Vitamins, herbs and other dietary supplements are sold as natural alternatives to pharmaceuticals and many people turn to them in an attempt to improve their health. Others seek supplements to lose weight or after hearing that they can help with serious medical conditions. These products are now used at least monthly by more than half of all Americans and their production, marketing and sales have become a .7 billion industry, according to the Nutrition Business Journal.
98-year-old Bob Stewart, a retired podiatrist and senior Olympian, credits his use of supplements for his healthy aging. Writer Betsy McMillan, a mother of two now adult children, however, nearly suffered permanent liver damage due to a supplement that contained potentially fatal levels of niacin.
Unlike pharmaceuticals which must be FDA-approved as safe and effective before they can be marketed supplements are considered as foods by regulators and assumed to be safe until proven otherwise. Although pharmaceutical manufacturers face inspections to ensure that the right dose is in the right pill without dangerous contaminants, supplements do not undergo such intense government scrutiny.
Despite many reports of health problems, only one supplement has ever been pulled from the market: the stimulant ephedra, which was banned in 2004 following reports of deaths. With such little regulation and oversight, safe supplement use requires that consumers be cautious and savvy.
"Supplement is a broad term that includes vitamins, minerals, herbs and botanicals," says Carol Haggans, a registered dietician and science and health communication consultant for the Office of Dietary Supplements of the National Institutes of Health. Herbs and botanicals are derived from plants, while other supplements may include animal sources. Vitamins are essential nutrients made up of organic compounds, while minerals is an imprecise term for certain chemical elements necessary to life, like calcium.
"They're regulated under the umbrella of foods and are not intended to treat, diagnose, mitigate, cure or prevent disease. If something claims to do that, then it becomes a drug under FDA regulation," Haggans says.
She adds, "The FDA has instituted 'good manufacturing practices' (GMP) that manufacturers must follow to ensure the identity and quality of supplements and they can take enforcement action if it's unsafe or unfit for human consumption, but they do not routinely test products." Once manufacturers implement these practices, they can display a seal on their packaging, noting their compliance.
But Dr. Bob Linden, a general practitioner and author who has used supplements but also has seen problems with them in patients, says he's rarely seen the GMP seal in stores where he lives in Connecticut, despite the agency's plan to complete most of the implementation by last year.
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