Aloe Barbadensis
FDA in 2002 ruled aloe is no longer GRAS as an OTC laxative drug, requiring removal/reformulation. NTP/IARC classify whole leaf extract of aloe vera as a possible human carcinogen (Group 2B).
What it is
Aloe vera (Aloe barbadensis Miller) — succulent plant whose inner leaf gel and whole-leaf extracts are used in foods, beverages, supplements, and cosmetics.
Inner gel used in beverages and supplements; whole-leaf extract historically used as a laxative; widely used in topical cosmetics.
Why it's flagged
- Whole-leaf extract IARC Group 2B (possibly carcinogenic)
- Hepatotoxicity reports
- Aloe latex no longer GRAS
What regulators actually say
"In 2002, the US Food and Drug Administration issued a final rule stating that use of Aloe as a nonprescription laxative drug is no longer generally recognized as safe and effective."
"The International Agency for Research on Cancer has classified whole leaf extract of aloe vera as a possible carcinogen in humans."
Regulatory status
United States — FDA
Not GRAS as OTC laxative (2002 rule); food/cosmetic uses regulated case-by-case; supplement under DSHEA.
European Union — EFSA
Hydroxyanthracene derivatives from Aloe (incl. whole-leaf preparations) prohibited in food in EU since 2021 (Reg. 2021/468).
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