10 | 27 | 2007 Posted By Regan Zambri & Long

Dietary Supplement Safety Tips: Natural and Herbal Labels Don't Guarantee Safety

U.S. Marshals recently seized $71,000 worth of dietary supplements at the request of the U.S. Food and Drug Administration (FDA).  The supplements, marketed and distributed by FulLife Natural Options, Inc., of Boca Raton, Florida, had been promoted for the treatment of diabetes, anemia and hypertension, but had never been approved by the FDA, making them unapproved new drugs.  The agency moved to have the supplements seized by federal agents after conducting multiple investigations of FulLife's business practices and issuing warnings regarding the unproven health claims.

Earlier this fall, the FDA directed U.S. Marshals to seize $41,000 worth of supplements distributed by Charron Nutrition of Tallahassee, Florida.  Those supplements were also marketed as disease prevention and treatment options without FDA approval.  Marketed under the names Glucobetic, Neuro-betic, Ocu-Comp, Atri-Oxi, Super-Flex, MSM-1000, and Atri-E-400, those supplements were promoted for use in patients suffering from diabetes, arthritis and other health issues. 

The National Center for Complementary and Alternative Medicine, a division of the National Institutes of Health, offers the following advice regarding the use of herbal and dietary supplements:

  • "It's important to know that just because an herbal supplement is labeled "natural" does not mean it is safe or without any harmful effects. For example, the herbs kava and comfrey have been linked to serious liver damage.

  • Herbal supplements can act in the same way as drugs. Therefore, they can cause medical problems if not used correctly or if taken in large amounts. In some cases, people have experienced negative effects even though they followed the instructions on a supplement label.

  • Women who are pregnant or nursing should be especially cautious about using herbal supplements, a type of dietary supplement that contains herbs, either alone or in mixtures, since these products can act like drugs. This caution also applies to treating children with herbal supplements.

  • It is important to consult your health care provider before using an herbal supplement, especially if you are taking any medications (whether prescription or over-the-counter). Some herbal supplements are known to interact with medications in ways that cause health problems. Even if your provider does not know about a particular supplement, he can access the latest medical guidance on its uses, risks, and interactions.

  • If you use herbal supplements, it is best to do so under the guidance of a medical professional who has been properly trained in herbal medicine. This is especially important for herbs that are part of a whole medical system.  A complete system of theory and practice that has evolved over time in different cultures and apart from conventional medicine. Examples of whole medical systems include traditional Chinese medicine, Ayurvedic medicine, homeopathy, and naturopathy, Traditional Chinese medicine is a whole medical system that originated in China. It is based on the concept that disease results from disruption in the flow of qi and imbalance in the forces of yin and yang. Practices such as herbs, meditation, massage, and acupuncture seek to aid healing by restoring the yin-yang balance and the flow of qi.  Or Ayurvedic medicine, a whole medical system that originated in India. It aims to integrate the body, mind, and spirit to prevent and treat disease. Therapies used include herbs, massage, and yoga.
  • In the United States, herbal and other dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods. This means that they do not have to meet the same standards as drugs and over-the-counter medications for proof of safety, effectiveness, and what the FDA calls Good Manufacturing Practices.
  • The active ingredient(s) in many herbs and herbal supplements are not known. There may be dozens, even hundreds, of such compounds in an herbal supplement. Scientists are currently working to identify these ingredients and analyze products, using sophisticated technology. Identifying the active ingredients in herbs and understanding how herbs affect the body are important research areas for the National Center for Complementary and Alternative Medicine (NCCAM).

  • Published analyses of herbal supplements have found differences between what's listed on the label and what's in the bottle. This means that you may be taking less--or more--of the supplement than what the label indicates. Also, the word "standardized" on a product label is no guarantee of higher product quality, since in the United States there is no legal definition of "standardized" (or "certified" or "verified") for supplements.

  • Some herbal supplements have been found to be contaminated with metals, unlabeled prescription drugs, microorganisms, or other substances.

  • There has been an increase in the number of Web sites that sell and promote herbal supplements on the Internet. The Federal Government has taken legal action against a number of company sites because they have been shown to contain incorrect statements and to be deceptive to consumers. It is important to know how to evaluate the claims that are made for supplements."

Previously on the D.C. Metro Area Medical Malpractice Law Blog, we have posted articles related to:

 For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.