The U.S Food and Drug Administration (FDA) brought a complaint against Butterfly Bakery and Isaac on Feb. 1, asking U.S District Court for the District of New Jersey to “enjoin and retain” the business and its owner from selling its misbranded food in interstate commerce.“This injunction demonstrates that FDA will seek enforcement action against companies that mislead consumers on the products they purchase,” said Melinda K. Plaisier, the agency’s acting assistant commissioner for regulatory affairs. “Until Butterfly Bakery meets FDA regulations, it will no longer be able to process or distribute their products.”
Isaac is the President and Chief Executive Officer of Butterfly Bakery, according to government attorneys, with “ultimate authority” over its operations, including manufacturing, processing, preparing, parking, holding and distribution.
Her bakery produced Sugar Free Decorated Devil’s Food Cakes, Sugar Free Decorated Golden Snack Cakes, Sugar Free Angel Food Cake, Sugar Free Double Chocolate Chip Muffins and No Sugar Added Blueberry Muffins.
FDA said the bakery was supplied with ingredients sent though interstate commerce, including eggs from New York and lactitol from Kansas. In turn, the bakery shipped to supermarkets nationwide.
During an inspection last March 7 through April 9, FDA inspectors took samples and through testing found the bakery under-reported the amount of fat in its products. The Golden Snack Cakes, for example, were labeled as containing 10 grams of total fat and 3 grams of saturated fat when in fact they contained 25 grams of fat and six grams of saturated fat.
Amounts of fat and saturated fat were understated in other products as well.
FDA warned the bakery about the misbranding problem last June 12. This letter also stated the defendant’s baked goods had been analyzed by state regulatory agencies in Florida, New York and Alabama, and these analyses showed sugar contents in excess of the amounts declared on product labels.
FDA also found that some of the bakery’s products were made from two or more ingredients whose common names were not listed on the label.
For these violations, FDA sought, and on March 5 successfully obtained, a permanent injunction against the New Jersey establishment. Under the order, the bakery is required to work with an expert without personal or financial ties to it on a consulting basis to correct the problems.
That expert will inspect the bakery and help the defendants come up with written quality, production and process controls. And the expert will work to ensure the defendants come up with labeling for each article of food that is manufactured, processed, prepared, packed or held by the defendant to make sure that in the future the labels are accurate.
The bakery must work with a laboratory “acceptable to FDA,” and the test results have to be shared with FDA.
The consent degree requires the bakery to accept FDA inspections and sets up a defined protocol for when those inspections might occur and what should be accomplished. After the bakery resumes operations, sampling and testing will continue every 3 months.
Fines for not complying with the extensive provisions of the order are a steep $4,000 per day plus another $1,000 per day for each violation. The consent decree will continue to be enforced for five years.
