{"hq_id":"hq-p-chd-000079","name":"Infant Gripe Water (Herbal Oral Supplement with Sodium Bicarbonate)","category":{"primary":"children","secondary":"oral_care","tags":["gripe water","infant","colic","oral supplement","sodium bicarbonate"]},"product_tier":"CHD","overall_risk_level":"high","description":"Liquid herbal supplement given orally to infants for colic, gas, and teething discomfort. Despite being marketed as 'natural,' many formulations contain sodium bicarbonate (which can disrupt infant stomach acid needed for pathogen defense), charcoal, alcohol (in traditional formulations), or fennel oil (a known estrogenic compound). Not FDA-regulated as a drug — classified as dietary supplement with no efficacy requirement. Given directly to newborns as young as 2 weeks in some brands.","synthesis":{"derived_risk_level":"moderate","synthesis_confidence":0.85,"synthesis_method":"compound_composition","context_used":"human_infant","context_source":"product_users","exposure_modifier":1.15,"vulnerability_escalated":true,"escalation_reason":"CHD tier product","compounds_resolved":4,"compounds_total":4,"synthesis_date":"2026-03-27","synthesis_version":"1.0.0"},"hazard_summary":{"sensitive_populations":"infants, children","overall_risk":"high","primary_concerns":["Sodium bicarbonate alters infant gastric pH, reducing pathogen defense; unregulated herbal ingredients; some contain alcohol or fennel (estrogenic); contamination risk in supplement manufacturing"],"exposure_routes":"Direct oral ingestion via dropper/spoon to infant; Gastrointestinal absorption of all components; Potential aspiration risk in very young infants during administration"},"exposure":{"users":["infant","child"],"routes":["oral"],"contact_types":["oral_direct"],"duration":"hours","frequency":"daily","scenarios":["Oral/ingestion exposure during use of Infant Gripe Water (Herbal Oral Supplement with Sodium Bicarbonate)","Incidental mouthing or hand-to-mouth transfer by children"],"notes":"Exposure to Infant Gripe Water (Herbal Oral Supplement with Sodium Bicarbonate) occurs via oral. Children and infants face higher exposure per body weight due to developing detoxification systems, higher surface-area-to-weight ratio, and behavioral factors (mouthing, crawling)."},"consumer_guidance":{"usage_warning":"Gripe water is not FDA-regulated and has no proven efficacy for colic. Sodium bicarbonate can disrupt infant stomach acid. Check for alcohol content — some brands contain ethanol. Fennel oil has estrogenic activity.","safer_alternatives":["Probiotic drops (L. reuteri — evidence-based for colic)","Gentle tummy massage and bicycle leg movements","White noise and swaddling for comfort","Simethicone drops (gas relief, better safety profile)"]},"regulatory":{"applicable_regulations":[{"jurisdiction":"USA","regulation":"Consumer Product Safety Improvement Act (CPSIA) 2008","citation":"15 U.S.C. 2051-2089","requirements":"Lead content limited to 100 ppm in children's products. Six phthalates permanently banned (DEHP, DBP, BBP, DINP, DIBP, DPENP) in children's toys and child care articles. Third-party testing and certification required.","compliance_status":null,"effective_date":"2008-08-14","enforcing_agency":"CPSC","penalties":null,"source_ref":null},{"jurisdiction":"USA","regulation":"16 CFR Part 1501 — Small Parts Regulation","citation":"16 CFR 1501","requirements":"Products intended for children under 3 must not contain small parts that pose choking hazards.","compliance_status":null,"effective_date":null,"enforcing_agency":"CPSC","penalties":null,"source_ref":null},{"jurisdiction":"EU","regulation":"Toy Safety Directive 2009/48/EC","citation":"Directive 2009/48/EC","requirements":"EN 71 compliance required. Migration limits for 19 elements. CMR substance restrictions. REACH SVHC reporting for >0.1% w/w.","compliance_status":null,"effective_date":"2011-07-20","enforcing_agency":null,"penalties":null,"source_ref":null},{"jurisdiction":"USA -- California","regulation":"California Proposition 65","citation":"CA Health & Safety Code 25249.5-25249.13","requirements":"Products containing listed chemicals above safe harbor levels require clear and reasonable warnings.","compliance_status":null,"effective_date":null,"enforcing_agency":"OEHHA","penalties":null,"source_ref":null}],"certifications":[{"name":"CPSIA","issuer":"CPSC","standard":"Consumer Product Safety Improvement Act","scope":"Lead, phthalate content limits for children's products"},{"name":"ASTM F963","issuer":"ASTM International","standard":"Standard Consumer Safety Specification for Toy Safety","scope":"Mechanical, flammability, chemical hazards"},{"name":"EN 71","issuer":"CEN","standard":"Safety of Toys (Parts 1-13)","scope":"EU toy safety directive covering mechanical, flammability, chemical migration"}],"labeling":{"required_disclosures":[],"prop65_warning":{"required":null,"chemicals":[],"endpoint":null,"notes":null},"ghs_labeling":{"required":null,"signal_word":null,"pictograms":[],"hazard_statements":[],"notes":null},"hidden_ingredients":{"trade_secret_protected":null,"categories_hidden":[],"estimated_count":null,"known_concerns":null,"notes":null},"notes":null},"recalls":[],"regulatory_gap":null,"notes":null},"lifecycle":{"recyclable":false,"disposal_guidance":"Donate if reusable; check local recycling for hard plastics; landfill for worn items","hazardous_waste":false,"expected_lifespan":"1-3_years"},"formulation":{"form":"oral liquid","key_ingredients":["Sodium bicarbonate","Fennel seed oil (estrogenic)"],"certifications":[]},"materials":{"common":[],"concerning":[],"preferred":[]},"compound_composition":[{"hq_id":"hq-c-org-000023","compound_name":"Ethanol (beverage alcohol)","role":"Solvent (ethanol in traditional formulations)","typical_concentration":"0-3.6%"},{"hq_id":"hq-c-org-000312","compound_name":"Citric acid","role":"pH buffer (citric acid)","typical_concentration":"0.1-0.5%"},{"hq_id":"hq-c-org-000533","compound_name":"Sorbitol (E420)","role":"Sweetener (sorbitol)","typical_concentration":"2-5%"},{"hq_id":"hq-c-org-000087","compound_name":"Methylparaben","role":"Preservative (methylparaben)","typical_concentration":"0.1%"}],"identifiers":{"common_names":["infant gripe water (herbal oral supplement with sodium bicarbonate)"],"aliases":[],"manufacturer":null,"brands":[]},"brand_examples":[{"brand":"Mommy's Bliss Gripe Water","manufacturer":"Unknown","market_position":"mass_market","notable":""},{"brand":"Little Remedies Gripe Water","manufacturer":"Unknown","market_position":"mass_market","notable":""},{"brand":"Woodward's Gripe Water","manufacturer":"Unknown","market_position":"mass_market","notable":""}],"sources":[{"type":"expert_curation","name":"ALETHEIA Safety Database","date":"2026-03-23"},{"type":"regulation","title":"Consumer Product Safety Improvement Act (CPSIA) 2008 (15 U.S.C. 2051-2089)","jurisdiction":"USA","year":2008,"citation":"15 U.S.C. 2051-2089","id":"src_9d01b546"},{"type":"regulation","title":"16 CFR Part 1501 — Small Parts Regulation (16 CFR 1501)","jurisdiction":"USA","citation":"16 CFR 1501","id":"src_3e241b80"},{"type":"regulation","title":"Toy Safety Directive 2009/48/EC","jurisdiction":"EU","year":2011,"citation":"Directive 2009/48/EC","id":"src_6c59b098"},{"type":"regulation","title":"California Proposition 65 (CA Health & Safety Code 25249.5-25249.13)","jurisdiction":"USA -- California","citation":"CA Health & Safety Code 25249.5-25249.13","id":"src_fe1d5adc"},{"id":"iarc_100e","type":"regulatory","title":"IARC Monographs Volume 100E: Alcohol Consumption and Ethyl Carbamate","year":2010,"inherited_from_compound":"hq-c-org-000023"},{"id":"who_alcohol_2018","type":"report","title":"WHO: No level of alcohol consumption is safe for our health","year":2018,"inherited_from_compound":"hq-c-org-000023"},{"id":"fda_gras_citric_acid","type":"regulatory","title":"FDA GRAS: Citric Acid (21 CFR 184.1033) — GRAS acidulant; not specified ADI; soft drinks; effervescent tablets; chelation; TCA cycle metabolite; dental erosion concern (2021)","year":2021,"inherited_from_compound":"hq-c-org-000312"},{"id":"efsa_citric_acid_2018","type":"regulatory","title":"EFSA ANS Panel: Re-evaluation of Citric Acid (E 330) — ADI not specified; dietary exposure assessment; dental erosion; calcium chelation; sour candy oral injury; safety conclusion (2018)","year":2018,"inherited_from_compound":"hq-c-org-000312"},{"id":"fda_efsa_sorbitol_2020","type":"regulatory","title":"FDA GRAS 21 CFR 184.1835 Sorbitol; EFSA E420 Re-evaluation 2019 ADI Not Specified; JECFA ADI Not Specified; Osmotic Laxative >50g/day; Contraindicated Hereditary Fructose Intolerance HFI Aldolase B; Hepatic Sorbitol Dehydrogenase Fructose Conversion; Toddler Diarrhea Apple Pear Juice Natural Sorbitol; 70% Solution Pharmaceutical Laxative; No IARC NTP EPA EFSA Carcinogenicity Classification","year":2020,"inherited_from_compound":"hq-c-org-000533"},{"id":"eu_sccs_parabens_2021","type":"regulatory","title":"EU Scientific Committee on Consumer Safety (SCCS): Opinion on Parabens (Methylparaben, Ethylparaben, Propylparaben, Butylparaben) in Cosmetics","year":2021,"inherited_from_compound":"hq-c-org-000087"},{"id":"iarc_3_methylparaben","type":"regulatory","title":"IARC Monographs Volume 101: Methylparaben — Group 3 Evaluation (Not Classifiable as to Carcinogenicity in Humans)","year":2013,"inherited_from_compound":"hq-c-org-000087"},{"type":"regulatory","title":"US Food and Drug Administration (FDA)","jurisdiction":"USA","id":"src_82d1cfcd","extraction":"description_reference"}],"meta":{"schema_version":"4.0.0","last_updated":"2026-03-25","timestamp":"2026-05-01T19:29:58.497Z"}}