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Recall: Muffin Mix Pulled for Possible Gluten Contamination

Hometown Food Company announced on Monday, Sept. 8 it is voluntarily recalling approximately 374 cases of Martha White Gluten Free Sweet Cornbread Muffin Mix for possible gluten contamination.

According to the company, quality testing showed the presence of gluten from wheat, rye, barley and other grains. Consuming gluten may cause adverse health effects or serious allergic reactions for people who have celiac disease, a wheat allergy or wheat sensitivity.

The recalled product was distributed across the country. The muffin mix has the following case item codes, UPC codes, and lot codes:

Martha White Gluten Free Sweet Cornbread Muffin 7oz 1 1330082014 5 0 1330082014 8 9 204 JAN 23 2021

Martha White Gluten Free Sweet Cornbread Muffin 7oz 1 1330082014 5 0 1330082014 8 9 205 JAN 24 2021

No other Martha White or Hometown Food Company products are impacted by this limited, voluntary recall.

If you have the above products, discard or return them to the store where they were purchased for a complete refund. For more information, call 1-866-219-9333 from Monday to Friday, 8 a.m. to 5 p.m. EDT.

Pork Sausages Incorrectly Labeled Gluten-Free Recalled

California-based Heatherfield Foods, Inc. has recalled approximately 4,380 pounds of pork sausage products due to misbranding. The U.S. Department of Agriculture’s Food Safety and Inspection Service made the announcement on Aug. 30.

The product has a gluten free claim represented on the front of the label; however, the product contains gluten in the form of wheat. Wheat is also listed in the product’s list of ingredients.

The raw Longanisa sausages were produced between March 8, 2019 and July 31, 2019. The following product is subject to recall:

One-pound thermoform tray packages containing “HAWAIIAN SAUSAGE COMPANY Sweet Filipino Longanisa ˙NO PRESERVATIVES ˙GLUTEN FREE ˙NO MSG” with lot codes 09067, 09081, 09088, 09113, 09130, 09148, 09156, 09163, 09170, 09179, 09193 and 09212 on the label. The products subject to recall bear establishment number “EST. 4846” inside the USDA mark of inspection.

These items were shipped to retail locations in Hawaii.

The problem was discovered after the U.S. Department of Agriculture’s Food Safety and Inspection Service received a consumer complaint.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider. Some product may be in consumers’ refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

The U.S. Department of Agriculture’s Food Safety and Inspection Service routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers.

Consumers with questions about the recall can contact John Brown, Vice President, Heatherfield Foods Inc., at 909-460-4150.

Why Breyers went gluten free

Breyers recently announced it would add a gluten-free label to 36 of its ice cream flavors, though the naturally gluten-free recipes remain unchanged. With this addition, Breyers joins a growing list of mainstream companies who have entered the gluten-free marketplace by calling out products that happen to be gluten free.

Over the past few years, Frito Lay chips (which includes Cheetos, Lay’s, Ruffles, Smartfood popcorn and Tostitos), Ore Ida potatoes, Heinz ketchup, Zatarain rice mixes and other large food manufacturers began adding a gluten-free label to many of their products.

Food companies have long said they would be more interested in gluten-free labeling once it was defined by the Food and Drug Administration and that’s what happened with proposed rules that were finalized last August. The FDA ruling says that a product with a gluten-free label must contain less than 20 parts per million of gluten, a standard considered safe by many celiac disease experts. Gluten from all sources, including cross-contamination, has to be taken into account.

Nick Soukas, director of ice cream for Unilever, Breyers’ parent company, says Breyers wanted to finalize and implement a validation program that ensured the gluten-free products were not at risk for cross-contamination. The validation process was in the works before the final FDA ruling.

“We’ve been planning to change the Breyers packaging for some time now to include the gluten-free claim on the label,” Soukas told Gluten-Free Living. “With more and more consumers adopting a gluten-free diet, Breyers wanted to help these consumers understand their options within our portfolio by clearly having gluten-free labels where this applies.”

Although Breyers uses its own gluten-free validation program, companies may also apply for a gluten-free certification seal from organizations like the Gluten Intolerance Group, through its Gluten-Free Certification Organization program. GFCO enforces stricter standards than the FDA, requiring products that use its seal to test to 10 ppm of gluten. The Celiac Support Association certifies products that contain less than 5 ppm of gluten for most products that use its seal. Third-party certification provides an extra level of assurance for consumers.

Some consumers think Breyers and other companies using gluten-free labels are only joining the “gluten-free bandwagon” that has evolved throughout the past few years. But as more mainstream companies adopt the gluten-free label, gluten-free consumers are seeing a wider range of options that fit into their lifestyles. And when the new labeling laws go into effect in August, companies that use the label will be held to federal standards.

What gluten-free food labels will look like under new FDA rules

Many of the gluten-free products on store shelves will look exactly the same as they do now once new gluten-free labeling rules go into effect next August.

A number of gluten-free food makers already meet the requirements spelled out by the Food and Drug Administration in the regulations approved Friday. Many of the final rules are the same as those proposed by the FDA in 2007. A number of food companies have voluntarily started to follow the proposed rules in anticipation they would ultimately be adopted by the FDA and won’t have to change labels.

Under the FDA rules any food labeled “gluten free” will have to contain less than 20 parts per million of gluten from all sources, including ingredients and cross-contamination. Wheat, barley and rye are banned outright and any ingredient made from these gluten-containing grains cannot be used unless processed to remove gluten to the extent that the finished food contains less than 20 ppm. Until the FDA rules go into effect, there is no standard for gluten-free labeling in the United States other than a general rule that a label has to be truthful. While wheat, barley and rye are prohibited in gluten-free foods, gluten from cross-contamination is not taken into account.

Here are some particulars on what you can expect to find on labels under the new FDA requirements:

The terms, “gluten free,” “no gluten,” “free of gluten” and “without gluten” can be used on labels of foods that meet the FDA gluten-free standard.
No universal symbol will appear on packages to indicate that a food meets the FDA gluten-free standard. If a food company wants to indicate that a product meets the standard, it has to use one of the gluten-free terms.
Certification seals from third parties, for example a seal from the Gluten Free Certification Organization, can continue to be used on labels. The FDA says it does not endorse or recommend any particular certification seal. Any food that uses a third party certification seal must meet the FDA labeling requirements at a minimum. Typically the standards for certification seals are stricter than the FDA requirements.
The label format is left up to food makers; the FDA does not have a mandated design or any requirements for where the gluten-free label has to be placed.
Food makers can continue to use the terms, “made with no gluten containing ingredients” and “not made with gluten containing ingredients.” If the terms are used in conjunction with a gluten-free label, the product must meet the FDA standard. If the terms are used without a gluten-free label, the FDA says, “consumers should not assume the food meets all FDA requirements.”
Food makers can continue to use advisory statements such as, “Made in a factory that also processes wheat products” on a food that also has a gluten-free label. The FDA says it will need to “look at foods on a case by case basis to determine whether a specific advisory statement with a gluten-free claim would be misleading.” Any product with the advisory statement and gluten-free label would have to meet the FDA requirements.
Naturally gluten-free foods can be labeled gluten free. This is a change from the proposed rules which would have prohibited the gluten-free label on inherently gluten-free foods including gluten-free grains and products like bottled water unless the label also said all foods of the same type were also gluten free. The final rule addresses concerns that some gluten-free grains, legumes and seeds have a high risk of cross-contamination. A gluten-free label on these kinds of products “provide the expectation that any gluten is less than 20 ppm,” the FDA says.
Gluten-free labeling continues to be voluntary so even products that are gluten free may not be labeled as such. This is likely to come up most often with naturally gluten-free products with a low risk of cross-contamination, fruits and vegetables for example. The lack of a gluten-free label does not mean the food contains gluten.

For more details on new gluten-free rules see our blogs on:

gluten-free beer

testing requirements for gluten-free products.

new gluten-free labeling rules

Gluten-free labeling rules finally approved

Long awaited gluten-free labeling rules were approved by the Food and Drug Administration today.

The approval comes nine years to the day after Congress passed the allergen labeling law that directed the FDA to set a standard for gluten-free food.

The regulations, which will go into effect August 2014, will require food makers to meet a 20 parts per million FDA standard before they can put a gluten-free label on a packaged product. Consumers have been pushing for rules so they can be sure the gluten-free products they purchase are safe.

As the gluten-free market has exploded, there has been concern that some food makers are not taking steps to assure their products are truly gluten free.

Once the new regulations go into effect, food companies are responsible for ensuring that their products have less than 20 ppm, a standard considered safe by many celiac disease experts and adopted in countries around the world. This would include gluten from any source, including cross-contamination that can occur anywhere from the field to the factory. Some companies that currently label products gluten free may choose not to do so if they can’t meet the FDA requirements.

Foods labeled “gluten free” cannot contain wheat, barley or rye. Ingredients made from these grains are also largely prohibited, but the gluten-free label can be used if they are processed to remove gluten as long as the final food contains less than 20 ppm.

“The goal of manufacturing any food labeled gluten-free should be for the food to not contain any gluten or to contain the lowest amount possible that is less than 20 ppm gluten,” according to the FDA.

Oats are not allowed unless they contain less than 20 parts per million of gluten.

A gluten-free label would be allowed on foods that inherently don’t contain gluten, for example raw carrots and grapefruit juice.

The rules would apply to foods regulated by the FDA, but the U.S. Department of Agriculture, which oversees meat, poultry and eggs, has said it will also apply FDA standards once the a gluten-free definition is approved. The FDA is also working with the Alcohol and Tobacco Tax and Trade Bureau regarding beer.

Use of the gluten-free label would continue to be voluntary.

The FDA says it will enforce the regulations through “periodic inspections of food manufacturing facilities; food label reviews; follow-up on consumer and industry complaints reported to the agency; and when needed, gluten analyses of food samples.”

Gluten-free certification seals like those authored by the Gluten Intolerance Group and the Celiac Sprue Association can still be used by companies that want to meet standards set by each group. These are stricter than the FDA requirements.

The Food Allergen Labeling and Consumer Protection Act, which was passed by Congress on Aug. 2, 2004, required food makers to always note the top eight allergens when they are used in a food. The law also directed the FDA to come up with gluten-free labeling rules by 2008, so their approval is five years late.

Beth Hillson, president of the American Celiac Disease Alliance, a celiac disease advocacy group that lobbied for the regulations, said the group has more work to do. “Now, we must turn our focus to partnering with FDA to educate patients, health professionals and industry about the standard and how it will benefit the entire community,” she said in a statement.

Gluten-Free Living has been covering gluten-free labeling from the beginning. We’ve long recognized how important good labeling laws are for consumer safety and confidence. And we’re happy to report they have finally cleared the last hurdle.

We’ll continue to provide updates both in print and online as we move closer to their implementation.

For more details on the new gluten-free labeling rules see our blogs on

what labels will look like

testing

gluten-free beer

Cross Contamination of Gluten-Free Grains

A small, preliminary study of cross contamination has raised questions about how much gluten there might really be in some naturally gluten-free grains and flours. The pilot study, published in the June issue of the Journal of the American Dietetic Association, found that seven of 22 samples of gluten-free grains, seeds and flours contained more gluten than allowed in proposed rules for gluten-free labeling in the US.

The seven samples, which included millet, buckwheat, sorghum and soy flours and millet grain, were tested and found to have gluten contamination that ranged from 2,925 to 25 parts per million of gluten. The US Food and Drug Administration has proposed allowing gluten-free food to contain up to 20 ppm of gluten.

Specific amounts (reported in mean ppm) were:

Soy flour, one brand 2,925 ppm and another 92 ppm
Millet flour, one brand 327 ppm and another 305 ppm
Sorghum flour, 234 ppm
Buckwheat flour, 65 ppm
Millet grain, 25 ppm

These results might have you wondering if many of the gluten-free foods you consider to be safe really are. While the numbers in the study are unnerving, there are a few things you should keep in mind.

First, the study was so small it is impossible to draw any definitive conclusions from it. In fact, Tricia Thompson, a dietitican who is one of the authors of the study, pointed this out in a blog she wrote announcing the findings.

“Sampling was not large enough to make any assessment on the overall percentage of contaminated product,” Thompson wrote. It was also too small to make any inferences on the specific grains, flours and seed likely to be cross contaminated, according to Thompson.

Thompson said in an email that study was designed specially to find out if gluten-free grains that are not labeled gluten free are likely to be cross contaminated. The intention is to use the study results to get the FDA to take a second look at a provision in its gluten-free labeling proposal that says when a naturally gluten-free food has a gluten-free label it must also say all foods of that type are gluten free. For example soy flour labeled gluten free would have to say all soy flour is gluten free. (The study suggests that’s not the case.)

Thompson said she hopes a larger study with statistically significant results will be conducted in the near future, but noted it would require testing of multiple samples of multiple brands. That kind of study would be exceedingly expensive, she said.

But an expanded study pretty cleary now needs to be done. It would be unfortunate if those who follow the gluten-free diet started to question all naturally gluten-free grains on the basis of results from a limited number of companies. And now that the question of just how cross contaminated naturally gluten-free grains really are has been raised, a definitive answer is needed.

A second thing to keep in mind is that since the pilot study looked only at grains not labeled gluten free, its conclusion that a certain percentage of inherently gluten-free grains contain gluten does not apply to sorghum, millet, soy and buckwheat flours that are labeled gluten free. Multi-ingredient gluten-free products, like baking mixes, were also not part of the study.

A number of companies that label their flours, grains and other products gluten free do test to be certain they contain less than 20 ppm of gluten. This information is often available on the labels themselves, on company websites and sometimes by calling the company directly.

Finally, nearly two thirds of the samples in the study did meet the FDA’s proposed standard for gluten-free labeling even though they did not have a gluten-free label. This was true even for three products that had allergen warning statements that said they may contain wheat.

Samples that tested below 20 ppm included basmati rice, long grain brown rice, enriched corn meal, instant polenta, rice flour, hulled buckwheat, amaranth flour, flax seed and amaranth seed. One sample of millet grain met the standard by testing to 14 ppm, but another exceeded it slightly at 25 ppm.

While you have to keep the results of the study in perspective, there is no denying it has uncovered some issues that have to be dealt with both by those who consume gluten-free grains and the FDA, which is supposed to regulate the companies that produce them.

We have known for a long time that all grains are cross contaminated to some extent by other grains because of the way they are grown, transported and milled. Still, the levels of cross contamination reported in the study are news to the gluten-free community. It’s well known that cross contamination of oats prevents them from being considered gluten free unless they are specially grown and processed. But the grains tested in the study have never before been singled out as potentially unsafe because of cross contamination.

While the study might have been intended mainly to provide information to the FDA about one labeling provision, it has farther reaching consequences. Alison St. Sure in her Sure Foods Living blog summed up the dilemma this way: “What are we to do now? Trace every grain, seed and flour, including those used as ingredients in gluten-free products, back to its origin to ensure it has not been contaminated with wheat?

I don’t think the situation is that dire, though I would like to know exactly which soy flour had more than 100 times the amount of gluten considered safe.

For now, it seems common sense and a bit more diligence regarding gluten-free flours in particular are in order. Gluten-free companies could help by making their testing information readily available to consumers, with the label being the best place to put it. Otherwise, stick with products you know and trust. Those who follow the gluten-free diet have managed to eat and maintain good health for many years relying on naturally gluten-free grains.

The study results might convince the FDA to revisit the labeling provision for naturally gluten-free grains and flours so we have more accurate information about them. And if the study of cross contamination is expanded, as it should be, it could provide us with more information that improves our gluten-free lives.

Gluten-free consumer survey

I’ve followed gluten-free labeling for a long time for Gluten-Free Living.

I’ve covered hearings and public meetings where I was the only press representative. And I’ve learned a few things about the Food and Drug Administration along the way.

That might explain why I had more questions than answers after I read the FDA announcement about the “Gluten-Free Labeling of Food Products Experimental Study.”

The first was, what the heck does that title mean?

Simply put, the FDA is going to survey about 5,000 people to see what they think of certain statements printed on the packages of gluten-free products. Examples given by the FDA include “no gluten,” “free of gluten,” “without gluten,” as well as “made in a gluten-free facility.” The FDA also wants to know how consumers think naturally gluten-free products should be labeled.

My second question was, why is the FDA doing this study now?

Congress approved the Food Allergen Labeling and Consumer Protection Act in 2004. This law gave the FDA four years to come up with an official definition for the gluten-free label on food. But when the deadline rolled around seven months ago, the FDA wasn’t able to meet it.

The FDA has already held a public hearing, gathered consumer comments, come up with a proposed definition of 20 parts per million, and completed a review of how safe that level is for those who have celiac disease.

The only thing that stands in the way of final approval of a much-needed standard for gluten-free food in the US is public release and comment on that safety review.

Suddenly, it seemed to me the FDA was going back to the beginning to ask people what they want on labels of gluten-free food.

I thought that question was asked and answered in 2007 when the FDA first detailed a “gluten free” label proposal and then collected public comments on it. The proposed definition already deals with the question of naturally gluten-free foods, saying that they can only be labeled gluten free if there is also a note that all foods of the same type are gluten free. For example, a can of peaches labeled gluten free would have to say all canned peaches are gluten free.

I started to wonder if the survey was just a way to put off final approval of the gluten free label even longer.

One of the things I’ve learned about the FDA is that speed is not usually a high priority. And neither is answering questions about documents full of confusing, technical language.

But I did finally get a response from a spokesman who said the survey is not expected to delay approval of the gluten-free definition. He said it’s something completely separate and that the FDA just wanted more insight on how people with celiac disease and those who take care of them interpret different statements that food makers might put on packages. He did note that if survey results are in before the gluten-free definition gets final approval, consumer comments might cause the FDA to make some changes.

I couldn’t get more information than that.

So I still have questions – why is the FDA asking about terms like “no gluten” or “free of gluten?” They seem pretty simple and self explanatory. Even if food companies use those words instead of “gluten free” they would still have meet the standard set by the FDA.

Would the FDA include a requirement that the 20 ppm standard be spelled out every time the gluten-free label is used? And is it possible that the restrictions proposed for naturally gluten-free foods might be lifted?

I’m not sure why statements about strictly gluten-free manufacturing facilities would be terribly important because once a definition is approved the bottom line on all food labeled gluten-free is that it can not contain 20 ppm of gluten or more. That’s true no matter what kind of food processing plant it’s made in so the dedicated facility statement seems unnecessary to me. But I don’t know if consumers or the FDA will see it that way.

Whatever the consequences of the consumer survey, I hope the FDA was giving it to me straight when I was told further delay won’t be one of them.

Rebuilding gluten-free confidence

The recent Chicago Tribune stories about gluten in products labeled “gluten free” probably left you wondering how safe the food in your pantry really is.

It was unnerving to read in one story that Wellshire Farms chicken bites, and chicken and beef corn dogs that were labeled “gluten free” were independently tested and found to contain anywhere from 200 to 2,200 parts per million of gluten.

“How could that be?” you probably asked yourself while either sighing with relief that you had never bought the products or searching through the freezer to chuck any that you had purchased.

But the real question is how wide spread the problem of mislabeled gluten-free food really is? And the unnerving answer is that no one knows.

The Tribune, in its broader stories about problems with allergen labeling, reported mislabeling of gluten from only one company. (There was mention of the potential for gluten in Whole Foods corn tortillas, but independent tests found no gluten in them). What would we find if we tested a number of products that are labeled “gluten free?”

There are many specialty gluten-free food makers who take steps to make sure their products are safe. They make them in manufacturing plants where no gluten-containing products are made. They test ingredients and then they test the final food. Many gluten-free companies were started by individuals who have celiac disease or gluten intolerance who are aware of the dangers of cross-contamination and all the precautions that are needed.

But some companies who don’t follow such strict practices. Some are small and can’t afford to. Others are large and don’t have the commitment to the gluten-free customer.

And there are still no regulations that establish one set of rules that every company has to follow before it can put a gluten-free label on a package.

That’s why final approval of the proposed definition of “gluten free” is so important and why it’s so frustrating that the Food and Drug Administration has let the deadline required in the Food Allergen Labeling and Consumer Protection Act go by without any action.

The Tribune stories faulted the FDA (and the US Department of Agriculture) for not doing a very good job enforcing the labeling laws that already exist. So you do have to wonder how the beleaguered agency will ever be able to police gluten-free companies adequately once a standard for gluten-free food is set.

But finalization of the standard is a necessary first step before those who have celiac disease can have real confidence in the gluten-free label.

It doesn’t seem there is anything gluten-free consumers can do to get the FDA moving on the definition. The agency says it is still studying the safety of allowing only foods with less than 20 ppm of gluten to use the gluten-free label.

Maybe bad publicity from the Tribune articles will kick start the FDA because it’s pretty clear that misleading consumers with a “gluten free” label on corn dogs that contain up to 100 times the proposed standard is not safe.

Labels “may contain” confusion

A “may contain” label on an otherwise gluten-free food has always made me a little nuts.

So I was glad to be able to cover the Food and Drug Administration’s hearing on advisory labels this week because it meant someone was going to start doing something about these pesky notations on foods.

When I’m in the grocery and I have one of those “Eureka” moments of finding a mainstream product that does not contain any wheat, barley or rye, I hate having it ruined by an aside that says something like, “May contain wheat,” or “Made in a plant that also processes wheat,” or “Made on a equipment that also processes wheat.”

What am I supposed to do with this information? Not buy the product?

Am I really supposed to worry that a fruit snack might be a threat to my daughter who has celiac disease because somewhere in the plant wheat might be used? And what should I make of products labeled “gluten free” that also have this kind of warning?

At the hearing I learned I have a lot of company in my confusion. It includes others with celiac disease, gluten intolerance, and food allergies. Many of us are playing a guessing game in which we try to figure out exactly what food companies are trying to tell us with these warning labels.

Consumer advocates at the hearing said people try to evaluate how risky a food might be based on the wording of the label. They conclude it is safer to eat something made in plant that processes wheat, for example, than to eat something made on equipment that processes wheat.

That makes sense to me.

But food industry representatives said the logic does not match up with the facts. One company that shares equipment might do a much better job cleaning it up than a company that has an allergen cross-contaminating the manufacturing plant.

So really, what are we, and the people with allergies who face life threatening reactions, supposed to do?

The first thing is to write to the FDA and tell them how big a problem these labels are in your daily life. Use personal stories, that always seems to get attention. You can send a letter by regular mail or over the Internet. (You’ll find both addresses on our website, http://www.glutenfreeliving.com/, under the current events/newsflash section.) The deadline is Jan. 14, 2009, which means improvements aren’t coming in a few weeks or months, but at least there’s hope they are coming.

The FDA said it wants to know if labels are helpful to consumers. That’s an easy question to answer and the answer is “No.”