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FDA has indicated it may reject vinpocetine’s status as a dietary ingredient, but leading industry trade associations argue the agency is reversing past positions in an “unprecedented” move.
Today, the comment period closed for the public to respond to FDA’s “tentative” conclusion that vinpocetine does not qualify as a dietary ingredient. As the past months of unease over the issue suggested, several industry trade associations, including the Natural Products Association (NPA; Washington, DC) and the Council for Responsible Nutrition (CRN; Washington, DC), submitted comments that challenge FDA’s stance and argue vinpocetine should absolutely remain a dietary ingredient.
In the wake of releasing its revised new dietary ingredient (NDI) draft guidance, FDA published a Federal Register notice on September 7 concluding that vinpocetine may not actually be a dietary ingredient, despite the agency having acknowledged five separate NDI notifications for vinpocetine since 1997. Vinpocetine, a synthetic ingredient produced from an alkaloid of the lesser periwinkle plant (Vinca minor), is not a dietary ingredient, FDA argued, because it is not a vitamin, mineral, or amino acid; because it is synthesized and therefore not a constituent, extract, or derivative of an herb or botanical; and because there are no documented food uses of vinpocetine. What’s more, vinpocetine was authorized for scientific investigation as a new drug in 1981, according to FDA, which nullifies vinpocetine’s status as dietary ingredient under the investigational new drug (IND) rule of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Given FDA’s past acceptance of vinpocetine as a dietary ingredient and its established place on the supplements market, industry was understandably shocked when FDA published its Federal Register notice. Today, industry leaders submitted comments flatly rejecting FDA’s conclusions on the ingredient.
In NPA’s comments to FDA, Dan Fabricant, PhD, NPA’s CEO and executive director, says NPA “believes FDA does not have the regulatory authority to re-evaluate vinpocetine as a dietary ingredient after it has been concluded to be an acknowledged NDI.” Further, Fabricant adds, FDA has not cited any “unreasonable risk of illness or injury to public health” resulting from vinpocetine’s use in dietary supplements. Taking action to ban the sale of an ingredient in the absence of any safety concern, he concludes, would be “unprecedented.”
“If this notice goes into effect it will distort the market and confuse manufacturers selling safe and legal products, and do nothing to protect consumers,” said Fabricant, in an accompanying press announcement. “Because of the far-reaching implications this rule could have and the dangerous precedent it would set if allowed to move forward, the FDA should conduct a full economic impact analysis and extend the comment period by a year, or withdraw it effective immediately.”
Striking a similar tone, Duffy MacKay, ND, senior vice president of scientific and regulatory affairs for CRN, called FDA’s announcement regarding vinpocetine “an unprecedented move by FDA that threatens to undermine the dietary supplement industry’s confidence in the NDI notification process.” He also criticized the agency for failing to acknowledge its past acceptance of NDI notifications for vinpocetine, failing to adequately explain its new position, and failing to assess the economic impact of its decision to potentially ban the sale of an ingredient that has now been on the market for 19 years.
“Once FDA has concluded that an ingredient is a lawful dietary ingredient by acknowledging an NDI notification, the agency should not revisit the ingredient’s status unless it has safety concerns,” MacKay wrote. “The agency has not alleged any safety concern with vinpocetine, nor has it offered any new information about the ingredient that was not available when it received the first NDI notification for vinpocetine nearly 20 years ago.”
Additionally, Senator Orrin Hatch (R-UT) also recently sent a letter to FDA Commissioner Robert Califf, MD, calling for the withdrawl of FDA's Federal Register notice on vinpocetine.
Currently, there are more than 377 brands of dietary supplements that contain vinpocetine on the market, according to NPA’s Fabricant.
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