Nutritionist calls for tighter regulation of supplements

September 17, 1999
Web posted at: 10:13 AM EDT (1413 GMT)

In this story: Sales of supplements on the rise The FDA's limited role Informing consumers should be a priority RELATEDS

By Laura Lane

(WebMD) -- There's a cabinet in Annie Liu's house that she rarely opens. For years, the 59-year-old Northern Californian stocked her cabinet with bottle after bottle of vitamins and herbs. But the supplements never lived up to their promises of sharpening her memory, improving her circulation or giving her more energy, and finally she became fearful that they might actually be doing her some harm.

Yet she hasn't quite lost hope that something on that shelf might be just what her body needs. And so the bottles remain, creating clutter in her kitchen and in her mind.

Across the country, Liu's story is repeated again and again as Americans begin to think twice about the safety of dietary supplements. Recent reports of the supplement ma-huang causing such side effects as heart palpitations, psychosis, heart attacks and strokes are substantiating their fears.

With health claims for dietary supplements only loosely regulated, consumers are dangerously muddled about what really works and what is actually harmful. Scientists are saying that tightening regulations now could avert problems -- and even deaths -- later on.

Sales of supplements on the rise

Sales of dietary supplements have skyrocketed over the past several years, according to the Nutrition Business Journal, a San Diego-based independent research and publishing company. In 1996, Americans spent more than $6 billion on dietary supplements. By next year, sales could top $14 billion.

With sales increasing and more than one-half of all Americans taking some kind of dietary supplement, the urgency for regulation is in order, says Dr. Steven Zeisel, chair of the nutrition department at the University of North Carolina at Chapel Hill, in a commentary published in this week's journal Science.

"Nobody's checking leaves and plants brought into the United States and manufactured into supplements," says Zeisel, who has studied nutritional supplements for more than 20 years.

Like food products and medications, supplements also need to be regulated because the ingredients used to make them may contain harmful dyes, chemicals and contaminants, Zeisel says.

The FDA's limited role

However, the Food and Drug Administration has its hands tied, he says. Federal legislation passed in 1994 severely limits the FDA from regulating the safety and efficacy of supplements that land on store shelves.

At the very least, the FDA should regulate safety, if not efficacy, Zeisel says. And that is exactly what the FDA has planned. In 1997, the FDA proposed a set of rules for good manufacturing processes and held a public meeting this past July in Las Vegas to discuss the rules. FDA officials failed to respond for this story.

Zeisel is not alone. Sen. Orrin Hatch, R-Utah, was a main proponent of the 1994 legislation, called the Dietary Supplement Health and Education Act. In a statement, Hatch said that the act was originally designed to "guarantee Americans the right to consume dietary supplements." However, the senator is now supportive of the FDA's increased role in regulating manufacturing standards.

Informing consumers should be a priority

Even with better standards, Americans still need to be adequately informed about what they're taking and purchasing, says Dr. David Heber, a supplement researcher who is director of the Center for Human Nutrition at the University of California in Los Angeles. He believes the FDA should form stricter rules for labeling and marketing, so consumers know exactly what they're getting. He says that supplement companies that do invest the time and money toward research should be rewarded.

Heber estimates that less than one-half of all supplement companies are currently involved in research. Americans still don't know which supplements are the most reliable and trustworthy and which claims are true.

Liu says she learned of certain supplements mostly through clerks at health-food stores or by word of mouth, both of which she finds too unreliable. "Right now you don't know what you're doing," Liu says. "You just hear something's good for you."

But labels found on bottles are designed to help the consumer, says Bill Soller, director of science and technology at the Consumer Healthcare Products Association, a trade group representing manufacturers of dietary supplements and over-the-counter medications. The 1994 act restricted companies from making claims of preventing or treating disease, and companies that abide by the law can help educate consumers about the supplements they are buying.

However, these companies are "unfairly tarred by the practices of some" who make claims that are beyond the confines of guidelines set in the law, Soller says.

He adds that dietary supplements are classified as foods, so they are subject to the same type of regulatory scrutiny. He and his association are currently talking with the FDA about directing more resources toward regulating dietary supplements.

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