For some of the 220 million people who have food allergies worldwide, the accurate labeling of your food products could be the difference between life and death. Even for consumers with less severe food allergies, inaccurate allergy labels can still pose risks, including skin, respiratory, and gastrointestinal symptoms. Between physical discomfort, fear, public backlash, and regulatory repercussions, allergen label inaccuracies can have serious consequences for both consumers and your business.
This makes prioritizing the accuracy of your allergy labeling practices all the more critical. Not only is accurate labeling required by the FDA, but it's also necessary to protect public health. Allergen labels are your consumers’ first line of defense against a potential allergic reaction, because even with the best of intentions and good manufacturing practices, allergen cross-contact can still happen through shared equipment, airborne particles, or ingredient sourcing. Taking extra precautions with allergen labeling demonstrates a commitment to public safety while helping you avoid fines, recalls, and lawsuits.
Learn more about the risks of mislabeled products and how to educate your team on the importance of mitigating them through best practices.
The Risks of Allergen Mislabeling
Shoppers rely on product labeling to make safe, informed decisions about which food products they purchase — and a mislabeled product puts this whole system at risk. Additionally, the downstream effects of inaccurate allergen labeling on your business can mean noncompliance, regulatory consequences, and even costly product recalls.
Whether caused by shared production lines, packaging mishaps, formula changes, or other unforeseen mistakes, allergen mislabeling can lead to a number of consequences. It’s crucial for your team to understand these dangers and take precautions to avoid them.
Physical danger to consumers
Above all else, the greatest risk in allergen mislabeling is the threat it poses to consumer safety. Every year, around 3.4 million people experience a food allergy-related emergency room visit in the U.S., and more than 40% of children with food allergies have experienced anaphylaxis.
This danger is not one that consumers with food allergies take lightly. For them, product allergen labels are like a lighthouse steering them away from the threat of a potentially deadly reaction. If your labels do not accurately reflect allergens present in your food products, it can lead to a loss of trust among your customers.
Customer exposure to undeclared allergens can also lead to legal action against your company, which not only puts your business at risk of financial loss, but also impacts your public perception, leading to the loss of existing and future customers.
Non-compliance with FDA regulations
Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act, packaged food manufacturers must comply with certain food allergen labeling requirements. These guidelines are consistently updated based on new information, but falling out of compliance with current standards can result in penalties from the FDA. The FDA’s major allergen list, for example, includes milk, eggs, peanuts, wheat, soybeans, fish, shellfish, tree nuts and, most recently, sesame.
Products that don't comply with FDA regulations are considered misbranded and subject to enforcement actions, including recalls, import refusal, and seizure by the FDA. The FDA may also issue warning letters or place products on the FDA's Import Alerts list — a resource designed to help consumers identify products with a history of known violations. These enforcement actions can be detrimental to operational, financial, and reputational success — making mislabeling a serious threat to your business.
Financial ramifications
Both FDA and consumer legal action carry financial penalties for allergy mislabeling — although they may be more or less direct depending on the issuer. FDA enforcement actions generate costs from product recalls and seizures, including sunk costs from unsold products and the costs of recalling mislabeled products from vendors.
Costs associated with consumer legal actions could include legal fees and punitive damages. Manufacturers may also incur additional costs related to label redesign, reprinting, and validation of updated allergen control procedures.
But how can you avoid these risks and optimize your labeling process? The right proactive strategies can help prevent these negative outcomes and provide a safer experience for your customers.
Strategies for Achieving More Accurate Allergy Labels
An effective allergen labeling process is an essential step in your manufacturing operation. But what are best practices for ensuring your allergen labels are as accurate as possible, consistently? Consider how you might shore up your defense against potential misbrandings with these tips.
Familiarize yourself with updated allergen information
Knowledge is power when it comes to avoiding mislabeling, and staying on top of the newest available information can help you stay in compliance. The first step to revamping your allergen labeling process is staying up to date with the latest FDA guidance, including current major allergens (as of 2023, the FDA recognizes nine) and labeling regulations.
If you're unsure about a specific allergen labeling-related issue, the FDA has a searchable database of frequently asked questions that you and your team can use as a resource. Investing in periodic food labeling training can also help your team keep up with the latest requirements. This training should include reviews of supplier documentation, verification of allergen cross-contact controls, and establishing awareness of recent FDA guidance updates.
Follow precautionary allergen labeling practices
Your facility is taking all proper steps to avoid allergen cross-contact, but whether because of shared production lines or a recent formula change, you’re still worried about the presence of undeclared allergens in your products. Adding optional precautionary allergen labeling (PAL) to your process can help shore up your defenses.
Precautionary allergen labeling, also referred to as allergen advisory statements by the FDA, includes adding statements like "may contain [allergen]" or "produced in a facility that also uses [allergen]" to your food products. It serves as an extra layer of protection against accidental cross-contact, though it must always work in conjunction with (not instead of) good manufacturing practices.
These labels take the extra step of warning consumers about the potential for an allergen to be present in your food product — even if it's not. This seemingly small detail increases transparency with your consumers and can even boost trust while protecting your business from the legal ramifications of accidental allergen exposure.
Embrace specificity
According to FDA regulations, if your product contains allergens that are a part of a broader category, you are required to specify the exact allergen being used. For example, if your product contains tree nuts, you must specify which tree nut varieties your product includes (e.g., almonds, pecans, walnuts, etc.), individually rather than providing a blanket "contains tree nuts" statement.
These distinctions are essential to maintaining compliance with FDA regulations. They also have the added benefit of helping you retain customers who may not be allergic to the specific allergen in your product — even if they are allergic to another allergen within the same category.
Keep labeling up to date
In addition to complying with the latest regulations, your allergy labels must also reflect your current in-house operations. If, for example, you adjust a product formula or add a new product to your production schedule that contains a new allergen, your labeling practices must reflect these changes.
Even if you already employ precautionary allergen labeling, a new product or product formula could still mean you must update your labels if your new product line features a previously unmentioned allergen. While these updates require an upfront financial investment, they may save you from more significant costs caused by mislabeling down the road. Regular internal label audits and verification before print release can further minimize the risk of costly recall action.
Improving Your Allergy Labeling Practices With AIB International
Effective allergy labeling practices are vital to both your business’s success and your customers’ safety. By investing time, effort, and even finances into your labeling process now, you can avoid more costly legal, regulatory, and financial ramifications down the line.
If you're looking for the latest in allergen labeling information, sign up for the food labeling online course with AIB International. This training can help your team stay ahead of FDA updates and learn how to successfully navigate the allergen labeling process — setting you up for future success.
