The letter was sent recently to Chill6, a Massachusetts-based manufacturer of a product branded with the same name. The beverage is marketed as the “most advanced 'over-the-counter' anti-anxiety supplement available.”
Chill6 features a blend of six amino acids, including GABA, phenibut, l-theanine, l-tyrosine, l-dopa and l-taurine. The company claims the combination of amino acids replenishes dopamine levels in the brain, which serves to quell anxiety symptoms.
But FDA contends the verbiage the company uses to market the product amounts to an illegal drug claim.
Among the allegedly impermissible claims cited in the letter were:
“Chill6™ is great to lower anxiety during benzo and alcohol withdrawal?”
“Phenibut [which you list as an ingredient in Chill6] has been used safely in Russia for over 50 years . . . safely treating hundreds of thousands of people for a variety of disorders, including; anxiety, insomnia, . . . alcoholism and post-traumatic stress disorder (PTSD).”
FDA particularly cited the inclusion of phenibut, alleging that the use of this ingredient rendered the product as adulterated. The ingredient was the subject of an enforcement action in 2019 in which FDA sent out three warning letters. Phenibut has never been approved for any drug usage in the United States, nor, according to FDA, has it cleared any of the regulatory hurdles to be considered as a legal New Dietary Ingredient.
In 2018, four trade associations (the American Herbal Products Association, the Consumer Health Care Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance) warned retailers not to sell products containing phenibut. The associations alleged that some troubling information had surfaced that phenibut could have psychotropic or even addictive properties at higher dosages.
Even with the enforcement action and the warning by the trade associations, a team led by Dr Pieter Cohen of Harvard Medical School found phenibut in products the team purchased on the open market and had tested. And the ingredient is still widely and openly for sale on the Internet, including at the site Nootropic Depot, which sells phenibut as a standalone product in powder and capsule forms.