By Steve Mister, President & CEO, Council for Responsible Nutrition04.26.22
Editor’s Note: Views and opinions expressed in guest articles are intended to engage stakeholders and do not necessarily reflect those held by Nutraceuticals World or editorial staff.
This week, Senator Richard Durbin (D-IL) introduced the Dietary Supplement Listing Act of 2022 (S. 4090), which would create a mandatory product listing requirement for dietary supplements. Basically, the legislation would require every marketer of finished product supplements to provide a copy of their labels to FDA as it brings the product to market. Under this legislation, FDA does not get to “approve” or “reject” the product—it must accept the label and post it in a publicly available website so that regulators, retailers, and consumers can see what supplements are in the U.S. marketplace at any given time. CRN has expressed strong support for this proposal.
Unfortunately, some stakeholders have opposed mandatory listing without completely understanding what it does—and doesn’t do. It’s been misrepresented as "pre-market approval” in disguise, a gateway to FDA’s removal of ingredients, and an overly burdensome bureaucratic headache. It is none of these.
I recently had the opportunity to assemble and refute many of these red herring arguments for the Senate Health, Education, Labor, and Pensions (HELP) Committee. In the interest of that same transparency promoted by mandatory listing itself, I want to share these myths and facts so industry members can make educated decisions about your own views toward mandatory listing.
Myth #1: It’s already easy for FDA to find dietary supplements in the market.
Facts: Yes, FDA currently has tools that were provided by the Dietary Supplement Health and Education Act (DSHEA) to regulate the industry, but the reality is that the agency can’t regulate what it can’t see. Food Safety Modernization Act (FSMA) facility registration identifies which facilities are engaged in supplement production, but it doesn’t tell FDA what’s being made in a facility. The much-touted ODS label database is not mandatory, comprehensive, or even current—it gets updated once or twice a year. And while FDA can get labels during an inspection, it currently only inspects about 5% of the industry each year. At that rate, it will take FDA 20 years to amass a complete collection of product labels. By comparison, a mandatory registry would immediately allow FDA to see what products and ingredients are available to U.S. consumers—something it can’t see now.
Myth #2: ODS already has a label database; we don’t need another one.
Facts: The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) does maintain a dietary supplement label database, but it is not a complete listing of dietary supplements currently in the market. The ODS database is voluntary, and a contractor is responsible for locating and entering many labels in the database (sometimes without the manufacturers’ knowledge). Without a formal, enforceable requirement to participate, there is no legal incentive to put labels in the ODS system.
Nor is there any accountability for the accuracy of those entries, or verification from the marketers that the “on market” designation is accurate or current. It’s no knock on ODS to admit that database was created as a research tool (and serves that purpose well), but it is not intended to be a real-time snapshot of the market. Even Amazon or Google searches and CRN’s Supplement OWL (Online Wellness Library) are not complete pictures. Only a mandatory listing will give an accurate and complete view of the marketplace.
Myth #3: A mandatory product listing will turn into pre-market approval for supplements.
Facts: This false claim seems to be getting a lot of traction these days, perhaps because “pre-market approval” is such a dog whistle to stop any proposal in its tracks. Mandatory listing can be implemented with safeguards to prevent potential abuses of this authority by FDA. CRN’s mantra for mandatory listing is that any proposal it supports must be “a birth certificate—not a driver’s license.” FDA cannot be authorized to reject a label or refuse to enter it into the registry.
A requirement to provide FDA with a copy of product labeling on the way to market does not give FDA the ability to refuse to accept it. This construct can be, and should be, enshrined in the legislation. If FDA has no ability to reject a product listing, then this requirement can’t serve to prevent introduction of new products or inhibit innovation. The listing serves as a record of products marketed under the moniker of “dietary supplement”—good or bad.
Myth #4: FDA can use the mandatory listing to keep products it doesn’t like off the market.
Facts: As described above, if FDA is required to accept all labels for the listing, FDA gets transparency, but not the ability to slow down market entry. Product innovation and speed to market are hallmarks of this industry—mandatory listing would not change that. The registry will give FDA visibility to find such products, but it would still have to pursue existing legal processes to remove a product from the market.
Myth #5: It’s too burdensome for companies. Small businesses can’t comply.
Facts: Over four years ago, CRN embarked on creating The Supplement OWL, a voluntary version of a mandatory listing of supplement labels and publicly available product information. The Supplement OWL can now serve as a template for mandatory listing because it works—without creating unreasonable burdens on participants.
Companies of all sizes participate in the Supplement OWL. Automating much of the data entry has permitted companies with six labels or 600 labels to upload their data efficiently. Because the registry is limited to only that information that is on the label, companies can scan the label and then extract the relevant data right into the database. Compared to adverse event reporting and GMP compliance—two initiatives the industry has long supported to raise confidence in our products—this requirement is a piece of cake.
Myth #6: Bad actors won’t enter their labels; it’s just one more administrative burden for the “good” companies to observe and “bad” companies to ignore.
Facts: Mandatory listing gives FDA an administrative violation that is easy to enforce. Failure to list would make the product misbranded under 21 USC 343 and marketing a product without listing it would be a prohibited act. Listing violations do not require lab testing, independent analysis, chain of custody and other obstacles to quick prosecution that burdens prosecutions for adulterated ingredients. They are easy to enforce and a few high-profile actions by FDA would send a clear message to companies to provide their labels.
Myth #7: A mandatory listing won’t solve all the industry’s problems, so let’s not do it.
Facts: Not so much a myth as a misguided excuse. We agree that FDA has not enforced existing regulations as aggressively as it should, but mandatory listing is the essential first step to creating a truly transparent industry. Consumers assume FDA already knows what is in the market; they are surprised to learn that FDA doesn’t even know how many products and ingredients are out there. Mandatory listing won’t immediately address willful bad actors, but it will bring many firms that operate in the grey areas into the sunshine for FDA’s evaluation.
Myth #8: If FDA isn’t using the enforcement tools it has, we shouldn’t give the agency any more.
Facts: FDA has repeatedly asked for mandatory listing in its budget requests. This tool will help the agency be more responsive to illegal behavior. CRN would be first in line to criticize FDA for not being aggressive enough with illegal ingredients brought to its attention, for being timid with warning letters, and slow to address adulterated supplements, counterfeit products and non-compliant manufacturers. But that is not a reason to deny the agency of a tool that will make its enforcement more efficient.
Mandatory listing will help FDA create enforcement priorities based on what’s actually in the marketplace. The agency can find noncompliant products quicker, address safety concerns faster, and utilize resources more efficiently. The notion that because industry doesn’t think FDA is aggressive enough, that’s an argument against helping it become more targeted and efficient just doesn’t make sense.
Myth #9: Instead of mandatory listing, the industry needs a massive reform of DSHEA—do it all or do nothing.
Facts: This argument is the flipside of #8. Some stakeholders urge that unless we can get a full package of changes to DSHEA, the industry should not agree to any incremental changes. That’s unrealistic and naïve in this complicated, uber-partisan Congressional environment. Responsible companies should want mandatory listing; it demonstrates accountability to our regulators and transparency to our consumers. It is a “win” for responsible players as much as it is for FDA. When did mandatory listing morph from being a benefit to industry to a “give” that requires a “get” in return? Mandatory listing is something we can all agree on, and it can pass on a bipartisan basis in this Congress. It's achievable when many other proposed reforms are not.
It’s easy to criticize efforts to construct policies that move industry forward. It’s harder to build consensus, forge compromises with detractors and develop pragmatic solutions that can be enacted. Industry would be wise to view both the mandatory listing legislation and the arguments against it with a critical eye. Be skeptical, but also recognize a red herring when you see it. Let’s try to address legitimate concerns while dismissing the strawmen. If we work together, we can devise a mandatory listing system that elevates this industry for the future.
Steve Mister has been President & CEO of CRN since 2005. Founded in 1973 and based in Washington, D.C., CRN’s mission is “to sustain and enhance a climate for our members to responsibly develop, manufacture and market dietary supplements, functional foods and nutritional ingredients.”
This week, Senator Richard Durbin (D-IL) introduced the Dietary Supplement Listing Act of 2022 (S. 4090), which would create a mandatory product listing requirement for dietary supplements. Basically, the legislation would require every marketer of finished product supplements to provide a copy of their labels to FDA as it brings the product to market. Under this legislation, FDA does not get to “approve” or “reject” the product—it must accept the label and post it in a publicly available website so that regulators, retailers, and consumers can see what supplements are in the U.S. marketplace at any given time. CRN has expressed strong support for this proposal.
Unfortunately, some stakeholders have opposed mandatory listing without completely understanding what it does—and doesn’t do. It’s been misrepresented as "pre-market approval” in disguise, a gateway to FDA’s removal of ingredients, and an overly burdensome bureaucratic headache. It is none of these.
I recently had the opportunity to assemble and refute many of these red herring arguments for the Senate Health, Education, Labor, and Pensions (HELP) Committee. In the interest of that same transparency promoted by mandatory listing itself, I want to share these myths and facts so industry members can make educated decisions about your own views toward mandatory listing.
Myth #1: It’s already easy for FDA to find dietary supplements in the market.
Facts: Yes, FDA currently has tools that were provided by the Dietary Supplement Health and Education Act (DSHEA) to regulate the industry, but the reality is that the agency can’t regulate what it can’t see. Food Safety Modernization Act (FSMA) facility registration identifies which facilities are engaged in supplement production, but it doesn’t tell FDA what’s being made in a facility. The much-touted ODS label database is not mandatory, comprehensive, or even current—it gets updated once or twice a year. And while FDA can get labels during an inspection, it currently only inspects about 5% of the industry each year. At that rate, it will take FDA 20 years to amass a complete collection of product labels. By comparison, a mandatory registry would immediately allow FDA to see what products and ingredients are available to U.S. consumers—something it can’t see now.
Myth #2: ODS already has a label database; we don’t need another one.
Facts: The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) does maintain a dietary supplement label database, but it is not a complete listing of dietary supplements currently in the market. The ODS database is voluntary, and a contractor is responsible for locating and entering many labels in the database (sometimes without the manufacturers’ knowledge). Without a formal, enforceable requirement to participate, there is no legal incentive to put labels in the ODS system.
Nor is there any accountability for the accuracy of those entries, or verification from the marketers that the “on market” designation is accurate or current. It’s no knock on ODS to admit that database was created as a research tool (and serves that purpose well), but it is not intended to be a real-time snapshot of the market. Even Amazon or Google searches and CRN’s Supplement OWL (Online Wellness Library) are not complete pictures. Only a mandatory listing will give an accurate and complete view of the marketplace.
Myth #3: A mandatory product listing will turn into pre-market approval for supplements.
Facts: This false claim seems to be getting a lot of traction these days, perhaps because “pre-market approval” is such a dog whistle to stop any proposal in its tracks. Mandatory listing can be implemented with safeguards to prevent potential abuses of this authority by FDA. CRN’s mantra for mandatory listing is that any proposal it supports must be “a birth certificate—not a driver’s license.” FDA cannot be authorized to reject a label or refuse to enter it into the registry.
A requirement to provide FDA with a copy of product labeling on the way to market does not give FDA the ability to refuse to accept it. This construct can be, and should be, enshrined in the legislation. If FDA has no ability to reject a product listing, then this requirement can’t serve to prevent introduction of new products or inhibit innovation. The listing serves as a record of products marketed under the moniker of “dietary supplement”—good or bad.
Myth #4: FDA can use the mandatory listing to keep products it doesn’t like off the market.
Facts: As described above, if FDA is required to accept all labels for the listing, FDA gets transparency, but not the ability to slow down market entry. Product innovation and speed to market are hallmarks of this industry—mandatory listing would not change that. The registry will give FDA visibility to find such products, but it would still have to pursue existing legal processes to remove a product from the market.
Myth #5: It’s too burdensome for companies. Small businesses can’t comply.
Facts: Over four years ago, CRN embarked on creating The Supplement OWL, a voluntary version of a mandatory listing of supplement labels and publicly available product information. The Supplement OWL can now serve as a template for mandatory listing because it works—without creating unreasonable burdens on participants.
Companies of all sizes participate in the Supplement OWL. Automating much of the data entry has permitted companies with six labels or 600 labels to upload their data efficiently. Because the registry is limited to only that information that is on the label, companies can scan the label and then extract the relevant data right into the database. Compared to adverse event reporting and GMP compliance—two initiatives the industry has long supported to raise confidence in our products—this requirement is a piece of cake.
Myth #6: Bad actors won’t enter their labels; it’s just one more administrative burden for the “good” companies to observe and “bad” companies to ignore.
Facts: Mandatory listing gives FDA an administrative violation that is easy to enforce. Failure to list would make the product misbranded under 21 USC 343 and marketing a product without listing it would be a prohibited act. Listing violations do not require lab testing, independent analysis, chain of custody and other obstacles to quick prosecution that burdens prosecutions for adulterated ingredients. They are easy to enforce and a few high-profile actions by FDA would send a clear message to companies to provide their labels.
Myth #7: A mandatory listing won’t solve all the industry’s problems, so let’s not do it.
Facts: Not so much a myth as a misguided excuse. We agree that FDA has not enforced existing regulations as aggressively as it should, but mandatory listing is the essential first step to creating a truly transparent industry. Consumers assume FDA already knows what is in the market; they are surprised to learn that FDA doesn’t even know how many products and ingredients are out there. Mandatory listing won’t immediately address willful bad actors, but it will bring many firms that operate in the grey areas into the sunshine for FDA’s evaluation.
Myth #8: If FDA isn’t using the enforcement tools it has, we shouldn’t give the agency any more.
Facts: FDA has repeatedly asked for mandatory listing in its budget requests. This tool will help the agency be more responsive to illegal behavior. CRN would be first in line to criticize FDA for not being aggressive enough with illegal ingredients brought to its attention, for being timid with warning letters, and slow to address adulterated supplements, counterfeit products and non-compliant manufacturers. But that is not a reason to deny the agency of a tool that will make its enforcement more efficient.
Mandatory listing will help FDA create enforcement priorities based on what’s actually in the marketplace. The agency can find noncompliant products quicker, address safety concerns faster, and utilize resources more efficiently. The notion that because industry doesn’t think FDA is aggressive enough, that’s an argument against helping it become more targeted and efficient just doesn’t make sense.
Myth #9: Instead of mandatory listing, the industry needs a massive reform of DSHEA—do it all or do nothing.
Facts: This argument is the flipside of #8. Some stakeholders urge that unless we can get a full package of changes to DSHEA, the industry should not agree to any incremental changes. That’s unrealistic and naïve in this complicated, uber-partisan Congressional environment. Responsible companies should want mandatory listing; it demonstrates accountability to our regulators and transparency to our consumers. It is a “win” for responsible players as much as it is for FDA. When did mandatory listing morph from being a benefit to industry to a “give” that requires a “get” in return? Mandatory listing is something we can all agree on, and it can pass on a bipartisan basis in this Congress. It's achievable when many other proposed reforms are not.
It’s easy to criticize efforts to construct policies that move industry forward. It’s harder to build consensus, forge compromises with detractors and develop pragmatic solutions that can be enacted. Industry would be wise to view both the mandatory listing legislation and the arguments against it with a critical eye. Be skeptical, but also recognize a red herring when you see it. Let’s try to address legitimate concerns while dismissing the strawmen. If we work together, we can devise a mandatory listing system that elevates this industry for the future.
Steve Mister has been President & CEO of CRN since 2005. Founded in 1973 and based in Washington, D.C., CRN’s mission is “to sustain and enhance a climate for our members to responsibly develop, manufacture and market dietary supplements, functional foods and nutritional ingredients.”
