In 1994, with the aid of Sen. Orrin Hatch, the US passed the Dietary Supplement Health and Education Act, which allowed "natural supplements to be marketed without any proof of their purity, safety or efficacy. Producers of these supplements are largely exempt from regulation by the Food and Drug Administration, which can take action against them only if they make claims about their products curing or alleviating disease — or if, say, their customers start dropping dead."
Or, if they start losing their sense of smell. Zicam protests its innocence, but is voluntarily recalling the affected products, now that the FDA has started to step in. (In 2006, Zicam also protested its innocence as it settled out of court with 340 anosmic users for $12 million.)