Health advocate decries proposed FDA rules on dietary supplements

Thursday, July 23, 1998

John Hammell claims a mixture of niacin, B-vitamins and herbs performed nothing short of a miracle in his ongoing battle against schizophrenia. After years of undergoing shock treatment and therapy sessions, the vitamin concoctions enabled Hammell to enjoy a relatively normal life.


For the past 10 years, Hammell, as the founder of the International Advocates for Health Freedom, has been promoting the benefits of vitamins, using his own story as evidence that dietary supplements work.


But Hammell fears his mission would suffer if the U.S. Food and Drug Administration approves a proposal forbidding claims that dietary supplements can treat or prevent diseases.


“Allegedly we have a First Amendment,” Hammell said. “If something is true, you should be allowed to say it. Right now, we have a situation going on where consumers are not going to be able to learn the truth.”


The FDA disagrees.


“Consumers want access to dietary supplements but also need reliable information about the products they are consuming,” said William Schultz, the agency's deputy commissioner for policy. “By clarifying for manufacturers what types of claims can and cannot be made on a dietary supplement label, this new proposal helps consumers make more informed and wiser choices.”


The latest move to change the agency's rules began this spring after the FDA's Commission on Dietary Supplement Labels suggested clarification of what claims may be made on supplement labels.


Under the proposal, the FDA would allow “truthful and non-misleading statements of effects on a body system, organ or function, provided that the context in which the claim appears does not suggest that the product treats, prevents or mitigates a disease.”


The agency plans to accept public comments on the proposal through Aug. 27.


Traditionally, the FDA has required food distributors or drug manufacturers to verify products with the agency before making any disease claims. If they don't go through the process, they must either forgo the claims or only make those based on the products' effects on the structure or function of the body.


For example, a dietary supplement manufacturer who can't verify that a product “protects against cancer” to the FDA's satisfaction may instead claim it “promotes the health of the urinary tract.” The latter statement also cannot be false or misleading.


For the First Amendment advocate, the process is troubling because the disease claims can only be made after securing FDA approval, says James Johnstone, an attorney who often handles cases involving the agency. That equates to prior restraint, he said.


But Johnstone says the FDA argument is that the process achieves an important governmental goal in preventing misleading claims and making sure substances are regulated properly. If it's the least restrictive means available, then the FDA's actions satisfy the U.S. Supreme Court's regulation test it established in 1980 in Central Hudson v. Public Service Commission of New York.


Despite that, Johnstone says the FDA historically has been able to enact very restrictive guidelines, such as forbidding labels that imply an effect on diseases.


Manufacturers “seldom go through the process,” Johnstone said. “The stakes are too high. It's a lot easier to change your labeling than to fight all of that.”


Hammell says he intends to fight the proposal not only by petitioning the FDA but also through Congress.


He says Rep. Ron Paul of Texas has sponsored legislation that would remove food from “the currently overbroad statute limitations of 'drug.' By doing that, the FDA could not keep us from making claims about dietary supplements if they are true.”