March 6, 2023
FDA on Monday introduced a directory for the public to search certain ingredients in products marketed as dietary supplements and learn what the agency has said about a particular ingredient and whether it has taken any action against it.
In a March 6 constituent update, FDA described the directory as “a one-stop shop of ingredient information that was previously found on different FDA webpages.”
“This directory is intended to help manufacturers, retailers and consumers stay informed about ingredients that may be found in products marketed as dietary supplements and quickly locate information about such ingredients on the FDA’s website,” the constituent update added.
In conjunction with the new launch, FDA is retiring the “FDA Dietary Supplement Ingredient Advisory List,” which the agency described as “a rapid-response tool meant to quickly alert the public when the agency identified ingredients that did not appear to be lawfully marketed in dietary supplements.”
Some industry stakeholders had criticized the ingredient advisory list, arguing it was confusing and/or misleading to the public.
The Dietary Supplement Ingredient Directory includes links to FDA information on 27 ingredients, including the following: 5-Alpha-Hydroxy-Laxogenin; Acacia rigidula; Biotin; BMPEA; Cannabidiol; Cesium chloride; Comfrey; DMAA; DMBA; DMHA; Ephedrine alkaloids; Higenamine; Higenamine HCl; Hordenine; Hordenine HCl; Kava; Kratom; Methylsynephrine; N-acetyl-L-cysteine; Octopamine; Phenibut; Picamilon; Pure and Highly Concentrated Caffeine; Pyridoxamine; Red yeast rice; Tianeptine; and Vinpocetine.
FDA cautioned “the directory is not intended to be a comprehensive list of all ingredients used in products marketed as dietary supplements and may not include all actions the agency has taken with respect to a particular ingredient.”
“For example, all actions may not be listed if the agency has taken many similar actions and some older actions may not be listed, especially if they do not reflect the agency’s current position,” FDA added in the constituent update. “The FDA will update the directory periodically to reflect new developments.”
Reactions to FDA ingredient directory
Blake Ebersole, president of NaturePro Scientific, a regulatory and scientific consulting firm for dietary supplement companies and other FDA-regulated industries, said he was hopeful the directory “would first appear as a more comprehensive or authoritative list for industry. At the same time, I understand that a list of ingredients lacking rigor is not helpful for anyone.”
Ebersole said his initial reaction to FDA’s announcement was that calling the list a “directory” is “misleading,” considering “most of the ingredients listed are actually not permitted” in supplements.
“I wonder what standards or criteria was applied to add an ingredient to the list versus leaving one off,” Ebersole added in an email to Natural Products Insider. “For example, FDA has an interest in CBD, but what about other cannabinoids on the market that don’t have a similar history of use and safety?”
Several industry sources, including Ebersole, questioned to what extent FDA would add ingredients to the list.
“But I’m hopeful that this initial effort will lead to better and more thoughtful guidance, resulting in a more authoritative list of prohibited or adulterated dietary Ingredients,” Ebersole said.
Industry attorney Rend Al-Mondhiry said it was unclear to her what criteria FDA used for its previous dietary supplement ingredient advisory list.
The ingredient directory “seems to be a list of ingredients where FDA has issued some type of communication, both safety and non-safety related,” capturing a “wider net,” she said via text.
Al-Mondhiry also expressed interest in how class action plaintiffs’ attorneys and retailers would leverage the list.
Natural Products Association (NPA) President and CEO Dan Fabricant described the ingredient directory as “a step in the right direction from the ingredient advisory, which was the double-secret probation FDA list.”
However, the ingredient directory “needs clarification as to why things are on the list and to address exactly why ingredients like NAC are next to DMAA on a list,” he said.
In the case of NAC, FDA determined the ingredient was excluded from the definition of a dietary supplement due to its approval as a drug in 1963, though FDA subsequently adopted a policy of “enforcement discretion” to enable the sale of NAC-containing supplements. In the case of DMAA, FDA concluded the ingredient posed health risks to consumers, and federal courts have ruled it cannot be lawfully marketed in supplements.
“I get that the agency is trying to consolidate information, but without context, it will only lead to misinterpretation,” Fabricant maintained. “I can see a third-party platform mistakenly using ‘the list’ to make decisions on what products go into commerce and which ones don’t. The agency knows that and should adjust [its] efforts accordingly.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), lauded efforts to provide the public information about ingredients. However, he cited shortcomings of the ingredient directory and underscored the need for a more comprehensive listing of dietary supplement products.
“Any efforts taken by the FDA to provide consumers, regulators and retailers with accurate information about the ingredients contained in supplements is a productive undertaking,” Mister said. “The agency's newly announced Dietary Supplement Ingredient Directory, however, only provides a partial list of ingredients contained in supplements, complied from already-available sources, and does not require companies to provide listings of ingredients.
“We continue to emphasize the need for a comprehensive registry of all supplement products and continue to agree with the FDA commissioner's recent position that ‘supplements should be required to list with the FDA and companies should be accountable for revealing what is in the supplement being sold,'" Mister added. “Until then, we encourage supplement companies to voluntarily register their products and ingredients with our registry."
Commenting on the ingredient directory, a representative of the Consumer Healthcare Products Association (CHPA) also highlighted the need for a listing requirement and other changes to the regulatory framework governing supplements.
“While none of this information is new or changes anything, we understand why FDA would take action to further ‘help manufacturers, retailers and consumers stay informed’ by putting it in one place," CHPA SVP of Dietary Supplements Duffy MacKay said. "CHPA will continue to underscore the need for a modernized framework that will increase innovation, transparency and informed decision-making. To that point, we agree with Dr. Califf’s recent statement that supplement manufacturers should be required to list ingredients with FDA, while at the same time recognizing that listing is only part of what is needed to enhance safety and build trust with consumers. Any modernization of existing framework should also include more comprehensive reforms to properly balance consumer access with FDA oversight.”
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