An FDA official in an interview described the predicament facing his office in reexamining the status of a component that has been encouraged for brain wellness and marketed in supplements since the 1990s: vinpocetine.
FDA concluded the vinpocetine doesn’t qualify as a dietary supplement component and has been banned from being marketed in supplements since vinpocetine was the subject of drug trials from the 1980s which were revealed in reports that were published.
FDA’s tentative decisions were announced fueling criticism since the agency was aware vinpocetine had been for approximately two decades available in supplements and astonishing the industry.
FDA, which requested information from all interested parties in response to its decisionsand finds itself in a quandary.
On the one hand, the bureau acknowledged receiving five separate new dietary ingredient (NDI) alarms from the 1990s from companies which planned to market vinpocetine in supplements. FDA objected to not one of them, effectively supplying the industry confidence that vinpocetine was a dietary component that was legal.
On the other hand, FDA now believes vinpocetine was approved for investigation as a new drug as well as the topic of substantial clinical investigations which were made public–thus diluting sale of this ingredient in supplements under a clause of the 1994 Dietary Supplement Health and Education Act (DSHEA). An report becomes authorized for investigation as a new drug following the sponsor has filed an investigational new drug application (IND) to FDA, along with the IND has taken influence, according to the Federal Register notice.
“We now have information that’s in front of us which leads us to think this isn’t a component we should acknowledge regardless of what occurred at the 1990s,” said Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP).
“We’ve got two choices,” Tave explained in a recent phone interview. “One is that we can dismiss that info. We can acknowledge another notification, even though we are aware that in the minimum, there were INDs from the 80s, so it appears like that provision [of DSHEA] comes into play. No. 2, is that we can say, ‘Well, we are now aware of this advice, and therefore below the statute, we are not likely to acknowledge your notification. We are planning to object to it. ”’
The latter option, Tave stated, “doesn’t seem quite fair” into a dietary supplement company which may be investing in a product containing vinpocetine and planning to apply an NDI notification to FDA.
“While we figured this out, we wanted to become transparent, and we all wanted to find advice, recognizing we do not know everything that’s on the market,” Tave stated. “It is possible that this product was advertised as a nutritional supplement prior to … the drug trials were publicized. If that’s the situation, that changes our opinion.”
FDA is seeking evidence that bears on the issue of if a dietary supplement ingredient is qualified as by vinpocetine.
In the Federal Register notice, FDA mentioned vinpocetine is not section or a manly of a manly. Instead, FDA characterized vinpocetine as a “synthetic compound” which can be formed synthetically from vincamine, which the bureau explained as “an alkaloid found in the Vinca minor plant.”
“It is possible that there is some science in here that … ties it [vinpocetine] a little bit longer to the botanicals,” Tave stated, “and then we do not have to grapple with that matter.”
Tave clarified FDA’s Sept. 8, 2016 Federal Register notice was a request for advice, not a proposed rulemaking. Still, the notice of a year was met with criticism.
It appears “FDA believes it can change its mind whenever it wants,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a phone interview last year. “That it could approve a thing and then return and take it away out of your industry after firms have invested in the study, invested in the advertising, making it a viable product.”
Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), clarified FDA’s opinion as a “form of double jeopardy. ”“This sets an extremely bad precedent and is no environment to run business in,” announced Fabricant, ” FDA’s former director of the Division of Dietary Supplement Programs, in an announcement last year.
Tave stated he wasn’t functioning in FDA in the 1990s, however he indicated his NDI review team would be able now to determine whether a component was subject to the IND clause of this law.
“I don’t know what happened in the time,” he said, clarifying the NDI vinpocetine alarms that FDA acknowledged without any objections. “I don’t know what phone calls were made. I don’t know what files were considered. All that I know is that which we know now.”
FDA issued its Federal Register notice about a year following Sen. Claire McCaskill (D-Missouri) wrote to the bureau, asking copies of NDI alarms on the ingredients vinpocetine and picamilon as well as adverse event reports (AERs) associated with either ingredient. In her Oct. 6, 2015 letter to FDA Acting Commissioner Stephen Ostroff, M.D., ” the senator described the 2 ingredients as “synthetic or semisynthetic substances.”
McCaskill’s letter referenced a study by investigators for Natural Products Research, School of Pharmacy, who studied the sale of vinpocetine in supplements.
Vinpocetine is present in more than 340 dietary nutritional supplements and continues to be marketed as a drug in countries outside the United States, the investigators reported. “At the minimum, we have several vinpocetine products that maybe should have filed notifications but didn’t,” Tave pointed out, clarifying that the hundreds of vinpocetine brands available on the market.
Vinpocetine was described by the researchers as a pharmaceutical drug that has never been accepted by FDA in the United States. They stated the substance has been “prescribed in Germany, Russia, China and other countries at dosages from 5 to 40 mg for serious stroke and cognitive impairment.”
McCaskill’s letter to FDA resulted in speculation that the bureau’s Federal Register notice might have been politically inspired. Questioned on that issue, Tave responded, “The petition from Senator McCaskill was not the only reason that vinpocetine was on our radar screen.”
FDA has received hundreds of comments in response. Hundreds of consumers have advocated FDA to keep vinpocetine.
“There is no requirement to re-classify this compound,” wrote one man, Mark Burger, who identified himself as a pharmacist in California. “It serves no purpose and will have profound financial effect on the ones that manufacture the merchandise, on pharmacies such as ours and on individuals who must look for prescription drugs to maintain the level of cognitive remember that they have enjoyed with vinpocetine.”
Tave didn’t indicate where the bureau is led–leaving the future regulatory standing of vinpocetine.
“I think we have very good comments, very useful comments,” he said. “We need to accept those and put them together and figure out what’s next.”
