10.22.20
During the Council for Responsible Nutrition (CRN) virtual conference, “New, Now, Next,” Steven Tave, director of FDA’s Office of Dietary Supplement Programs, identified a number of legislative steps he believes could “bridge a regulatory gap” at points where, for example, the agency’s hands may be tied with respect to enforcement.
Tave characterized this regulatory gap as a barrier to enforcement, leading to a significant amount of non-compliance in the dietary supplements industry compared to other industries under FDA oversight. Still, Tave said, “we have a clear segment of industry participants who we believe are consistently willing to distribute compliant products.”
That there are non-compliant products on the marketplace today “isn’t a matter of FDA not wanting to enforce the law,” he said, but rather, “there are a number of tools identified which would allow us to enforce the law more effectively.”
Barriers to Enforcement
Tave said to remain skeptical of suggestions that FDA would, in any circumstance, be unwilling to enforce the law; rather, that there are a number of structural, legal, and practical forces that “reflect a divergence between how the [Dietary Supplement Health and Education Act of 1994] was written, and how it is enforced.”
It would be wrong to assume that FDA enforcement begins where a firm’s compliance ends, Tave said. A number of factors prevent the agency from acting upon every violation, being able to identify every instance of non-compliance, allocate resources toward every violation, or navigate a number of quirks in DSHEA.
One of the most pressing issues Tave identified was the lack of regulatory clarity regarding single-ingredient products containing substances excluded from FDA’s definition of dietary supplements, which therefore cannot be regulated as dietary supplements—such as products spiked with naturally-occurring endocrine drugs, for example.
“We can’t bring dietary supplements charges against those products, even if they’re marketed with the intended use as a dietary supplement,” Tave said. “Issues like these might seem esoteric, but they have tangible, real-world consequences, and we need to pay attention to these issues if we expect to bridge the gap.”
“The good news is that that problems at the heart of the gap can be addressed without disrupting broader framework,” Tave said.
‘We Can’t Enforce Against What We Can’t See’
He described the agency’s oversight of the dietary supplements industry as a whole as something that needs to be expanded upon; and that expansion would benefit responsible industry shareholders.
“New Dietary Ingredient Notification requirements are not absolute,” Tave said. “There are alternative pathways for ingredients present in the food supply, and we’re aware that most companies use the self-GRAS process, which the FDA receives no notification about. We don’t have a window into every retail corner of the Internet, and we can’t enforce against what we can’t see.”
For these reasons, Tave and others at FDA support a mandatory product listing, which first became known via public record during a 2020 budget request to Congress. Essentially, the mandatory public listing would require all products “marketed as dietary supplements” to register with FDA on a publicly accessible database. Though the exact language of the bill is not clear, CRN is among those in support of the measure, though trade associations are split on it.
“No one is claiming it would be a cure-all, but it would be a dramatic step forward,” Tave said. “Responsible industry participants are ready for this change.”
Tave said FDA’s position, by and large, is not to expand what the law requires or place additional burdens on companies selling dietary supplements, but to enact measures which would allow the agency to enforce current regulations with greater ease.
Intention of Use Issues
Additional challenges include ingredients that were initially studied as drugs, and thus cannot be sold legally as dietary supplements, despite being marketed as such with open intentions for that type of usage.
Intention of use, to the detriment of actionable enforcement, boils down to whether a product claims to change the normal structure or function of the human body, or reports to treat a disease. Dietary supplement law can only be enforced depending on whether the ingredient is being marketed for the former.
“We can’t change the law, and I think an important piece of any legislation would be that any product representing itself as a dietary supplement is subject to the same laws as any legitimate dietary supplement. People shouldn’t be able to evade litigation by saying that their product technically isn’t a dietary supplement.”
Under Dosing
Currently, it appears FDA does not intend to expand enforcement action against companies whose labels don’t reflect the actual quantity of active ingredients in dietary supplement products. The issue becomes especially burdensome on the industry as a whole when certain companies under-dose their products in comparison to quantities of active ingredients listed on labels in order to sell those products at a lower price point.
While FDA monitors reports about companies engaging in such a practice, Tave said the FDA doesn’t “want to take it upon [themselves] and say they’re going to become a labeling agency full-time.” Even if FDA did, he said, under-dosed or otherwise mislabeled products would still come up, and judicial actions against companies engaging in unscrupulous labeling practices have more potential to result in some kind of an injunctive action.
Tave characterized this regulatory gap as a barrier to enforcement, leading to a significant amount of non-compliance in the dietary supplements industry compared to other industries under FDA oversight. Still, Tave said, “we have a clear segment of industry participants who we believe are consistently willing to distribute compliant products.”
That there are non-compliant products on the marketplace today “isn’t a matter of FDA not wanting to enforce the law,” he said, but rather, “there are a number of tools identified which would allow us to enforce the law more effectively.”
Barriers to Enforcement
Tave said to remain skeptical of suggestions that FDA would, in any circumstance, be unwilling to enforce the law; rather, that there are a number of structural, legal, and practical forces that “reflect a divergence between how the [Dietary Supplement Health and Education Act of 1994] was written, and how it is enforced.”
It would be wrong to assume that FDA enforcement begins where a firm’s compliance ends, Tave said. A number of factors prevent the agency from acting upon every violation, being able to identify every instance of non-compliance, allocate resources toward every violation, or navigate a number of quirks in DSHEA.
One of the most pressing issues Tave identified was the lack of regulatory clarity regarding single-ingredient products containing substances excluded from FDA’s definition of dietary supplements, which therefore cannot be regulated as dietary supplements—such as products spiked with naturally-occurring endocrine drugs, for example.
“We can’t bring dietary supplements charges against those products, even if they’re marketed with the intended use as a dietary supplement,” Tave said. “Issues like these might seem esoteric, but they have tangible, real-world consequences, and we need to pay attention to these issues if we expect to bridge the gap.”
“The good news is that that problems at the heart of the gap can be addressed without disrupting broader framework,” Tave said.
‘We Can’t Enforce Against What We Can’t See’
He described the agency’s oversight of the dietary supplements industry as a whole as something that needs to be expanded upon; and that expansion would benefit responsible industry shareholders.
“New Dietary Ingredient Notification requirements are not absolute,” Tave said. “There are alternative pathways for ingredients present in the food supply, and we’re aware that most companies use the self-GRAS process, which the FDA receives no notification about. We don’t have a window into every retail corner of the Internet, and we can’t enforce against what we can’t see.”
For these reasons, Tave and others at FDA support a mandatory product listing, which first became known via public record during a 2020 budget request to Congress. Essentially, the mandatory public listing would require all products “marketed as dietary supplements” to register with FDA on a publicly accessible database. Though the exact language of the bill is not clear, CRN is among those in support of the measure, though trade associations are split on it.
“No one is claiming it would be a cure-all, but it would be a dramatic step forward,” Tave said. “Responsible industry participants are ready for this change.”
Tave said FDA’s position, by and large, is not to expand what the law requires or place additional burdens on companies selling dietary supplements, but to enact measures which would allow the agency to enforce current regulations with greater ease.
Intention of Use Issues
Additional challenges include ingredients that were initially studied as drugs, and thus cannot be sold legally as dietary supplements, despite being marketed as such with open intentions for that type of usage.
Intention of use, to the detriment of actionable enforcement, boils down to whether a product claims to change the normal structure or function of the human body, or reports to treat a disease. Dietary supplement law can only be enforced depending on whether the ingredient is being marketed for the former.
“We can’t change the law, and I think an important piece of any legislation would be that any product representing itself as a dietary supplement is subject to the same laws as any legitimate dietary supplement. People shouldn’t be able to evade litigation by saying that their product technically isn’t a dietary supplement.”
Under Dosing
Currently, it appears FDA does not intend to expand enforcement action against companies whose labels don’t reflect the actual quantity of active ingredients in dietary supplement products. The issue becomes especially burdensome on the industry as a whole when certain companies under-dose their products in comparison to quantities of active ingredients listed on labels in order to sell those products at a lower price point.
While FDA monitors reports about companies engaging in such a practice, Tave said the FDA doesn’t “want to take it upon [themselves] and say they’re going to become a labeling agency full-time.” Even if FDA did, he said, under-dosed or otherwise mislabeled products would still come up, and judicial actions against companies engaging in unscrupulous labeling practices have more potential to result in some kind of an injunctive action.
