What Exactly “Certified Gluten-Free” Means
Scouring food labels for signs of gluten-containing ingredients can feel like a scavenger hunt for gluten-free shoppers. That’s why, in 2013, the Food and Drug Administration (FDA) introduced new guidelines for gluten-free labeling so that those with celiac disease can “choose foods with greater confidence.” And while the guidelines have certainly been helpful for gluten-free shoppers, they have also led to some questions and confusion, especially when shoppers see foods labeled “gluten-free” on shelves next to foods bearing a “certified gluten-free” symbol. What’s the difference? Here’s our comprehensive guide to understanding gluten-free labeling rules—and why you can trust the “certified gluten-free” symbol.
What it means when you see “gluten-free” on a package
When you see a food package marked “gluten-free” without a certification symbol it means the food must meet the FDA rules for gluten-free labeling. Primarily, that means the food cannot contain any gluten-containing ingredients, and any trace amounts of wheat, barley, or rye in the food (such as cross-contamination from shared storage or manufacturing equipment) must be less than 20 parts per million (ppm). These rules apply to all foods and supplements produced in the United States or imported and sold in the United States.
The FDA set 20 ppm as the threshold for gluten-free labeling because celiac disease research suggests that most people with celiac disease can tolerate trace amounts of gluten up to 20 ppm, according to the Celiac Disease Foundation.
All that sounds pretty straightforward, but there are a few situations where these rules have been known to trip up shoppers:
- 1. Gluten-free labeling is optional. While the FDA allows food manufacturers to label foods gluten-free, it doesn’t require it. That’s why you may see a “gluten-free” label on inherently gluten-free foods like fresh produce and bottled water, but not on a bag of chips that only includes gluten-free ingredients like potatoes, salt and oil.
- 2. There are no rules on what the gluten-free label should look like. If a food or supplement meets the FDA’s rules for gluten-free labeling, the manufacturer may simply print the words “gluten-free” somewhere on the package (see the illustration above). There are no rules about where the words must be placed or how big they should appear.
- 3. A food can be labeled “gluten-free” even if it contains wheat. If a product uses a gluten-containing ingredient that has been processed to remove gluten and contains less than 20 ppm of gluten, such as wheat starch or wheat dextrin, it may be labeled gluten-free. Fiber supplements, for example, are often made with wheat dextrin and bear the FDA allergen warning “contains wheat.” However, these supplements may still be labeled gluten-free if gluten has been removed below 20 ppm, which is common.
- 4. Manufacturers must follow the rules, but they don’t need to test for gluten. This is a big one for people with celiac disease: Manufacturers are NOT required to test for the presence of gluten in finished food products labeled gluten-free. It is up to the manufacturer to determine how it will ensure the food does not contain 20 ppm or more of gluten. The FDA may review labels, follow up on consumer complaints and analyze food samples.
What it means when you see the “certified gluten-free” symbol on a package
When you see the “certified gluten-free” symbol on a food package, it means the manufacturer has followed stringent steps to prevent gluten cross-contamination and that the food has been independently tested by a third-party for the presence of gluten. This is the main difference between third-party gluten-free certification and gluten-free labeling, since the FDA does not require manufacturers to test for gluten in finished food products.
There are a few organizations that offer third-party gluten-free certification. Foods that are certified gluten-free will carry a symbol on the package to denote the certification. At a minimum, gluten-free certification must meet all of the FDA’s gluten-free labeling rules and may go above and beyond. The most common gluten-free certification is administered by the Gluten-Free Certification Organization (GFCO), and it is the one we use at Mikey’s.
How we make sure Mikey’s products are always gluten-free
Scheduling, sanitizing, strict cross-contamination prevention procedures, testing and auditing are key for ensuring safe gluten-free food production, says Analee Johnson, who handles quality assurance for Mikey’s. Here’s what that looks like at the facilities where Mikey’s products are made.
- 1. Scheduling. At the facilities where Mikey’s products are made, a full day is typically set aside for only gluten-free production. On the rare occasion that gluten-free and gluten-containing production are scheduled for the same day, the gluten-free production is always done first, with ample time built in the schedule to make sure all gluten-free foods are wrapped and packed before any gluten-containing ingredients are opened.
- 2. Sanitizing. Before a gluten-free production run, all equipment is sanitized and swabbed for gluten. Gluten is the protein found in wheat, barley and rye, and the swab will show a positive result if it comes into contact with the gluten protein. “The swabs are deliberately taken in areas that are more difficult to clean,” explains Analee. “Imagine you are washing a cookie tray. The curved corners are always harder to clean than the flat surface. That’s where you would swab for gluten.” If the gluten swab comes back positive for gluten, the equipment is sanitized and tested again. Production cannot begin until the test comes back negative for gluten.
- 3. Cross-contamination prevention. At the start of any gluten-free production run, strict guidelines must be followed:
- - All raw ingredients are verified gluten-free and labeled with green signs that state “GLUTEN-FREE.” These ingredients may not be opened prior to the start of gluten-free production.
- - All employees must wear green hairnets and green gloves as a constant reminder of the importance of maintaining a gluten-free environment. Managers wear green jackets.
- - When the production managers have verified that the plant is sanitized and ready for gluten-free production, signs are posted throughout the production and packaging areas.
- - Samples of the finished product are collected hourly throughout the production run for gluten testing.
- 4. Testing. Finished product samples are sent to a third-party laboratory to be tested to ensure that gluten levels are below 20 ppm. All Mikey’s products are held at the production facility until the results come back. If the product did test positive for gluten above 20 ppm (which has never happened!), we would not be allowed to sell it with the gluten-free label or certification symbol. The external laboratory that does our testing actually tests for gliadin, a glycoprotein within gluten, at a level of 2.5 ppm, well below the required 20 ppm.
- 5. Auditing. In order to maintain gluten-free certification from GFCO, our manufacturing facilities must undergo a vigorous audit and review every year. During the audit, inspectors review the policies and procedures outlined above and examine the food storage areas to ensure there is a clear separation of gluten-free and gluten-containing ingredients.
How can a food be “certified gluten-free” and also made in a facility that processes wheat?
Many gluten-free foods are manufactured in facilities that also process wheat, but that does not mean shoppers with celiac disease should be worried about contamination. “It would be very difficult for a manufacturing facility to sustain its business on only gluten-free production because there is simply not enough demand,” Analee says. “However, as you can see, the gluten-free certification process is very stringent. People with celiac disease should not be worried about consuming gluten-free certified foods.”
Is “made with no gluten-containing ingredients” the same as “gluten-free?”
No. According to the FDA, statements like “made with no gluten-containing ingredients” and “not made with gluten-containing ingredients” are allowed on food products providing the statement is true and not misleading. However, the FDA says this is not the same as labeling a food gluten-free and shoppers should not assume the food meets the FDA’s gluten-free standards.
The “certified gluten-free” logo is getting a refresh
GFCO is phasing out the “certified gluten-free” logo you are used to seeing and replacing it with a new logo with an updated look. None of the criteria for gluten-free certification is changing.
Image courtesy of GFCO.org.
The bottom line
Foods that are simply labeled “gluten-free” cannot contain 20 ppm or more of gluten, and food manufacturers must follow all of the gluten-free labeling rules set by the FDA. However, the FDA does not require manufacturers to test for gluten in the finished product.
Gluten-free certified foods, like Mikey’s, are verified by third-party organizations to ensure the strictest gluten-free standards are met. Independent laboratories test the finished food products for gluten, and the foods cannot be sold with the words “gluten-free” OR the “certified gluten-free” symbol on the package if the test reveals gluten traces of 20 ppm or higher. Certified gluten-free foods are among the safest choices for people with celiac disease.