Editor’s note: This is 2017 winner of the “Publisher’s Award” for essays written as part of a food safety litigation class at the University of Arkansas Law School taught by Bill Marler and Denis Stearns of the Seattle law firm MarlerClark LLP.

In 2015, General Mills announced that it would produce gluten-free Cheerios and Honey Nut Cheerios. This was a boon to nearly 30 percent of consumers who avoid gluten. However, in July of that year, due to a transportation mix-up at General Mills’ Lodi, CA, facility, wheat flour was mistakenly used instead of gluten free oat flour to make the cereal.

That October, General Mills announced a recall of approximately 1.8 million units of Cheerios produced at the California facility. Nevertheless, as a result of this mix-up, plaintiffs who bought the cereals brought class action lawsuits in the Eastern District of California against General Mills for claims related to selling misbranded food, alleging that the Cheerios cereals were labeled, “gluten free” when in actuality they were not.

Is this just another instance of an opportunistic plaintiffs’ bar trying to profit off of a simple error? No. General Mills’ error, and the actions taken as a result, are a helpful gauge for evaluating the steps that should be taken by a company to assure that its products contain what their labels say they contain, especially for people suffering from food allergies.

Food allergies are a serious problem in the United States, and indeed, around the world. According to FARE, an advocacy group for food allergy research and education, it is estimated that up to 15 million Americans have food allergies. Nearly 6 million, or 8 percent of children, have food allergies, with young children being affected most. The number of people with allergies in the US is growing.

Food intolerances are another, although milder, negative biological reaction to food. A severe form of food allergy is Celiac’s disease, an allergy to gluten, the protein found in wheat. Celiac’s disease is a condition that causes damage to the lining of the small intestine in response to eating gluten. The damaged intestine does not absorb needed components of food and this can lead to other problems like delayed growth and intestinal cancer.

Food intolerances do not involve the immune system, as allergies do, although they may cause some of the same symptoms as a food allergy. An example of an intolerance would be lactose intolerance, when a person’s small intestine does not produce enough of the lactase enzyme and is unable to digest lactose, the natural sugar in dairy products. This causes gas, bloating, and other intestinal discomfort.

Eight foods account for 90 percent of all food allergic reactions: milk, wheat (and gluten, the protein found in wheat), eggs, peanuts, tree nuts (such as walnuts and almonds), soy, fish, and shellfish. Even proteins from these foods released into the air from vapor or steam while cooking can potentially cause allergic reactions.

The most severe allergic reaction is anaphylaxis. Anaphylaxis can be life-threatening. It can occur within seconds or minutes of exposure to an allergen, such as peanuts or bee stings. It causes the immune system to release a flood of chemicals that can cause an allergy sufferer to go into shock, their blood pressure drops suddenly and the airways narrow, blocking breathing.  Anaphylaxis can be fatal.

This is why the “mix-up” at General Mills in July of 2015 is a matter of real concern. Immediately after General Mills started selling these products, the U.S. Food and Drug Administration — the agency charged with ensuring that foods manufactured and sold in the U.S. are correctly labeled and branded — began receiving complaints about the level of gluten in the cereals. The FDA tested samples of the cereals and found that the level of gluten exceeded the FDA’s permissible levels.

The FDA  is the oldest consumer protection agency in the United States government. It was established in 1906 to prevent the introduction of adulterated foods into commerce. In 1938, Congress passed the Federal Food, Drug and Cosmetic Act (FDCA). This established the legal framework for the FDA’s current operation.

The FDA’s primary work was to protect public health by:

“assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation … FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.”

Although the FDA’s responsibilities are not solely related to food but include medicines and cosmetics, the agency has been a ground breaker in its regulation of food labeling. The FDCA’s ingredient labeling requirements, which mandated that the name of a food, “a statement of ingredients, the net quantity of contents, and the name  and address of the manufacturer … in a standardized format on food labels” were previously unheard of.

The FDA began to actively concern itself with allergen labeling in the 1990s.  Food sensitive consumers began to advocate for more informative food labeling. By the early 1990s organizations for food sensitive individuals were growing due to the increase in the awareness of food sensitivities, diagnosis of food sensitivities, and the use of the internet. People who were having allergic reactions to foods they were eating that contained allergens that were not clearly labeled as having contained them were contacting the FDA and triggering recalls. The FDA was receiving petitions to improve allergen labeling and in 2001, held public meetings to discuss food labeling.

In addition to the FDA’s efforts to focus on allergen labeling, Congress joined the effort. U.S. Rep. Nita Lowey introduced legislation to improve allergen disclosure on food labels in 200. Senators Ted Kennedy of Massachusetts and Judd Gregg, a Republican from New Hampshire, promoted allergen labeling initiatives.

Improving allergen labeling became a national issue. Congress unanimously passed the Food Allergy Labeling and Consumer Protection Act (FALCPA) in 2004. It amended the FDCA by adding the requirement that foods list the allergens they contained near the ingredient label, or be deemed misbranded, and unable to circulate in commerce.

The act’s labeling requirements are mandatory, and apply to foods labeled on or after Jan. 1, 2006. The congressional findings emphasize the facts that 2 percent of adults and 5 percent of infants and young children suffer from food allergies, and that each year 150 people die from allergic reactions to food. It referenced celiac disease. It also noted that the FDA sampled baked goods that were publicly sold and found that a quarter of them failed to disclose that they contained peanuts and eggs, major food allergens. In addition, many consumers did not realize that certain ingredients contained allergens. The act was intended to empower consumers with more information about the food they were buying so that they were not risking their lives with every food purchase.

The Act also required the FDA to start a process for formulating a definition for the term “gluten free.” In 2013 the FDA issued a final rule defining the requirements for foods labeled “gluten-free.” Foods labeled “gluten-free” “must contain less than 20 ppm (parts per million) of gluten” because scientific testing cannot reliably detect gluten levels below that amount.

By the FDA’s safety assessments, a 0.01 parts per million thresholds for gluten in food would be safe even for the most sensitive person with celiac disease.   The “gluten-free” label can also be used with foods that do not contain any type of wheat or rye.

The purpose of FALCPA is to provide consumers with information so that they can make informed food choices and not inadvertently put their lives at risk. Although some critics of the act argue that if a product has any gluten at all, even under 20 ppm, it should be so labeled, so that the consumer has knowledge of what their food contains. However, the FDA set that limit so that foods containing trace amounts of gluten weren’t completely unavailable to people who are already burdened by having to maintain a “gluten-free” diet.

There are penalties to violating FDA regulations, ranging from warning letters, to fines, to jail time.  However, as a matter of policy, the FDA prefers self-correction. In light of that fact, how can consumers like the ones in Van Lengen or Haddix trust that their “gluten-free’ items are actually that, and not the product of some mix-up?

In recent years there has been an increase in the number of consumer class action lawsuits challenging labeling claims as misleading. Whether plaintiffs obtain money judgments or not, lawsuits such as Van Lengen and Haddix cause companies to take corrective action to assure that they comply with FDA regulations.

In the case of General Mills in particular, as a result of the lawsuits, the company began “testing all finished product… [and has] instituted additional flour handling protocols at all facilities to ensure this will not happen again.”   Plaintiff lawsuits help keep companies cognizant of their responsibilities to do their best to be worthy of the public’s trust, by producing products that are exactly as their labels claim they are.

About the author: Brenda Hall-Busch is an LL.M. candidate in the Agricultural and Food Law Program at the University of Arkansas Law School. She is deeply passionate about consumer education and access to healthy food. Her prior legal experience includes criminal prosecution and insurance defense. 

 

 

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