Under the Food Allergy Labeling and Consumer Protection Act of 2004, firms must specially label any food that contains an ingredient that contains, in some part, protein from a “major food allergen”: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans (known also as the “big eight”).1 Though there are over 160 known foods that can cause allergic reactions, the “big eight” accounts for over 90 percent of reactions in the United States. Allergic reactions are a major health risk without a cure, hospitalizing 30,000 Americans per year and killing 150 annually. They’re also a condition which requires everyday vigilance for over 15 million Americans, including the author himself. Those who have food allergies need to watch carefully for allergens, and they also need food manufacturing plants to accurately represent and label the contents of their products.
To comply with labeling requirements under FALCPA, your firm will need to make special note of “big eight” allergens either by printing them in parenthesis on the ingredient list after the relevant ingredient if they do not appear elsewhere, or by noting, at the end of the ingredient list, all major allergens, in the form of a statement: “Contains…” followed by all allergens present.1 Ingredients which are derived from these allergens need to be expressed in terms of the common name of these allergens; for example, only using the term “lecithin” on a label is not a valid substitute for indicating the presence of soy. A statement which would comply would be in the form of “… lecithin (soy).” If the ingredient already uses the common name of the allergen, such as “eggs,” no parenthetical statement is necessary. The law requires labels to specify the types of allergens used alongside their type, in the case of fish, shellfish, and nuts. Raw agricultural commodities, generally fresh fruits and vegetables, highly refined oils, and products using these highly refined oils are not subject to FALCPA labeling requirements.
Gluten-free labeling is another substantial rule issued under FALCPA authority. To label a product “gluten-free,” or any similar statement, the product must not be made with any gluten-containing grain or any ingredient which is derived from a gluten-containing grain and has not been sufficiently processed to remove gluten below 20 ppm. Note that the FDA considers wheat, rye, barley, or a hybrid of them to be a gluten-containing grain. Because oats are an unclear area for those with Celiac’s disease, they are not covered by this rule. The product must contain unavoidable levels of gluten below 20 ppm. Products which do not contain gluten by nature may be labeled “gluten-free” so long as they clearly indicate that all such foods are, not just the brand’s products (i.e. “milk is gluten-free” would be allowed, but “Our new and improved milk is gluten-free!” would be misleading). Any product which fails these criteria will be considered misbranded. If the product lists wheat in the ingredient list or in a special allergy label, and the label also indicates “gluten-free,” or a similar statement, the label must make clear that the wheat has been processed to remove gluten as required by the rule.2
While many manufacturers opt to use statements such as “may contain,” “processed in a facility that also processes,” or “processed on equipment with,” these advisory statements are not required by FALCPA, and may or may not indicate the presence of allergens in food.3Though there is some lasting confusion over what these statements mean in the context of individual plants, especially for cross-contact on production lines, it remains important to completely follow recently updated current Good Manufacturing Practices on preventing such cross-contact.4 A recent FDA study surveying dark chocolate bars found that 77% of dark chocolate bars with an advisory statement had some milk present, but in widely ranging amounts. A majority had milk products present at over 1,000 parts per million.5 To help protect consumers, and protect your operations from recalls, it is recommended to routinely sample and test products for relevant allergens, and to accurately represent your products’ content (i.e. not labeling dark chocolate containing 1,000 ppm of milk as “dairy-free”).
If products are found to be improperly labeled, then the FDA will initiate recall procedures to protect at-risk consumers from unknown consumption of allergens. In a globally connected food market, recalls may also be conducted by international agencies with similar standards to the FDA, primarily the Canadian Food Inspection Agency or the European Food Safety Agency. Common issues leading to recalls are largely the result of using incorrect packaging, often for products that appear similar, incorrect terminology (i.e. “butter” instead of “milk”) under FALCPA, failure to include allergen information from previous ingredients, and failure to account for cross-contamination.6 Notably, undeclared allergens have accounted for a larger share of reported incidents over the period of the Reportable Food Registry, and in 2015, for which an official RFR report has not been released, this trend appears to be continuing unabated.7 This is primarily because of computerized printing is especially susceptible to simple but deadly file errors, cross-contamination that has gone unnoticed, and increasing complexity in global supply chains, which creates difficulties in compliance both in the U.S. and abroad. For example, mustard is a required allergen to be disclosed in Canada, which led Kraft in 2015 to recall a brand of its barbecue sauce.8 Canada requires the disclosure of the “big eight” as well as mustard, sesame, and sulphites,9 while the European Union requires the “big eight” as well as cereals containing gluten, celery, mustard, sesame, sulphites, and lupine.10 As an FDA study noted in 2013, the most common recalls are of bakery products, the most commonly undeclared allergen is milk, and the most common error made was in using the wrong package or label for a product.11
To avoid these dangerous mistakes, firms should implement Current Good Manufacturing Practices to minimize cross-contamination, implement “good printing practices” to ensure that labeling information is correct, and create specific subplans to focus on the threat of cross-contamination. Such plans might include a comprehensive flowchart envisioning every location where allergens are present in your factory so that you can keep them distinct from any other products not meant to contain them.12 These plans should detail more than just the “big eight”: also track any other ingredients that could provoke an allergic or adverse reaction.13 Even different types of tree nuts, with different proteins, need to be tracked and prevented from cross-contamination (unless they are intentionally sold together). For further assistance developing such an allergen plan, see here.14
This act and its related regulations have contributed significantly to consumer protection for those with food allergies. According to a 2008 survey, clear labeling on packaged food products reduced accidental ingestion of food allergens by 24.4%, in the two years since FALCPA went into effect.15 However, the same study found that FALCPA left one critical facet of allergen ingestion untouched: consumption in restaurants. Even though federal legislation does not require restaurants to indicate the presence of allergens in their meals, five states: Massachusetts, Maryland, Michigan, Rhode Island, and Virginia, require various forms of allergy awareness to be provided by restaurants, as do New York City and Saint Paul.16 Safe handling of food allergens in the kitchen remains a major Current Good Manufacturing Requirement, and informing consumers about food allergens used in restaurants is always a good business practice. Food-service establishments can train their employees to be proactive about asking about food allergies, work to accommodate substitutions in meals, and print menus which note food allergens to better serve individuals with allergies.17
We hope that this primer helps you to better understand your requirements for handling food allergens and labeling them for consumers!
The FDA’s official comments and industry guidance about FALCPA.
The FDA’s official responses during the question-and-answer period of issuing their rule on gluten labeling.
Note that, as per FDA guidance, these voluntary statements “should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading.”
4 http://scholarship.law.upenn.edu/cgi/viewcontent.cgi?article=9446&context=penn_law_review. The complaints in this article have been partially addressed by updated cGMPs regarding allergen cross-contact, though it still brings appropriate attention to the ambiguity surrounding advisory statements.
“In 75% of the chocolate bar products with a milk advisory statement, milk concentrations were above the limit of quantitation (2.5 µg/g [ppm]), with the majority having concentrations > 1,000 ppm. An additional 67% of chocolate bars with a ‘‘traces of milk’’ statement contained 3 to 6,700 ppm of milk.” [emphasis added]
“…use of the wrong package or the incorrect label for a product was the most common problem… The second most frequent cause of allergen recalls was the use of the wrong terminology in the ingredient list or the allergen “contains” statement… The third most common cause of allergen recalls was failure to carry forward allergen information from an ingredient to the final product label.”
“In November, FSIS unveiled plans to counteract what they determined to be an increase in the number of undeclared allergen recalls in recent years.”
“7/24/15: Kraft Canada Inc. is recalling Bull’s-Eye Hot Southern Cajun Barbecue Sauce from the marketplace because it contains mustard which is not declared on the label.”
CFIA official information on Canadian allergen labeling regulations.
A University of Nebraska-Lincoln summary of EU allergen labeling regulations.
“Bakery products were the most frequently recalled food type, and milk was the most frequently undeclared major food allergen. Use of the wrong package or label was the most frequent problem leading to food allergen recalls.”
Food Safety lays out several recommended practices for food and beverage processors.
The author, a food safety professional, relates his story of surprise after his own allergic reaction to mangos to best industry practices to prevent cross-contamination for all allergens, not just the largest offenders.
This checklist is a smart way to check your firm’s operations, and make corrective actions if necessary.
“The annual accidental food allergen ingestion rate of adults decreased by iv a significant 24.4% in the two years since the FALCPA was passed… Restaurant prepared food was the number one cited reason for accidental ingestion both prior to and after the passage of the FALCPA.”
Food Allergy Research and Education was instrumental in assisting with FALCPA itself, and has also advocated for state and local food allergy policies in restaurants. Here, it explains these state and local laws.
Eater Magazine explores the implications of the rising prevalence of food allergies on the restaurant industry and the adjustments being made to prevent accidental ingestions.