By Mike Montemarano, Associate Editor 04.12.22
Strengthening the ability to regulate the dietary supplements industry and take enforcement action against products in violation of the law was a top priority noted by U.S. Food and Drug Administration commissioner Dr. Robert Califf in this year’s $8.4 billion budget request, which asked for a 34% funding increase compared to last year.
The agency’s request for appropriations and a legislative initiative that would establish a mandatory listing for products marketed as dietary supplements would likely have the most seismic consequences in terms of the agency’s priorities in the coming years. Mixed opinions were abound from trade associations representing the nutraceuticals business. However, there were additional priorities to begin efforts for other program areas relevant to the dietary supplement industry as well.
This year’s budget request seeks $43 million in additional investments in food safety modernization, which includes oversight of animal food, as part of the agency’s initiative, New Era of Smarter Food Safety. This entails employing new technology for prevention-oriented food safety practices, with predictive analytics, machine learning, and artificial intelligence platforms. These platforms would operate under a framework of prevention established by the Food Safety Modernization Act.
Legislative Requests
The agency is seeking $14 million for its operations under the Healthy and Safe Food for All Initiative. Beyond an amendment to DSHEA (Dietary Supplement Health and Education Act) which would establish a mandatory product listing for dietary supplements, the agency is seeking regulatory clarity which would give it a more express authority to pursue enforcement actions against unlawful products. “In the more than 25 years since [DSHEA] was enacted, the dietary supplement market in the U.S. has grown from approximately 4,000 products to somewhere between 50,000 and 80,000 products,” the agency noted.
Historically, FDA has been hesitant to take enforcement actions against certain products which don’t officially market themselves as dietary supplements on-pack, according to the Council for Responsible Nutrition. “CRN believes FDA’s Office of Dietary Supplement Programs does indeed have authority over products that call themselves out as supplements regardless of their contents,” Mister said. “We are on record supporting legislation to provide clarity on this matter. We are glad to see FDA advancing this issue.”
The agency is also seeking legislation which would require companies making infant formula or essential medical foods for patients with certain metabolic disorders to notify the agency if they anticipate significant interruptions in supply. “This proposal would ensure the agency routinely receives timely and accurate information about likely or confirmed shortages in the U.S. and help the FDA to take steps to promote the continued availability of these foods,” the agency said. “Additionally, the FDA is seeking authority to require firms to provide shortage notification for other FDA-designated categories of food during a declared public health emergency.”
Core Operations
When it comes to core operations, the agency is seeking a number of budget increases to better monitor and regulate food products and dietary supplements. The agency requested a $68 million increase appropriated toward improving data technology capabilities. “Artificial intelligence, machine learning, and state-of-the-art solutions like blockchain will be critical to support the FDA’s public health priorities,” the agency said, in part to deal with the scale at which the dietary supplements industry has grown.
The agency is also requesting an increase of $24 which it intends to earmark for improving inspectional capacity, through both hiring new personnel and spending more on both new and existing inspectional tools.
CRN applauded the call for increases dedicated to the agency’s core functions involving dietary supplements. “Currently, FDA inspects less than 5% of registered dietary supplement facilities each year,” the trade association said in a statement. “We have suggestions for improved efficiency of these inspections, including creating risk-based priorities for inspections, frequent re-inspections for habitual offenders, and authorizing third parties to conduct routine, low-risk inspections on behalf of FDA. But it also comes down to insufficient resources to keep up with this fast-growing industry. FDA needs more funding to conduct more inspections.”
Additionally, the agency requested $5 million in order to develop alternative product testing programs that don’t rely on the use of animals, which CRN applauded.
Notable Figures
FDA provided a rundown on some of its regulatory and enforcement activity this year as part of its justifications for the 2023 budget it seeks.
In FY 2021, FDA’s total dietary supplement compliance activity included issuing 111 warning letters, 1,299 import refusals, three injunctions, and one product seizure, and achieved 22 criminal convictions related to dietary supplement enforcement activity. “FDA’s operations and oversight, including inspection activities, continued to be impacted by the COVID-19 pandemic,” the agency noted. “While fewer dietary supplement facility inspections were conducted in FY 2021 as compared with previous years, the agency’s overall dietary supplement compliance activity continued…”
FDA noted that it continued to emphasize regulatory actions aimed at either dangerous or fraudulent products, some of which were not dietary supplements but marketed themselves as such. These included products with disease-related claims related to COVID-19, diabetes, depression, other mental health disorders, and infertility. FDA posted 69 public notifications for products that were found to be tainted with undeclared drugs, many of which were marketed as dietary supplements.
FDA responded to 49 NDI (New Dietary Ingredient) notifications, which it stated is the agency’s “only opportunity to identify potentially unsafe supplements before they are available to consumers.” Of these, FDA acknowledged 27 with no objection, raised safety or identity concerns with 11 NDIs, seven were determined not to pertain to a dietary ingredient/supplement, and four were deemed incomplete.
FDA responded to a total of 2,400 adverse events reports related to dietary supplements, each of which are evaluated by clinical reviewers to monitor the safety of consumer products.
Cannabinoids Not in Discussion
CRN called attention to the elephant in the room that is the prospective legal pathway to market for dietary supplements containing CBD or other cannabinoids sourced from industrial hemp, stating that the association is “dismayed that no funds are being requested for additional research into the safety of cannabinoids or specifically designated for developing a safe and legal market for cannabinoid-containing dietary supplements.
“FDA’s inaction over the past three years has created a marketplace where reputable products compete with ones of questionable quality or making unsupported claims. FDA has an opportunity to reclaim this market for consumers by creating a legal pathway for these products as dietary supplements and directing enforcement activity against the ones that don’t measure up,” CRN continued.
Similarly, the American Herbal Products Association (AHPA) called for amendments to the drug preclusion provision of DSHEA, which is considered the key obstacle for a legal pathway to market for CBD supplements. FDA approved of a drug called Epidiolex, which contains extremely high doses of isolated CBD, and in letters to the first two new dietary ingredient notifications for CBD-containing products submitted, the agency cited the drug preclusion provision as a reason for rejection.
“AHPA similarly advocates for amendments to the prior drug exclusion provision to establish a more reasonable pathway to market for all natural products, even if that means that certain ingredients would eventually exist in both the pharmaceutical and dietary supplement markets,” Michael McGuffin, AHPA president, said.
The agency’s request for appropriations and a legislative initiative that would establish a mandatory listing for products marketed as dietary supplements would likely have the most seismic consequences in terms of the agency’s priorities in the coming years. Mixed opinions were abound from trade associations representing the nutraceuticals business. However, there were additional priorities to begin efforts for other program areas relevant to the dietary supplement industry as well.
This year’s budget request seeks $43 million in additional investments in food safety modernization, which includes oversight of animal food, as part of the agency’s initiative, New Era of Smarter Food Safety. This entails employing new technology for prevention-oriented food safety practices, with predictive analytics, machine learning, and artificial intelligence platforms. These platforms would operate under a framework of prevention established by the Food Safety Modernization Act.
Legislative Requests
The agency is seeking $14 million for its operations under the Healthy and Safe Food for All Initiative. Beyond an amendment to DSHEA (Dietary Supplement Health and Education Act) which would establish a mandatory product listing for dietary supplements, the agency is seeking regulatory clarity which would give it a more express authority to pursue enforcement actions against unlawful products. “In the more than 25 years since [DSHEA] was enacted, the dietary supplement market in the U.S. has grown from approximately 4,000 products to somewhere between 50,000 and 80,000 products,” the agency noted.
Historically, FDA has been hesitant to take enforcement actions against certain products which don’t officially market themselves as dietary supplements on-pack, according to the Council for Responsible Nutrition. “CRN believes FDA’s Office of Dietary Supplement Programs does indeed have authority over products that call themselves out as supplements regardless of their contents,” Mister said. “We are on record supporting legislation to provide clarity on this matter. We are glad to see FDA advancing this issue.”
The agency is also seeking legislation which would require companies making infant formula or essential medical foods for patients with certain metabolic disorders to notify the agency if they anticipate significant interruptions in supply. “This proposal would ensure the agency routinely receives timely and accurate information about likely or confirmed shortages in the U.S. and help the FDA to take steps to promote the continued availability of these foods,” the agency said. “Additionally, the FDA is seeking authority to require firms to provide shortage notification for other FDA-designated categories of food during a declared public health emergency.”
Core Operations
When it comes to core operations, the agency is seeking a number of budget increases to better monitor and regulate food products and dietary supplements. The agency requested a $68 million increase appropriated toward improving data technology capabilities. “Artificial intelligence, machine learning, and state-of-the-art solutions like blockchain will be critical to support the FDA’s public health priorities,” the agency said, in part to deal with the scale at which the dietary supplements industry has grown.
The agency is also requesting an increase of $24 which it intends to earmark for improving inspectional capacity, through both hiring new personnel and spending more on both new and existing inspectional tools.
CRN applauded the call for increases dedicated to the agency’s core functions involving dietary supplements. “Currently, FDA inspects less than 5% of registered dietary supplement facilities each year,” the trade association said in a statement. “We have suggestions for improved efficiency of these inspections, including creating risk-based priorities for inspections, frequent re-inspections for habitual offenders, and authorizing third parties to conduct routine, low-risk inspections on behalf of FDA. But it also comes down to insufficient resources to keep up with this fast-growing industry. FDA needs more funding to conduct more inspections.”
Additionally, the agency requested $5 million in order to develop alternative product testing programs that don’t rely on the use of animals, which CRN applauded.
Notable Figures
FDA provided a rundown on some of its regulatory and enforcement activity this year as part of its justifications for the 2023 budget it seeks.
In FY 2021, FDA’s total dietary supplement compliance activity included issuing 111 warning letters, 1,299 import refusals, three injunctions, and one product seizure, and achieved 22 criminal convictions related to dietary supplement enforcement activity. “FDA’s operations and oversight, including inspection activities, continued to be impacted by the COVID-19 pandemic,” the agency noted. “While fewer dietary supplement facility inspections were conducted in FY 2021 as compared with previous years, the agency’s overall dietary supplement compliance activity continued…”
FDA noted that it continued to emphasize regulatory actions aimed at either dangerous or fraudulent products, some of which were not dietary supplements but marketed themselves as such. These included products with disease-related claims related to COVID-19, diabetes, depression, other mental health disorders, and infertility. FDA posted 69 public notifications for products that were found to be tainted with undeclared drugs, many of which were marketed as dietary supplements.
FDA responded to 49 NDI (New Dietary Ingredient) notifications, which it stated is the agency’s “only opportunity to identify potentially unsafe supplements before they are available to consumers.” Of these, FDA acknowledged 27 with no objection, raised safety or identity concerns with 11 NDIs, seven were determined not to pertain to a dietary ingredient/supplement, and four were deemed incomplete.
FDA responded to a total of 2,400 adverse events reports related to dietary supplements, each of which are evaluated by clinical reviewers to monitor the safety of consumer products.
Cannabinoids Not in Discussion
CRN called attention to the elephant in the room that is the prospective legal pathway to market for dietary supplements containing CBD or other cannabinoids sourced from industrial hemp, stating that the association is “dismayed that no funds are being requested for additional research into the safety of cannabinoids or specifically designated for developing a safe and legal market for cannabinoid-containing dietary supplements.
“FDA’s inaction over the past three years has created a marketplace where reputable products compete with ones of questionable quality or making unsupported claims. FDA has an opportunity to reclaim this market for consumers by creating a legal pathway for these products as dietary supplements and directing enforcement activity against the ones that don’t measure up,” CRN continued.
Similarly, the American Herbal Products Association (AHPA) called for amendments to the drug preclusion provision of DSHEA, which is considered the key obstacle for a legal pathway to market for CBD supplements. FDA approved of a drug called Epidiolex, which contains extremely high doses of isolated CBD, and in letters to the first two new dietary ingredient notifications for CBD-containing products submitted, the agency cited the drug preclusion provision as a reason for rejection.
“AHPA similarly advocates for amendments to the prior drug exclusion provision to establish a more reasonable pathway to market for all natural products, even if that means that certain ingredients would eventually exist in both the pharmaceutical and dietary supplement markets,” Michael McGuffin, AHPA president, said.
