Cognitive enhancers in South Africa: Regulation, ethics, and evidence in an international context

Abstract

Background: Nootropics are a wide range of substances, including prescription medications and natural supplements that are indicated for the enhancement of cognitive function. Regulatory approaches differ locally and internationally with notable discrepancies in the regulation of synthetic nootropics compared to natural nootropics. These differences in regulations raise concerns regarding safety, evidence standards, and ethical use among healthy individuals.

Aim and objectives: To map the existing evidence on pharmacological classification, regulation, and ethical considerations of nootropics globally, with specific reference to nootropics available in South Africa.

Methods: This paper employs two methodologies to examine the regulation and use of cognitive enhancers in South Africa. A comprehensive scoping review, conducted in accordance with PRISMA and JBI guidelines, synthesised evidence from peerreviewed scientific publications and regulatory documents. A thematic analysis of South African regulatory texts was then undertaken to identify key regulatory themes related to cognitive enhancer scheduling and oversight. Building on these findings, two case studies were incorporated: first, a comparison of methylphenidate scheduling across countries identified in the scoping review; and second, an evaluation of the evidence supporting the use of two natural nootropics, phosphatidylserine and Hericium erinaceus, currently available in South Africa. Together, these approaches provide an integrated view of the scientific evidence base and regulatory landscape shaping access to, and governance of, cognitive enhancers in the South African context.

Results: The search returned 1686 records, from which 124 studies met the inclusion criteria. A scoping review of these studies identified variability in global regulatory classifications, evidence requirements, and ethical stances regarding nootropic use. Most research originated from high-income countries, with limited studies from South Africa. Thematic analysis highlighted three consistent themes: safety and efficacy, regulatory inconsistency, and ethical considerations. The methylphenidate case study showed varied scheduling between countries, reflecting differences in regulatory frameworks. Evidence for natural nootropics such as phosphatidylserine and Hericium erinaceous demonstrated limited evidence, resulting in minimal support for cognitive benefits and underscoring the need for more robust clinical research.

Conclusion: The results of the study show that nootropic regulation differs significantly across countries. Synthetic nootropics such as methylphenidate are well-regulated, but natural nootropics like Hericium erinaceous and phosphatidylserine often fall into regulatory gaps, as the evidence supporting their cognitive benefits remains limited. Across the studies, safety, efficacy, and ethical concerns, particularly regarding fairness and autonomy were recurring discussions. In South Africa, the lack of local data and unclear regulatory classification of natural nootropics underscores the need for increased local research efforts and clearer guidance to support safe and responsible use.