Concern with Dietary Suppliments Increases as Dietary Ingredient Recalled Due to Salmonella

An Illinois company is recalling its dietary ingredient after ‘several’ lots tested positive for Salmonella. This ingredient, made by a subsidiary’s plant in South Korean subsidiary, had already been used in a number of products including a children’s product - which was also recalled (http://www.fda.gov/Safety/Recalls/ucm311050.htm). The ingredient is an undigestable fiber made from milk and is marketed as an aid for the health of the immune and digestive systems.

There has been a growing concern with dietary supplements. Most of this concern has related to medical claims that are made. Some substances do not live up to the claims, while others may actually have adverse effects (http://health.wolterskluwerlb.com/2012/01/dietary-supplement-concerns-in-2012/ and http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm).

There has also been issue with how some of these are processed. A Chicago Tribune article (below) reported that half of the 450 firms inspected had violations. In the UK, it was just reported that 40% of dietary supplements were irradiated illegally (http://www.dailymail.co.uk/health/article-121486/Concerns-dietary-supplements.html).  

Sales of dietary supplements continues to increase. Consumers view dietary supplements as a way to prevent health issues. Some see herbal supplements as more natural. In many cases, supplements are less expensive than over-the-counter drugs. Without the pharmaceuticals industry’s requirements for scientific research to back label claims, an increasing number of companies have entered this market, including pharmaceutical and food companies. 

Westchester firm recalls salmonella-contaminated supplements
No illnesses have been reported; FDA investigating
http://www.chicagotribune.com/health/ct-met-salmonella-supplements-20120719,0,6096142.story

By Trine Tsouderos, Chicago Tribune reporter
July 19, 2012

 Concern over salmonella 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 immune system 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, calcium chews, echinacea 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 FDA 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.

Sen. Dick Durbin, D-Ill., and Sen. Richard Blumenthal, 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 Corn Products International, 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."ttsouderos@tribune.com


U.S. senators call supplement-makers to account
Durbin, Blumenthal send letter to industry trade organizations in response to Tribune story on lax compliance with FDA standards

July 10, 2012|By Trine Tsouderos, Chicago Tribune reporter
 http://articles.chicagotribune.com/2012-07-10/news/ct-met-supplements-durbin-20120710_1_dietary-supplement-programs-supplement-companies-natural-products-association)

In response to a Tribune story detailing widespread problems in the manufacture of dietary supplements, Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., have sent letters to three major supplement organizations asking them to spell out their plans to improve conditions in the $28 billion industry.
"We are deeply concerned about the poor manufacturing standards that expose consumers to potentially serious health risks," Durbin and Blumenthal wrote. "Consumers should have access to dietary supplements that meet fundamental quality controls."
The senators addressed their July 6 letters to the heads of the Council for Responsible Nutrition, the American Herbal Products Association and the Natural Products Association, all prominent industry trade organizations.

"The good manufacturing standards have been final since 2007, and many of the practices that have been cited as failing to comply are basic, common sense safety practices that should not require regulatory guidance in the first place," they wrote.


Last month, the Tribune reported on the results ofU.S. Food and Drug Administrationinspections of supplement companies since it began enforcing new manufacturing rules four years ago. FDA inspectors found violations of the rules in half of the 450 firms they inspected. One in 4 received a warning letter from the FDA, considered a significant enforcement action. Dan Fabricant, head of the FDA's Division of Dietary Supplement Programs, has characterized the inspection results as "downright scary."

In an interview, Durbin, who has fought for greater regulation of the dietary supplement industry for years, said he was alarmed by the Tribune's report. "Everyone should expect products be safe and wholesome," he said.

The letters from Durbin and Blumenthal stressed the need for improvements from the industry.

"The (Natural Products Association) welcomes this dialogue with Senators Durbin and Blumenthal," John Shaw, CEO of the Natural Products Association, wrote Monday in an email to the Tribune in response to the letters. "We look forward to sharing with them what we are doing to make sure that dietary supplement manufacturers meet high quality standards."

Shaw wrote that his organization's supply and retail members agree that the industry must continue to follow the strict guidelines set out by the FDA.

"Supplements have an excellent safety record and we appreciate this opportunity to provide more information to the senators," he wrote. "While we appreciate any concerns the senators may have, reopening a closed debate based on distorted facts causes our members concern, as they work to ensure that consumers get the high quality products they expect and deserve."

A spokeswoman with the Council for Responsible Nutrition declined to comment until the organization had responded to the senators' letter. Attempts to reach the American Herbal Products Association for comment were unsuccessful.