A Healthy Dose of Science : FDA wants vitamin and supplement sellers to document health claims
Dietary supplements represent a $4-billion-a-year industry, but a regulatory loophole leaves consumers relying largely on faith when it comes to judging their purity, potency and the health claims made for them. The Food and Drug Administration rightly wants to close that loophole by applying the same standards to vitamins and other supplements that are now applied to food. That has the supplement makers crying foul.
If the FDA gets its way, they claim, consumers will be denied valuable information and some popular products could even disappear from the market. FDA Commissioner David A. Kessler defines the issue more calmly. “We want people to have access to products that are safe and we want to assure consumers that claims made about (their) health and nutritional benefits are truthful.” Requirements for safety and honesty are unlikely to destroy a thriving industry, most of it reputable, any more than similar regulations have adversely affected the food industry.
The FDA doesn’t intend to limit access to vitamins and minerals. It does seek to allow health claims to be made for the supplements only when there is “significant scientific agreement” that they are valid. Right now only calcium supplements to deter osteoporosis meet that standard, though next month the FDA will act to allow claims that folic acid benefits women of childbearing age by preventing neural tube defects.
“Significant scientific agreement” is not as lofty a requirement as compelling scientific proof, but it demands more than just suggestive evidence. Vitamins C and E and beta-carotene, for example, may contribute to preventing certain cancers, heart disease and other conditions. Is the area of scientific agreement on that possibility broad enough to warrant such claims to be made for these supplements? The FDA will probably decide soon. The important thing is it will decide on the basis of what accepted studies show, not just on what is suspected. “Hype,” as Kessler put it, “cannot overwhelm science.” That is not, as some allege, regulatory overkill, but simple regulatory responsibility.
