Aloe Vera Extract | whatsinit

About

What it is and where it shows up.

Aloe vera extract is derived from the leaves of Aloe barbadensis Miller and encompasses several distinct fractions: the inner leaf gel (polysaccharide-rich, low anthraquinone), the latex (anthraquinone-rich exudate), and whole leaf extract (combination of both). It is widely used in food supplements, functional beverages, and flavouring applications for purported digestive, antioxidant, and general wellness benefits.

Safety summary

The regulatory and scientific consensus.

Non-decolorized whole leaf extract of aloe vera has been classified by IARC as a possible human carcinogen (Group 2B) based on clear evidence of large-intestine carcinogenicity in rats, and EFSA (2018) concluded that hydroxyanthracene derivatives (HADs) naturally present in aloe leaf preparations are genotoxic and likely carcinogenic, with no safe daily intake establishable. Oral ingestion of aloe preparations has been associated with adverse effects including diarrhea, hypokalemia, pseudomelanosis coli, and kidney failure. Purified inner leaf gel with HAD content below trace thresholds shows a markedly more favourable toxicological profile, but regulatory uncertainty over commercially available products persists.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
EFSA (European Food Safety Authority) (European Union)	Banned	Commission Regulation (EU) 2021/468 (OJ 2021 L 96, p. 6) placed 'preparations from the leaf of Aloe species containing hydroxyanthracene derivatives' in Part A of Annex III to Regulation (EC) No 1925/2006, prohibiting their addition to food or use in the manufacture of food. EFSA (2018) found hydroxyanthracene derivatives (aloe-emodin, emodin, danthron) genotoxic in vitro and in vivo and could not establish a safe daily intake; the European Commission subsequently drafted the ban in 2020 and enacted it in 2021. Aloe preparations not containing HADs (e.g., highly purified inner leaf gel) are not explicitly covered by Part A, but market compliance is under ongoing scrutiny.source
FDA (Food and Drug Administration) (United States)	Approved	Aloe vera is approved by the FDA as a natural flavouring substance in food under 21 CFR 172.510. However, in 2002 the FDA issued a final rule stating that aloe is no longer generally recognized as safe and effective (GRAS/E) as a nonprescription (OTC) laxative drug ingredient. It remains permissible as a dietary supplement ingredient and food flavouring; no formal GRAS notice has been filed covering all extract types.source

Who should approach with care

Whose guidance would steer them away.

Pregnancy — NCCIH advises that aloe in gel, latex, or whole leaf extract form when taken orally may be unsafe during pregnancy, with anthraquinones potentially exerting stimulant laxative and possible uterotonic effects.

Lactation — NCCIH advises against oral aloe during breastfeeding, as anthraquinone components such as aloin may be excreted into breast milk and affect the nursing infant.

Children — Safety of oral aloe preparations in children has not been established; the NTP noted broad population exposure concerns including children from aloe-containing products.

Kidney Disease — Oral ingestion of aloe preparations has been associated with kidney failure, posing additional risk to individuals with pre-existing renal impairment.

Heart Disease — Overuse of aloe latex can cause hypokalemia and may potentiate adverse effects from cardiac glycosides such as digoxin used in heart failure, as noted by NCCIH.

Research citations

The sources behind this verdict.

1PubMed. Aloe gel-base food products: Chemical, toxicological, and regulatory aspects, 2020. pubmed.ncbi.nlm.nih.gov
2EFSA. Safety of hydroxyanthracene derivatives for use in food, 2018. efsa.europa.eu
3IARC. Some Drugs and Herbal Products – IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 108, 2016. publications.iarc.who.int
4PubMed. Aloe vera: A review of toxicity and adverse clinical effects, 2016. pubmed.ncbi.nlm.nih.gov
5other. Clear Evidence of Carcinogenic Activity by a Whole-Leaf Extract of Aloe barbadensis Miller (Aloe vera) in F344/N Rats, 2013. pmc.ncbi.nlm.nih.gov

Independently researched5 citations