Claim: Used as a flavoring in alcoholic beverages, aloin was a component of some laxative medications until May 2002, when it was ruled to no longer be "generally recognized as safe," which is a distinctly different designation from the FDA's "Generally recognized as safe and effective."
Evidence: This food application is generally limited to use in quite small quantities as a flavoring in alcoholic beverages and may usually be identified only as a "natural flavor." Plant-derived remedies containing aloin and other anthraquinones have been used as traditional medicines since antiquity, but harsh side effects make aloin generally unsuitable for household or daily use. It is used as a stimulant-laxative, treating constipation by inducing bowel movements. In May 2002, the U.S. Food and Drug Administration (FDA) issued a ruling that aloe laxatives are no longer generally recognized as safe (GRAS) and effective, meaning that aloin-containing products are no longer available in over-the-counter drug products in the United States, because they may be carcinogenic and more data is needed to establish otherwise. Not to be confused with Generally recognized as safe and effective. Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements. Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is designation for certain old drugs that do not require prior approval from the U.S. Food and Drug Administration in order to enter the United States marketplace because they are generally recognized as safe and effective by medical professionals.