can be enacted this year. We believe that final legislation should be structured in a manner that results in the broadest possible compliance so that it truly does provide FDA and consumers with useful information.”
NPA Opposition
The Natural Products Association (NPA) said the proposed legislation amounts to pre-market approval and “would heap unneeded, unfair, and ineffective new tasks on FDA when the agency can’t meet existing obligations.”
“The FDA has several tools at its disposal, including mandatory facility registration, with associated penalties for failure to comply,” said Daniel Fabricant, president and CEO of NPA.
In his floor speech, Durbin called attention to the example of tianeptine, an unapproved drug in the U.S. that had been found in adulterated products marketed as dietary supplements in 2018.
FDA sent Warning Letters to two companies in November 2018, but according to NPA, the agency knew of these products for months before taking action. NPA further argued that the Durbin-Braun bill would not solve problems like tianeptine, which was marketed and sold by criminals who would not have voluntarily filed information with FDA.
“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,” Fabricant added. “The Durbin-Braun approach will hurt consumers and needlessly damage the industry. It mirrors over-the-counter pre-market drug regulations and is more stringent than current regulations, including the NDI provision, a notification rather than a pre-market approval. The Dietary Supplement Listing Act is entirely at odds with the current regime, which has delivered world-class consumer safety and broad access to important nutritional supplements for over a generation.”
NPA said it has fought against this type of proposal for several years, that it was engaging its grassroots network, and urging the industry to contact their members of Congress to warn them about economic harm from this legislation.
“The late Senator Hatch, Congressman (Henry) Waxman, President Clinton, and others unanimously passed DSHEA in 1994 because they understood the importance of an appropriately regulated industry for dietary supplements,” said Fabricant. “The federal government has a wide variety of enforcement powers and a significant track record of punishing criminals who break the law. We support transparency, but this legislation fails to recognize the deficiencies of the FDA by making them less accountable to the industry.”
Congress should instead conduct a performance review and analysis of FDA’s current authorities, Fabricant suggested, “to determine if they are effectively using those which they currently have before creating a pre-market approval process for dietary supplements that FDA will only misuse to create problems as we’ve seen with NAC and CBD.”
As proposed, two groups would benefit from this approach, he continued: “1) the trial-attorney industry through additional frivolous class-action lawsuits based on alleged injuries caused by foods or supplements, and 2) disreputable individuals looking to create counterfeit products based on the ingredients and formulations in the database, hoping they can turn a quick profit.”
Fabricant added: “Unfortunately, and surprisingly, the Council for Responsible Nutrition is foursquare in support of this misguided and dangerous legislation, so there is a great risk that Members of Congress may be led to believe that it is supported by industry when that couldn’t be further from the truth.”
AHPA Opposed to MPL, Open to Modernization Discussion
The American Herbal Products Association (AHPA) also opposes the Dietary Supplement Listing Act. President Michael McGuffin said AHPA has “a significant track record” of supporting changes to the Federal Food, Drug, and Cosmetic Act “when they clearly benefit consumers and when such amendments achieve their ends in a manner that minimizes burdens on the regulated trade.”
To this point though, neither FDA nor other MPL advocates “have clearly articulated the need for this pre-market product listing requirement. In addition, the legislation introduced by Senators Durbin and Braun would create unnecessary, significant, and redundant burdens on industry.”
“AHPA has emphasized for several years that the current federal regulatory framework for dietary supplements supports the industry and consumers,” McGuffin continued. “Further, AHPA has stated this framework provides FDA with all of the authority needed to properly regulate dietary supplements, and thus an MPL requirement is unnecessary. Nothing in this newly introduced legislation has modified these views.”
At the same time, McGuffin said AHPA recognizes the interest of FDA and the support of some trade associations and others in establishing an MPL requirement for dietary supplements.
“We have therefore communicated with FDA, numerous Congressional offices, industry colleagues, and other stakeholders to share alternate suggestions for modernizing the federal laws under which FDA regulates dietary supplements. We look forward to future opportunities to engage in robust and transparent discussions about how we can work cooperatively to advance health with increased education and broad access to a wide range of safe and well-regulated dietary supplement products.”
CHPA Urges Further Modernization of DSHEA
The Consumer Healthcare Products Association (CHPA) urged Congress to go further on DSHEA modernization, calling for additional consumer protections.
CHPA President and CEO Scott Melville said MPL is “an important component of modernizing DSHEA, but 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.”
Consumers depend on dietary supplements to address nutritional gaps and promote overall wellness, he added. “However, regulation has not kept pace with changes in the marketplace. The time is ripe for a more comprehensive approach to modernizing DSHEA and CHPA remains committed to working with Congress to share ideas and proposals that will further promote consumer safety and enhance public health.”
Melville said "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.”
Debate Continues
The matter of MPL has been debated within the dietary supplement industry for years.
Speaking about the MPL issue at SupplySide East, before Durbin introduced new legislation, Len Monheit, CEO of Trust Transparency Center, said he understands the divide on the MPL issue, adding that he’s “concerned” about the industry’s current relationship with FDA and that he’d hoped there would be more transparency.
“I think that in a proper environment—in a collegial and collaborative environment—mandatory product listing, with the best of intentions, would be a great tool,” Monheit said, noting his support for more funding of the Office of Dietary Supplements at the National Institutes of Health.
“The issue is still that we’re not getting proper enforcement of DSHEA as currently written,” he added. “I really would like to see that. And that’s the main issue of the naysayers: ‘do what you’re already empowered to do.’ This is a digital age though, and so digital tools do make sense. I too am afraid of misuse or abuse of that information that doesn’t solve the problem.”
U.S. Senate Majority Whip Dick Durbin (D-IL) has introduced the Dietary Supplement Listing Act of 2022 (S. 4090) with Sen. Mike Braun (R-IN), aimed at requiring dietary supplement manufacturers to submit information about their products to FDA.
While introducing the proposal on the Senate floor on Apr. 26, Durbin argued that FDA and consumers are “flying blind” and should have basic information about what products are on the market, what’s in them, where they’re manufactured, etc.
“Seventy percent of people in America take a dietary supplement including me,” Durbin said. “I also believe that Americans who take vitamins, minerals, and herbs for their health and well-being have a right to know what’s in those supplements. Many people assume that if a product is sold in the United States of America, somebody has inspected it and it must be safe. Unfortunately, that’s not always true.”
FDA “has the authority to regulate dietary supplements and take dangerous products off the market, but it lacks information that it needs to use this authority effectively,” Durbin argued on the Senate floor.
Under the Dietary Supplement Health and Education Act (DSHEA) and the Food Safety Modernization Act (FSMA), supplement manufacturers must ensure safety of their products, register food facilities with FDA, and maintain current Good Manufacturing Practices (cGMPs), but there is no pre-market approval of products. However, FDA must be notified when a company introduces a New Dietary Ingredient (NDI) into commerce.
In his floor speech, Durbin said manufacturers “are not required to notify FDA what products they are selling, under what names, or what’s in them or where they are manufactured.”
The bill he and Braun are introducing would require dietary supplement manufacturers to provide “the names of their products, the ingredients they contain, an electronic copy of the label, a list of any health claims made, and more,” Durbin said.
Companies that refuse to comply “would be considered misbranded, and FDA should be given the appropriate authority to take action against them.”
The proposed bill responds to FDA’s request for more insight and regulatory authority over the dietary supplement industry.
In its FY2023 budget, the agency said it was seeking annual listing of individual dietary supplement products, including basic information about each unique product. “Additionally, the agency seeks to clarify its authorities over marketed dietary supplement products to better facilitate enforcement against unlawfully marketed products, allowing the FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers.”
A History of Opposition
Durbin acknowledged his adversarial relationship with the dietary supplement industry. For example, in 2013, he introduced the Dietary Supplement Labeling Act, which was met by fierce resistance that ultimately sank the bill.
“I’ve been down this road before,” he said, noting he worked “for years” to get adverse event reporting (AER) legislation passed with former Senator Orrin Hatch (R-UT), who died Apr. 23 and is regarded as a champion of the dietary supplement industry, having coauthored DSHEA.
“Eventually we worked out an agreement,” Durbin continued. “Adverse event reporting was required. Now I might argue that it never worked quite as we expected it to, but at least it was an effort to alert people that what sometimes looks like an innocent vitamin or mineral can be dangerous. And the notion that the government has already checked it out is just plain wrong.”
Saluting Change
Today though, he noted a “significant change” among the industry. "A strong majority of dietary supplement industry now supports responsible reporting requirements and stronger protections. Hats off to them,” Durbin said.
He noted support for the proposal from the Council for Responsible Nutrition, which has openly advocated for MPL.
[CRN President and CEO Steve Mister laid out his argument for MPL in this article.]
The legislation was also endorsed by the Pew Charitable Trusts, the American Medical Association, and U.S. Pharmacopeia.
[The Natural Products Association opposes the bill and offered its rebuttal in a letter to Durbin and Braun.]
“Responsible dietary supplement manufacturers should welcome this because the people who are abusing the market and endangering consumers are giving them a bad name,” said Durbin. “Our bill will give FDA information they need to protect Americans from dangerous products being sold as health supplements.”
He further called the proposal a “common sense, bipartisan compromise that will protect consumers’ health and save lives.”
“The bottom line is I’m willing to fight to protect every American’s right to buy safe dietary supplements. It may help them, it might not; that’s not my judgement. Each individual consumer should make that choice.”
However, the government should have basic information about products on the market, he added.
UNPA: 'A Positve Step Forward'
The United Natural Products Alliance (UNPA) said it “has consistently supported steps to assure the appropriate regulation of dietary supplements,” and sees the introduction of this bill as “a positive step forward.”
“We support the concept of mandatory product listing for supplements and we are reviewing the important details of the Durbin-Braun bill.”
UNPA noted its long history of working with Congress on dietary supplement law, “and we plan to continue our work with members of the Senate and House on this priority issue so that a bill can be enacted this year. We believe that final legislation should be structured in a manner that results in the broadest possible compliance so that it truly does provide FDA and consumers with useful information.”
NPA Opposition
The Natural Products Association (NPA) said the proposed legislation amounts to pre-market approval and “would heap unneeded, unfair, and ineffective new tasks on FDA when the agency can’t meet existing obligations.”
“The FDA has several tools at its disposal, including mandatory facility registration, with associated penalties for failure to comply,” said Daniel Fabricant, president and CEO of NPA.
In his floor speech, Durbin called attention to the example of tianeptine, an unapproved drug in the U.S. that had been found in adulterated products marketed as dietary supplements in 2018.
FDA sent Warning Letters to two companies in November 2018, but according to NPA, the agency knew of these products for months before taking action. NPA further argued that the Durbin-Braun bill would not solve problems like tianeptine, which was marketed and sold by criminals who would not have voluntarily filed information with FDA.
“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,” Fabricant added. “The Durbin-Braun approach will hurt consumers and needlessly damage the industry. It mirrors over-the-counter pre-market drug regulations and is more stringent than current regulations, including the NDI provision, a notification rather than a pre-market approval. The Dietary Supplement Listing Act is entirely at odds with the current regime, which has delivered world-class consumer safety and broad access to important nutritional supplements for over a generation.”
NPA said it has fought against this type of proposal for several years, that it was engaging its grassroots network, and urging the industry to contact their members of Congress to warn them about economic harm from this legislation.
“The late Senator Hatch, Congressman (Henry) Waxman, President Clinton, and others unanimously passed DSHEA in 1994 because they understood the importance of an appropriately regulated industry for dietary supplements,” said Fabricant. “The federal government has a wide variety of enforcement powers and a significant track record of punishing criminals who break the law. We support transparency, but this legislation fails to recognize the deficiencies of the FDA by making them less accountable to the industry.”
Congress should instead conduct a performance review and analysis of FDA’s current authorities, Fabricant suggested, “to determine if they are effectively using those which they currently have before creating a pre-market approval process for dietary supplements that FDA will only misuse to create problems as we’ve seen with NAC and CBD.”
As proposed, two groups would benefit from this approach, he continued: “1) the trial-attorney industry through additional frivolous class-action lawsuits based on alleged injuries caused by foods or supplements, and 2) disreputable individuals looking to create counterfeit products based on the ingredients and formulations in the database, hoping they can turn a quick profit.”
Fabricant added: “Unfortunately, and surprisingly, the Council for Responsible Nutrition is foursquare in support of this misguided and dangerous legislation, so there is a great risk that Members of Congress may be led to believe that it is supported by industry when that couldn’t be further from the truth.”
AHPA Opposed to MPL, Open to Modernization Discussion
The American Herbal Products Association (AHPA) also opposes the Dietary Supplement Listing Act. President Michael McGuffin said AHPA has “a significant track record” of supporting changes to the Federal Food, Drug, and Cosmetic Act “when they clearly benefit consumers and when such amendments achieve their ends in a manner that minimizes burdens on the regulated trade.”
To this point though, neither FDA nor other MPL advocates “have clearly articulated the need for this pre-market product listing requirement. In addition, the legislation introduced by Senators Durbin and Braun would create unnecessary, significant, and redundant burdens on industry.”
“AHPA has emphasized for several years that the current federal regulatory framework for dietary supplements supports the industry and consumers,” McGuffin continued. “Further, AHPA has stated this framework provides FDA with all of the authority needed to properly regulate dietary supplements, and thus an MPL requirement is unnecessary. Nothing in this newly introduced legislation has modified these views.”
At the same time, McGuffin said AHPA recognizes the interest of FDA and the support of some trade associations and others in establishing an MPL requirement for dietary supplements.
“We have therefore communicated with FDA, numerous Congressional offices, industry colleagues, and other stakeholders to share alternate suggestions for modernizing the federal laws under which FDA regulates dietary supplements. We look forward to future opportunities to engage in robust and transparent discussions about how we can work cooperatively to advance health with increased education and broad access to a wide range of safe and well-regulated dietary supplement products.”
CHPA Urges Further Modernization of DSHEA
The Consumer Healthcare Products Association (CHPA) urged Congress to go further on DSHEA modernization, calling for additional consumer protections.
CHPA President and CEO Scott Melville said MPL is “an important component of modernizing DSHEA, but 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.”
Consumers depend on dietary supplements to address nutritional gaps and promote overall wellness, he added. “However, regulation has not kept pace with changes in the marketplace. The time is ripe for a more comprehensive approach to modernizing DSHEA and CHPA remains committed to working with Congress to share ideas and proposals that will further promote consumer safety and enhance public health.”
Melville said "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.”
Debate Continues
The matter of MPL has been debated within the dietary supplement industry for years.
Speaking about the MPL issue at SupplySide East, before Durbin introduced new legislation, Len Monheit, CEO of Trust Transparency Center, said he understands the divide on the MPL issue, adding that he’s “concerned” about the industry’s current relationship with FDA and that he’d hoped there would be more transparency.
“I think that in a proper environment—in a collegial and collaborative environment—mandatory product listing, with the best of intentions, would be a great tool,” Monheit said, noting his support for more funding of the Office of Dietary Supplements at the National Institutes of Health.
“The issue is still that we’re not getting proper enforcement of DSHEA as currently written,” he added. “I really would like to see that. And that’s the main issue of the naysayers: ‘do what you’re already empowered to do.’ This is a digital age though, and so digital tools do make sense. I too am afraid of misuse or abuse of that information that doesn’t solve the problem.”
