Regulation · 2 min read
What FDA Said About Aloe And Cascara In 2002
This is a quotation rather than an argument. The rule is short, public and specific.
The rule: 67 FR 31125, Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients
, 9 May 2002.
It covers aloe (including aloe extract and aloe flower extract) and cascara sagrada.
They should be deemed not generally recognized as safe and effective for OTC use before a final monograph is established
, and the agency is reclassifying these ingredients to category II (nonmonograph)
.
The basis: the lack of data and information and the failure of interested persons to submit any new data from carcinogenicity studies.
This rule is effective November 5, 2002.
What happened
In 1998 FDA asked for mutagenicity, genotoxicity and carcinogenicity data on these ingredients and said that if none arrived they would be moved to category II. None arrived. In 2002 they were moved.
That is the entire mechanism. It is not a finding that either ingredient causes harm; it is a finding that nobody produced the safety data a regulator asked for, and that in the absence of it the ingredients could not stay on the approved list.
What it does not mean
- It does not make aloe or cascara unlawful as dietary-supplement ingredients. They remain lawful, and this product is not sold unlawfully as far as this site can tell.
- It does not say either ingredient is carcinogenic. It says the studies that would answer that question were not submitted.
- It is not about this product, which did not exist in 2002 and is not an over-the-counter drug.
Still deciding?
The two sentences to hold on to: the first three ingredients on this label are stimulant laxatives, and every over-the-counter senna product sold in the United States warns do not use laxative products for longer than 1 week, unless directed by a doctor.
Everything else on this page is detail.
Where to buy itThe 365-day window
- Eleven ingredients named, none with an amount
- The first three are stimulant laxatives
- U.S. stocking partner for BellyFlush
Prices on this site were supplied with the product pack. The checkout governs, and no delivery date is printed here because none was supplied.
The third one is different
Senna stayed. It remains an approved over-the-counter laxative, which means it has a label — a real one, with the active ingredient declared in milligrams, a stated purpose, a duration limit and a stop-use instruction.
That label is the most useful document in this whole subject, and it is the subject of the next piece.
Questions
Can I still buy cascara?
Yes, as a dietary supplement. The rule concerns over-the-counter drug use.
Did FDA find these ingredients cause cancer?
No. It found that the carcinogenicity studies it had asked for were never submitted.
Has anything changed since 2002?
Nothing this site found in the sources it opened. If you know otherwise, write in.
Sources
- Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients — final rule, 67 FR 31125U.S. Food and Drug Administration / Federal Register, 9 May 2002The rule reclassifying aloe and cascara sagrada for OTC laxative use to
category II (nonmonograph)
, on the grounds ofthe lack of data and information and the failure of interested persons to submit any new data from carcinogenicity studies
. Effective 5 November 2002. - Aloe Vera: Usefulness and SafetyNIH National Center for Complementary and Integrative HealthFDA's removal of aloe latex from OTC laxatives, the abdominal pain and cramping from oral aloe latex, the acute hepatitis cases linked to oral leaf extract, the digoxin interaction, and IARC's classification of whole leaf extract as a possible human carcinogen.
What this page was checked against
Every figure on it is transcribed from the supplied Supplement Facts panel and checked-out pack, derived by arithmetic from those, or taken from a source on the references page.