contamination has prompted a Chicago-area firm to recall nearly 40,000 pounds of a dietary ingredient, a move that in turn prompted several recalls of supplements containing the suspect material.
U.S. Food and Drug Administrationofficials said they are investigating whether the ingredient, sold by Westchester-based Ingredion and made in a subsidiary's plant in South Korea, wound up in other dietary supplements sold to consumers and whether more recalls are necessary.
The recalls began in May after Ingredion discovered that several lots of galactooligosaccharides tested positive for salmonella, bacteria that can cause serious and even fatal illness.
Sold by Ingredion under the brand name Purimune, the recalled galactooligosaccharides are an undigestible fiber made from milk that are marketed as an aid to the
and digestive health.
Some of the recalled Purimune already had made its way around the world, to places as far-flung as New Zealand and the United Kingdom. In the U.S., at least two companies had mixed the recalled Purimune into their products.
The recalls come amid calls for improved manufacturing practices among companies that make and sell dietary supplements — the vitamins, fish oils, bodybuilding protein powders,
capsules and similar products consumed by half of America at a cost of $28 billion a year.
Last month the Tribune reported that inspectors from the
had found violations of its rules on good manufacturing practices in half of the nearly 450 supplement companies they have inspected since 2008. Many violations were as basic as not verifying what ingredients are before mixing them into products and not having a recipe set out for each supplement.
, D-Ill., and Sen.
, D-Conn., recently sent letters to three supplement trade organizations seeking explanations, saying they were "deeply concerned" about the industry's record.
So far the FDA has received no reports of illness related to Ingredion's product. But Dan Fabricant, head of the FDA Division of Dietary Supplement Programs, said the incidents highlight the importance of the rules on good manufacturing practices, which should prevent salmonella-tainted products from making it into customers' hands. A spokeswoman for Ingredion, formerly known as
, said the company recalled the lots that tested positive for salmonella and launched an investigation that prompted the company to widen its recall "out of an abundance of caution."
"Product safety is one of our highest priorities, and we are working with the FDA to resolve this," said spokeswoman Claire Regan.
One company that used the recalled Purimune was Ferndale, Wash.,-based Botanical Laboratories, which recalled more than 300 bottles of its Wellesse Digestive 3-in-1 Health supplements in June, according to FDA documents.
In a June 4 news release about the recall, the company reported that testing of the raw ingredient and the final product for salmonella had been negative.
Arizona's Sedona Labs, which is owned by Quebec-based Atrium Innovations, recalled six lots of iFlora Kids Multi-Probiotic and iFlora Kids Powder on July 9 because they contained recalled Purimune.
Barry Ritz, vice president for scientific and regulatory affairs for Atrium Innovations, said there were no reports of illness and that the company had tested its products and found no evidence of salmonella. The company is confident in the quality of its products, he said.
The recall, which was initiated quickly despite a lack of evidence of actual contamination in the products, is evidence that the system is working, Ritz said.
"That being said, it is never nice to have a product recall," he said.
In a separate case, Standard Process, of Palmyra, Wis., recently announced a recall of three products — Cataplex C, Cataplex A-C-P and Pancreatrophin PMG — that might be tainted with salmonella.
In a June 29 news release, Standard Process stated that it has not received any reports of illness and that samples of the recalled products have tested negative for salmonella.
Karren Jeske, a spokeswoman for Standard Process, wrote in an email that the recall was unrelated to Ingredion. Jeske declined to answer any other questions.
Fabricant said the FDA was continuing to investigate the Ingredion case and said he could not comment on whether more related recalls would be announced or whether the agency would be inspecting the involved companies' facilities.
"We are really following the trail right now," Fabricant said. "We are seeing what else is out there."