Practices:

 

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Dietary SupplementsDietary Supplements

Health care practitioners, both “conventional” and “alternative,” recommend, and sometimes sell, dietary supplements, such as vitamins, herbs and minerals. Some supplements are safe and effective when properly used and some are deadly, but for most the safety and efficacy is unknown. Unfortunately, a 2002 Harris Poll indicated that a majority of adults are misinformed about the extent to which government regulates the safety of dietary supplements. If you are considering use of a dietary supplement, you should know the following:

  • The federal government does NOT approve dietary supplements before they are marketed to consumers. The Food and Drug Administration (FDA) has no authority to require that supplements be approved for safety or effectiveness prior to marketing.
  • Unlike drug manufacturers, who are required to include warnings related to adverse effects and contraindications, dietary supplement manufacturers are required to include few such warnings about adverse effects on product labels. Thus, the lack of a warning label on a dietary supplement does NOT mean that it is safe. One 2003 government study of 100 supplement labels found that the labels were limited in their ability to guide the informed and appropriate use of dietary supplements among consumers and often did not present information in a manner that facilitates consumer understanding.
  • “Natural” does not mean “safe.” In addition, taking combinations of some supplements or using certain products in conjunction with prescription drugs could lead to harmful and potentially life-threatening results.
  • Only recently has the FDA been given authority to require supplement manufacturers to report post-marketing serious adverse events. There is still no requirement that manufacturers report mild or moderate adverse events. The FDA recently estimated that the actual number of adverse events per year at over 50,000, which indicates serious underreporting of adverse events.
  • Once the FDA has identified a safety concern about a supplement, it has limited ability to efficiently and effectively remove a product from the market. For example, the FDA lacks mandatory recall authority. It took ten years after the FDA issued its first advisory on ephedra, a widely-used weight-loss and body-building aid, to ban this ingredient, and then only after thousands of reports of adverse events, including a number of deaths.
  • The fact that a dietary supplement is recommended by a healthcare practitioner does NOT necessarily mean the supplement is safe and effective. Make sure your practitioner is not just relying on the label and that he/she has a source of accurate, up-to-date information. Only someone with sufficient education in pharmacology, such as an M.D., D.O., or Pharmacist, is qualified to determine whether a supplement might adversely interact with any medications you are taking.
  • Do NOT rely on health food store clerks and other untrained persons to recommend dietary supplements for your condition.

In summary, reading the label on a dietary supplement will NOT tell you whether it is safe or effective or what ingredients it actually contains. For more information about supplements, you can go to the FDA’s website, www.fda.gov or to the National Institutes of Health Office of Dietary Supplements, http://dietary-supplements.info.nih.gov. ALWAYS TELL YOUR HEALTH CARE PROVIDERS ABOUT YOUR SUPPLEMENT USE AND MAKE SURE YOU HAVE ACCURATE INFORMATION ABOUT POSSIBLE DRUG INTERACTIONS.

If you think your healthcare provider, or a person not licensed as a healthcare provider, has inappropriately prescribed, recommended or sold you dietary supplements, see “Your rights as a healthcare consumer under Florida law.”

References:

U.S. Government Accountability Office, GAO 09-250, “Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding,” January 29, 2009. http://www.gao.gov/products/GAO-09-250

Food and Drug Administration, www.fda.gov

Office of Dietary Supplements, National Institutes of Health, http://dietary-supplements.info.nih.gov
 

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