FDA Responds to Gluten-Free Cheerios Recall

A sample of gluten-free Honey Nut Cheerios included in Monday’s recall of the cheerios 6cereal contained nearly double the amount of gluten allowed under federal law, a test by the U.S. Food and Drug Administration found.

In response to consumer complaints, the FDA tested 36 samples of Cheerios labeled  gluten-free from different manufacturing facilities and lots.

A sample from cereal made at General Mills’ Lodi, California, plant during the nearly two-week period covered by the recall was the only one that did not meet the FDA’s labeling standard of less than 20 parts per million of gluten. The FDA found it contained 43 ppm. All other samples contained less than 20 ppm and met FDA requirements.

The FDA is working with General Mills to facilitate the company’s voluntary recall of 1.8 million boxes of original Yellow Box Cheerios and Honey Nut Cheerios produced in July at the Lodi plant. The company said gluten-free oat flour was cross-contaminated by wheat flour when it was transported in shared trucks. Usually, the oat flour is transported in dedicated rail cars, but the rail line was down and the trucks were used instead, according to the company.

Since mid-September, the FDA has received 125 reports of adverse events from and about consumers who ate Cheerios labeled gluten-free, according to an FDA spokesperson. Most noted gastro-intestinal discomfort.

“We recognize the importance of this issue to people with celiac disease, wheat allergy, and gluten sensitivity, and we will continue to provide updates and advice as needed,” the FDA said.”As with all recalls, the FDA will work to ensure the recall is effective and the underlying cause is identified and addressed.”

The cross-contamination with wheat flour was discovered in response to consumer complaints General Mills  received about lot numbers produced at the Lodi plant, the company said. Follow up testing showed that Honey Nut Cheerios produced over 13 days and Yellow Box Cheerios over four days contained more than 20 ppm of gluten.

This mistake occurred only at the Lodi plant, and the Cheerios and Honey Nut Cheerios produced at our other plants were not affected, according to General Mills. Other gluten-free flavors were also not affected.

But gluten-free consumers who have celiac disease and gluten sensitivity are increasingly wary of the gluten-free status of Cheerios. While an active group on social media has been suspicious of the company’s handling of oats from the beginning, those who had previously accepted the cereal as safe have been commenting on facebook and Twitter that they are now concerned, too.

Jim Murphy, senior vice president and president of the cereal division, said the company had to acknowledge it had failed to meet its commitment to ensure its products were gluten free “for a time.” He said he was “embarrassed and truly sorry” to announce the recall.

Mike Siemienas, General Mills spokesman, said the company will have to work hard to regain the trust of the gluten-free community.

The company says the oat supply initially tested to be gluten free. Oats used in Cheerios products have come under scrutiny because General Mills mechanically processes them instead of using specialty gluten-free oats. Oats are gluten free, but they are highly likely to be cross-contaminated by wheat, barley or rye in the field, in transport, storage and milling. Specialty oat suppliers take precise steps to prevent this cross-contamination.

General Mills instead separates the gluten-containing grains from the oats at a cleaning facility  it built in Minneapolis after 5 years of research into making mainstream Cheerios gluten free. Processed oat flour is then sent to several plants around the country to be made into Cheerios. Some of these plants also process gluten-containing products. The company says Cheerios lines are separated by distance and physical barriers.

General Mills had previously said it was routinely testing the oats, the oat flour and the finished cereal. However,  Siemienas Monday said this testing was not done on the finished lots of cereal included in the recall. He said General Mills is now testing all finished product at the Lodi plant.

Tests have shown that cereal produced there since the Best If Used By date of 25JUL2106LD – the last affected code date –  meet the FDA standard, he said.Finished product testing is also being done at all the other plants that produce Cheerios, and new flour handling protocols have been put in place.

Products with the following  information on the top of the box are included in the recall.

“BETTER IF USED BY” code dates and the plant code LD which indicates the product was produced at Lodi, California:

Honey Nut Cheerios



Yellow Box Cheerios

Consumers requesting refunds or calling with further questions should contact General Mills Consumer Services at 1-800-775-8370.

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