Is GABA (Gamma-Aminobutyric Acid) supplement approved for use in children?

GABA Supplements Are Not Approved for Use in Children

GABA (gamma-aminobutyric acid) supplements are not approved for use in children, and there is insufficient evidence supporting their safety and efficacy in pediatric populations. 1

Understanding GABA

GABA is a non-proteinogenic amino acid that functions as the main inhibitory neurotransmitter in the mammalian brain 2. While GABA plays important roles in:

• Stress reduction and relaxation effects 3
• Sleep enhancement 2
• Neurotransmission in the central nervous system 4

Regulatory Status for Children

The regulatory landscape for GABA supplements in children is clear:

• GABA supplements lack FDA approval for pediatric use 1
• Pharmacotherapy in children and adolescents should only include approved medications with established safety profiles 1
• The use of unapproved supplements in children requires extreme caution due to lack of well-controlled studies and long-term safety data 1

Evidence Gaps for Pediatric Use

Several critical limitations exist regarding GABA supplements for children:

• There is a lack of well-controlled studies on GABA supplements specifically in pediatric populations 2, 5
• No long-term safety data exists for GABA supplement use in children 5
• The risk versus long-term benefit ratio remains uncertain for unapproved supplements like GABA 1

Safety Concerns

The United States Pharmacopeia (USP) safety review of GABA identified several concerns:

• GABA can affect neurotransmitters and the endocrine system, including increases in growth hormone and prolactin levels 5
• GABA has been associated with transient and moderate drops in blood pressure in some studies 5
• Special caution is advised for pregnant and lactating women due to potential effects on neurotransmitters and the endocrine system 5
• Potential drug interactions exist, particularly with anti-hypertensive medications 5

Current Pediatric Medication Guidelines

For context, medications approved for pediatric use undergo rigorous testing:

• Medications for children require specific FDA approval with established safety and efficacy data 1
• The FDA has established specific regulations governing drug testing in children to ensure safety 6
• Pharmacotherapy should only be considered for children when approved medications have demonstrated efficacy and safety in pediatric clinical trials 1

Clinical Implications

Healthcare providers should consider the following when addressing GABA supplement inquiries:

• Recommend only FDA-approved therapies with established pediatric safety profiles 1
• Recognize that even for approved medications, pediatric pharmacotherapy requires close monitoring by qualified healthcare providers 1
• Be aware that most dietary supplements, including GABA, lack the rigorous testing required for pediatric medications 6, 5
• Consider that alternative pathways for addressing the symptoms for which GABA might be considered should utilize approved therapies 1

Conclusion

Given the lack of FDA approval, insufficient safety data, and absence of well-controlled studies in children, GABA supplements should not be used in pediatric populations. Healthcare providers should recommend only approved therapies with established safety profiles for children 1, 5.