FDA WARNS COMPANIES OVER HERBAL INGREDIENTS

SARAH MULHOLLAND

WASHINGTON -- The Food and Drug Administration here recently sent letters of warning to Hansen Beverage Co., U.S. Mills and Fresh Samantha -- a unit of Odwalla -- regarding the manufacturers' use of gingko biloba, Siberian ginseng and echinacea in some of their products. The agency contends that these ingredients have never been approved for consumption in food, although they are widely recognized within the realm of herbal supplements.

The companies are required to respond to the letters this month. While the FDA is prepared to seize product if there is no response, a spokesman for the FDA told SN this is highly unlikely and he anticipates full cooperation on the part of manufacturers. At this juncture, manufacturers must either file a new food additive petition or provide the FDA with evidence supporting the ingredients' designation as "generally recognized as safe" (GRAS).

In addition to expressing concern over the safety of these ingredients, the letters questioned the validity of various health claims made on the labels that come precariously close to drug claims.

"These letters are part of an effort to maintain the integrity of the conventional food supply," the FDA's spokesman said.

The FDA will continue to send out letters to other food and beverage companies making use of novel herbal ingredients.

Critics of the way herbally enhanced foods and beverages are being marketed today claim that the amount of herbal ingredients used in these products is too small to have any measurable effects. J.B. Pratt, chief executive officer of Pratt Foods Supermarkets, Shawnee, Okla., maintains that the FDA's action has been a long time coming. In Pratt's opinion, exploiting herbal ingredients as a kind of "magic bullet" for health and wellness dilutes the real benefits of these products when used correctly.

"It sends the wrong message about products that have a good place in certain situations," he said. "I don't like piggybacking on a category that could really work to benefit consumers' health and wellness, making a marketing game out of it."

According to Pratt, consumers in his area have had a rather weak response to herbally enhanced food products, although beverages like SoBe have done well. However, he attributes much of that segment's success to the eye-catching graphics and contemporary packaging, as opposed to the products' perceived nutritional value.