The Food and Drug Administration has issued a final rule to address the labeling and marketing of dietary supplements. Many health advocates are distressed about some of its content.
The new rule outlines how the FDA will now differentiate between “structure and function” claims and disease claims. In an earlier version of the rule, the agency included some common conditions, such as pregnancy-related morning sickness and aging-related senility, as disease states. The revised, final rule allows manufacturers to make unregulated claims about common conditions associated with aging, pregnancy, menopause, and adolescence.
Some health authorities are concerned that expansion of the structure-function category of claims will pose a danger to at least some segments of the population.
Dr. Roger P. Maickel, professor emeritus of pharmacology and toxicology at Purdue University, expressed concern about the possibility of agents being marketed to treat early-pregnancy morning sickness without sufficient safety testing. “Society is worried about environmental contaminants having adverse effects upon the developing fetus. In the absence of adequate premarketing safety testing, new agents may cause fetal deformities or even miscarriages. That may not be recognized until it is too late.”
Although dietary supplement manufacturers are legally required to have evidence to substantiate any claims made for their products, the FDA is not required to review the evidence before the supplements are placed on the market. For that reason, supplements must carry the statement that their claims are not reviewed by the FDA.
In 1994 Congress passed the Dietary Supplement Health and Education Act, or DSHEA, a law that paved the way for an explosion of promotional marketing of a wide variety of products–all under the category of “dietary supplement.” As part of DSHEA, Congress charged the FDA with implementing the new law by setting the standards for health claims and package labeling, among other directives.
The recent changes in the rules governing what manufacturers may claim about their products suggests that the FDA is weakening its already-loose oversight of these products. Dietary supplement labels or ads may not claim that a product can cure, prevent, or treat a disease, without scientific evidence to support that claim. Such claims are in the realm of drug regulation, and drug claims are subject to much stricter requirements for safety and efficacy testing. This distinction was made in DSHEA, but it was left to the FDA to decide exactly how to distinguish between drug and supplement claims.
Supplement labels and ads may make structure-function claims. Claims that supplements support the normal functioning of the body are allowed, as long as they do not state that the product can treat, cure, or prevent a specific disease. For example, manufacturers of calcium supplements may state that their products “support bone health,” but may not claim that they could “prevent or cure osteoporosis.”