Abstract
Gamma-amino butyric acid (GABA) is marketed in the U.S. as a dietary supplement. USP conducted a comprehensive safety evaluation of GABA by assessing clinical studies, adverse event information, and toxicology data. Clinical studies investigated the effect of pure GABA as a dietary supplement or as a natural constituent of fermented milk or soy matrices. Data showed no serious adverse events associated with GABA at intakes up to 18 g/d for 4 days and in longer studies at intakes of 120 mg/d for 12 weeks. Some studies showed that GABA was associated with a transient and moderate drop in blood pressure (<10% change). No studies were available on effects of GABA during pregnancy and lactation, and no case reports or spontaneous adverse events associated with GABA were found. Chronic administration of GABA to rats and dogs at doses up to 1 g/kg/day showed no signs of toxicity. Because some studies showed that GABA was associated with decreases in blood pressure, it is conceivable that concurrent use of GABA with anti-hypertensive medications could increase risk of hypotension. Caution is advised for pregnant and lactating women since GABA can affect neurotransmitters and the endocrine system, i.e., increases in growth hormone and prolactin levels.
Highlights
Gamma-amino butyric acid (GABA) is a four-carbon, non-protein amino acid that is widely distributed throughout biological organisms, including plants, animals, and microorganisms
Prior to developing a dietary supplement monograph, USP conducts a dietary supplement admission evaluation that includes a safety evaluation intended to determine whether an ingredient is associated with any serious risk(s) to health that would preclude its admission for monograph development
This review was conducted as part of a dietary supplements admission evaluation that is performed for dietary ingredients prior to admission into the USP monographdevelopment process
Summary
Gamma-amino butyric acid (GABA) is a four-carbon, non-protein amino acid that is widely distributed throughout biological organisms, including plants, animals, and microorganisms. GABA has been investigated for its effects on reducing stress and enhancing sleep in human studies [13] and for its other biological activities, which include anti-hypertension, anti-diabetes, anti-cancer, antioxidant, anti-inflammation, anti-microbial, and anti-allergy effects [14]. Because of the extensive use of GABA as an ingredient in dietary supplements in the U.S market, USP decided to develop a dietary supplement quality monograph. This evaluation of GABA was conducted according to USP guidelines for the admission of dietary ingredients into the monograph development process [18] and includes an assessment to determine whether GABA presents a serious risk to human health This comprehensive review examined the use of GABA to control blood pressure and as an ergogenic in sports supplements; USP examined its potential interaction with antihypertensive medications
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