The Food Safety Modernization Act (FSMA) is requiring significant changes for food companies, and allergen controls are one area of focus. Although the U.S. Food and Drug Administration (FDA) hasn’t yet released its final guidance on allergens, it’s never too early for businesses to take a closer look at what they’re doing to make sure allergens aren’t introduced inadvertently into products.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 already lays out the basics about labeling of foods containing allergens. The “Big Eight” allergens—milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans—are still the major focus, as they account for some 90 percent of food allergies.
What’s new is the emphasis on undeclared allergens, now described as hazards that should be controlled. Although products containing allergens are occasionally misbranded, “undeclared allergens” often refers to allergens that were never supposed to be there in the first place. Allergens could be introduced into a food product many ways, most involving accidental cross-contact of some kind.
In the past, many companies were required to have in place Hazard Analysis and Critical Control Points (HACCP) plans, which are evolving under FSMA into Hazard Analysis and Risk-based Preventive Controls (HARPC) plans. HACCP plans focused on analysis and control of biological, chemical and physical hazards to minimize risk. HARPC plans focus on preparing for a wider variety of risks or hazards, including allergens.
The Danger of Allergens
In fact, there are myriad reasons besides FSMA to strive to be meticulous about allergen control. Undeclared allergens are the number one cause of recalls, and recalls can have a devastating economic impact on a company. Expenses associated with a recall could even bankrupt a small business. Costs include notifying consumers, removing food from shelves and paying damages that could potentially result from lawsuits. Short-term revenue evaporates when a product is recalled and destroyed, and depending on the nature of the recall, damage done to a brand can also be costly.
Even more serious, undeclared allergens can kill. Although most reactions to food allergens are mild and self-limiting, about 20 percent of reactions lead to anaphylaxis—a systemic reaction that can cause breathing passages to swell shut and blood pressure to plummet, resulting in shock and, too often, death. There are some 30,000 cases of anaphylaxis per year in the United States, causing some 2,500 hospitalizations. About 150 people per year die from anaphylactic shock. When someone shows up at an emergency room with anaphylaxis, the most likely cause is a food allergy, with tree nuts and peanuts being the most common culprits.
A high-profile case that illustrates how quickly an allergen can kill is that of Natalie Giorgi, a 13-year-old girl who, in 2013, took a bite of a Rice Krispies square that contained a trace of peanut butter. Natalie knew she was allergic to peanuts and was careful about what she ate, but the dessert bars were unlabeled and the kitchen staff, although alerted to her allergy, didn’t tell her family about the ingredient. Natalie’s father, a physician, couldn’t save her. The incident occurred at a family camp run by the city of Sacramento, CA; the family recently reached a $15 million settlement with the city.
In Great Britain, food manufacturers have been warned to ensure comprehensive risk management over allergens after the owner of an Indian restaurant was sentenced to 6 years in prison after a customer died from anaphylactic shock. The customer ate curry containing peanuts. The restaurateur had switched almond powder for a cheaper ground-nut mix that contained peanuts.
The Role of Preventive Controls
Retail food establishments are under no obligation to prepare and serve allergen- or gluten-free food (see “What about Gluten?”). These two cases, however, show the danger posed by carelessness with allergens. The good news is that food processors and manufacturers have done their job if products are labeled correctly under FALCPA. When products are correctly labeled, people with serious allergies can check to be sure the food is safe for them to consume.
Problems arise, however, when food products are accidentally contaminated, and that’s why preventive controls are so important. As noted, undeclared allergens—not pathogens—drive the overwhelming majority of recalls. Between 2005 and 2014, some 12 million pounds of product were recalled because of undeclared allergens, and many of those allergens were present because of cross-contact in the manufacturing process.
The maximum amount of an allergenic food that can be tolerated in a product without producing any adverse reaction is called the “threshold,” and at present, there are no regulatory allergen thresholds or action limits for any of the Big Eight food allergens. Thus, finding any allergenic protein-containing ingredient that is not declared on the label or misbranded is problematic, and that product is potentially subject to recall. Manufacturers should identify steps in their process where prevention and control of allergen cross-contact can be implemented as well as identify methods to ensure that the finished product is properly labeled.
What about Gluten?
More consumers are requesting “gluten-free” foods, but what is gluten? Gluten is the protein in wheat, rye and barley that provides the properties that hold dough together and to which some people develop hypersensitivity. An abnormal response to gluten can lead to the development of either a wheat allergy or celiac disease, which damages the small intestine. Both are immunologic responses.
Many products today are advertised as gluten-free, and some companies advertise a product as gluten-free as a marketing ploy as well as out of concern for the sensitivities of their customers. Sometimes, food products are advertised as gluten-free, even if they would not logically include gluten.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) permits the voluntary use of the term “gluten-free” (GF) on food labels. If a food manufacturer chooses to use the GF label, the product must contain less than 20 parts per million (ppm) of gluten. The 20-ppm threshold applies only to the GF label. Under FALCPA, any product that contains wheat (one of the Big Eight allergens) also must declare “wheat” on the label.
FALCPA regulations on GF labeling include other members of the Triticum family, such as spelt, kamut, triticale and durum, as well as common wheat. Although not considered among the Big Eight in the U.S., rye and barley also contain gluten, so a product must contain no more than 20 ppm of rye or barley to earn the GF label. Oats do not contain gluten. A product may contain a gluten-containing grain that has been processed to remove gluten, like wheat starch.