Cascara sagrada isn’t completely banned, but the FDA ruled in 2002 that it can no longer be sold as an over-the-counter laxative drug in the United States. The core reason: no one submitted the safety data the FDA asked for. Without evidence ruling out cancer risk, the agency pulled cascara from its list of ingredients considered safe and effective for nonprescription use. The rule took effect on November 5, 2002.
What the FDA Actually Did
The FDA classifies OTC drug ingredients into categories. Category I means an ingredient is generally recognized as safe and effective (GRASE). Category II means it’s not. In the 1990s, the FDA flagged several stimulant laxative ingredients, including cascara sagrada, and requested data on whether they could cause mutations in DNA or promote cancer with long-term use.
Manufacturers of bisacodyl and senna submitted the requested studies, and those ingredients stayed on the market. Nobody submitted data for cascara sagrada or aloe. The FDA had warned that without new evidence, these ingredients would be reclassified as “not generally recognized as safe and effective or misbranded.” That’s exactly what happened. The final rule covered cascara sagrada bark, its extracts, and a derivative called casanthranol. After November 2002, none of these could legally be marketed as OTC laxative drugs.
The Cancer and DNA Damage Concerns
Cascara sagrada contains compounds called anthraquinones, which are responsible for its laxative effect. These same compounds raised red flags in laboratory studies. One anthraquinone found in cascara, emodin, has shown the ability to damage DNA in multiple ways. It generates reactive oxygen species (essentially, unstable molecules that harm cells), which can lead to oxidized DNA, damaged proteins, and destruction of cell membranes. In lab experiments, anthraquinones caused genetic mutations in mouse cells, created breaks in DNA strands, and interfered with an enzyme called topoisomerase II that cells need to properly copy their genetic material.
The picture isn’t entirely clear-cut, though. Longer-term animal studies looking at whether emodin actually causes cancer found no evidence or only ambiguous results. The general scientific assessment is that emodin is likely a weak genotoxic compound. Research suggests cascara sagrada may not pose a DNA damage risk under short-term, prescribed-dose conditions, but chronic use could cross into territory where mutations accumulate. That uncertainty is precisely why the FDA wanted formal safety data, and why the lack of it led to cascara’s removal from OTC drug status.
Liver Injury Reports
Beyond the cancer question, cascara sagrada has been linked to liver damage in several documented cases. The pattern varies: some people developed symptoms within days of starting cascara, while others used it for up to two months before problems appeared. Liver injury showed up as either direct damage to liver cells or as a blockage in bile flow, and the severity ranged from mild to serious.
In one published case, a 48-year-old man developed jaundice just three days after starting cascara sagrada. His liver enzymes spiked dramatically, and he went on to develop fluid buildup in his abdomen and increased pressure in the veins around his liver. He recovered within three months of stopping the supplement. In another case from a Spanish liver toxicity registry, a patient developed severe liver cell damage after two months of use, which also resolved within three months of discontinuation.
Most reported cases have been self-limited, meaning the liver recovered once the person stopped taking cascara. But severe outcomes, including acute liver failure with complications like fluid retention and portal hypertension, have been documented. Restarting cascara after a previous liver injury episode has caused the damage to come back. Researchers initially attributed the injury to direct toxicity from anthraquinones, but the pattern of cases looks more like an unpredictable, individual reaction rather than a dose-dependent poisoning, which makes it harder to predict who’s at risk.
What Cascara Does to the Gut
Cascara sagrada works by increasing muscle tone in the wall of the large intestine. Its anthraquinone compounds irritate the colon lining and stimulate the wave-like contractions that push stool through. This makes it an effective short-term laxative, but it’s also why long-term use causes problems.
One well-documented consequence of prolonged use is a condition called melanosis coli, a brownish discoloration of the colon’s inner lining. It can develop within five months of regular use of anthraquinone laxatives like cascara, senna, or aloe. What’s happening at the cellular level: the compounds damage the cells lining the colon, and immune cells called macrophages sweep up the debris. The leftover pigment from digested cell material gives the colon its characteristic dark appearance. Melanosis coli is considered benign and typically reverses within 6 to 12 months after stopping the laxative.
You Can Still Buy It as a Supplement
Here’s where confusion often sets in. The 2002 FDA rule specifically applies to cascara sagrada marketed as an OTC drug, meaning a product that claims to treat constipation. It did not ban cascara from the dietary supplement market. Under U.S. supplement regulations, cascara sagrada can still be legally sold as long as it’s not labeled with drug claims like “relieves constipation.” You’ll find it on shelves at health food stores and online, typically marketed as a digestive support or detox product.
This distinction matters because dietary supplements face far less regulatory scrutiny than OTC drugs. The FDA doesn’t require supplement manufacturers to prove their products are safe or effective before selling them. So the same ingredient the FDA deemed insufficiently proven for drug use remains widely available in a different regulatory category.
Coffee Cherry Cascara Is Something Else Entirely
If you’ve also seen headlines about “cascara” being banned in Europe, that’s a different product. Coffee cascara is the dried fruit pulp of the coffee cherry, the berry that surrounds coffee beans. It’s brewed into a tea-like drink. The word “cascara” comes from Spanish for “peel” or “husk,” which is why the name overlaps, but it comes from a completely different plant and has nothing to do with cascara sagrada bark.
Coffee cherry cascara was restricted in the European Union not over safety concerns but because it hadn’t been consumed in Europe before 1997, making it a “novel food” that required authorization before it could be sold. The EU approved dried coffee cherry pulp and its infusions in January 2022, so it’s now legal there as well.