In 2002, the U.S. Food and Drug Administration (FDA) issued a final rule prohibiting the use of cascara sagrada as an active ingredient in over-the-counter (OTC) laxatives. This action, which also applied to aloe ingredients, stemmed from a multi-decade regulatory review and the failure of manufacturers to provide the necessary safety and efficacy data requested by the agency. While this ruling removed cascara from the shelves of many pharmacies as a non-prescription drug, it did not impose a complete ban, as the substance can still be sold as a dietary supplement. Understanding the specific reasons for this regulatory decision is key to appreciating the distinction and the associated health concerns.
The 2002 FDA Ruling and the OTC Drug Review
The FDA's decision was a culmination of its ongoing OTC Drug Review, which systematically evaluates the safety and effectiveness of non-prescription drugs. In 1998, the FDA had requested additional data, including studies on mutagenicity, genotoxicity, and carcinogenicity, for several laxative ingredients, including cascara sagrada. Manufacturers were given the opportunity to submit the requested information to support the continued inclusion of these ingredients in the OTC monograph, which is a regulatory standard that allows for marketing without individual product approval.
However, when the deadline arrived, no comments or data were submitted to the FDA regarding the safety and efficacy of cascara sagrada. Because the manufacturers did not provide the required evidence, the FDA proceeded with its final ruling. Effective November 5, 2002, cascara sagrada ingredients, including the bark, extracts, and fluidextracts, were reclassified from Category III (more data needed) to Category II (not generally recognized as safe and effective) for OTC laxative use. This required all OTC laxative drug products containing cascara to be reformulated or removed from the market within 180 days.
Insufficient Evidence and Safety Concerns
The core issue leading to the ban was the lack of scientific evidence demonstrating that cascara sagrada was safe and effective for its intended use, rather than outright proof of harm. The bark contains potent laxative compounds called anthraquinones. While these compounds have a documented laxative effect, stimulating intestinal motility and fluid secretion, they also carry risks, especially with long-term or excessive use. The FDA needed definitive data to establish safe dosage levels and to rule out potential carcinogenic effects, especially following inconclusive animal studies. The failure to provide this data prompted the agency's action to protect public health.
Documented Health Risks
- Electrolyte Imbalance: Prolonged use of cascara can lead to a loss of electrolytes, particularly potassium. Low potassium levels (hypokalemia) can result in heart problems, muscle weakness, and other serious health issues.
- Liver Toxicity: Cases of liver injury have been reported, particularly with long-term or high-dose use of cascara sagrada. The duration before liver injury appears can range from days to months, and the severity varies.
- Dehydration: As a powerful stimulant laxative, cascara can cause severe diarrhea, leading to dehydration.
- Melanosis Coli: Long-term use of anthraquinone laxatives like cascara can cause a harmless but visually dark pigmentation of the colon lining, known as melanosis coli. However, recent research has explored a potential link between melanosis coli and an increased risk of colorectal cancer, though this link is still debated.
- Dependence: Like many stimulant laxatives, cascara is habit-forming. Chronic use can lead to the colon becoming dependent on the stimulant effect to function, resulting in a "lazy bowel".
Differentiating Cascara Sagrada and Coffee Cascara
The term "cascara" can be confusing, as it is also the name given to the dried husks of coffee cherries. The coffee cascara has recently gained popularity as a tea and food ingredient, but its regulatory history is entirely separate from that of cascara sagrada bark.
Cascara Comparison Table
| Feature | Cascara Sagrada (Rhamnus purshiana) | Coffee Cascara (Coffea sp.) |
|---|---|---|
| Source | Dried bark of the buckthorn tree, native to North America. | Dried husks/pulp of the coffee cherry fruit. |
| Primary Use | Historically, an over-the-counter stimulant laxative. | Used to make tea or as an ingredient in food/drinks. |
| FDA Action (2002) | Removed from the OTC drug monograph due to lack of safety data. | Not affected by the 2002 OTC drug ruling. |
| Regulatory Status (US) | Not allowed as an OTC drug. Can be sold as a dietary supplement. | Generally not regulated by the FDA as an OTC drug. |
| Associated Risks | Liver toxicity, electrolyte imbalance, dehydration, potential carcinogenicity with chronic use. | Concerns over potential contamination from pesticides or processing, though generally considered safe for consumption. |
In the European Union, coffee cascara faced its own regulatory issues, being classified as a "novel food" that required additional safety testing before widespread sale. However, this is distinct from the FDA's 2002 ruling on the herbal laxative, cascara sagrada.
Safe and Effective Alternatives
For those seeking relief from occasional constipation, many safer and more effective alternatives are available, often without the same risks as stimulant laxatives like cascara sagrada. These options include both lifestyle adjustments and pharmaceutical interventions:
- Fiber-Rich Foods: Incorporating more fiber from fruits, vegetables, and whole grains helps bulk and soften stool.
- Osmotic Laxatives: These work by drawing water into the colon, making stool softer and easier to pass. Examples include polyethylene glycol (MiraLAX) and milk of magnesia.
- Stool Softeners: Ingredients like docusate sodium help mix water into the stool, softening it.
- Increased Water Intake: Staying hydrated is crucial for preventing and relieving constipation, as water helps soften stool.
- Exercise: Regular physical activity can help stimulate bowel movements.
- Senna: While also an anthraquinone laxative, senna has more safety data and was not removed from the OTC monograph by the FDA in 2002. However, like other stimulant laxatives, it should only be used for short periods.
Conclusion
The FDA's 2002 decision to remove cascara sagrada from the over-the-counter drug market was a public health measure based on a lack of scientific data demonstrating its safety and effectiveness for long-term use. This action was not a complete ban on the substance but prevented its marketing as a non-prescription laxative. The ruling highlights the potential risks associated with prolonged use of certain herbal stimulant laxatives, including liver issues, electrolyte imbalance, and dependence. For safe and reliable constipation relief, consumers should look to FDA-approved products or well-established dietary and lifestyle changes, distinguishing the medicinal bark from the unrelated coffee cascara. The FDA's action ultimately encouraged the use of safer, better-researched alternatives for digestive health.
One resource for further reading is the National Institutes of Health's LiverTox section, which discusses the hepatotoxicity risks associated with cascara.
