No one knows how many more people will become victims of an ongoing E. coli outbreak traced to soy nut butter products, partly because consumers don’t know what foods could be contaminated — and the FDA refuses to name the manufacturer.

However, a civil action filed Monday by an outbreak victim’s parents may free up the flow of so-called confidential corporate information (CCI).

The lawsuit names Kentucky-based Dixie Dew Products Inc. as the soy paste manufacturer and a defendant along with the SoyNut Butter Co., which has recalled some products because of the outbreak.

“The FDA can confirm that the agency is investigating the SoyNut Butter Co. and its contract manufacturer,” according to a statement from a spokesperson at the Food and Drug Administration on Monday afternoon.

“Consistent with law, FDA releases information, including CCI, to the extent necessary to effectuate a recall. We have no evidence at this time challenging the effectiveness of this recall.”

On March 3, the SoyNut Butter Co. of Glenview, IL, recalled one size of one flavor of its I.M. Healthy branded soy nut butter, which it markets as a peanut butter substitute specifically to schools and childcare centers across the country. It expanded the recall twice, ultimately including all flavors and sizes of the soy nut butter under I.M. Healthy and Dixie Diners Club brands, as well as I.M. Healthy granola.

Then the SoyNut Butter Co. revealed in a statement on its website that it uses a contract manufacturer for the soy nut butter. It did not name the manufacturer or indicate whether the implicated soy nut butter was sold to any other companies.

While the FDA reports it has that information, agency officials will not make it available to consumers.

“The agency is determining next steps in its investigation and will promptly updat the public when new information becomes available,” an FDA spokesperson said Monday.

‘promptly’ a question of perspective
New information could no doubt be helpful in the future, but known information could have already been put to use to help contain the outbreak, according to one of the attorneys representing Travis and Morgan Stuller, the Seattle area parents who filed suit in federal court Monday. Theirs is the fourth case to be filed in relation to the outbreak.

“The scope of this outbreak is much larger than originally believed, affecting a number of brand names. Early on, SoyNut Butter Co. was allowed to not disclose the name of the original manufacturer,” said Bill Marler of Marler Clark LLP, who is joined by Newland & Newland LLP in representing the Stullers.

“This calls into question the integrity of not only the products sold by SoyNut Butter Co., but all of those manufactured by Dixie Dew Products. Are there other related products on the shelf right now that could make people sick?”

That scenario isn’t one of fantasy or fiction, it’s what happened in 2008-09 when peanut butter and paste from Peanut Corporation of America (PCA) in Blakely, GA, sickened more than 700 in a Salmonella outbreak that killed nine people.

As of the CDC’s March 13 updat on the soy nut butter E. coli O157:H7 outbreak, 16 people across nine states, including people on both coasts, have been confirmed as victims. Fourteen of them are children. Eight of the 16 have required hospitalization and five, including the Stullers’ daughter developed hemolytic uremic syndrome (HUS), a life-threatening complication that can cause kidney failure.

The Stullers’ daughter and 14 of the other confirmed victims ate I.M. Healthy brand soy nut butter in the days before becoming ill. Dietary information on the 16th victim was not available, according to the CDC.

Advice to consumers

To read the CDC’s most recent updat on the E. coli outbreak linked to I.M. Healthy brand soy nut butter products from SoyNut Butter Co., please click on the image.

Anyone who has eaten I.M. Healthy brand or Dixie’s Diner’s Club brand soy nut butter products or anything containing the products and developed symptoms of E. coli infection should immediately seek medical attention and tell their doctors about the possible exposure to the bacteria.

“The symptoms of STEC infections vary but often include severe stomach cramps, diarrhea — often bloody — and vomiting,” according to the CDC.

“Most people get better within 5 to 7 days, but some infections are severe or even life-threatening. Very young children and the elderly are more likely to develop severe illness and HUS than others, but even healthy older children and young adults can become seriously ill.”

The CDC advises people to watch for diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.