What FDA ruled in 2002, and what every senna label warns

Three of the eleven ingredients have a regulatory history. This page is that history, quoted.

The problem with the question

Safety in a laxative is a question about dose and about duration. This product declares neither: no amount for any of the eleven ingredients, no sennoside content, and no duration limit anywhere. Every statement on this page is therefore about an ingredient rather than about this capsule, and is labelled as such.

FDA's 2002 rule, quoted

On 9 May 2002 FDA published a final rule titled Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients. It covers a list of ingredients including aloe (including aloe extract and aloe flower extract) and cascara sagrada.

The ingredients should be deemed not generally recognized as safe and effective for OTC use before a final monograph is established.
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. FDA had asked for mutagenicity, genotoxicity and carcinogenicity data in 1998 and said the ingredients would move to category II if none came.
This rule is effective November 5, 2002.

What an actual senna label says

This is the Drug Facts content of a current over-the-counter senna laxative sold in the United States. It is reproduced here because it is the nearest comparable product with a complete label, and because every line of it is something BellyFlush does not say.

Active ingredient: Sennosides 8.6 mg (in each tablet)
Purpose: Laxative
Do not use: laxative products for longer than 1 week, unless directed by a doctor
Stop use and ask a doctor if: rectal bleeding or failure to have a bowel movement after use of a laxative — these may indicate a serious condition

BellyFlush declares no sennoside content, no purpose statement, no duration limit and no stop-use instruction.

Ingredient by ingredient

01stimulant laxativeCascara Sagrada barkreclassified by FDA to Category II in 2002no amount is declared for this ingredient, or for any other
what the sources say
FDA's final rule of 9 May 2002, Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients, reclassified cascara sagrada for OTC laxative use to category II (nonmonograph), meaning it should be deemed not generally recognized as safe and effective for OTC use. The reason was the lack of data and information and the failure of interested persons to submit any new data from carcinogenicity studies. The rule took effect on 5 November 2002.
U.S. Food and Drug Administration / Federal Register, 9 May 2002 →
02stimulant laxativeCape Aloe leafreclassified by FDA to Category II in 2002no amount is declared for this ingredient, or for any other
what the sources say
The same 2002 rule reclassified aloe (including aloe extract and aloe flower extract) for OTC laxative use to category II on the same grounds. NCCIH records that FDA required manufacturers to remove aloe latex from over-the-counter laxative products because of a lack of safety data, that oral use of aloe latex can cause abdominal pain, cramps, and diarrhea, that oral aloe leaf extract has been related to cases of acute hepatitis, and that overuse of aloe latex may increase the risk of adverse effects from cardiac glycosides, such as digoxin. It also records that the International Agency for Research on Cancer has classified whole leaf extract of aloe vera as a possible carcinogen in humans.
NIH National Center for Complementary and Integrative Health →
03stimulant laxativeSenna leaf extractOTC labels say not longer than 1 weekno amount is declared for this ingredient, or for any other
what the sources say
Senna is the one of the three that remains an approved OTC laxative, and the terms are explicit. A US OTC senna label declares Sennosides 8.6 mg per tablet with the purpose Laxative, and warns: do not use laxative products for longer than 1 week, unless directed by a doctor. It also says to stop use and ask a doctor for rectal bleeding or failure to have a bowel movement after use of a laxative because these may indicate a serious condition. This product declares no sennoside content and no duration limit at all.
DailyMed, U.S. National Library of Medicine →
04named in the packTriphala fruitno dose published by the sources openedno amount is declared for this ingredient, or for any other
what the sources say
None of the government health sources this site opened publishes a human dose or a safety review for triphala, so none is printed here.
05named in the packFennel seedno dose published by the sources openedno amount is declared for this ingredient, or for any other
what the sources say
A culinary seed. None of the sources this site opened publishes a supplement dose for it.
06named in the packBentonite clayno dose published by the sources openedno amount is declared for this ingredient, or for any other
what the sources say
A mineral clay rather than a botanical. It has no Daily Value and no established intake. None of the sources this site opened publishes a dose for it, so none is printed here, and no claim is made about what it does in a capsule.
07named in the packMarshmallow rootno dose published by the sources openedno amount is declared for this ingredient, or for any other
what the sources say
None of the sources this site opened publishes a human dose for marshmallow root.
08named in the packLicorice root extractglycyrrhizin is the part that mattersno amount is declared for this ingredient, or for any other
what the sources say
NCCIH: licorice contains a component called glycyrrhizin, or glycyrrhizic acid, that can cause serious adverse effects, and even small amounts of glycyrrhizin from licorice root products have been linked to severe adverse effects — particularly in people with hypertension and in people with heart or kidney conditions, and especially when consumed in large amounts or in the long term. Licorice without glycyrrhizin might be safe for up to 4 months. Nothing supplied with this product says which kind is in it.
NIH National Center for Complementary and Integrative Health →
09named in the packSlippery Elm barkno dose published by the sources openedno amount is declared for this ingredient, or for any other
what the sources say
None of the sources this site opened publishes a human dose for slippery elm bark.
10named in the packCayenne pepper fruitno dose published by the sources openedno amount is declared for this ingredient, or for any other
what the sources say
None of the sources this site opened publishes a human dose for cayenne in this context.
11named in the packMilk Thistle seedwell tolerated; the evidence is thinno amount is declared for this ingredient, or for any other
what the sources say
NCCIH: there isn't enough high-quality evidence to allow definite conclusions to be reached, and two NCCIH-funded trials did not show benefits from supplementation with the milk thistle extract silymarin. Oral use appears to be well tolerated. NCCIH also notes that concerns have been raised about poor chemical and microbiological quality of milk thistle dietary supplements.
NIH National Center for Complementary and Integrative Health →

The first three cards are the stimulant laxatives. Not one of the eleven carries an amount, so every figure on the research side of a card is something somebody else measured — never a statement about this capsule.

U.S. stocking partner for BellyFlush

$33 a bottle at six, and 365 days to send them back

The first three ingredients are stimulant laxatives, and every US over-the-counter senna label warns do not use laxative products for longer than 1 week. Read both before you pay.

Where to buy it Read the guarantee

Eleven ingredients named, none with an amount
The first three are stimulant laxatives
U.S. stocking partner for BellyFlush

This site holds no stock and takes no payment. The prices above were supplied with the product pack and the checkout governs. No shipping figure and no delivery date is printed anywhere on this site, because none was supplied.

Interactions worth raising with a pharmacist

Digoxin and other cardiac glycosides. NCCIH: overuse of aloe latex may increase the risk of adverse effects from cardiac glycosides, such as digoxin.
Blood pressure, heart and kidney medicines. NCCIH records that glycyrrhizin from licorice has been linked to severe adverse effects particularly in people with hypertension and in people with heart or kidney conditions.
Diuretics, and anything where potassium matters. Laxatives and licorice both bear on this and the combination is a pharmacist's question.
Any daily oral medicine. A laxative changes how much of an oral medicine is absorbed, which is a reason to space them and a reason to ask.
Pregnancy and breastfeeding. NCCIH records that oral aloe may be unsafe in both.

And the cautions the bottle does not carry

No caution, warning, interaction line, storage line or duration-of-use limit appears on any artwork supplied to this site. On a formula whose first three ingredients are stimulant laxatives, that is the omission that matters most.

Every caution on this site therefore comes from a named source rather than from the product. That is the wrong way round, and on this particular formula it is worth saying twice.

U.S. stocking partner for BellyFlush

$33 a bottle at six, and 365 days to send them back

The first three ingredients are stimulant laxatives, and every US over-the-counter senna label warns do not use laxative products for longer than 1 week. Read both before you pay.

Where to buy it Read the guarantee

Eleven ingredients named, none with an amount
The first three are stimulant laxatives
U.S. stocking partner for BellyFlush

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.

Written byThe MyBellyFlush editorial desk

Medically reviewed byDr. Mark Johnston, MD, Physician

RoleMedical reviewer

Review dateOctober 13, 2026

Revised13 October 2026

Editorial standards Report an error