The finding was published as a basic research paper today in the journal Clinical Toxicology. The research team included Dr Cohen, of Harvard Medical School, John Travis, PhD, of NSF and several other collaborators.
The researchers tested two samples each of four products that listed phenibut or a synonym on the product label. Each product was made by a different manufacturer, and none of the companies received one of the warning letters that FDA sent out during the 2019 enforcement action.
Phenibut is also known as aminophenylbutyric acid among many other synonyms. It was reportedly was first developed in the Soviet Union in the 1960s.
Phenibut has a chemical structure similar to the brain chemical called gamma-aminobutyric acid (GABA). The ingredient has been used to treat anxiety, insomnia, post traumatic stress disorder, alcoholism and other conditions. It has reportedly also been used as a recreational drug. It is openly for sale on Internet sites like Nootropics Depot.
The ingredient has never been approved for use in the United States, either as a drug or a dietary ingredient. It is still used as a prescribed pharmaceutical in Russia.
Situation didn’t just continue; it got worse
The research team tested the four products first in 2017 and went back and acquired new bottles of the same products to test in August 2019, after the FDA enforcement action.
They found that not only were the products still openly for sale on the market, but that in three of the four cases the phenibut dosages had actually increased. In once case, a product contained 1,137 mg of phenibut, which is more than four times the typical dosage of the drug in Russia, where it is dispensed in 250 mg tablets. That product did not declare a dosage on the label, the team noted.