Product Code Database
Vinpocetine ( ethyl apovincaminate), sold under the brand name Cavinton among others, is a synthetic derivative of the vinca alkaloid vincamine, differing by the removal of a hydroxyl group and by being the ethyl rather than the methyl ester of the underlying carboxylic acid. Vincamine is extracted from either the seeds of Voacanga africana or the leaves of Vinca minor (lesser periwinkle).
The FDA has tentatively ruled that vinpocetine, due to its synthetic nature and proposed therapeutic uses, is ineligible to be marketed as dietary supplement under the Federal Food, Drug, and Cosmetic Act. Despite this, vinpocetine remains widely available in dietary supplements often marketed as nootropics.
Vinpocetine does not fully support a benefit in either dementia or stroke. As of 2003, three controlled had tested "older adults with memory problems".
Vinpocetine has also been studied for the prevention and recovery of acquired hearing loss in a phase II, longitudinal and prospective open clinical study on humans.
Adverse effects of vinpocetine include flushing, nausea, dizziness, dry mouth, transient hypo- and hyper-tension, headaches, heartburn, and decreased blood pressure. FDA issued a statement in 2019 warning that "vinpocetine may cause a miscarriage or harm fetal development".
A 2015 analysis of 23 brands of vinpocetine dietary supplements sold at GNC and Vitamin Shoppe retail stores reported widespread labeling errors. Only 6 of the 23 supplement labels (26%) provided consumers with accurate dosages of vinpocetine (ranging from 0.3 to 32 mg per recommended daily serving), while 6 of 23 (26%) contained no vinpocetine at all, despite their labels claiming that the ingredient was in them. In total, 9 of the 23 products tested were mislabeled, and 17 of 23 (74%) did not provide any information on the quantity of vinpocetine.
In response to the study, then-senator Claire McCaskill, while at the time serving as the top Democrat on the Senate Special Committee on Aging, urged the FDA to suspend sales of vinpocetine supplements and asked 10 retailers to voluntarily stop selling vinpocetine products. McCaskill stated: "The way we regulate these supplements isn't working—and it's putting the lives and well-being of consumers at risk. We've seen products with false labels, tainted ingredients, wildly illegal claims, and, now, products containing synthesized ingredients that are classified as prescription drugs in other countries."
In July 2015, the U.S. Federal Trade Commission (FTC) ruled that marketing claims for Procera AVH, which promoted the product as a "solution" to memory loss and cognitive decline, were false, misleading, unsubstantiated, and in violation of the FTC Act. BRL and its affiliated companies Brain Power Partners, Brain Power Founders, and MedHealth Direct (all based in Laguna Beach, California) were fined $91 million. KeyView Labs, the Tampa, Florida-based company that purchased BRL in 2012, was fined $61 million. Also named in the FTC complaint were George Reynolds (aka Josh Reynolds), founder and chief science officer of BRL, and John Arnold, the sole officer and employee of MedHealth. The FTC complaint charged Reynolds with making deceptive expert endorsements for Procera AVH. The defendants in the case ultimately agreed to pay $1.4 million to settle the allegations of deceptive advertising brought by the FTC and California law enforcement officials. In addition, a permanent injunction barred the defendants from making similar deceptive claims about Procera AVH in the future and from misrepresenting the existence, results, or conclusions of any scientific study.
|
|
