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Why Does the FDA Want to Ban this Supplement that has Been Around for Decades?

Vinpocetine

by Paul Fassa
Health Impact News

Vinpocetine, a natural nootropic (nōəˈträpik), is an active ingredient in several brain boosting supplement formulas. It is also sold as an inexpensive supplement by itself. Nootropics are neurologically active memory and cognitive enhancers, promoting well being and learning potential.

It is the sole ingredient of an Eastern European medicine, used since 1978 for recovering stroke victims and other neurological issues called Cavinton [1]. Its use has spread throughout Asia and other parts of Europe.

Both Cavinton and Vinpocetine, extracted from the periwinkle plant, have been tested, studied, and tried internationally for several neurological issues with mostly highly positive results since 1978. Along the way, other benefits were discovered related to heart health, vision, hearing, and more.

Now there is a current controversy involving the FDA and a Missouri Senator seeking to restrict public access to this supplement which has a long history of use outside the U.S.

The FDA Case Against Vinpocetine

For over two decades, Vinpocetine and the supplement industry coexisted peacefully. Then came Missouri Democratic party Senator Claire McCaskill’s October 2015 letter to the FDA claiming she had research showing Vinpocetine is at least partially synthetic, and demanding the FDA investigate – with this paragraph:

“In the interest of public safety, I request the FDA take all appropriate action to immediately cease the sale of dietary supplements containing these ingredients [vinpocetine and picamilon] until it can be determined if they are appropriate for consumption as dietary supplements.”

Here’s the complete letter. [2]

Senator McCaskill had referenced research from Harvard Medical School and the University of Mississippi’s National Center for Natural Products Research, School of Pharmacy, who examined the sale of Vinpocetine in dietary supplements.

The researchers described Vinpocetine as a pharmaceutical substance “prescribed in Germany, Russia, China and other countries at dosages from 5 to 40 mg for acute stroke and cognitive impairment.” On September 7, 2016, the FDA issued a notice for comments. It is not a ruling – yet. From the notice:

[We, FDA] are requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that Vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). (FDA request) [3]

But the FDA currently considers that Vinpocetine isn’t a botanical or a constituent of a botanical. Instead, the FDA characterized Vinpocetine as a “synthetic compound” that can be copied and formed synthetically from vincamine, which the agency described as “an alkaloid found in the Vinca minor plant.”

There are already synthesized vitamins allowed as supplements, such as folic acid and ascorbic acid as vitamin C. Also, the process of chemically extracting plant compounds to concentrate active ingredients is fairly common.

The FDA even admits they received five separate new dietary ingredient (NDI) notifications in the 1990s from companies intending to market Vinpocetine in supplements without objecting to any of them.

The supplement industry claims this was a tacit agreement to use Vinpocetine as a supplement, and the FDA had been aware of Vinpocetine being marketed as a supplement from the 1990s to now. Many comments were sent to the FDA urging them to leave Vinpocetine alone.

A part of this issue is that drug trials for Vinpocetine may have been registered prior to Vinpocetine’s use as a supplement. But the trials were only registered and not performed.

Steven Tave is director of the FDA’s Office of Dietary Supplement Programs (ODSP).

Insider Law journalist, Josh Long, posted part of a telephone interview of Tave. Here are excerpts:

“We now have information that’s in front of us that leads us to believe this is not an ingredient we should acknowledge regardless of what happened in the 1990s,” said Steven Tave, director of FDA’s Office of Dietary Supplement Programs (ODSP).

“It’s possible that there’s some science in here that … ties it [vinpocetine] a little bit more to the botanicals,” Tave said, “and then we don’t have to grapple with that issue.”

“While we figured this out, we wanted to be transparent, and we wanted to seek information, recognizing we don’t know everything that’s out there,” Tave said. “It’s possible that this product was marketed as a supplement before … the drug trials were publicized. If that’s the case, that changes our view.” (Source) [4]

Vinpocetine Has Been Used Internationally for Nearly Four Decades

deaths in one year due to drugs vs supplements

There have been several studies involving Vinpocetine or Cavinton. A wide range of benefits were discovered since Cavinton was created from Vinpocetine in 1978 without serious adverse reactions or deaths.

Here are the known benefits:

Improves Cognition

Improve hearing function

Improve visual function

Improve cardiovascular function

Scavenges toxic metals in the body, such as aluminum and lead (Source) [5]

Dr. Ward Dean, a cognitive expert and life extension physician, says,

“It’s [Vinpocetine] one of the few cognitive enhancers with which I can actually notice a difference.”

If you want to see some third party peer-reviewed studies, go here [6].