FDA loosens reins

The US Food and Drug Administration once had the power to force manufacturers of over-the-counter dietary supplements, including herbal remedies, to prove those products were safe, if the agency felt such a pre-market review was warranted.

That changed in 1994, when Congress passed the Dietary Supplement Health and Education Act, which gives sellers of vitamins and herbs the freedom to tout the alleged benefits of their products without much FDA intervention.

Since DSHEA, it’s been possible to put a supplement on the market and keep it there until the FDA finds clear evidence that the product is harmful. Unlike drugs regulated by the FDA, dietary supplements and herbs do not have to be proven to be safe or effective to be sold.

Before DSHEA, all health claims on supplements – as on food – had to have FDA approval before marketing. Since DSHEA, manufacturers have been able to make “structure/function” claims without prior approval. That means they haven’t been able to say a product prevents a particular disease, like depression, but they can say something vague like the product is a “mood enhancer.”

But the vagueness of struc ture/ function claims has caused considerable confusion among consumers. In response to that, last week, the FDA issued a new ruling on disease claims, which takes effect in 29 days.

It states that a number of common conditions such as aging and pregnancy are normal life stages, not diseases, and therefore manufacturers can make structure/function claims for products aimed at them, says Peggy Dotzel, acting associate commissioner for policy at the FDA.

But some consumer advocates say the ruling is a blow to consumer protection. The change is a “huge weakening” of the previous FDA proposal, says Dr. Sidney M. Wolfe, director of Public Health Citizen Research Group in Washington, D.C. It is “a snake-oil exemption” and a “complete cave-in to the industry.”

On the other hand, industry representatives were delighted.

“The FDA has backed down from its previous, ill-considered proposal to redefine the word `disease’ by broadening it. . .to include nonpathological states that are a normal function of aging or the body,” said Mark Blumenthal, executive director of the American Botanical Council in Austin, Texas, a nonprofit research and education organization funded in part by the herbal industry.

Under the FDA’s original proposal, “menopause would be considered a disease. Even balding and graying of a beard would have been considered a disease,” he said.

In essence, he added, the final rule now “allows herbal products to continue making certain kinds of claims that might not have been able to be made had that definition of disease gone into final status.”

With manufacturing of herbal products, DSHEA requires only that manufacturers produce them in accordance with “good manufacturing practices” of the food industry. But there is a wide range of standards within the food regulations, which are often less stringent than those in the pharmaceutical industry.

The FDA is now writing more stringent manufacturing regulations for supplements and has sought comments from supplement makers and the public.

While the United States continues to struggle with ways to regulate the herbal industry, other countries have long had a better grip on things.

In Germany, herbal products are regulated largely as pharmaceuticals – both as prescription and over-the-counter drugs, notes John Cardellina of the Council for Responsible Nutrition, a Washington-based group representing the supplement industry. But, he adds, the German “approval process for drugs is not as stringent as the FDA approval process.”