Why Does FDA Suddenly Care So Much About Allergens?

In the last few months manufacturers of ice cream, granola bars, pretzels, spice mixes, canned soup, ravioli, snack cakes, and salad – just to name a few – have felt the sting. The domino-like spread can quickly turn ingredient recalls into unpleasant, complicated messes felt by the entire supply chain as the impact widens. The disastrous effect is felt even more strongly by at-risk consumers, accounting for a large number of hospital visits and even deaths each year. We’re talking about food allergy recalls. They’re costly, damaging, and sometimes deadly – so why do they occur so often and what is FDA doing to change that?

Peanuts in Wheat Flour – Nothing to Sneeze At

As you read this, one of the largest trickle-down recalls continues to unfold. There are several companies pulling multiple affected products off of their shelves right now due to peanut-contaminated flour. The initial recall, which was initiated by a major flour producer in April 2016, began when a customer found peanut residue in cookies and subsequent analysis revealed the source of the peanut residue to be its flour. The flour manufacturer ceased production and distribution of its affected product and issued a recall to its customers, and since that time the industry has seen a seemingly daily list of consumer product recalls including some major household brands. The peanut-contaminated flour has been found in snack cakes and donuts, cakes and cookies, pretzels, and other snack foods.

The 10 Million Dollar Ticking Time Bomb in Your Facility

It’s been estimated that the average product recall costs food companies $10 million, although the Grocery Manufacturers Association’s 2011 survey revealed that 18% of international food companies interviewed estimated the hit from the recall and lost sales was between $30 million and $99 million, and 5% said the financial impact was $100 million or more! The long-term damage to a company’s brand can have an even steeper price tag.

And these are just the immediate financial costs, which typically include notification to regulating bodies, affected members of your supply chain, and consumers; product retrieval, storage, and destruction; unsaleable product; and of course, the additional labor costs associated with these activities as well as determining the root cause of the event. They do not include what could arguably be the more significant costs to the company that are often more difficult to calculate. These costs include litigation, post-recall regulatory oversight, lost sales, and brand damage. While the true costs of a recall are dependent on a number of factors, it is important to gain an understanding of the widespread impact that will directly affect your company’s financial outlook.

Reportable Food Registry’s Triple Threat

FDA just released its annual Reportable Food Registry (RFR) on May 24, 2016. Unsurprisingly, the presence of bacteria and undeclared allergens resulted in the greatest number of reports in the RFR’s fifth year. In total SalmonellaListeria, and undeclared allergens made up about 88% of the total primary entries for all five years of the RFR. The number of recalls associated with undeclared allergens shows that this is a real issue in the industry. Undeclared allergen reports have steadily increased since RFR inception, representing 30% of reports in Year 1 and rising to 47% of reports in Year 5. The majority of undeclared allergens reports were associated with bakery products.

Getting to the Root of Things

So how are undeclared allergens slipping through the cracks of so many manufacturers into consumers’ kitchens? In order to be able to develop solutions to reducing the number of food allergen reportable foods and recalls, we first need to know what is leading to these issues.

In most cases of undeclared allergen recalls, the correct product was produced according to the allergen-containing formula without cross-contact, but at the end of the manufacturing process, the wrong packaging was used or the allergen was not properly declared on the packaging, leading to an undeclared allergen.

The Food Allergen Labeling and Consumer Protection Act of 2004 requires that all packaged food labels regulated by FDA declare the presence of the Big 8 food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans). Even with that law in place, some of the most common causes of undeclared allergen recalls are attributed to the wrong label or package being used, incorrect ingredient terminology, mislabeled ingredients, and no carry-through of info from ingredient to finished product. Sometimes a processor may overlook a minor ingredient in one of their ingredients and not include it on the label. Food allergens in processing aids should be considered and may need to be included in an allergen labeling declaration. A supportive way AIB helps with this particular issue is with our Food Label Services. The regulatory knowledge our experts provide allows you to meet FDA and USDA food labeling requirements cost-effectively, enjoy peace of mind from an FDA-sanctioned nutrition program, and prepare your packaging for U.S. and Canadian markets.

Other common causes of undeclared allergens are due to cross-contamination, using the wrong ingredient, using rework with a different allergen profile in a formulation, and formula changes. In reality, allergen contamination can occur at any step in the process including: receiving, storage, formula control, personnel practices, production controls, changeover cleaning, labeling, engineering, supplier control, quality assurance, and even purchasing.

A well-developed Allergen Control Program will ensure that allergens that are intentionally added to a product are declared on the ingredient statement and that no unintentional allergens contaminate the product through cross-contact.

FSMA to the Rescue?

We are certain that you have been watching the requirements of the Food Safety Modernization Act (FSMA) unfold over the last 5 years. FDA is taking big strides to address allergen cross-contamination and looking at undeclared allergens with a brand new, preventive approach. Gone are the days when allergen control was a strong recommendation or best practice – now strong programs and detailed documentation will be regulated. In fact, FSMA’s Hazard Analysis and Risk-Based Preventive Controls for Human Food Rule (HARPC) revised several provisions of the cGMP, Part 110, to address and control potential allergen cross-contact as part of the preventive controls. These new allergen control requirements – about 24 of them to be exact – are contained in Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls. Basically there are allergen controls within every operational step – from cross-contact with handling, storage and use, to sanitation practices.

While many FSMA requirements immediately took effect in 2011, such as bi-annual facility registration, others required rulemaking and have staggered effective dates. One of the most significant effective dates is almost upon us. The effective date for compliance to the HARPC rule is as follows:

Very small business (<$1,000,000 USD annual revenue)   September 17, 2018

Small business (<500 FTE)                                                  September 17, 2017

All other                                                                                September 17, 2016

A GMP Inspection confirms your ability to remain current on legislative issues and assesses your allergen control program to ensure it is effective in preventing undeclared allergens from reaching consumers. As your partner in food safety, if you need assistance in understanding FSMA requirements, including preventive controls and validation of baking as a kill step, please let us know. We have mapped out 5 simple steps you can take to ensure a FSMA-ready facility before enforcement begins.

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