Why was Cascara sagrada banned? A Look into the 2002 FDA Ruling

October 6, 2025 •

3 min read

In May 2002, the U.S. Food and Drug Administration (FDA) issued a final rule removing cascara sagrada from the over-the-counter (OTC) drug market. This regulatory action prompted questions about the safety of the long-standing herbal remedy and why was Cascara sagrada banned from being sold as an OTC laxative. The decision highlights the rigorous standards required to prove a product is both safe and effective for public consumption, even for natural substances.

Quick Summary

The U.S. FDA banned cascara sagrada from over-the-counter laxatives in 2002 due to insufficient evidence of its safety and effectiveness. Manufacturers failed to provide required toxicity data to support its continued use. Concerns over long-term risks, including dependency, electrolyte imbalances, liver toxicity, and conflicting data on potential carcinogenicity, led to the withdrawal of OTC products.

Key Points

FDA Mandate: In 2002, the FDA issued a final rule stating that cascara sagrada was not “generally recognized as safe and effective” (GRASE) for over-the-counter (OTC) laxative use.
Lack of Evidence: The primary reason for the ban was the failure of manufacturers to submit the required scientific data, particularly concerning toxicity and long-term use, despite the FDA's request.
Health Concerns: The FDA's decision was driven by concerns over potential side effects like electrolyte imbalance, liver toxicity, the development of cathartic colon, and unproven carcinogenicity.
OTC vs. Supplement: The ban applies only to OTC drug products; cascara sagrada can still be sold as a dietary supplement under different, less stringent regulations.
Consumer Safety: The ban ensured that OTC laxatives available to the public are backed by sufficient scientific evidence of safety and effectiveness.
Stimulant Laxative Class: The action was part of a larger, multi-decade review of OTC drug ingredients, which also affected other stimulant laxatives like aloe.

The FDA's OTC Drug Review and Cascara Sagrada

Cascara sagrada, sourced from the Rhamnus purshiana shrub's dried bark, was historically a widely used OTC laxative in the U.S.. Its active compounds, anthraquinones, work by stimulating intestinal contractions and reducing water and electrolyte reabsorption. The FDA's decision to ban cascara sagrada from OTC products was part of a broader review of non-prescription drugs initiated in the 1970s to classify ingredients based on safety and efficacy. By the mid-1990s, cascara sagrada was categorized as needing more data.

The Critical Lack of Manufacturer Data

A key turning point occurred in 1998 when the FDA requested genotoxicity, mutagenicity, and carcinogenicity data for cascara sagrada. Unlike manufacturers of other laxative ingredients, those producing cascara sagrada did not submit the necessary evidence. This failure to provide data demonstrating safety, particularly regarding long-term use and potential risks, led to the FDA's final rule. In May 2002, the FDA declared cascara sagrada and aloe ingredients not generally recognized as safe and effective (GRASE) and required their removal from OTC laxative products within 180 days.

Health Concerns Driving the Regulatory Action

The FDA's decision was influenced by several health concerns, especially with prolonged use. While effective short-term, long-term use risks included electrolyte imbalance (particularly low potassium), which can affect heart function. Chronic use could also lead to cathartic colon, a condition where the colon becomes dependent on laxatives. Liver injury, though rare, has also been linked to cascara sagrada. Concerns about potential carcinogenicity, based on studies of anthraquinones and a lack of definitive human data, also played a role.

The Distinction Between OTC Drugs and Dietary Supplements

It is important to note that the FDA's ban specifically targeted cascara sagrada when marketed as an OTC drug. It remains available as a dietary supplement, which is subject to different, less stringent regulations. Supplements do not undergo the same level of safety and efficacy testing as drugs.

Comparison of Cascara Sagrada (Pre-2002) vs. Regulated Laxatives (Post-2002)


Feature	Cascara Sagrada (Pre-2002 OTC Drug)	Regulated Alternatives (e.g., Senna, Bisacodyl)
Regulatory Status	Originally recognized as GRASE; status revoked by FDA in 2002.	Currently recognized as GRASE for OTC laxative use.
Manufacturer Data	Manufacturers failed to submit data proving safety and efficacy.	Manufacturers submitted data establishing general recognition of safety.
Long-Term Use Risks	Dependence, cathartic colon, electrolyte imbalance, liver toxicity.	Potential for dependence and electrolyte imbalance with chronic misuse.
Carcinogenicity Concerns	Unproven risk due to lack of data on anthraquinone components.	Manufacturers provided carcinogenicity data to address concerns.
Current Availability	Banned from OTC drug products; available as dietary supplement.	Widely available as OTC laxatives and often in reformulated products.

Conclusion

The FDA's ban on cascara sagrada in OTC drug products in 2002 was primarily due to the failure of manufacturers to provide sufficient scientific data to prove its safety and effectiveness. This action reinforces the principle that medical products must be scientifically validated before being marketed as drugs. While available as a supplement, the ban highlights potential risks associated with unproven remedies, especially with long-term use. Consumers should consult a healthcare professional before using any herbal supplement.

Frequently Asked Questions

Cascara sagrada is a natural, stimulant laxative derived from the dried bark of the Rhamnus purshiana shrub, native to North America.

The FDA banned cascara sagrada from over-the-counter laxatives in 2002 because manufacturers did not provide sufficient data to prove its safety and effectiveness for chronic use.

No, it is not illegal to sell cascara sagrada entirely. The FDA ban prohibits its sale in OTC drug products. It is still legally available for purchase and sale as a dietary supplement, which falls under different regulatory guidelines.

Prolonged or high-dose use of cascara sagrada can lead to potential health risks such as dependency, electrolyte imbalances (especially low potassium), liver injury, and a condition called cathartic colon.

Dietary supplements are not regulated by the FDA with the same level of scrutiny as OTC drugs. While OTC drugs require proof of safety and effectiveness, supplements do not have to undergo rigorous testing before they can be sold.

Yes. Following the ban, the FDA affirmed the safety of other stimulant laxatives like senna, for which manufacturers did provide adequate data. Consumers can also consider other types of laxatives, such as bulk-forming agents or osmotic laxatives, under a doctor's guidance.

Studies on the potential carcinogenicity of anthraquinones in cascara sagrada have produced conflicting results, particularly in animal models. The lack of definitive data and the existence of potential concerns contributed to the FDA's decision to ban it as an OTC drug.