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Herbs Disturb FDA

Agency tells food makers they can't make health claims

FRIDAY, June 8, 2001 (HealthDayNews) -- The U.S. Food and Drug Administration (FDA) slapped the hands of three food makers this week, telling them to stop claiming the herbs in their foods and drinks make people healthier.

The agency said in a statement that these "novel ingredients" have not been recognized as safe in foods and have not been approved as food additives. It warned the companies they had two weeks to comply with regulations or the products could be seized.

The herbs involved are ginkgo biloba, Siberian ginseng and echinacea, and the companies that received the FDA letter were: Hansen Beverage, in Corona, Calif.; U.S. Mills, in Needham, Mass.; and Fresh Samantha, which is owned by Odwalla, in Dinuba, Calif.

"It's important to protect the integrity of the conventional food supply, which is why we are sending these letters out," said an FDA spokesperson. "More and more products are appearing on shelves, which have what we call 'novel ingredients' in them, and which are not yet considered as safe. And you have to notify the FDA that you have a new food ingredient, which these manufacturers have not yet done."

Although the letters were sent to only three manufacturers, the warning is aimed at "all food manufacturers," the FDA says.

Health advocates claim the three herbs can do everything from boost the immune system to increase memory, but critics say the herbs, when combined with certain medications, can cause excessive bleeding, nausea, skyrocketing blood pressure or fever.

"We stand by the safety of our products," says Linda Frelka, vice president of quality assurance for Odwalla. "But we will respond to the FDA regulatory issues in the time frame provided. Each one will be addressed and we will go from there." Odwalla has not yet received the letter from the FDA, Frelka adds.

Under federal law, food manufacturers can only add ingredients to their products with FDA approval or if the ingredients are "generally recognized as safe" by scientists. Otherwise, the FDA can declare the foods "mislabeled," seize the product or move to have the foods yanked off store shelves.

Foods that make health claims through the addition of herbs are a rapidly growing segment of the food market. Sales in 1999 totaled $5.5 billion, up 54 percent from 1998, reports Kalorama Information, a market research company. Once the purview of small health-food makers, the items now are also made by big-brand producers like PepsiCo, which makes SoBe beverages, or Cadbury Schweppes' Snapple, both of which can include echinacea. Gingko biloba and Siberian ginseng can be found not only in drinks and juices but cereals and other foods, as well.

"In some European studies, herbs have been shown to be effective when taken regularly in measured doses," says Sheah Rarback, a spokeswoman for the American Dietetic Association and a registered dietitian on the faculty of the University of Miami School of Medicine in Florida. "But there's no research, no proof, that adding an herbal supplement to a food will have any effect, other than raising the price."

"If someone thinks they are going to eat a food with gingko and their memory is going to improve, they are probably going to be disappointed," she continues.

"Let me give you an analogy," she adds. "Most people take aspirin to treat a headache or pain. But would you crumble up aspirin in food and then think you're going to prevent a headache or pain?"

What To Do

For more on the FDA regulations on food additives, visit the Center for Food Safety & Applied Nutrition. And for more on the safety of medicinal herbs, visit the Therapeutic Initiative.

Or, you can take a look at these previous HealthDay stories on herbs.

SOURCES: Interviews with Linda Frelka, vice president of quality assurance, Odwalla, Dinuba, Calif.; Sheah Rarback, registered dietitian, University of Miami School of Medicine, Miami, Fla.; FDA spokesperson; June 4, 2001, FDA Letters to Hansen Beverage Company, US Mills, Inc., and Fresh Samantha, Inc.
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