09.20.16
The Food and Drug Administration (FDA) has reached a tentative conclusion that vinpocetine is not a dietary ingredient and should be excluded from the definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act (FDCA). The agency released a Federal Register (FR) notice (Docket No: FDA-2016-N-2523) on Sep. 6 requesting comments related to the regulatory status of vinpocetine and its tentative conclusion until Nov. 7.
This notice comes on the heels of the recently released redrafted New Dietary Ingredient (NDI) guidance. Additionally, on Oct. 6, 2015, Senator Claire McCaskill (D-MO), the ranking member of the U.S. Senate Special Committee on Aging, called for the FDA to suspend sales of supplements containing vinpocetine pending an investigation.
The Natural Products Association (NPA), Washington, D.C., called the FDA’s FR notice “unprecedented,” and said the action has major implications. Noting that the first of five successful NDI submissions for vinpocetine dates back to 1997, NPA said the agency has not mentioned any public health concern and has not considered the economic impact on firms that have been lawfully selling the ingredient for almost two decades.
“FDA appears to be attempting to shift the burden of demonstrating reasonable expectation of safety for vinpocetine on the industry by using the hook that it can’t qualify as a dietary ingredient,” the association said in a press statement.
FDA’s notice said vinpocetine is “a synthetic compound that is derived from vincamine, an alkaloid found in the Vinca minor L. plant. Vinpocetine can also be derived from tabersonine, an alkaloid found in Voacanga seeds. According to the information we’ve reviewed, vinpocetine is not a constituent of these plants, or of any other plants. Instead, it is synthetically produced.”
The agency continued to say that according to a report by NIH’s National Toxicology Program, dietary supplements containing vinpocetine are marketed for uses that include “improvement of brain function, rapid weight loss and/or fat loss, increases in energy, and improvement in visual acuity, memory, and focus. Vinpocetine is also reportedly marketed for uses including the prevention of motion sickness and the treatment of menopausal symptoms, chronic fatigue syndrome, seizure disorders, and hearing and eye disorders. The FDA has not assessed whether vinpocetine is effective for any of these uses.”
NPA argued that vinpocetine has five acknowledgements from FDA in its NDI database. “This means that vinpocetine has already undergone intense scrutiny five times over by the leading authority on food safety in the U.S. Each time, FDA responded with a letter stating that they had no concerns over the ingredient or the data provided in their safety dossiers. From the FR notice, FDA does not appear to have any clear safety signal based on SAERs (serious adverse event reports) or other means. However, the agency is looking to remove the ingredient via a rendering that they have been silent on for approximately 20 years regarding the ingredient’s status.”
Daniel Fabricant, CEO and executive director of NPA said the agency’s actions constitute a form of double jeopardy. “To go through the regulatory gate a second time is akin to finishing a round of golf and winning but then having to play a second round while someone charges at you while you hit each golf shot. This sets a very bad precedent and is no environment to conduct business in.”
“The FR notice was also absent any economic impact analysis,” he continued. “There is an economic impact here as firms have been lawfully marketing this ingredient since it was successfully notified in the 90s. Consistent with the statute, is the agency planning to conduct an economic impact analysis? The original economic impact analysis on 21 CFR 190.6 never presented a situation where a properly notified ingredient, considered lawful for a period of time, could be removed instantaneously approximately 20 years ex post facto. It would appear that removal of this ingredient would bear little incremental public health effect (per the notice) but a significant incremental cost associated with the change in regulatory status, which is, by law, generally considered in such actions and how to provide more or other cost-effective alternatives or enforcement discretion. No discussion on enforcement discretion is present either. Why? Is this what responsible industry can expect in the future with other new dietary ingredients?”
This notice comes on the heels of the recently released redrafted New Dietary Ingredient (NDI) guidance. Additionally, on Oct. 6, 2015, Senator Claire McCaskill (D-MO), the ranking member of the U.S. Senate Special Committee on Aging, called for the FDA to suspend sales of supplements containing vinpocetine pending an investigation.
The Natural Products Association (NPA), Washington, D.C., called the FDA’s FR notice “unprecedented,” and said the action has major implications. Noting that the first of five successful NDI submissions for vinpocetine dates back to 1997, NPA said the agency has not mentioned any public health concern and has not considered the economic impact on firms that have been lawfully selling the ingredient for almost two decades.
“FDA appears to be attempting to shift the burden of demonstrating reasonable expectation of safety for vinpocetine on the industry by using the hook that it can’t qualify as a dietary ingredient,” the association said in a press statement.
FDA’s notice said vinpocetine is “a synthetic compound that is derived from vincamine, an alkaloid found in the Vinca minor L. plant. Vinpocetine can also be derived from tabersonine, an alkaloid found in Voacanga seeds. According to the information we’ve reviewed, vinpocetine is not a constituent of these plants, or of any other plants. Instead, it is synthetically produced.”
The agency continued to say that according to a report by NIH’s National Toxicology Program, dietary supplements containing vinpocetine are marketed for uses that include “improvement of brain function, rapid weight loss and/or fat loss, increases in energy, and improvement in visual acuity, memory, and focus. Vinpocetine is also reportedly marketed for uses including the prevention of motion sickness and the treatment of menopausal symptoms, chronic fatigue syndrome, seizure disorders, and hearing and eye disorders. The FDA has not assessed whether vinpocetine is effective for any of these uses.”
NPA argued that vinpocetine has five acknowledgements from FDA in its NDI database. “This means that vinpocetine has already undergone intense scrutiny five times over by the leading authority on food safety in the U.S. Each time, FDA responded with a letter stating that they had no concerns over the ingredient or the data provided in their safety dossiers. From the FR notice, FDA does not appear to have any clear safety signal based on SAERs (serious adverse event reports) or other means. However, the agency is looking to remove the ingredient via a rendering that they have been silent on for approximately 20 years regarding the ingredient’s status.”
Daniel Fabricant, CEO and executive director of NPA said the agency’s actions constitute a form of double jeopardy. “To go through the regulatory gate a second time is akin to finishing a round of golf and winning but then having to play a second round while someone charges at you while you hit each golf shot. This sets a very bad precedent and is no environment to conduct business in.”
“The FR notice was also absent any economic impact analysis,” he continued. “There is an economic impact here as firms have been lawfully marketing this ingredient since it was successfully notified in the 90s. Consistent with the statute, is the agency planning to conduct an economic impact analysis? The original economic impact analysis on 21 CFR 190.6 never presented a situation where a properly notified ingredient, considered lawful for a period of time, could be removed instantaneously approximately 20 years ex post facto. It would appear that removal of this ingredient would bear little incremental public health effect (per the notice) but a significant incremental cost associated with the change in regulatory status, which is, by law, generally considered in such actions and how to provide more or other cost-effective alternatives or enforcement discretion. No discussion on enforcement discretion is present either. Why? Is this what responsible industry can expect in the future with other new dietary ingredients?”
