With all the talk about healthcare reform going around Washington, one thing that has been overlooked is an industry in which tens of billions of dollars is spent annually with relatively limited federal oversight—namely dietary supplements, or "complimentary medicine." The passage of the Dietary Supplement Health and Education Act (DSHEA), in 1994, represented an attempt by Congress to regulate the burgeoning marketplace in "natural" health remedies. The intent was to protect consumers from snake-oil salesman while allowing access to a large and legitimate category of health options. The most important reform in DSHEA established that dietary supplements would be regulated as foods rather than medicines. For that reason alone, it's time to review the shortcomings of DSHEA.
To address this issue, it's important to understand "structure and function" claims. In February 2000, FDA published regulations defining the types of structure and function claims permitted on dietary supplement labels. During the rule-making process, the agency considered what factors make for a suitable structure and function claim, as well as a disease claim. A structure and function claim, for example, is, "Arouses or increases sexual desire and improves sexual performance," or "Helps promote urinary tract health," or "Promotes relaxation."
Disease claims include statements like "Improves urine flow in men over 50 years old," "Lowers cholesterol," "Reduces joint pain," or "Relieves headache." This includes claims that are explicit—made as statements on the label—as well as claims that are implied in the name of a product (e.g., "Natural Prozac").
More than a few manufacturers of dietary supplements purposely blur the distinctions between structure and function claims and disease claims. Here are just a few from a recent Google search: "Herbal dietary supplements and depression treatment," "Alternative medicine from Japan helps curb malignant tumor growth," "How a dietary supplement can help protect against Alzheimer's Disease." And my personal favorite: "Get the same effects of real extacy without the risks—our all natural herbal ecstacy can keep you up and active at raves all night long."
Are these products foods or medicines? Well, to paraphrase the great Hoosier poet James Whitcomb Riley, "If it walks like a duck and swims like a duck and quacks like a duck, I call that bird a duck."
The truth is that none of those claims refer to products that bear any resemblance to food. Rather, these products are being marketed—and consumed—as treatments for medical conditions or as lifestyle enhancements. They should be regulated as such—and at least as rigorously as over-the-counter products.
Consider also that under DSHEA, FDA does not approve manufacturers' claims on the labels of such products, as it does with drugs. This must change, along with dietary supplement marketing and promotion. Compared to FDA's oversight of pharmaceutical advertising, "complementary medicine" communications are a free-for-all.
Yet another DSHEA reform issue concerns dietary supplements and adverse-events reporting. Under current law, manufacturers of dietary supplements are not required to report adverse events to the FDA. Recent product warnings and recalls point to the need for this important reform. In June, ABC News reported that "about 130 consumers have filed complaints, saying they permanently lost their sense of smell after using [the popular homeopathic cold remedy] Zicam." Hydroxycut, a popular weight loss product, was recently recalled by its manufacturer in the wake of adverse events reports that included liver damage and one death. If we want greater safety when it comes to health-related products, then reporting of adverse events for dietary supplements must be mandatory.
To those who would peddle dietary supplements as medicine, the message must be that FDA has the authority to stop you if and when you cross the line. And to Congress, the message is that if FDA is to embrace a "safety first" philosophy, then DSHEA needs to be reformed—because the line has been crossed too many times. This oversight must be corrected immediately.
