If It Walks Like a Duck - Pharmaceutical Executive

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If It Walks Like a Duck


Pharmaceutical Executive

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." In 1994, to regulate the burgeoning marketplace in "natural" health remedies, Congress passed the Dietary Supplement Health and Education Act (DSHEA). Formalizing the regulation of dietary supplements as food, the intent of DSHEA was to protect consumers from snake-oil salesman while allowing access to a large and legitimate category of health options. DSHEA also gave the FDA more enforcement tools—like the mandate for supplement-specific Good Manufacturing Practices, and a provision that provided FDA with the ability to remove unsafe products from the market.

To address the issue of food vs. drug, 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.

Companies that blur the line between structure function claims and disease claims are making illegal claims under the law. And, under the law, FDA has the authority to take action against companies that make treatment claims.

Yet another DSHEA reform issue concerns dietary supplements and adverse-events reporting. Under the law, dietary supplement manufacturers are required to report serious adverse events to FDA. 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, the reporting of adverse events for dietary supplements must be diligently policed.

As in all industries, there are good and bad players and, when it comes to supplements, it’s unfortunate that it is often the outliers who generate most of the publicity. 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. Responsible companies play by the rules and abide by the laws. DSHEA already has provisions in place to take care of those bad actors—and so perhaps it’s not the law that needs to be revisited—maybe it’s time for us to ensure that FDA gets the staff resources and funding necessary to ensure that existing laws can be more fully enforced.

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