How involved is the FDA in the regulation of dietary supplements?

Once upon a time (early 1990's to be exact), the Food and Drug Administration (FDA) tightly regulated dietary supplements. In addition, Congress was pondering passing two bills that would help the FDA fight cases of health fraud on the market. The first bill would have strengthened the FDA's enforcement hand while simultaneously spiking the penalties for violating the Food, Drug and Cosmetic Act. The second bill would have closed a loophole advertisers had found. See, the therapeutic promises and nutritional claims on a supplement label were subject to regulations, but advertisements for the product were not. This second bill, an amendment to the Federal Trade Commission Act, would have made the health claims in advertisements abide by the same regulations for the health claims on product labels.

Sounds like good ideas, right? Not if you're the U.S. dietary supplement industry, whose total sales as of 2006 were an estimated $22.1 billion. More regulations would dent profits. So the health-food industry and their associated lobby groups implored Congress to "preserve the consumer's freedom to choose dietary supplements." They argued that regulations meant the FDA could "put anybody out of business." They told consumers that if the bills were passed, consumers wouldn't be able to buy vitamins. This set off an avalanche of angry communications from consumers to Congress. The end result of this pressure from lobbyists, industry, and consumers was the passage of Dietary Supplement and Health Education Act (DSHEA). A bill that accomplished the exact opposite of what Congress had set out to do; instead of helping the FDA fight health fraud, it took away much of the FDA's power over dietary supplements, making the industry virtually unregulated. A 2010 U.S. Government Accountability Office (GAO) report concluded that consumers of dietary supplements are not adequately protected under current U.S. law and regulations.

So where does that leave us? What does DSHEA do? It defines a "dietary supplement" as any product containing dietary ingredients (including vitmains, minerals, herbs, botanical, amino acids) that is taken by mouth in addition to usual food and drink, and labeled as a dietary supplement. The FDA takes a back seat regulatory role under DSHEA. Instead of being in charge of pre-market approval of supplements, the burden of ensuring evidence of safety or efficacy in humans is left unto the manufacturer (no, they're not biased at all *note sarcasm*). Manufacturers have a green light for including ingredients with a safe history of use prior to 1994, and newer ingredients go through a notification process with the FDA. If after a supplement is released, it is found to be unsafe, then and only then can the FDA move in for damage control and take action to remove the product from shelves (see govt crackdown on HCG weight loss supplement).  The FDA uses adverse events reports as evidence of safety concerns, but this reporting system captures only an estimated 1 to 10 percent of all cases where supplements are linked to causing harm.

Now that I've got you all worried and paranoid about the state of supplement regulation (sorry about that, don't shoot the messenger), check out this link with information on what to know before you buy herbal supplements. For information on the labeling that is currently allowed on supplements, check out this link.