NPA requests one-year extension to vinpocetine comment period
Vinpocetine, a compound positioned for brain health formulations, is derived from vincamine obtained from the lesser periwinkle plant (Vinca minor L.) and there is evidence to support its role as a vasodilator – or increasing blood flow to the brain. It’s being investigated as a drug in many countries but is not permitted as a pharmaceutical in the US, instead being sold as a supplement.
Vinpocetine is considered a new dietary ingredient (NDI) after the FDA acknowledged notifications in the late 1990s from Amrion Inc (1997), Leiner Health Products (1998 & 1999), GNC (1999), and Pharmavite (1999). Vinpocetine is used in over 350 supplement brands, according to the Natural Medicines Comprehensive Database.
FDA’s revised position
Despite the five positive NDI notifications for the ingredient, FDA announced on September 7, 2016 that it has initiated a proceeding to take vinpocetine off the market despite a number of successful NDI notifications filed on the ingredient.
FDA’s tentative decision that vinpocetine is not a legal dietary ingredient hinges on two factors:
- FDA said a search of its files reveals that the ingredient was the subject of an Investigation New Drug application in 1981 and that multi-center trials on the substance were conducted in the mid-1980s. Under Federal law a compound can first be marketed as a dietary supplement and then developed into a drug, but not vice versa, so an IND filing pre-empts a supplement application. One view of this provision of the law is to protect the huge investment that pharmaceutical companies must make to bring new drugs to market;
- Vinpocetine is synthetic. Since the release of the first NDI draft guidance in 2011 and re-released in updated form just a few weeks ago, the agency has taken the tack that bioidentical compounds, or so-called ‘synthetic botanicals’ do not qualify as dietary ingredients because synthetic compounds, even if they are identical in all respects to their botanical progenitors, did not themselves arise from plants and therefore don’t meet the definition of a dietary ingredient. “Vinpocetine is not found in V. minor, Voacanga, or any other botanical, but rather is a synthetic derivative of vincamine or tabersonine,” the agency said.
In a letter to the Agency dated October 3, 2016, Dr Dan Fabricant, NPA’s CEO and executive director, writes: “Since it was lawfully marketed for the first time, the manufacture, distribution, and use of vinpocetine by consumers has increased substantially in good conscience over the course of nearly 20 years, such that the ingredient is documented to have been produced, distributed, sold and used in a lawful manner after proper notification.
“The Agency never objected to the legal status on any of the five notifications, which effectively creates a binding norm on the industry and places this ingredient in the diet legally, as dietary supplements are a part of the diet.
“To sufficiently respond to FDA’s view on vinpocetine, the industry will need time to do additional research as well as identify the extent to which these changes may impact manufacturers, distributors and consumers,” writes Dr Fabricant.
“[T]his change in FDA’s opinion on the regulatory status of an ingredient that had successfully notified FDA with one or more NDI submissions is a cause for great concern among our membership. This precedence may be applied to other lawfully notified dietary ingredients and impact their manfucture [sic] and sale to consumers who want continued access to these safe ingredients. NPA requests an extension of one year (until September 6th, 2017) in light of the depth of review required for an appropriate response.”
The American Herbal Products Association’s Botanical Safety Handbook (Second Edition, 2013) notes that there are no known side effects for Vinca minor L.
“Lesser periwinkle contains small amounts (0.02-0.13%) of the compound vincamine,” explains the Handbook. “Vincamine and the closely related compound vinpocetine have been widely studied, and vinpocetine is sold as a dietary supplement.”