Undeclared allergens are one of the leading causes of food product recalls. In 2024, around 34% of all recalls were a result of undeclared allergens — 101 in total. But allergen cross-contact can pose a risk beyond recalls.
Even if your facilities take all the right steps to avoid allergen cross-contact, accidents can still happen. Facilities that manufacture products containing multiple allergens are inherently at risk, and without the right labeling practices, your business can be held responsible for the consequences of allergen cross-contact — whether by the FDA or affected consumers.
In addition to complying with labeling regulations, you can also implement precautionary allergen labeling (PAL) to cover your bases and protect public health in the event of potential cross-contact. This optional labeling practice offers an additional layer of protection to help prevent common issues like recalls, regulatory action, and legal liability. Follow along to learn more about how this proactive practice can help mitigate the risks of allergen cross-contact.
Common Cross-Contact Risks
Maybe in an ideal world, manufacturers could produce allergen-containing products in completely isolated facilities from their other product lines. But between logistics, productivity goals, and costs, this dream is highly unrealistic. That means many manufacturing facilities must risk allergen cross-contact during production. When allergens unknowingly enter products that are not meant to contain that ingredient, it can incur consequences like:
- Supply chain cross-contact: Allergen cross-contact can occur upstream during ingredient sourcing, transportation, and storage. If suppliers do not follow allergen controls properly, undeclared allergens can enter your process before production even begins.
- Danger to public health: Cross-contact poses a risk for consumers with food allergies to have unexpected allergic reactions. These reactions can range in severity depending on the consumer, and your operation will most likely be held responsible.
- Legal liability: Consumers who experience allergic reactions due to undeclared allergens are likely to take legal action against your company. This can further damage your brand and your bottom line.
- Product recalls: Whether it be voluntary or mandated by the FDA, product recalls damage both your finances and your reputation. Between tracing affected batches and navigating public relations, the recall process can be long, costly, and impact future success.
- Financial costs: Cross-contact can lead to many potential costs, from legal damages to recall expenses to lost revenue.
- FDA repercussions: Products that are contaminated by cross-contact will be considered misbranded by the FDA — meaning your label doesn't accurately reflect your product's contents. Misbranded products violate the FDA allergen labeling regulations set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and may be met with enforcement actions like recalls, import refusal, seizure by the FDA, warning letters, or being added to the FDA’s import alerts list.
- Loss of trust: If a consumer experiences an allergic reaction even after checking your product's allergen label, they are unlikely to trust your brand again. Not only does this mean losing a customer, but it also can lead to negative word of mouth that will detract from your brand as a whole.
But if the potential risk of allergen cross-contact isn't 100% avoidable, how can you protect yourself from these consequences? The secret lies in proactive practices like precautionary allergen labeling.
What is precautionary allergen labeling?
Also referred to as Allergen Advisory Statements by the FDA, precautionary allergen labels are optional labels that describe the potential for unintended allergens in a food product. PAL is typically used in facilities that make products featuring multiple major food allergens. Since there is no way to eliminate the possibility of cross-contact altogether, precautionary allergen labeling provides protection for your consumers (and business) by issuing a proactive warning.
Precautionary allergen labels are typically formatted in one of two ways:
- May contain [allergen]
- Produced in a facility with [allergen]
Highlighting the potential for an allergen used within your facility to be present in a product lets your consumer make a more informed decision on whether to buy it. If a consumer chooses to purchase and consume a product despite this warning, your business has at the very least done its due diligence.
These labels are not required under the FD&C Act. Instead, they are optional for manufacturers looking to increase the safety of their food products. Precautionary allergen labeling must be truthful and not misleading, and cannot be used for an ingredient that is listed in a "contains" statement.
For example, a product cannot have both a "contains peanuts" and "may contain peanuts." The former statement is a required allergen label indicating the intentional inclusion of an ingredient, while the latter is an optional label highlighting the possibility of unintentional cross-contact.
It's important to note that although these statements help warn consumers of the potential for allergen cross-contact, they are not a substitute for adherence to good manufacturing practices and preventive controls. When used appropriately, PAL serves as a supplemental measure in a comprehensive allergen control program, not as a replacement for one.
Benefits of Using Allergen Advisory Statements
So what does precautionary allergen labeling have to offer your business? Implementing this optional step in your labeling process will require time and resources on your part, but the safeguards it provides will likely be well worth the effort.
Mitigation of risk
Most of all, precautionary allergen labeling diminishes some of the consequences of unavoidable allergen cross-contact and the risks associated with it, from legal liability to recalls.
If your facility is following proper protocol and complying with regulations to prevent cross-contact, this statement on your product labels protects you from potential liability and ramifications beyond your control. By going beyond the required standards of the FDA, you can avoid repercussions that would otherwise cost you resources and time, as well as damage your reputation.
Improved consumer trust
PALs demonstrate a commitment to transparency and allergen management to customers who are considering buying your products. Shoppers with food allergies rely on allergy labels to safely decide which products to consume. By going the extra mile, you can provide peace of mind for consumers, which will translate into how they perceive your brand.
Proactively addressing customer concerns can also help build brand loyalty and improve brand perception. Customers who feel particularly passionate about food allergies may become advocates for your brand if you invest in additional safeguards to protect them.
Elevated internal focus on allergen management
To determine whether your products are at risk of cross-contact and could benefit from PAL, you must first conduct a risk assessment of your production process for potential cross-contact. This review helps identify potential problem areas and evaluate your current allergen preventive controls.
Using this risk assessment as an opportunity to realign your allergen management efforts can help you further reduce the chances of cross-contact and increase your organization’s transparency. Consistent communication between quality assurance, production, and labeling teams is also essential to maintaining accuracy and preventing mixed messages on finished product labels.
Allergen advisory statements can enhance already effective manufacturing practices. But to ensure this practice is effective, you must consider employee buy-in and make the importance of allergen labeling a core concern in your food safety training.
Educate your team on the importance of allergen labeling with AIB International
If you think precautionary allergen labeling is an important addition to your labeling workflow, getting your team up to speed on the latest labeling practices is a key first step. Before you implement this optional process, sign up for AIB International’s food labeling online training to help secure team buy-in and ensure seamless incorporation of a new process.
