‘Nootropic’ is a fairly new bit of nomenclature in the dietary supplement world. But it has been bandied about on forums on the Internet for years where a certain subset of consumers seek out products that ‘they’ don’t want you to have.
‘Smart drugs’ is another term used by these enthusiasts. And in fact a category of ingredients that drift in the dead space between drugs and dietary ingredients still forms the basis of many supplement like products that can be found for sale online.
Operating in the penumbra of banned ingredients should be an uncomfortable area for the dietary supplement industry, in the view of attorney Marc Ullman, who is of counsel with the firm Rivkin Radler LLC. Ullman has a long history in the industry including helping to shepherd some ingredients through the New Dietary Ingredients process.
“I think there is a stigma associated with nootropics,” Ullman told NutraIngredients-USA. “A lot of these ingredients are really old drugs that have been abandoned. I think that’s where the stigma comes from.”
“I have worked with some companies with cognitive health products who would never market their products as nootropics,” he said.
Rejected NDI filing
In an NDI filing, one of the first things that the Federal Drug Administration looks at is whether the ingredient in question fills the definition of a dietary supplement as set down in DSHEA. One of the popular ingredients among nootropic enthusiasts—known as piracetam—went through this process in late 2003 and was found wanting. FDA ruled that the ingredient, which reportedly was discovered by a Romanian chemist in 1964, did not fit the description of a dietary ingredient.
Piracetam is just the most prominent of a whole category of ingredients, collectively known as ‘racetams.’ Despite the NDI failure, these ingredients started showing up on the market. FDA sent a warning letter in 2010 in which it reiterated the position that piracetam was not a legal dietary ingredient. But supplement-like products containing these compounds are still widely for sale on some lower profile web portals.
“FDA clearly stated in the warning letter that piracetam does not meet the definition. As a result, because piracetam was marketed to affect the structure/function of the human body, it is considered a drug, or new drug, by FDA,” said attorney Rick Collins, co-founder of the firm Collins Gann McCloskey & Barry.
Flying under radar... for now
While piracetam and its analogues clearly are being sold in contravention of certain aspects of federal law, FDA has not chosen to take a large scale enforcement action. Collins said evidence of a clear and present public health risk is what motivates action for an agency with too much on its plate.
“FDA has limited resources and tends to focus its enforcement on ingredients that receive a lot of media attention (Kratom, CBD) or result in alleged consumer injury or death (DMAA, Ephedra). The lack of enforcement from FDA against companies that are marketing and selling these ingredients is likely because FDA is currently focusing on other ingredients,” Collins said.
“Kratom is high on FDA's radar, as well as the usual categories that FDA looks at with greater scrutiny – stimulants, bodybuilding products, and sexual enhancement products. There always seem to be companies willing to take the risk of selling supplements that are not compliant with DSHEA, in hopes that they will stay below the radar of enforcement actions. It’s a gamble that can have serious consequences,” he said.
Jay Manfre, another attorney in Collins’ firm, said whatever enforcement there has been in the area of nootropics generally has focused on claims, with the regulatory status of the ingredient in question rarely figuring in.
For example, a warning letter was sent about a year ago to a company marketing a product called Neurospike, which is said to be “a perfect blended matrix of nootropics aka smart drugs.” The letter mentioned the claims associated with this product (and many other products the company was selling) made it an unapproved drug. But it was silent on the subject of the ingredients themselves.
“I haven’t seen a wide-scale enforcement action for piracetam or other ‘racetam’ ingredients as was seen with DMAA. When other nootropic products have been targeted, it was mostly for their claims. As you know, even if a dietary supplement contains only legal ingredients, the marketing and claims made about a product can cause it to be considered a misbranded drug by the FDA,” Manfre said.
“It is possible that enforcement will intensify if a consumer is injured by one of these nootropics, just as it did when a soldier reportedly died after taking a product that contained DMAA. FDA has been more aggressive when such serious allegations hit the news,” he said.
One nootropic ingredient that did acquire a high enough profile to induce FDA action was picamilon. This ingredient, like the racetam ingredients, is associated with the neurotransmitter GABA (gamma aminobutyric acid). And it also found itself in the ‘off label drug’ limbo that the racetams do.
FDA sent out a raft of warning letters on the ingredient, but once again, did so mostly based on claims. Picamilon, along with vinpocetine, had been targeted by Sen. Claire McCaskill, D-MO, as having been marketed to a vulnerable elderly population who were highly concerned about age related cognitive decline.
Attorney Justin Prochnow, who is a shareholder in the firm Greenberg Traurig, said the process of matching claims to science is no different with nootropics than it might be with other ingredients. But because potentially vulnerable populations might be involved, it’s important to tread carefully.
“Typically this has been a bigger deal from the FTC perspective. It’s more of an issue of what type of groups are being targeted and making sure they aren’t unfairly being taken advantage of. That’s why they would want to see more science supporting that type of claim than they might for an immune health ingredient, for example,” he said.