Mike Montemarano, Associate Editor 04.28.21
Today, the Council for Responsible Nutrition (CRN), a trade association representing the dietary supplement and functional food industry, announced its support for revisions to the federal Food, Drug, and Cosmetic Act that address a clarification to the definition of ‘dietary supplement.’ The proposed modifications will clarify FDA’s authority over products masquerading as dietary supplements, regardless of their content, to further clamp down on adulterated products in the market.
According to CRN, if a product is marketed as a dietary supplement, but technically doesn’t contain any dietary ingredients, it is uncertain as to whether the FDA has legal authority to regulate such a product, as it technically doesn’t meet the definition of a dietary supplement in the statute. Even if a product contains a Supplement Facts label, or a Statement of Identity as a dietary supplement, FDA contends that it may be beyond the regulatory reach of FDA’s dietary supplement authority if the adulterated product doesn’t actually contain one or more dietary ingredients.
CRN supports a clarification on this matter to make clear FDA’s authority to prosecute adulterated products which are marketed as dietary supplements, but contain only illegal ingredients.
“If a product is branded or marketed as a dietary supplement, then it should be held to account as if it was a dietary supplement,” Julia Gustafson, vice president of government relations for CRN said. “CRN and our members want to get rogue and illegal products out of the supplement market as they jeopardize public health and hurt consumer confidence in the responsible industry.”
FDA has discussed this issue publicly for two years, and offered proposed amendments to address these concerns in its Technical Assistance Comments on HR 8179 in 2020, CRN said. The agency’s proposed provisions will clarify its authority to take action against illegitimate products that market themselves as dietary supplements, but do not meet the statutory definition of a supplement. The proposed legislative language creates a new prohibited act, the ability to exclude imports, and the ability to seize an product labeled as a dietary supplement that fails to meet the definition of a dietary supplement.
“If enacted, these amendments will provide concrete steps toward building a safer supplement market and a more effective FDA,” Gustafson said. “Products marketed as supplements should be held to the requirements and restrictions the FD&C Act imposes on this class of regulated products, and should be subject to the enforcement tools that law provides, like seizures, mandatory recalls, and criminal prosecution. CRN agrees that FDA needs these enforcement clarifications, and calls on Congress to enact these amendments to the statute to protect consumer safety for the three quarters of Americans who rely on these products to support their health and wellness.”
CRN supports other amendments to the legislation that would provide other methods of enhancing FDA’s oversight. CRN is working to establish a mandatory product listing, to give FDA the ability to see into the market. It is also taking action to revise the drug preclusion language in the definition of dietary supplements that is currently blocking the sale of CBD supplements, and revisiting the new dietary ingredient provisions to clarify uncertainties.
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
According to CRN, if a product is marketed as a dietary supplement, but technically doesn’t contain any dietary ingredients, it is uncertain as to whether the FDA has legal authority to regulate such a product, as it technically doesn’t meet the definition of a dietary supplement in the statute. Even if a product contains a Supplement Facts label, or a Statement of Identity as a dietary supplement, FDA contends that it may be beyond the regulatory reach of FDA’s dietary supplement authority if the adulterated product doesn’t actually contain one or more dietary ingredients.
CRN supports a clarification on this matter to make clear FDA’s authority to prosecute adulterated products which are marketed as dietary supplements, but contain only illegal ingredients.
“If a product is branded or marketed as a dietary supplement, then it should be held to account as if it was a dietary supplement,” Julia Gustafson, vice president of government relations for CRN said. “CRN and our members want to get rogue and illegal products out of the supplement market as they jeopardize public health and hurt consumer confidence in the responsible industry.”
FDA has discussed this issue publicly for two years, and offered proposed amendments to address these concerns in its Technical Assistance Comments on HR 8179 in 2020, CRN said. The agency’s proposed provisions will clarify its authority to take action against illegitimate products that market themselves as dietary supplements, but do not meet the statutory definition of a supplement. The proposed legislative language creates a new prohibited act, the ability to exclude imports, and the ability to seize an product labeled as a dietary supplement that fails to meet the definition of a dietary supplement.
“If enacted, these amendments will provide concrete steps toward building a safer supplement market and a more effective FDA,” Gustafson said. “Products marketed as supplements should be held to the requirements and restrictions the FD&C Act imposes on this class of regulated products, and should be subject to the enforcement tools that law provides, like seizures, mandatory recalls, and criminal prosecution. CRN agrees that FDA needs these enforcement clarifications, and calls on Congress to enact these amendments to the statute to protect consumer safety for the three quarters of Americans who rely on these products to support their health and wellness.”
CRN supports other amendments to the legislation that would provide other methods of enhancing FDA’s oversight. CRN is working to establish a mandatory product listing, to give FDA the ability to see into the market. It is also taking action to revise the drug preclusion language in the definition of dietary supplements that is currently blocking the sale of CBD supplements, and revisiting the new dietary ingredient provisions to clarify uncertainties.
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at mmontemarano@rodmanmedia.com.
