Some products on the market that position itself as a nootropic dietary supplement contain the ingredient phenibut, which is related in structure to the neurotransmitter gamma-aminobutyric acid (or GABA).
“It’s being marketed for an effect similar to nootropics—that sort of validated level of awareness and calmness and focus,” Duffy MacKay, ND, senior vice president of scientific and regulatory affairs at the trade group Council for Responsible Nutrition (CRN) told NutraIngredients-USA.
The main difference is that phenibut is nowhere to be found on the FDA’s GRAS or NDI databases. Top searches for the word ‘phenibut’ online return over-the-counter drugs from Russia. A study conducted by British researchers in 2015 reported that the drug is not approved for clinical use in the US and most of Western Europe.
Additionally “our understanding is that that’s a sliding scale, and once you go to a higher amount it becomes a ‘high’ if you will, and has some addictive principles, and that’s where it harms,” MacKay said.
CRN was one of the trade associations that issued the warning yesterday in a joint press release with the American Herbal Products Association (AHPA), United Natural Products Alliance (UNPA), and Consumer Healthcare Products Association (CHPA).
“Anything that’s that psychoactive with addictive principles is not appropriate as a supplement,” he added. “Supplements are intended to be nutritious and support normal structure function, and help support the body’s normal function.”
What comes next?
The trade associations announced in the press release that they have taken action “to keep tainted products falsely claiming to be dietary supplements out of consumers’ hands.”
This included notifying the FDA, which is currently doing its own investigation of the matter after the notification from trade associations, as well as notifying any retailer selling products selling phenibut that the trade associations come across.
“[We’ll] tell any retailer we see selling this, we’ll call them and say, this is not a dietary ingredient, don’t be fooled into thinking that it is, stop selling it today unless you have other information,” MacKay said.
“And if you don’t, I want you to go to your supplier and get them to verify why they think this is a dietary ingredient because we don’t think it is.”
“It doesn’t mean someone can’t come forward and say ‘Oh we filed an NDI, or we have evidence to believe it’s grandfathered and here’s our safety information,’” he added.
“That would shock me if someone stepped out of the woodwork like that. We’re so confident that we’re saying no until we see that this is not a legal ingredient.”
How prevalent is phenibut in supplements?
In addition to the over-counter drugs bearing Cyrillic script on their labels, searching for the word ‘phenibut’ on Google returned a top row of sponsored nootropic products, none of which actually contain the ingredient. But the online retailer that was the top result (Nootropics Depot) does sell a product called Phenibut HCL Powder.
A search in the Dietary Supplement Label Database collected by the National Institutes of Health, listed two products (accessed 11/5/18). This suggests that phenibut is not widely available on the market, but MacKay said it’s important to be cautious.
Members of these trade associations, many of which are dietary supplement manufacturers with access to laboratory analyses, first raised the alarm. “So really what brought this about was literally texts and phone calls between responsible players of this industry,” MacKay said.
“And we’ve just been here before so many times with these illegitimate ingredients, DMAA, BMPEA, you know the list goes on and on. And every time it happens, a critic of ours identifies that this ingredient is being sold in some remote shadow of the industry but the effect is the responsible industry takes the burden to its reputation,” he said.
“I personally said I don’t want to wait until I see a study that Pieter Cohen has written up in JAMA, I don’t want to wait until I hear FDA put out a consumer announcement. I want to act today, and I want to act in cooperation with the other responsible players in this industry.”
