By Mike Montemarano, Associate Editor 03.31.22
Within its FY2023 budget request, the U.S. Food and Drug Administration (FDA) requested that Congress pass legislation to amend the Dietary Supplement Health and Education Act (DSHEA) to establish a mandatory product listing program and clarify its authority to facilitate enforcement. The idea of a mandatory product listing has been floated before, and opinions among trade associations have been mixed.
In this year’s budget request, recently-appointed FDA Commissioner Robert Califf, MD, requested a budget of $8.4 billion, representing a 34% ($2.1 billion) increase from last year’s budget. While FDA identified many spending priorities relevant to the dietary supplements world, industry leadership weighed in mostly on the mandatory product listing portion of the request, which included both appropriations and legislative change.
In the request, “Justification of Estimates for Appropriations Committees,” the agency said that it seeks “a package of legislative proposals designed to bolster the FDA’s authorities.” Among other legislative items, the agency seeks to “modernize dietary supplement regulation, seeking to require annual listing with the FDA of individual dietary supplement products, including basic information about each unique product. It is estimated that the current supplement market is between 50,000 and 80,000 products. 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.”
The mandatory product listing is included in a $13.5 million component of the budget request, called the “Healthy and Safe Food for All” initiative, to complement the requested regulatory change.
“There has been a ten-fold increase in the dietary supplement market since the passage of DSHEA, from $4 billion to $40 billion. This trend has only increased during the COVID-19 pandemic. Yet most dietary supplements can be lawfully introduced to the market without ever notifying FDA. The resources requested will support the legislative proposal to amend [DSHEA] by establishing a product listing requirement,” FDA stated.
The agency also requested the passage of legislation which would clarify its authority to take enforcement action against products that may be marketed as dietary supplements but do not, in fact, meet those legal definitions, such as those which contain drug ingredients.
Pros and Cons
In a statement, the Council for Responsible Nutrition shared its support for the agency’s request. “CRN is pleased to see FDA continuing the call for legislation to create a mandatory product listing. We share FDA’s interest in creating a more transparent industry for regulators and consumers alike. We also appreciate FDA’s continued efforts to clarify its jurisdiction over products that are marketed as dietary supplements but fail to actually contain a legal dietary ingredient. While we differ from FDA’s current reservations on enforcement—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—we are on record supporting legislation to provide clarity on this matter. We are glad to see FDA advancing this issue.”
As a condition of membership, CRN member companies are required to submit their product information to its Supplement OWL (Online Wellness Library), which serves as a self-regulatory initiative. CRN also expressed support for the agency’s request for increased funding toward enhanced inspection capacity and alternative methods for product testing. However, the association lamented FDA’s apparent lack of interest in additional funds for cannabinoid safety research, or funds designated to create a legal market for supplements containing cannabinoids.
Scott Melville, president and CEO of the Consumer Healthcare Products Association, supported the key aspects of FDA’s budget request involving dietary supplements, including the significant increase in funding itself.
“FDA’s recent request for a 34% budget increase in FY2023 shows that new FDA Commissioner Robert Califf recognizes the critical importance of self-care in public health,” Melville said. “FDA’s budget aligns with CHPA’s priorities to empower self-care by ensuring Americans continue to have access to safe, reliable, and affordable personal healthcare products including over-the-counter medicines, consumer medical devices, and dietary supplements. Specifically, we’re pleased to see FDA’s proposed budget also prioritizes modernization of dietary supplement regulation by supporting mandatory product listing, increasing inspection capacity, and clarifying its authority to better facilitate enforcement against unlawfully marketed products. The budget proposal makes it clear that Dr. Califf views stronger oversight of dietary supplements as a key part of FDA’s mission to advance the health and wellbeing of every American.”
Michael McGuffin, president of the American Herbal Products Association (AHPA), expressed reservations about a mandatory product list citing several “unaddressed concerns, including that such a requirement could prove not only harmful, unnecessary, redundant and inaccurate, but would restrict consumer choice and access to dietary supplements. MPL also threatens to distract FDA from more essential regulatory enforcement of the dietary supplements category.”
In a statement, McGuffin said AHPA has interest in potential regulatory modernization, “provided that it actually benefits consumers. To this end, there remain many unaddressed concerns about MPL proposals—including that any MPL requirement could destabilize the balance that the Dietary Supplement Health and Education Act struck between informed consumer access and appropriate FDA authority. With the goal of modernizing regulation while retaining this balance, AHPA advocates for the removal of obstacles to the dissemination of truthful and not misleading information to consumers. 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.
The Natural Products Association called mandatory product listing “a non-starter,” arguing it amounts to pre-market approval that jeopardizes safe and substantiated ingredients like NAC, CBD, and whatever else FDA itself may deem unlawful.
Daniel Fabricant, president and CEO of NPA, said: “Year after year, FDA receives more funding, including a $2 million increase in FY22. Yet, despite these increases, FDA consistently does less with more. Mandatory product listing is pre-market approval disguised as transparency and would only add to the bureaucratic nightmare the industry is experiencing with NAC and CBD. Instead of framing the dietary supplement industry as a regulatory crisis, FDA should recognize the importance of dietary supplements to the health and wellness of American consumers, as evident by the nearly 80% who use our products.”
In this year’s budget request, recently-appointed FDA Commissioner Robert Califf, MD, requested a budget of $8.4 billion, representing a 34% ($2.1 billion) increase from last year’s budget. While FDA identified many spending priorities relevant to the dietary supplements world, industry leadership weighed in mostly on the mandatory product listing portion of the request, which included both appropriations and legislative change.
In the request, “Justification of Estimates for Appropriations Committees,” the agency said that it seeks “a package of legislative proposals designed to bolster the FDA’s authorities.” Among other legislative items, the agency seeks to “modernize dietary supplement regulation, seeking to require annual listing with the FDA of individual dietary supplement products, including basic information about each unique product. It is estimated that the current supplement market is between 50,000 and 80,000 products. 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.”
The mandatory product listing is included in a $13.5 million component of the budget request, called the “Healthy and Safe Food for All” initiative, to complement the requested regulatory change.
“There has been a ten-fold increase in the dietary supplement market since the passage of DSHEA, from $4 billion to $40 billion. This trend has only increased during the COVID-19 pandemic. Yet most dietary supplements can be lawfully introduced to the market without ever notifying FDA. The resources requested will support the legislative proposal to amend [DSHEA] by establishing a product listing requirement,” FDA stated.
The agency also requested the passage of legislation which would clarify its authority to take enforcement action against products that may be marketed as dietary supplements but do not, in fact, meet those legal definitions, such as those which contain drug ingredients.
Pros and Cons
In a statement, the Council for Responsible Nutrition shared its support for the agency’s request. “CRN is pleased to see FDA continuing the call for legislation to create a mandatory product listing. We share FDA’s interest in creating a more transparent industry for regulators and consumers alike. We also appreciate FDA’s continued efforts to clarify its jurisdiction over products that are marketed as dietary supplements but fail to actually contain a legal dietary ingredient. While we differ from FDA’s current reservations on enforcement—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—we are on record supporting legislation to provide clarity on this matter. We are glad to see FDA advancing this issue.”
As a condition of membership, CRN member companies are required to submit their product information to its Supplement OWL (Online Wellness Library), which serves as a self-regulatory initiative. CRN also expressed support for the agency’s request for increased funding toward enhanced inspection capacity and alternative methods for product testing. However, the association lamented FDA’s apparent lack of interest in additional funds for cannabinoid safety research, or funds designated to create a legal market for supplements containing cannabinoids.
Scott Melville, president and CEO of the Consumer Healthcare Products Association, supported the key aspects of FDA’s budget request involving dietary supplements, including the significant increase in funding itself.
“FDA’s recent request for a 34% budget increase in FY2023 shows that new FDA Commissioner Robert Califf recognizes the critical importance of self-care in public health,” Melville said. “FDA’s budget aligns with CHPA’s priorities to empower self-care by ensuring Americans continue to have access to safe, reliable, and affordable personal healthcare products including over-the-counter medicines, consumer medical devices, and dietary supplements. Specifically, we’re pleased to see FDA’s proposed budget also prioritizes modernization of dietary supplement regulation by supporting mandatory product listing, increasing inspection capacity, and clarifying its authority to better facilitate enforcement against unlawfully marketed products. The budget proposal makes it clear that Dr. Califf views stronger oversight of dietary supplements as a key part of FDA’s mission to advance the health and wellbeing of every American.”
Michael McGuffin, president of the American Herbal Products Association (AHPA), expressed reservations about a mandatory product list citing several “unaddressed concerns, including that such a requirement could prove not only harmful, unnecessary, redundant and inaccurate, but would restrict consumer choice and access to dietary supplements. MPL also threatens to distract FDA from more essential regulatory enforcement of the dietary supplements category.”
In a statement, McGuffin said AHPA has interest in potential regulatory modernization, “provided that it actually benefits consumers. To this end, there remain many unaddressed concerns about MPL proposals—including that any MPL requirement could destabilize the balance that the Dietary Supplement Health and Education Act struck between informed consumer access and appropriate FDA authority. With the goal of modernizing regulation while retaining this balance, AHPA advocates for the removal of obstacles to the dissemination of truthful and not misleading information to consumers. 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.
The Natural Products Association called mandatory product listing “a non-starter,” arguing it amounts to pre-market approval that jeopardizes safe and substantiated ingredients like NAC, CBD, and whatever else FDA itself may deem unlawful.
Daniel Fabricant, president and CEO of NPA, said: “Year after year, FDA receives more funding, including a $2 million increase in FY22. Yet, despite these increases, FDA consistently does less with more. Mandatory product listing is pre-market approval disguised as transparency and would only add to the bureaucratic nightmare the industry is experiencing with NAC and CBD. Instead of framing the dietary supplement industry as a regulatory crisis, FDA should recognize the importance of dietary supplements to the health and wellness of American consumers, as evident by the nearly 80% who use our products.”
