What Do the Gluten-Free Claims on Your Food Labels Mean?

Posted by Magalie J. Lawrence on 17th Apr 2015

Do you wonder what gluten-free, wheat-free, and other claims on your food labels really mean? Is there a difference between food labeled "gluten-free" or "GF" and food labeled "Certified Gluten-Free"?

If you have been diagnosed with celiac disease or have a non-celiac gluten sensitivity, making sure you read and understand the food claims on your label will go a long way in helping you stay safe and stress-free.

I recently attended a symposium hosted by the New England Celiac Organization and The Celiac Program at Harvard Medical School where many health professionals discussed various topics pertaining to celiac and non-celiac gluten sensitivity. Today's topic focuses on two major FDA regulations that make it easier for consumers with food allergies to detect and avoid most common food allergens.

The first was the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004, which amended the Federal Food, Drug and Cosmetic Act. It requires food manufacturers to list any  food ingredient that contains protein from the eight major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans). Effective January 1, 2006, the law made it easier for consumers who suffer from these eight major food allergies to easily identify and avoid these ingredients in packaged food products. Manufacturers must list  the major allergens in one of two ways:

1) Immediately following each allergenic source ingredient above, if it is not clearly listed as one of the eight allergens. For example, if the food product contains spelt, casein, lecithin, and lobster, the manufacturer must list the ingredients as: spelt (wheat), casein (milk), lecithin (soy), lobster (crustacean shellfish) to alert consumers of the presence of these allergens.

2) If the manufacturer does not immediately display the name of the source allergen after each ingredient, it has the second option to list each source allergen in a "Contains" statement after the ingredients list. In the previous example, if a manufacturer lists the ingredients as: spelt, casein, lecithin, lobster. A statement must follow the ingredients list as "Contains: wheat, milk, soy, crustacean shellfish."

The Food Allergen Labeling and Consumer Protection Act (FALCPA) was a great start. However, it still left those with gluten allergies and those who suffer from non-celiac gluten sensitivity in a lurch because it did not go far enough. Gluten, the protein found in wheat, barley, and rye, can create significant health dangers for the 3 million Americans who suffer from celiac disease. FALCPA only addressed gluten in wheat and did not require gluten allergens from barley, rye, and crossbreeds of these grains to be listed on the food label.

In August 2013, the FDA passed regulation to standardize gluten-free claims on food labels across the industry and make it easier for consumers to make informed decisions. Gluten-free is a voluntary claim manufacturers are not obligated to make; however, once they choose to list the specific gluten-free terms as described by the regulation, they are accountable to make truthful claims and comply with all the regulations, which are enforced by the FDA. In a nutshell below are the regulation's major requirements:

Type of Gluten Allergens

- Wheat

- barley

- rye

- crossbred hybrids of the above

The FDA definition also states "A grain can be labeled gluten-free once it is processed to remove gluten and the presence of any unavoidable gluten due to “cross-contact” is less than 20 ppm."

What are the only terms a manufacturer can use to communicate it meets the FDA food labeling guidelines?

- "gluten-free"

- "without gluten" -

- "free of gluten"

- "no gluten"

What is the Purity standard?

The food label must contain less than 20 parts per million (ppm) of gluten, a level that has been determined to be safe for most people with celiac disease to be considered in compliance. The FDA does not require manufacturers to label their food gluten-free whether the food is naturally gluten-free or has been processed to remove gluten to below 20 ppm. However, once the manufacturer uses any of the four terms above, it becomes subject to the FDA and must abide by the regulations or be in violation of the law. Manufacturers who do not use any of the four terms above but use similar words or variations of the above words are not subject to or accountable to the FDA. They are not obligated to keep the level of gluten below 20 parts per million.

Besides the FDA gluten-free food labeling, how can consumers ensure consistency in their packaged food across the industry?

Besides the FDA ruling, there are separate third party certifications that require the food to be well below the 20 parts per million-- usually between 5 and 10 parts per million. Manufacturers must pass the requirements of one of the independent certification companies, and pay a fee to use the company's certified gluten-free logo on its label.

Is gluten-free food regulated by the FDA significantly different from gluten-free food with the certified gluten-free logo from third party certification organizations?

A recent test conducted by Gluten-Free Watchdog tested 158 foods labeled gluten-free in both categories and found 95% of the gluten-free products to have less than 20 parts per million (ppm) -- 87% had less than 5 parts per million (ppm). In addition, 5% of FDA labeled food and 4% of foods with certified gluten-free logos had levels above the 20 ppm. For more information see the attached links.

I hope you will find it easier to navigate your allergy-free and gluten-free supermarket aisles with a little more confidence whether a food product label claims to be wheat-free, gluten-free, certified gluten-free, or just with a picture suggesting a product is without gluten. If you would like more information, please go the links below.