Prevent FSMA Allergen Control Recalls with Three Key Principles
Dr. Steven Gendel
FSMA allergen control is an extremely important part of food safety. When adequately instituted and enforced, allergen control can save lives. Unfortunately, food recalls due to the presence of undisclosed allergens are all too common, leading to disastrous consequences for suppliers, manufacturers, and consumers.
Dr. Steven Gendel, Senior Advisor of Food Safety at TAG, describes three essential components of a thorough allergen control plan: know what you make, watch what you say, and control what you do. Understanding these pillars — and why they occur — is critical to reducing the risk of unintentionally exposing consumers to allergen-related risks in your products.
In this blog, we review these three pillars, as well as provide information to help manufacturers understand why food allergen recalls happen. We’ll help you to identify known and reasonably foreseeable failures within your food safety plan, think about vulnerabilities, and move from a hazards approach to a systems approach to ultimately prevent allergen recalls.
Table of Contents
Overview
Why manufacturers fail FDA allergen control requirements
Specifically, 21 CFR 117 requires organizations to protect against allergen cross-contact in two ways:
by ensuring the protection of food from allergen cross-contact, including during storage, handling, and use
by labeling the finished food, ensuring that the finished food is not misbranded
This seems simple enough, but the data doesn’t lie: food and beverage manufacturers aren’t doing a good enough job of adhering to 21 CFR 117 requirements for allergen controls.
When 21 CFR 117 became effective, manufacturers should have had allergen control programs properly instituted in their facilities. Manufacturers still don’t understand the nature of the problem and how to control allergens effectively.
The rise of recalls due to undisclosed food allergens
In 2019, undeclared allergens only compromised 38% of all food recalls. We haven’t seen the 30s for some time now.
2023
In 2023, undeclared allergens comprised 49% (154) of all food recalls in 2023, up from 42% (121) in 2022. Additionally, the total number of food items recalled due to allergens increased by 27% from the previous year.
Sesame was a major contributor to the rise, the disclosure of which was a new requirement as of Jan. 1, 2023. Overall, milk was the single largest contributor.
Major brands issued allergen-based recalls, including Lay’s, Doritos, Quaker, belVita, Tostitos, Nature’s Path Organic, Wegmans, Safeway, 365 Whole Foods Market, and Trader Joe’s.
U.S. Public Interest Research Groups Food for Thought 2024 report
2024 (so far)
Unfortunately, the outlook for 2024 isn’t much better.
As of June 2024, there are currently 55 entries in the FDA Food & Beverage recall database for 2024. When viewing products recalled due to a single allergen, nuts are the most prevalent, followed by sulfites and wheat. When viewing products recalled due to multiple allergens, wheat and nuts are at the forefront, followed by milk, eggs, and soy.
High-profile recalls of 2024
Great Value
In March 2024, Great Value Honey Roasted Cashews for undeclared coconut and milk allergens. The product was distributed in Walmart stores across 30 states.
Chick-fil-A
In February 2024, Chick-fil-A announced undeclared wheat and soy allergens in its Polynesian sauce dipping cups. The fast-food chain has over 3,000 establishments across 48 states, and had to post notices to customers who may have taken the dipping cups home in addition to recalling the units in-stores.
The Three Pillars of Allergen Recall Prevention
The increased number of undeclared allergens from 2023 and 2024 doesn’t bode well. Recalls are expensive, estimated at $10 million on average for US companies — and that’s only for direct costs like pulling the items from shelves, disposal, and the time needed to execute a recall. Loss of sales, lawsuits, recall insurance, damaged brand reputation, and stock value drop can bring this number much higher.
The best way for manufacturers to protect their business, brand, customers, and consumers is to have a plan that is proactive in its preventative measures. This brings us to the Three Pillars of Allergen Recall Prevention to organize your allergen management system.
Pillar 1: Know what you make
Recipes and formulas often change over time, commonly due to ingredient availability and affordability or product improvements. It’s critical to stay on top of changes that have been made and, significantly, ensure that you are not adding unnecessary risks with these changes.
Verify formulas
First, verify whether you’ve made any formula changes. Then, if you discover changes, determine whether they affect the allergen content of your product.
Upgrade intelligently
When developing, changing, or improving products, it’s best to avoid adding new allergens when possible to minimize the risk of distributing a product with undeclared allergens. When introducing a new allergen, much needs to be taken into consideration. For example, you may need to make production changes to scheduling or storage, increase controls for cross-contact, provide employees with additional training, and implement additional allergen testing processes.
Double-check ingredients
Another consideration is to take steps to control the ingredients used during production to ensure the right ingredients are being used. This may sound self-explanatory, but it’s easy to make mistakes when utilizing ingredients with similar physical properties, such as white powders.
Pillar 2: Watch what you say
Once you’re sure you know what you’re making, the next step is to ensure you’re accurately communicating those ingredients.
Before printing labels
Check to ensure that the formula — the one you just verified — matches your labels. Make sure the labels also take into account any changes that have happened on the supplier side.
After printing and throughout the packing process
Particularly when using an outside, third-party printer, what you get may not align with what you ordered. A common issue is unintentional splicing in the middle of a long roll, which can cut off allergens. Be sure the right product gets into the right package. Lastly, especially in large production runs, be sure that you start correctly, continue correctly, and finish correctly.
Pillar 3: Control what you do
While Pillar 1 and Pillar 2 deal exclusively with intended allergens, Pillar 3 applies to both intended and unintended allergens, focusing on cross-contact controls, cleaning, and supplier controls.
Cross-contact
Cross-contact controls involve keeping products separate both in space and time. For example, products that contain allergens should ideally be made after products that are not intended to include allergens so that the allergen is not accidentally introduced into the non-allergen product. Products should also be stored properly with a physical distance between allergens.
Cleaning
When it comes to cleaning, allergen cleaning specifically refers to removing protein residues. This goes beyond simply sanitizing, which only aims to kill microbes. Similarly, validation or verification that looks for organic residues from microbes is not the same as looking for the removal of protein residues. Manufacturers should use processes and cleaning products that specifically target protein residues to ensure that equipment is free of allergens.
Suppliers
Requirements for suppliers to notify you if they make formula changes are helpful, but you also need to ensure they are following through with that requirement — and be sure to act on that information once you receive it.
When Manufacturers and Suppliers Aren’t On the Same Page
On January 11, 2024, Órla Baxendale, a 25-year-old ballet dancer, went into anaphylactic shock and tragically passed away, despite using her EpiPen, after consuming undisclosed peanuts in Stew Leonard’s brand cookies. Baxendale moved from England to New York in 2018 on a scholarship to train at The Ailey School, the official school of the acclaimed Alvin Ailey American Dance Theater, before starring in numerous productions throughout the northeastern United States.
Stew Leonard’s issued a recall of the cookies, but claimed, “Unfortunately, the supplier changed the recipe and started going from soy nuts to peanuts, and our chief safety officer here at Stew Leonard's was never notified.” The supplier (Cookies United) issued a response providing evidence that it sent an email to 11 Stew Leonard’s employees notifying them of the change in July 2023, in addition to providing updated labels.
Baxendale’s family has filed a wrongful death lawsuit against both Stew Leonard's and Cookies United for “grossly negligent, intentional, reckless, callous, indifferent to human life, and a wanton violation as the manufacturer and seller were required under the law to properly declare the ingredients.”
Get Your FSMA Allergen Control Plan on Track
You can’t prevent a problem if you don’t know why it happens. The Three Pillars of Allergen Recall Prevention will go a long way toward helping your company develop its customized 21 CFR part 117 compliance checklist, but human error may still persist. Outsourcing as much as possible of the manual components to a digital solution yields consistent quality records keeping, streamlined operations, and seamless compliance with 21 CFR 117 and other critical food safety regulations.
Despite the FDA’s Preventive Controls for Human Food (PCHF) Rule, nearly 50% of all FDA recalls are allergen-related BECAUSE manufacturers still don’t understand how to control allergens effectively. Strong allergen control relies on food safety systems that monitor what’s actually happening through quality verifications and CAPA management, not the paperwork.
Allergen control requires:
Supply Chain Controls (know where/when suppliers check material)
Label Controls (standardized verification that avoids incorrect labels)
Allergen Handling (SOPs and clear workflows that monitor QC checks)
Discover more about how digital solutions can elevate your FSMA allergen control plan.
