Gluten-free. Dairy-free. Nut-free. Peanut-free. Allergen-free. The food marketplace increasingly features such claims on product labels, but what do they mean? Do regulatory agencies police use of such terms?

Food products with “free” claims are primarily intended for consumers with food allergies and related illnesses.

Gluten-free foods have been around for many years and are primarily intended for consumers with celiac disease, making them unable to tolerate the gluten proteins of wheat, rye, barley and related grains. The gluten-free food market has exploded in recent years due to consumers who do not have celiac disease, but purchase gluten-free products anyway. These consumers cite various reasons for selecting gluten-free foods:

• They feel better on a gluten-free diet.
• Gluten-free aids in weight loss. (This has not yet been proved.)
• A gluten-free diet can combat depression. (This also has not been proved.)

Dairy-free foods have also been marketed for decades. Most were probably originally intended for consumers with lactose intolerance and thus experience mild intestinal discomfort after eating dairy products. Today, dairy-free foods must also be milk-free because of the prevalence and recognition of milk allergies.

Peanut-free, nut-free, allergen-free and other such claims also have recently begun to appear. You must understand these illnesses to determine whether your company can safely make special “free” products.

True food allergies are abnormal responses of the human immune system to food proteins. The most common allergenic foods are peanuts, tree nuts, crustacean shellfish, fish, milk, eggs, soybeans and wheat. They can cause immediate symptoms ranging from mild and annoying (hives, for instance) to severe and life-threatening. An estimated 12 million to 14 million Americans have food allergies, with an unknown number at risk for severe reactions.

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Celiac disease involves an abnormal cell-based immune response to a particular food protein (gluten). When those afflicted consume a food containing gluten, an intestinal inflammatory response occurs, leading to a loss of absorptive function. Symptoms include diarrhea, weight loss, anemia and bone pain. One in every 2,000 Americans has symptomatic celiac disease associated with the consumption of the gluten protein, which is found in wheat, rye, barley and related grains.

Food intolerances do not involve abnormal immune responses. Lactose intolerance is the best example and occurs in individuals with low levels of an intestinal enzyme needed to properly digest lactose. Intestinal bacteria ferment the unabsorbed lactose to CO2 (carbon dioxide), H2 (hydrogen) and H2O (water), causing mild symptoms such as flatulence, abdominal cramps and frothy diarrhea. Lactose intolerance occurs in more than 50 percent of people of Hispanic, Asian or African origin. Affected individuals often tolerate small doses of lactose in their diets.

With true food allergies and celiac disease, people’s tolerance of offending foods is incredibly low, so they must avoid them.

With the exception of gluten-free, the use of “free” statements on packaged foods is not specifically defined or restricted, but it must be truthful and not misleading. Gluten-free may only be used on the labels of products that contain less than 20 parts per million (ppm) gluten as measured by gluten-specific ELISA (enzyme-linked immunosorbent assay) methods. Such methods can generally detect down to 5 ppm gluten and are used to establish the gluten-free status of food products.

No regulatory definitions exist for terms such as peanut-free, dairy-free, nut-free or allergen-free. “Free” suggests that the food should contain no detectable residues, but the availability, specificity and sensitivity of detection methods to support such claims can vary. Selecting test methods will be the subject of a future column.

 The potential market for consumers with food allergies and intolerances—real and perceived—is sizeable. While the gluten-free marketplace is exploding and dairy-free appears relatively mature, other market opportunities may exist. The size and profitability of these “free” markets is uncertain. The degree of difficulty involved in making products for such markets will be the subject of a future column.  

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