Food or drug . . . or neither?

Before herbal remedies became big business, most were homemade or made in small batches, with the grower/producer selling directly to the end user. Because the government didn’t regulate or oversee these transactions, consumers had to trust that the herbal concoctions contained what their makers said they did. However, over the last few decades, interest in “natural” remedies has grown, and bigger and bigger players — including large pharmaceutical companies — have entered the market, driving the stakes higher.

Talk began to circulate about the possibility of the government stepping in to regulate herbal remedies. The reaction was swift and strong. Manufacturers feared that government regulations would prevent them from selling their wares; consumers rebelled against government control over what they could put into their bodies. A grassroots campaign to limit government regulation was successful, and the result was the Dietary Supplement Health and Education Act of 1994 (DSHEA).

You may have noticed that the medicinal claims of herbal products are couched in vague terms and that the products are described as supplements, not remedies. There’s a good reason for this. The DSHEA defines a dietary supplement as a product that’s intended to supplement the diet rather than cure a disease. The result is that the makers of dietary supplements are per-mitted to make broad claims that the product can support this or that structure or function. For example, vendors can say that echinacea supplements “support a healthy immune system” or that chamomile “calms the digestive tract.” They can’t claim that the product cures an ailment; doing so would change the product classification from supplement to drug, and thus require the clinical trials and rigorous testing pharmaceutical companies must do before introducing a medicine to the market.

Under DSHEA, a manufacturer is responsible for determining that the dietary supplements it makes are safe and that claims made about them are substantiated by adequate evidence to show that they aren’t false or misleading. However, dietary supplements don’t need FDA approval before they’re marketed.