NEW CHOICE AGREES TO WITHDRAW REMAINING GEL SNACKS ON US MARKET

FDA CONTINUES EFFORTS TO PROTECT PUBLIC AGAINST CONJAC CANDIES

The Food and Drug Administration (FDA) and New Choice Food Inc., a distributor of conjac gel candies, have entered into a consent decree which will lead to the FDA-supervised destruction of 13,000 cases of mini-cup gel candies containing the ingredient conjac. This is the latest in a series of actions the agency has taken to protect the public against conjac gel candies, which pose an unacceptable choking hazard.

Conjac gel candies are typically packaged as individual, mouth-sized servings in several fruit flavors. Each gel cup is about the size of a single-serve coffee creamer.

Various brands of conjac candies have been associated with the choking deaths of children.

"FDA has repeatedly warned consumers not to eat these candies. This warning applies especially to children," said FDA Deputy Commissioner, Dr. Lester M. Crawford. "This consent agreement is the latest step in helping to get this product off the market."

Under the terms of the consent decree with New Choice, conjac gel candies that were seized by the United States, valued at approximately $500,000, will be destroyed. New Choice has also agreed to withdraw adulterated and misbranded products like those seized that may still be on the market. The company has posted a penal bond of $800,000 as assurance that it will meet the terms of the consent decree.

The decree states that New Choice must present for FDA approval a written product withdrawal plan. FDA will supervise the withdrawal and the destruction of the seized items. New Choice is responsible for the costs that the government may incur under the consent decree.

The decree, entered in the U.S. District Court for the Central District of California, follows the seizure of the gel candies at New Choice's Irwindale, Calif., facility in late May of 2002. The products are considered "unfit for food" and therefore adulterated under the Federal Food Drug and Cosmetic Act (the Act). They also are considered to be misbranded under the Act. New Choice refused to recall the products.

The United States initiated the seizure so that the gel candies would not be distributed to consumers. Other firms have voluntarily recalled similar products.

In August and October of 2001, FDA issued warnings against consuming mini-cup gel candies that contain the ingredient conjac. In October of 2001, the agency issued an Import Alert (#33-15) to detain the mini-cup gel candy when offered for entry into the United States. FDA continues to investigate this issue. If consumers have these products at home, they should not eat them and should throw them away. If consumers discover these gel candies on store shelves, they should contact the local Food and Drug Administration office with detailed information about the product and the location where it is offered for sale. The phone number of the local Food and Drug Administration office can be found at www.fda.gov/opacom/backgrounders/complain.html

A history of conjac candy recalls and FDA's alerts is available at: http:www.fda.gov/oc/firmrecalls/topics/konjac.html.

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(Complete list of Konjac candy recalls)

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