The Food and Drug Administration (FDA) regulates herbal supplements, but not in the same way that it regulates food or medicine. Herbal remedies are categorized as "dietary supplements." The rules for dietary supplements are not nearly as strict as the rules that apply to food and drugs. For example, manufacturers of herbal supplements don't have to get their products approved by the FDA before they put them on the market. Once the dietary supplement is on the market, it is ultimately the FDA's responsibility to monitor its safety. However, the FDA doesn't have the manpower or funding to keep up with all of the new products that are constantly being introduced. If the FDA does find that an herbal supplement isn't safe, it can issue a warning or require that the manufacturer or distributer remove that product from the market.
These rules can assure us that herbal supplements meet certain standards for quality and that the FDA can take action to stop dangerous products from being sold. However, these rules don't assure consumers that these herbal products are safe for use. They certainly don't assure consumers that these products are proven effective. Many herbal supplements contain powerful, active ingredients that have strong, drug-like effects on your body, which can put you at risk for unexpected adverse effects. Some herbal supplements may interact with your prescription medications and can cause harmful, life-threatening complications. Also, research has shown that many of these "natural" remedies don't actually contain the ingredients listed on their label, and if so, they usually don't contain the correct amounts. Some supplements have been found to be contaminated with ingredients like arsenic, a poison.
Herbal products may also be labeled with certain health claims, such as the ability to correct a nutrient deficiency, support certain aspects of your health and help with certain bodily functions, but they must include a disclaimer that states that the FDA has not evaluated said health claim. Manufacturers of herbal supplements do have to follow good manufacturing practices (GMPs) in order to ensure that their products are processed consistently and meet quality standards. GMPs are supposed to ensure that the supplements contain the correct ingredients listed on their labels and that they are free of contaminants or incorrect ingredients, but this doesn't always happen.
So how can you protect yourself and ensure that the herbal product or dietary supplement you are purchasing is safe, effective and worth your hard-earned money? First, before taking any herbal supplement, be sure to discuss the issue with your physician. You can also check out ConsumerLab.com, an independent lab that tests dietary supplements. Two other reliable sources are the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (both have websites). Take caution if there isn't evidence-based scientific research that supports that the herbal supplement is safe and effective.
Kari Hartel, RD, LD is a Registered Dietitian and freelance writer based out of St. Louis, MO. Kari is passionate about nutrition education and the prevention of chronic disease through a healthy diet and active lifestyle. Kari holds a Bachelor of Science in Dietetics from Southeast Missouri State University and is committed to helping people lead healthy lives. She completed a yearlong dietetic internship at OSF St. Francis Medical Center in Peoria, IL, where she worked with a multitude of clients and patients with complicated diagnoses. She planned, marketed, and implemented nutrition education programs and cooking demonstrations for the general public as well as for special populations, including patients with cancer, heart disease, diabetes, Alzheimer's disease, obesity, and school-aged children. Contact Kari at KariHartelRD@gmail.com.