FDA reversal on NDI status cause for concern, industry says

WASHINGTON – The Food and Drug Administration earlier this week released a Federal Register notice that has major implications for new dietary ingredient notifications and has created a stir among industry advocate groups.



The agency has reversed course on allowing the sale of vinpocetine, a supplement found in some mental alertness supplements, suggesting that the product is not a dietary ingredient even though the FDA has acknowledged vinpocetine in its New Dietary Ingredients Database at least five times in the past 20 years. "This means that vinpocetine has already undergone intense scrutiny five times over by the leading authority on food safety in the U.S.," the Natural Products Assocation stated. "Each time, FDA responded with a letter that they had no concerns over the ingredient or the data provided in their safety dossiers."



"We're taken aback by that," Steve Mister, president and CEO of the Council for Responsible Nutrition, told Drug Store News. "After having reviewed this ingredient on five separate occassions and giving companies non-objection letters, that FDA would simply change its mind and tell industry that after all this investment into this ingredient, you can't sell this anymore," he said. "And as far as we can tell there are no safety problems. They're not citing any instances of adverse events or any spike in consumer complaints; they've just decided it's not a legitimate ingredient."



Mister explained that while the ingredient is wholly created out of plant material, it's not necessarily "synthetic" as the banned workout supplement DMMA (which is not formulated out of plant material, Mister said). "We're very concerned as an industry that FDA would change its mind and take a product off of the market without any problem with safety," he said. "This is not ephedra; this is not DMMA, where you have a safety concern that you have to react to."



“This is a form of double jeopardy," suggested Daniel Fabricant, NPA CEO. "This sets a very bad precedent and is no environment to conduct business in."



NPA also expressed concerned that the agency's course reversal sets a dangerous precedent borne out of political pressure as opposed to actual safety concerns.



"On Oct. 6, 2015, Sen. 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," NPA reported. "In a somewhat unprecedented move for a legislator, Sen. McCaskill sent letters to 10 retailers to ask them to voluntarily remove it from their shelves, despite no rendering from the FDA that it was not a legitimate dietary ingredient."