FDA Asks Cereal Makers for Proof That Psyllium Is Safe
The Food and Drug Administration challenged two giant cereal makers Friday to prove that a controversial ingredient in their new cereals is safe for human consumption in the high levels found in Benefit and Heartwise breakfast foods.
Psyllium, a grain grown in India, has been approved for use in the over-the-counter laxative Metamucil. The grain, which is high in soluble fiber, has also been approved for use in tiny amounts in frozen desserts, according to letters sent Friday to Kellogg Co. and General Mills Inc.
But “on the basis of the data available to us, FDA is of the opinion that the use of psyllium husk in the Heartwise cereal has not been shown to be generally recognized as safe,” said the letter to Kellogg.
A similar missive raised the same concern about General Mills’ Benefit. Both Benefit and Heartwise are touted as lowering cholesterol levels in consumers’ bloodstreams if those consumers eat enough of the cereal and stick to a low-fat diet.
At issue is the amount of psyllium found in a serving of the cereals.The FDA letters raise “general concerns about the safety of high fiber intakes” and note that psyllium “has the potential for harmful intestinal effects” and could cause allergic reactions when used in dry form.
“We have informed both companies that they should submit formal petitions to the FDA providing evidence demonstrating that the ingredient can be consumed safely at the levels intended,” said Jeff Nesbit, an FDA spokesman. “They can show a long history of common use in food, or they can present scientific evidence that represents the views of experts.”
A spokesman for Kellogg, the maker of Heartwise, refused to comment Friday on whether it would file the appropriate paper work on its product.
But Gary E. Costley, president of Kellogg’s U.S. Food Products division said in a written statement that “we are confident psyllium is safe. . . . We welcome the opportunity to provide the FDA with additional scientific data.”
In contrast, General Mills sent a reply Friday to the FDA outlining its past cooperation with the agency and its promise to submit the necessary documents.
“This product has been more thoroughly researched than any we know of,” said Craig Shulstad, a spokesman for General Mills. “We’re confident that the scientific data support the safety of psyllium grain for use in our product.”
General Mills’ confidence wanes a bit, however, when it comes to the effects of bad publicity on Benefit’s sales. “Our consumer research indicates that this kind of coverage for the product is dampening the sales,” Shulstad said.
