About the Author
Helen Pervanas, PharmD, RPh, is a professor of pharmacy practice at Massachusetts College of Pharmacy and Health Sciences, and her practice site is at the Lamprey Health Center in Nashua, New Hampshire.
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Advise Patients to Use Caution When Purchasing Nootropic Agents Online
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Although each of the product samples of phenibut contained the actual active ingredient, the exact amount of the active ingredient was inaccurate and, in one sample, found to be at a higher dose.
Purchasing nootropic agents online may be easy and convenient, but buyers should be aware that they may not be getting what they pay for. According to recent study published in Medicina, the authors noted that many products contained undeclared ingredients, suboptimal amounts of active ingredients, or higher levels of active ingredients.1
Patient shopping an online pharmacy | Image credit: © Andrey Popov | stock.adobe.com
Many individuals are using nootropic agents, also referred to as “smart drugs” or cognitive enhancers, to improve brain function.2,3 These agents claim to improve concentration, alertness, and performance.
One such drug, phenibut, is a medication that is prescribed in Eastern European countries to treat medical conditions such as stuttering, tics, insomnia, and anxiety.4,5 This drug has gained popularity over the years because of active marketing and ease to purchase the product online.Although the FDA warns that such products should not be permitted in dietary supplements, these products continue to be sold.6
This study’s researchers aimed to identify and quantify ingredients of online marketed phenibut-containing products.1 The researchers tested 6 phenibut samples, ordered online from 3 internet suppliers. They weighed the contents of 20 capsules from 6 samples then ground them into a fine powder. They utilized high-performance liquid chromatography with diode array detection (HPLC–DAD) to analyze the phenibut contents and an HPLC–DAD method to separate and quantify the listed active pharmaceutical ingredients.
All of the samples contained phenibut, but the amount of phenibut differed among the products. Two samples that claimed 500 mg of the active ingredient contained 494 mg and 524 mg, respectively. Three samples contained less of the active ingredient than claimed. One sample had 113 mg instead of 250 mg, another had 385 mg instead of 500 mg, and yet another had 689 mg instead of the 900 mg that was stated on the packaging. Higher levels were found in 1 sample where an average of 668 mg was found instead of 500 mg.1
The researchers reported that other ingredients were present at varying amounts, including 5-HTP, L-DOPA, L-Theanine, piperine, naringenin, huperazine A, piperyline, naringin, and aniracetam. Many of these added ingredients were not declared on the packaging.1
This study showed that although each of the product samples of phenibut contained the actual active ingredient, the exact amount of the active ingredient was inaccurate and, in one sample, found to be at a higher dose. According to the FDA, acceptance criteria for the amount of active ingredients relative standard deviation is less than or equal to 2%.7 Many of the samples did not meet these criteria and all samples contained undeclared amounts of other active ingredients with the potential to cause unwanted adverse effects and drug interactions.1
It is important to educate patients that dietary supplements may not contain what is listed on the packaging. These products are not tested by the FDA and can contain undeclared active ingredients that can be harmful. Using reputable websites, exercising due diligence, and using medications that are proven to work and approved by the FDA are recommended.
REFERENCES
1. Upmanis T, Sevostjanovs E, Zvejniece L, et al. Purchasing “nootropics” online: identification and quantification of ingredients in phenibut-containing products. Medicina (Kaunas). 2024;60(10):1561. doi:10.3390/medicina60101561
2. Giurgea C. [Pharmacology of integrative activity of the brain. Attempt at nootropic concept in psychopharmacology]. Actual Pharmacol (Paris). 1972;25:115-156
3. Napoletano F, Schifano F, Corkery JM, et al. The psychonauts’ world of cognitive enhancers. Front Psychiatry. 2020;11:546796. doi:10.3389/fpsyt.2020.546796
4. Lapin I. Phenibut (beta-phenyl-GABA): a tranquilizer and nootropic drug. CNS Drug Rev. 2001;7(4):471-481. doi:10.1111/j.1527-3458.2001.tb0021.x
5. Kupats E, Vrublevska J, Zvejniece B, et al. Safety and tolerability of the anxiolytic and nootropic drug phenibut: a systematic review of clinical trials and case reports. Pharmacopsychiatry. 2020;53(5):201-208. doi:10.1055/a-1151-5017
6. Cohen PA, Ellison RR, Travis JC, Gaufberg SV, Gerona R. Quantity of phenibut in dietary supplements before and after FDA warnings. Clin Toxicol (Phila). 2022;60(4):486-488. doi:10.1080/15563650.2021.1973020
7. Information for Industry on Dietary Supplements. FDA. Updated April 3, 2024. Accessed January 2, 2025. https://www.fda.gov/food/dietary-supplements/information-industry-dietary-supplements
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