FDA

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

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.”