The AMA has adopted a new policy for members that discourages “the non medical use of prescription drugs for cognitive enhancement in healthy individuals.” The policy goes on to describe these products as “a variety of prescription drugs, supplements, or other substances that claim to improve cognitive functions of healthy individuals, particularly executive function, memory, learning or intelligence.” The street catch-all name for these—and one that is used by some of the marketers of these products—is ‘smart drugs.’
Dangers of off label use
The AMA said that prescription drugs that are FDA-approved to treat attention-deficit hyperactivity disorder or narcolepsy are commonly associated with the off-label use by students and others seeking to boost memory, learning or other aspects of cognition. Such use is associated with a variety of adverse mental health conditions and patterns of substance misuse, the association said.
"As temptation grows to use prescription drugs for a competitive advantage at work and school, the non medical use of these drugs should be discouraged given potential for substance misuse and other adverse consequences," said AMA member Maya A. Babu, MD, MBA. "The AMA believes physicians can support this goal by not prescribing any drug for the purpose of cognitive enhancement in otherwise healthy individuals.”
The communication blurs the line between dietary supplements and drugs, but that could be seen as simply a reflection of the marketplace, said attorney Marc Ullman, of counsel with the firm Rivkin Radler LLC. It speaks to the ease with which certain marketers can take borderline ingredients and disguise them under a supplement-type mantel, he said.
“When you look at the category, the products that the AMA is talking about, you are not talking about things like ginkgo or any other common dietary supplements,” Ullman said. “These products use ingredients that don’t belong in supplements and many of them use ingredients that have been marketed as drugs.”
Gaining traction in marketplace
The excitement about this class of products seems to be ramping up in the marketplace. Social media platform Reddit has a subsection devoted to the sharing of information about nootropics, where the close to 50,000 subscribers talk about products that contain common dietary ingredients that appear in many dietary supplements such as omega-3s, Alpha-GPC and l-theanine. But the users of the platform also enthuse about ingredients such as noopept, phenylpiracetam, pramracitam and others in the general category of central nervous system stimulants that in some cases have been marketed as drugs in other countries. (As with other discussion boards of this sort, there is no way to tell of some of the posts come from the marketers of those same ingredients.)
The AMA communication said that there is no evidence that any of these products make people ‘smarter.’ “The available evidence suggests the cognitive effects of prescription stimulants appear to be highly variable among individuals, are dose-dependent, and limited or modest at best in healthy individuals,” the association said.
Ullman concurred that the claims for many of these products are over the top. Even for those substances that have any data behind them, the claims are often many steps beyond what the evidence might support, he said.
“Just because a mouse might be able to negotiate a maze five seconds faster than a mouse taking a placebo, I don’t see the connection to supporting cognitive function in humans,” he said.
Supplement lookalikes
One platform that sells these products is called smartdrugsforthbought.com. The labels of the bottles mimic those of the more pharmaceutical-looking end of the dietary supplement spectrum, though the labels do not say ‘dietary supplement’ on them. There are no representations on the website of the ingredients portion of the labels, so it’s unclear if the manufacturer is using a Nutrition Facts panel, a Supplement Facts panel, or some other format for delineating the ingredients.
The crossover of questionable ingredients into this marketplace could be a potential threat to legitimate dietary supplements positioned for brain health, much in the same way that above board sports nutrition products have been besmirched by the DMAA and DMBA scandals. Last year Sen. Claire McCaskill sent a letter to FDA asking the agency to pull supplements containing picamilon and vinpocetine from the shelves. Vinpocetine, a synthetic copy of a fraction of the lesser periwinkle plant (Vinca minor L.), has some evidence of its use as a vasodilator and has appeared in brain health formulations. It is also one of the ingredients of interest for the Reddit nootropics group. McCaskill has also opened an inquiry into brain health supplements marketed toward seniors. The Senator’s letter to the agency marking the start of that push did not use the term ‘nootropics,’ but then again the term continues to gain steam in the marketplace, and McCaskill drafted her letter more than a year ago. According to information from Google Trends, the use of ‘nootropics’ as a search term has risen sharply in the past three years.
“It’s a category that is rife with potential pitfalls for the consumer,” Ullman said.