In April of 2019, The U.S. Food and Drug Administration (FDA) issued warning letters relating to the use of phenibut in dietary supplements. The letters did not include any allegations regarding promotional claims or violations of good manufacturing practices. This action prompted many popular products, including Kavinace by NeuroScience, to reformulate their products in order to comply.
The agency alleged that the mere presence of phenibut in a supplement renders it unlawful, as phenibut does not meet the statutory definition of a dietary ingredient under the Federal Food, Drug and Cosmetic Act (FD&C) that regulates dietary supplements. The FD&C Act defines a dietary supplement as “a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract or combination of preceding substances.”
Per the FDA, the Dietary Supplement Ingredient Advisory List is an integral part of the FDA’s overall effort to strengthen the agency’s regulation and oversight of dietary supplements to meet the demands of the growing supplement industry. ”Because phenibut does not fit any of the categories of dietary ingredients under the FD&C Act, any dietary supplements that declare phenibut as a dietary ingredient are misbranded.”
Sometimes referred to as a “smart drug,” phenibut appears to have mood and cognitive enhancing effects and the potential to improve productivity and focus due to its ability to cross the blood brain barrier. Until recently phenibut was utilized as a dietary supplement ingredient, largely for its calming, relaxing effects, as well as for improved concentration and attentiveness.
Initially developed by Russian chemists in the 1960’s, phenibut was primarily utilized by cosmonauts during space flights to combat anxiety and insomnia. Similar in structure to the inhibitory neurotransmitter GABA, which plays a role in reducing excitability and anxiety, phenibut stimulates dopamine receptors and binds to GABA receptors, where it activates similar reactions.
Phenibut is a licensed medication in Russia, where it is widely used for a variety of conditions, including insomnia, anxiety and tension relief, and is utilized as a therapeutic agent for depression, alcohol withdrawal syndrome and post-traumatic stress disorder.
Inclusion on the advisory list is not necessarily an indication of safety concerns. It means that phenibut does not meet the current agency standards and therefore cannot legally be marketed as a dietary supplement or ingredient. This does not mean that the FDA’s position is indisputable as the definition of “increased dietary intake” remains open to debate.
Sleep Balance Herbal by Diamond Formulations has been formulated to comply with FDA regulations. Sleep Balance Herbal provides well researched therapeutic ingredients known to support calming neurotransmitter production to improve sleep quality, promote sleep onset and encourage healthy restorative sleep. These specific nutrients contribute to feelings of calmness and relaxation, as well as support a healthy positive outlook and a general sense of wellbeing. Free of wheat, yeast, soy, gluten, dairy, animal products, fish, shellfish, peanuts, tree nuts, eggs and artificial colors, sweeteners and artificial preservatives. Non-GMO, Kosher formulation.
FDA Acts of Dietary Supplements Containing DMHA and Phenibut. https://www.fda.gov/food/cfsan-constituent-updates/fda-acts-dietary-supplements-containing-dmha-and-phenibut
Phenibut (beta-phenyl-GABA): a tranquilizer and nootropic drug. https://www.ncbi.nlm.nih.gov/pubmed/11830761
FDA Announces Actions Against Phenibut and DMHA Dietary Supplements. https://www.venable.com/insights/publications/2019/04/fda-announces-actions-against-phenibut-and