A proposed class action claims Pure Nootropics, LLC has unlawfully marketed and sold certain supplements that are, without FDA approval, no more than adulterated drugs and therefore illegal to sell.
According to the 20-page lawsuit, Pure Nootropics’ Aniracetam, Oxiracetam, and Phenylpiracetam are advertised as able to improve a user’s memory, learning, focus, energy and mood even though claims pertaining to the supplements’ effects are, as far as the FDA is concerned, “false and unsupported by scientific evidence.” The case out of New York federal court contends that because Pure Nootropics has not obtained FDA approval to sell its products, which the agency has warned are not generally recognized as safe and effective, the supplements are adulterated and thus “worthless.”
Further, although Pure Nootropics’ supplements are advertised on the defendant’s website as able to improve brain function, including memory, focus and other aspects of cognition, they are in reality unable to produce their advertised benefits, the complaint alleges, claiming the defendant’s representations are “designed to induce consumers” into believing the supplements’ capabilities have been proven.
The lawsuit cites a 2020 study published by the Neurology Clinical Practice that found that the use of cognitive enhancement supplements such as the “piracetam analogs” used in the defendant’s products “poses potentially serious health risks given the unpredictable dosing and lack of clinician supervision.” According to the study, supplements marketed as cognitive enhancement products may contain “unpredictable combinations of unapproved drugs” and have been associated with “adverse effects including increased and decreased blood pressure, insomnia, agitation, dependence, sedation, hospitalization and intubation,” the complaint relays.
The suit goes on to state that the FDA and FTC issued a joint warning letter to the defendant in February 2019 in which the agencies noted that Pure Nootropics’ piracetam product was not generally recognized as safe and effective for the uses and benefits claimed by the defendant and therefore is considered an unapproved new drug. Moreover, the case says the FDA expressed concern that “one or more of the efficacy claims . . . may not be substantiated by competent and reliable scientific evidence” and urged Pure Nootropics to review its product claims and ensure that they were properly supported.
The lawsuit asserts that Pure Nootropics’ sale of the products is a violation of the Federal Food, Drug, and Cosmetic Act because the supplements have not been approved by the FDA as new drugs. Moreover, the supplements are also misbranded given they fail to state adequate directions for their intended use, the suit alleges.
“Such illegally sold products are worthless and have no value,” the complaint scathes.
The lawsuit claims the defendant’s representations concerning its aniracetam, oxiracetam and phenylpiracetam supplements, in light of the foregoing, are “false and misleading.”
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