Safe and Unsafe Herbs According to the FDA

The U.S. Food and Drug Administration (FDA) has a list of safe and unsafe herbs and supplements. The FDA performs these safety assessments based on available research, reported use, and historical data.

Let’s take a look at what they have to say…

It should be noted that the safe and unsafe assessments are different from the way pharmaceutical drugs are evaluated.

First, pharmaceutical drugs undergo rigorous testing and clinical trials to demonstrate their safety and efficacy before they are approved by the FDA. This process includes several phases of testing, from laboratory and animal studies to extensive human trials.

In contrast, herbs and supplements are not subject to the same level of stringent pre-market evaluation.

The FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products.

As a result, the safety and effectiveness of herbs and supplements are often assessed post-market.

This approach means that the information about the safety and efficacy of many herbal products and supplements can be less comprehensive compared to pharmaceutical drugs.

The following unsafe herb list includes those that are known or believed to cause herbal toxicity.

What is Herbal Toxicity?

Herbal toxicity refers to the harmful effects that can occur from using herbal products or supplements.

While herbs are often perceived as natural and safe, they can still cause adverse reactions, toxicity, or interact negatively with other medications.

Toxicity can arise from various factors:

Active Ingredients: Herbs contain active compounds that can have strong biological effects. In excessive amounts, these compounds might be toxic.
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Contamination: Herbs can be contaminated with heavy metals, pesticides, or other harmful substances during cultivation, harvesting, processing, or storage.
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Adulteration: Some herbal products might be adulterated with other, sometimes harmful, substances that are not listed on the label.
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Interactions with Medications: Herbs can interact with prescription or over-the-counter medications, potentially leading to increased side effects or decreased effectiveness of the medication.
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Variability in Strength and Composition: Unlike pharmaceuticals, the concentration of active ingredients in herbal products can vary significantly from one batch to another, leading to unpredictability in their effects.
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Improper Use: Using herbs inappropriately, such as in the wrong dosage or for the wrong conditions, can lead to toxic effects.
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Individual Health Factors: Individual health conditions, such as liver or kidney disease, can make a person more susceptible to the toxic effects of certain herbs.

Symptoms of herbal toxicity can range from mild to severe and include:

gastrointestinal disturbances
allergic reactions
headaches
liver damage
heart problems, and in extreme cases
even death

It’s crucial to use herbal products responsibly, under the guidance of healthcare professionals, especially for people with existing health conditions or those taking other medications.

As with any treatment, the key lies in using the right herb, in the right amount, for the right person.

Overview of Safe and Unsafe Herbs

Unsafe Herbs

Borage: Contains pyrrolizidine alkaloids, which can cause liver damage and carcinogenic effects.
Calamus: Has been found to contain asarone, a compound that is potentially carcinogenic and neurotoxic.
Coltsfoot: Contains pyrrolizidine alkaloids, which can lead to liver damage and have carcinogenic properties.
Comfrey: Also contains pyrrolizidine alkaloids and is associated with liver damage and possibly cancer.
Life Root: Contains liver-toxic pyrrolizidine alkaloids.
Sassafras: Contains safrole, a substance that has been shown to be carcinogenic in animals.
Chaparral: Linked to serious liver damage.
Germander: Associated with hepatotoxicity (liver damage).
Licorice: In large amounts or with long-term use, can cause potassium depletion and increase blood pressure.
Ma Huang (Ephedra): Contains ephedrine and pseudoephedrine, which can cause serious heart problems and has been linked to significant adverse effects, including death. This is why it if no longer sold in the USA.

Example: The Ephedra Ban

Ephedra, a herb known for its stimulant properties, was banned in the United States primarily due to concerns over its safety. This decision was made by the U.S. Food and Drug Administration (FDA) and took effect in 2004.

This was one of the first major actions against a dietary supplement in the U.S. The reasons for the ban include:

Severe Health Risks: Ephedra was found to have significant health risks. It contains ephedrine, a compound that can stimulate the heart and central nervous system. This stimulation was linked to serious side effects, including heart attacks, strokes, seizures, and sudden deaths.
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Adverse Event Reports: The FDA received numerous reports of adverse events associated with ephedra-containing supplements. These reports were a key factor in banning the substance.
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Limited Medicinal Benefits: At the time of the ban, it was concluded that the potential benefits of ephedra for weight loss and enhancing athletic performance did not outweigh the risks.
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Legal Battles and Controversies: The ban on ephedra was met with legal challenges from supplement manufacturers. However, after reviewing the available evidence, the courts generally upheld the FDA’s decision, emphasizing the agency’s role in protecting public health.
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Regulatory Action and Public Safety Concerns: The FDA’s decision to ban ephedra was a significant step in asserting the agency’s regulatory authority over supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). It highlighted the FDA’s commitment to intervene when a supplement poses a risk to public health.

In summary, ephedra was banned in the U.S. due to its serious health risks, particularly its association with cardiovascular events and other severe side effects, which were deemed to outweigh any potential benefits.

This decision marked a critical moment in the regulation of dietary supplements in the U.S.

Potentially Safe Herbs

Feverfew: Used for migraine prevention; generally considered safe when used appropriately.
Garlic: Known for cardiovascular benefits; generally safe but can interact with blood-thinning medications.
Ginkgo: Used for cognitive enhancement; generally safe but can interact with blood thinners and other medications.
Asian Ginseng: Used for its adaptogenic properties; generally considered safe but may interact with other drugs.
Saw Palmetto: Often used for prostate health; generally safe for most people.
St. John’s Wort: Commonly used for depression; relatively safe but has significant interactions with many medications.
Valerian: Used for sleep disorders; generally considered safe for short-term use.

The term “Potentially Safe” is used to reflect the nuanced nature of herbal supplement safety.

Why are they labeled “potentially safe herbs”?

Individual Variability: People can react differently to herbs based on their unique physiology, existing health conditions, and sensitivities. An herb that is generally safe for the majority may still pose risks to certain individuals.
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Interaction with Medications: Some herbs, even though safe on their own, can interact with prescription or over-the-counter medications, potentially causing adverse effects or altering the effectiveness of the medication.
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Lack of Comprehensive Research: Many herbs have not been studied as extensively as conventional medications. While current research might suggest their safety, the full range of their effects, especially long-term, might not be completely understood.
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Quality and Purity Issues: The safety of an herb also depends on its quality and preparation. Contamination, adulteration, or incorrect labeling can turn an otherwise safe herb into a health risk.
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Dosage and Preparation: The safety of herbs can depend on how they are used — including the form they are taken in (such as tea, tincture, capsule), the dose, and the duration of use. An herb that is safe at a low dose might be harmful at a higher dose or if used over a long period.
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Regulatory Aspects: Unlike prescription drugs, the regulation of herbs and supplements is less stringent. The term “potentially safe” acknowledges this regulatory difference and the fact that the safety assessments for these products are not as rigorous as for pharmaceutical drugs.

Therefore, labeling herbs as “potentially safe” is a way to communicate that, while they are generally considered safe based on current knowledge and use, there are still conditions and variables that can influence their safety.

This underscores the importance of using herbs responsibly and with the guidance of healthcare professionals.

Important Notes

Individual Reactions: People can react differently to herbs. What is safe for one person might not be for another.
Medication Interactions: Many herbs can interact with prescription or over-the-counter medications.
Quality Control: The purity and composition of herbal supplements can vary, affecting safety.
Long-Term Effects: Less is known about the long-term safety of many herbal supplements.

Learn About Safe and Unsafe Herbs

Learning about the herbs you intend to take and consulting with a medical professional are essential steps in ensuring safe and effective use of herbal supplements. Here’s why this approach is important:

Understanding Effects and Risks: Researching herbs helps you understand their potential health benefits, side effects, and risks. This knowledge enables you to make informed decisions about their use.
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Personal Health Considerations: A healthcare professional can advise you based on your personal health history, current health conditions, and medications. This is crucial because some herbs can interact with medications or worsen certain health conditions.
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Dosage and Administration: Medical professionals can provide guidance on the appropriate dosage and form (e.g., capsules, teas, tinctures) of herbs to use, helping to avoid overdosing or improper use.
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Monitoring for Side Effects: If you start taking an herb, a healthcare professional can monitor you for any adverse reactions or side effects, adjusting the regimen as necessary.
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Evidence-Based Advice: A medical professional, particularly one knowledgeable in both conventional medicine and herbal supplements, can offer advice based on the latest scientific evidence.
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Navigating Regulatory Issues: Since the regulation of herbal supplements can be less stringent than for pharmaceuticals, a healthcare professional can help in choosing products from reputable sources to ensure quality and purity.

In summary, taking the time to learn about herbal supplements and seeking professional medical advice before using them is key to maximizing their benefits while minimizing risks. This approach helps integrate herbal supplementation safely and effectively into your overall health plan.

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