Phenibut is currently not approved for medical use in the United States. While it does remain legal to buy, sell, and possess the drug, phenibut it is not considered a safe substance to consume. It is a synthetic nootropic drug originally designed as an anti-anxiety medication in Russia.
The U.S. Food and Drug Administration (FDA) has banned the marketing of phenibut as a dietary supplement and requires all products listing phenibut as an ingredient be pulled from shelves and retailers.1 Phenibut can still be found in tablet and powder form, mostly through online sources.
Phenibut is currently a legal, uncontrolled substance, but its potential for abuse, dependence, addiction, and serious side effects may lead to stricter regulation of the substance.
Legal & Uncontrolled
In Russia, where phenibut was developed, the drug is legal for medical use as an anti-anxiety medication, as a sleep aid, and to help with alcohol withdrawal. In the United States, the Centers for Disease Control and Prevention (CDC) does not regulate phenibut as a pharmaceutical product, and it is not approved for medical use.2
Phenibut is a GABA-B (gamma-aminobutyric acid subtype B) agonist. It works to suppress the central nervous system (CNS) in similar fashion to benzodiazepine drugs.3
Phenibut causes relaxation and euphoria, making it a desirable drug of abuse.6 It is also addictive and has potentially serious withdrawal symptoms, which is why it is not approved as a pharmaceutical in the United States.7
Hazards of Phenibut
Phenibut can cause the following negative side effects:4
- Delayed reaction time
- Impaired cognition
- Slowed pulse
- Difficulties breathing
- Lowered blood pressure
- Tremors and/or seizures
- Irregular heart rate
Phenibut use can also quickly lead to drug tolerance, meaning that it will take more and more of the substance to feel its effects. This is part of the reason phenibut is not used for medical purposes in the United States. There are far better medications on the market that do not have as many potential negative side effects.4
The Ban on Phenibut as a Dietary Supplement
Until spring 2019, phenibut was widely available in products marketed as dietary supplements, primarily from online retailers. In April 2019, the FDA sent warning letters to companies marketing products containing phenibut and labeling them as “dietary supplements.”1 The warning was due to the fact that the substance is not FDA-approved for this purpose.
The FDA reports that phenibut is not an approved “dietary ingredient,” and these products are misbranded and misleading. A dietary ingredient must fit into one of the following categories:8
- Amino acid
- Dietary supplement that increases dietary intake
Phenibut does not fit any of these categories. It is therefore banned from being sold as a dietary supplement in the United States and has been pulled from major online retailers.
It is still available through smaller online retailers in powder and tablet form. It is not illegal to buy, sell, or possess the substance. It just cannot be branded as a dietary supplement or enhancement.
Legal Action Against Phenibut
Overdoses and toxic exposure to phenibut is on the rise, jumping from only a few calls to poison control centers involving the substance each year in 2015 to 300 to 400 per year in both 2018 and 2019.2 About 10 percent of the exposure calls had serious reactions, with 80 people ending up in a coma and 3 people dying.
The rising numbers of overdoses involving phenibut indicates an uptick in recreational use and abuse of the substance. This type of increase puts phenibut on the radar of law enforcement and authorities.
In Australia, phenibut was listed as a prohibited substance and banned in the country in 2018.5 Other countries may soon follow suit.
The Current Status of Phenibut & Nootropics
Nootropics are designed to enhance the mind. They are typically either natural or synthetic products that are not FDA approved and also are not scheduled or controlled substances by the Drug Enforcement Administration (DEA).
While phenibut is banned from being sold as a dietary supplement in the United States, it is not illegal to have or use the substance. It is also still available for purchase through online retailers as long as it is not marketed as a “dietary ingredient.”
The legal status of nootropics such as phenibut is murky. It has the potential to change as these substance gain popularity, and more people have adverse reactions to them. At this point, phenibut and drugs like this are technically legal, although they are considered unsafe and potentially hazardous to your health.
Phenibut should not be used for any purpose as it is not regulated, not approved, and highly addictive. Its use comes with many potentially dangerous and even life-threatening side effects.
1 (April 2019). FDA Acts on Dietary Supplements Containing DMHA and Phenibut. U.S. Food and Drug Administration (FDA). Retrieved April 2021 from https://www.fda.gov/food/cfsan-constituent-updates/fda-acts-dietary-supplements-containing-dmha-and-phenibut
2 (September 2020). Notes from the Field: Phenibut Exposures Reported to Poison Centers- United States 2009-2019. Morbidity and Mortality Weekly Report (MMWR). Centers for Disease Control and Prevention (CDC). Retrieved April 2021 from https://www.cdc.gov/mmwr/volumes/69/wr/mm6935a5.htm#suggestedcitation
3 (2018). Phenibut (β-Phenyl-γ-aminobutyric Acid) Dependence and Management of Withdrawal: Emerging Nootropics of Abuse. Case Reports in Psychiatry. Retrieved April 2021 from https://www.hindawi.com/journals/crips/2018/9864285/
4 (October 2019). Phenibut Overdose: Coming to an ED Near You. Emergency Medicine Residents’ Association (EMRA). Retrieved April 2021 from https://www.emra.org/emresident/article/phenibut-overdose/
5 (February 2018). What Is Phenibut? The Cosmonaut Drug That May Have Caused a School Overdose. ABC News. Retrieved April 2021 from https://www.abc.net.au/news/2018-02-23/what-is-phenibut-the-drug-suspected-in-school-overdose/9475814
6 (March 2015). Analytically Confirmed Recreational Use of Phenibut Bought Over the Internet. Clinical Toxicology. Retrieved April 2021 from https://www.tandfonline.com/doi/full/10.3109/15563650.2015.1059944
7 (March 2019). Phenibut: An Easily Obtainable ‘Dietary Supplement’ With Propensities for Physical Dependence and Addiction. Current Psychiatry Reports. Retrieved April 2021 from https://pubmed.ncbi.nlm.nih.gov/30852710/
8 (July 2019). Questions and Answers on Dietary Supplements. U.S. Food and Drug Administration. Retrieved April 2021 from https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements
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