The FDA regulates both dietary supplement products and the ingredients found within them, and it does so under a different set of regulations than those governing “conventional” foods and drugs. Unlike drug regulation, the FDA does not approve dietary supplements for their effectiveness or safety before they are made available to consumers. Dietary supplements do not undergo the rigorous testing for effectiveness, interaction, or safety requirements that prescription and over-the-counter drugs do. In fact, as DSHEA dictates, the manufacturer of a dietary supplement or ingredient is responsible for ensuring that the product is safe, unadulterated, produced with good manufacturing practices, and properly and truthfully marked with a label that identifies the product as a dietary supplement and includes specific information about the supplement and its use.

Although dietary ingredients found in supplements are federally regulated, ingredients and additives that were already in the food supply prior to when DSHEA went into effect on October 15, 1994, were grandfathered in as “generally recognized as safe” (GRAS). GRAS substances don’t need FDA approval before being marketed, so many long-standing supplement ingredients have not actually endured FDA scrutiny for safety.

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For new dietary ingredients, DSHEA requires that manufacturers must notify the FDA 75 days before the product is to be introduced and provide the agency with evidence that the supplement is “reasonably expected to be safe”. Unfortunately, it is common for supplement distributors and manufacturers to ignore this requirement, as well as other regulations.

Because the FDA does not regulate dietary supplements as rigorously as it does drugs, supplements are sometimes sold contaminated with banned substances or prescription drugs. In 2010, for instance, the agency warned consumers not to take the Chinese weight-loss supplement Fruita Planta, because FDA testing had revealed it contained sibutramine, a drug that had been withdrawn from the United States market earlier that year for safety reasons. And in a 2013 study, Pieter Cohen, an assistant professor of medicine at Harvard Medical School who studies dietary supplement safety, and his colleagues found traces of a methamphetamine-like substance in a popular workout supplement.

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The FDA is responsible for taking action against unsafe or improperly labeled dietary supplements after they go to market, but this is not easy to do: The agency has to prove that the product is unsafe to restrict its use or remove it, and “there’s no effective system that the FDA has to identify these supplements, so hazardous supplements stay on the marketplace for years,” Cohen says. Even when the FDA announces that a supplement is unsafe, it may not cease being sold. In a 2011 study, Cohen and his colleagues found that after the FDA recalled a popular weight-loss supplement called Pai You Guo in 2009, women were able to continue buying it for years. This all said, the 2011 Food Safety Modernization Act (discussed in Chapter 20) expanded some of the FDA’s authority over supplement manufacturers. (INFOGRAPHIC 12.3)

Question 12.2