MANAGED/dpi1st/mark2nd

By HOWARD FINE

Staff Reporter

They have exotic names like St. John’s wort and ginkgo biloba and promise to “detoxify the body” or “harmonize the body’s energies” eerily reminiscent of potions sold by traveling salesmen 100 years ago.

The risks associated with these products also remain pretty much the same as they were with products sold a century ago, when customers had no way of knowing what they were buying and no assurance that their health would not be harmed by using them.

In other words, there was no regulation then, and there is not much more today.

“Dietary supplements, herbs and minerals are completely unregulated,” said Sidney Wolfe, director of Public Citizen’s Health Research Group. “It’s playing a version of Russian roulette. You take a big dose of some chemical that doesn’t have to be tested in any way and you are putting it in your body. Most are probably harmless, but there are always some that are not.”

Unlike drugs, dietary supplements and herbs are not regulated by the U.S. Food and Drug Administration. They are not peer-reviewed by scientific panels and not required to go through clinical trials and the lengthy FDA approval process to get on the market.

“The FDA cannot vouch for the safety and efficacy of dietary supplements,” said FDA spokesman Brad Stone.

The only restrictions are what manufacturers can advertise and put on labels. They cannot, for example, claim that the substance will cure cancer or any other medical condition.

Yet, even here, not every product is screened; agencies respond primarily to complaints. When warranted by a significant number of serious complaints and sufficient proof, the FDA can order a product removed from store shelves.

But the FDA says such serious problems are rare.

“By and large, dietary supplements have not given strong indications of risk to the public,” Stone said. “In a few instances, there have been some ingredients that have been of some concern. If we receive complaints about a dietary supplement product, we can certainly look into whether there is a problem.”

The Federal Trade Commission, which regulates advertising of dietary supplements, also responds mostly on a complaint basis. FTC attorney Michelle Rusk said the agency has opened about 50 cases of deceptive advertising in the last 10 years, including recent cases against a company promoting impotence cures from an herbal product and a company with a supplement to treat attention deficit disorder.

“In most of the cases we take up, it is pretty clear there is no support for the claims they are making. In some cases, they border on fraud,” Rusk said. “We tend not to bring cases that are close calls.”

While industry officials downplay any risk, consumer and health advocates argue that the federal government is not doing its job in protecting the public.

“From the consumer’s point of view, it is definitely buy at your own risk. There are no publicly enforced standards,” said V. Srini Srinivasan, senior scientist at U.S. Pharmacopeia, a Rockville, Md.,-based non-profit organization that develops standards for the manufacture of medicines. “If I buy a tablet of an herb or dietary supplement, I don’t even know whether it will dissolve in the body, much less what the effects will be.”

So why is there so little regulation?

The answer lies mostly with a single piece of legislation passed by Congress in 1994: the Dietary Supplement Health and Education Act, or DSHEA. That act, passed despite opposition to some of its provisions from the FDA, essentially gave dietary supplement and herbal remedy makers the freedom to market their products.

“Given this law, there is not a lot that anyone can do to regulate this industry,” said Wolfe. “In fact, since the law has passed, one of the hottest investment tips around has been to put money into one of these supplement companies. They don’t have to spend any money to demonstrate the effectiveness of their products.”

DSHEA did establish an office under the National Institutes of Health to coordinate research on these products, but it’s too strapped to fully research the exploding number of new herbal and dietary supplement products coming to market.

“The market is moving much faster than the ability of scientists to figure out the effects of these products,” said Dr. Rebecca Costello, deputy director of the Office of Dietary Supplements at the National Institutes of Health. “Private industry, academia and government are all working on aspects of research, but that takes time and money. Right now, we really know very little about how botanicals and herbs react in the body and the types of adverse reactions they may engender. There is also very little data on supplement interactions, and interactions between supplements and drugs.”

There have been several episodes of illnesses and even deaths attributed to these substances. One of better-known examples occurred earlier this decade with the amino acid L-tryptophan, which was cited as the principal cause of death in about three dozen cases. The herb ephedra has also been tied to several cases of seizures, heart attack, stroke and death, according to the FDA.

So many other complaints have surfaced that the FDA has published a two-page list of substances that have had negative side effects reported. But Wolfe said this is no way to go about regulating dietary supplements and alternative medicines.

“How many more episodes of people being seriously injured or killed must occur before the law is changed?” Wolfe asked.

With little regulation on the federal level, a few states have stepped in. Florida, for example, has banned products containing ephedra, according to the FDA’s Guide to Dietary Supplements. California, though, is generally in line with the federal government with respect to dietary supplements, according to Susan Loscutoff, staff toxicologist in the food and drug branch of the state Department of Health Services.

Loscutoff said the only area where California has moved beyond federal regulation is in requiring label notices on ingredients that can cause stimulant-laxative effects, such as senna or rhubarb root.

Loscutoff said the state has set up a hotline for complaints but that line is little used. “We get very few complaints because people don’t know who to call or don’t feel their complaint is serious enough,” Loscutoff said. “Over the years, I’ve talked to many people who have used dietary supplements and have had tingling fingers or blood in their urine. But these people just stopped using them; they didn’t call anyone and report these symptoms at the time.”

In the absence of regulation, industry is stepping in to establish guidelines. U.S. Pharmacopeia is now trying to come up with manufacturing standards for the 15 most common types of dietary supplements and herbal products. But it is up to the manufacturer itself to determine whether it wishes to conform to the standard; no manufacturer is required to do so, Srinivasan said.