Wow! Is it possible? Ginseng slows aging, increases mental capacity, and increases sexual performance. Stinging nettle has been thought to fight urinary tract infections, kidney and bladder stones, and rheumatism1,4. Echinacea is used to prevent colds. This all sounds pretty great! But what are the promoters of herbal supplements not telling us?
What is an herbal supplement?
An herbal supplement is a product made from plants (“botanicals”) and can be ingested as a pill, brewed as herbal tea, applied to the skin as gels, or added to bath water4. Herbal supplements are not intended to replace a healthy diet. Herbal supplements typically aim to treat medical problems, maintain health, or offer some physical benefit. However, unlike drugs, supplements are “not intended to treat, diagnose, prevent, or cure diseases.”1
How are they regulated?
While herbal supplements may look similar to over-the-counter (OTC) and prescription medications, they are not treated the same by the Food and Drug Administration (FDA). Herbal supplements fall under the category called dietary supplements under the FDA, and are regulated differently from drugs1. The biggest difference you’ll see is that prescription and OTC drugs are strictly regulated before entering the market, but herbal supplements are only monitored after they enter the market.
|FDA Dietary Supplement regulations||FDA Drug regulations|
|Quality Control||Manufacturers and distributors are responsible for following the current Good Manufacturing Process by ensuring their products are not contaminated, have impurities, or are misbranded.||Same as dietary supplements.|
|Safety||Only after the supplement is on the market can the FDA monitor its safety. Dietary supplement firms are required to report to the FDA any serious adverse events that are reported to them by consumers or health care professionals. If the FDA finds a product to be unsafe, they can take action against the manufacturer or the distributor, and may issue a warning or require that the product be removed from the market.||Before a drug can go on the market, companies must perform a series of clinical trials in humans, in which the FDA monitors, to test if the drug is effective and safe. If the review establishes that the benefits outweigh the known risks, the drug is approved for sale. Once on the market, the FDA monitors its performance through MedWatch, healthcare practitioners, and pharmaceutical companies. If an unexpected drug-related health risk is detected, a Drug Safety Communication may be issued to consumers and healthcare professionals.|
|Labeling||Manufacturers and distributers of dietary ingredients are responsible for making sure they meet all of the safety and labeling requirements for DSHEA and FDA regulations. Label approval is not required in order to import or distribute a dietary supplement.||All data collected is sent to the FDA, in which a team of scientists and professionals review the data and proposed labeling. All changes to a drug’s label must be approved by FDA.|
|Health Claims||Law does not require the manufacturer or seller to prove the FDA’s satisfaction with the accuracy or truthfulness of claims before it appears on the product.||Claims are required to review data and be evaluated by a team of physicians, statisticians, toxicologists, pharmacologists, chemists, and other scientists to before it is labeled with the health claim.|
The FDA Adverse Events Reporting System (FAERS) keeps track of all of the reports received for drugs and herbal supplements that cause adverse effects. The total amount of received reports for the year 2014 was 1,289,133.
“Natural” does not mean “Safe”
Anything strong enough to have effects like “enhancing mood” and “lowering cholesterol” is strong enough to have other effects on your body2. Supplements can interact with other medications to make them ineffective, and even harmful, such as certain heart medications like warfarin, digoxin, simvastatin, and atorvastatin6. Some herbs can cause serious damage your organs, such as your kidneys (aristolochia)7 or liver (kava, pennyroyal)8. Be sure to talk to your doctor before you start taking any herbal supplements.
Common Herbal Supplement Claims and Potential Risks3,4
|Herbal Supplement||Health Claims||Potential Risks|
|Echinacea||Stimulates the immune system to help cure colds, flu, and other infections; wounds and skin problems such as acne or boils||Fatigue, dizziness, headache, and gastrointestinal symptoms|
|Garlic||To lower cholesterol; to prevent and treat colds and certain infections||Increases the risk of bleeding when taken with blood thinning drugs. Nausea, burning sensation in mouth, throat, and stomach, halitosis, and body odor.|
|Ginkgo||To improve memory, circulation, and mental function as well as prevent altitude sickness||Increases risk of excess bleeding when taken with blood thinning drugs. Nausea, dyspepsia, headache, and heart palpitations|
|Ginseng||Slows aging, increases mental capacity, and increases sexual performance||Anorexia, rash, changes in blood pressure, and headache|
|St. John’s Wort||To treat mental disorders and nerve pain; malaria; as a sedative; and as a balm for wounds, burns, and insect bites. Today used for depression, anxiety, and/or sleep disorders||Photosensitivity, dry mouth, dizziness, anxiety, confusion, gastrointestinal symptoms, sexual dysfunction. Several adverse reactions with medications.|
|Licorice Root||To treat cough, cirrhosis, and stomach ulcers||May increase blood pressure and has been associated with heart rhythm abnormalities|
|Hawthorn||To alleviate congestive heart failure and high blood pressure||Increase risk of bleeding when taken with blood-thinning drugs|
|Goldenseal||To alleviate constipation, acts as an anti-inflammatory||May decrease or increase blood pressure. May cause heart rhythm abnormalities. Increases risk of bleeding when taken with blood-thinning drugs.|
Other names: Chinese ephedra, ma huang
**Has been banned by the FDA from the market
|To treat cough and obesity||Life threatening increases in heart rate and blood pressure. Potentially has fatal interactions with many cardiac medicines.|
For more information about other herbs, click here.
If you are considering buying an herbal supplement5:
- Consult with your doctor FIRST. Be sure your doctor knows all the medications and supplements you are taking.
- Educate yourself. Learn as much as you can about the herbs before you take them. Are there any interactions with medications you’re taking? Are they hard on your kidneys or do you have kidney disease?
- Choose a brand that has independent quality control testing. Be on the lookout for USP, NSF, and Consumer Lab labels. These labels assure customers that the product has gone through rigorous testing and meet safety and quality standards.
- Follow directions. If you do end up using an herbal supplement, use the recommended dosage on the label. Keep track of what you take so you don’t accidentally overdose.
- Be alert for allergic reactions. A severe reaction can cause difficulty breathing.
- Check alerts and advisories. The FDA and the National Center for Complementary and Alternative Medicine (NCCAM) have lists on their websites of supplements that have been reported to cause adverse health effects, as well as current alerts and advisories for certain supplements.
Ask your Doctor before you begin taking herbal supplements if5:
- You’re taking prescription or OTC medications
- You’re pregnant or breastfeeding
- You’re having surgery
- You’re younger than 18 or older than 65
Just like with your prescription or over-the-counter medications, herbal supplements can produce some powerful effects on your body. While some herbal supplements may have benefits that outweigh the risks, there are certainly many for which this is not the case. Remember, herbal supplements are not intended to replace a healthy, well-balanced diet. For optimal health, talk to your doctor if you are considering taking an herbal supplement.
- Dietary Supplements fda.gov
- “Herbal Supplements: Helpful Or Harmful?” My.clevelandclinic.org
- “Herbs At A Glance“NCCIH.
- “Office Of Dietary Supplements – Background Information: Botanical Dietary Supplements” Ods.od.nih.gov
- “Using Dietary Supplements Wisely” NCCIH
- Cohen, P. A. and Ernst, E. (2010), Safety of Herbal Supplements: A Guide for Cardiologists. Cardiovascular Therapeutics, 28: 246–253. doi: 10.1111/j.1755-5922.2010.00193.x
- Combest, Wendell et al. “Effects Of Herbal Supplements On The Kidney”. Urologic Nursing 25.5 (2005): 381-386. Document preview
- Bunchorntavakul, C. and Reddy, K. R. (2013), Review article: herbal and dietary supplement hepatotoxicity. Alimentary Pharmacology & Therapeutics, 37: 3–17. doi: 10.1111/apt.12109