When a Manufacturer Says ‘Trust Us’ Regarding Allergens

Do you spend time in food allergy chat groups like those on Facebook? If you do, someone will inevitably make a statement that reads something like: “I trust XYZ Company. I called them and they told me they label for allergens when necessary.” But what does it mean when a manufacturer assures you they will label for potential allergen cross-contact when it’s necessary?

We at SnackSafely.com spend a significant amount of time talking with representatives of food manufacturers when we vet them for membership in our Manufacturer Partnership and work through the details of their product submissions.

In the event we need clarity on an issue of concern for a product that is not manufactured by a Partnership member, we generally resort to doing the same thing you do: calling the company’s consumer line and working our way up the management chain until we receive a response we believe is credible. Often, the representative will tell us, “Don’t worry… we label when we think there may be an issue with a specific allergen.” When we do receive that response, we immediately ask to speak to the next level of management.

Why? The answer is complex, but it all starts with the lax US labeling guidelines food manufacturers are required to follow. To summarize, manufacturers are required to label for the top 9 allergens only when they are ingredients of a product, not when there is a danger that product may be contaminated with an allergen due to shared lines or facilities. Warnings like “processed on equipment that also processes tree nuts” are entirely voluntary and are often omitted by companies.

Why might a company omit these warnings? There are many reasons, but here are the two most common we come across:

1. They sanitize the equipment between runs. “Sanitize” may mean anything from a cursory rinse of the equipment to complete disassembly of portions of the line and treatment with detergents and chemicals, but seldom will a company provide details nor are they required to do so. Can you assume all allergen residue is removed during the sanitization process? The FDA doesn’t provide specific guidelines for what the threshold should be when equipment can be declared free of an allergen nor does it require testing of the line for traces of allergens after sanitization, so who knows?
2. They manufacture their products in separate areas of the facility. Anyone who has seen an ingredient like powdered milk billow when added to a vat will want to know if specialized air filters and barriers are employed and whether employees are required to strip off and don new gowns, gloves, and other protective equipment when moving from area to area, but seldom will a company provide those details nor are they required to do so. Does this mean the allergen is effectively prevented from contaminating another line? Again, the FDA doesn’t require testing for allergen trace in the finished product, so who knows?

The fact is, unless you know how the company determines whether to label for potential cross-contact and what sanitization, testing, and barrier methods they employ during manufacture, “Trust Us to Label” should inspire little trust.

The Risk Calculation

A common misconception is that big companies are quick to label for potential cross-contact because they want to avoid lawsuits. In fact, companies make a complex determination whether to issue a voluntary advisory based on many factors, which we’ll mash together and call the Risk Calculation.

Despite their slogans, large corporations are first and foremost beholden to their shareholders, so their decisions are made largely based on what will ultimately maximize profits, which itself depends on the consumer profile for each product, image, brand loyalty, and a host of other factors.

As a company is not required to disclose the potential for cross-contact, they make the call whether to do so based on a calculation that compares the risk vs reward. Now, that calculation might not exist as a mathematical formula, but it does exist as a concept in the minds of the executives of the company responsible for making the decision.

What are the risk factors? The primary risk is that their consumer suffers a reaction due to cross-contact exposure. But even if that happens, there are many mitigating factors a company might consider:

• How many allergic reactions might occur per million units of product sold?
• Given the number of consumers that experience a reaction, how many will assume it was caused by the specific product vs. everything else they consumed within the last few hours?
• Given they identify the product, how likely are they to contact the company?
• Given they contact the company, how likely is it they will be pacified with an apology, refund, free product, or a small check?
• Given they cannot be pacified, how likely is it they will have the resources to sue the company, given the company is not required to disclose the potential for cross-contact in the first place and follows generally accepted manufacturing procedures?
• Given they elect to sue the company, how likely is it they would reach a settlement amenable to the company before the issue ever goes to trial?
• And given the above, how likely is it the press will follow up causing harm to the brand and the company’s reputation if the exposure did not result in death or critical injury?

The reward is simple to understand: there are millions of consumers with food allergies representing potential revenue of billions of dollars, and that number is multiplied when you consider the foods that might be served in settings where the allergic and non-allergic come together, such as schools, cafeterias, etc.

All of these considerations factor into the calculation. The company then decides how to label each product that rolls off each manufacturing line in each facility they operate.

The Effect

What is the effect of leaving it all up to corporations to decide when to issue advisory cross-contact warnings? That’s a difficult question requiring rigorous scientific study; we simply can’t tease out the facts because there is little data available to analyze.

But if you’re a food allergy sufferer or the parent of a child who is, you’ve heard myriad stories of people experiencing reactions to foods despite the lack of an advisory statement on the label, and maybe this has even happened to someone in your family. Is this iron-clad proof that cross-contact is the culprit? No, and that’s the problem.

The real question to ponder is why there aren’t regulations in place that dictate how and when companies must disclose the potential for cross-contact, like other countries have. Until the FDA mandates such disclosure, the issue will remain problematic to the allergic community.

What to Ask

When you do decide to call a company, ask them very specific questions about their manufacturing and labeling practices for each product, as they can differ from product to product depending on where and how they are manufactured. These can include:

• Is your ABC variety cookie manufactured in a line or facility that processes allergen X?
• How does your company sanitize the line between runs? Do they test for allergen residue after sanitizing? How?
• Do you include an advisory statement for an allergen every time your products are manufactured on a shared line or in a facility where the allergen is processed, or are there other considerations?

If they repeat the “Trust Us to Label” mantra without providing specific answers to your questions, ask to speak to management or their head of consumer relations. If they refuse or cannot provide those answers, you must decide whether to place your trust in the company and their Risk Calculation or find an alternative.

How We Can Help

We at SnackSafely.com work directly with responsible manufacturers to help them disclose the potential for allergen cross-contact in their products above and beyond what the FDA requires, and we offer this service to any size manufacturer for free.

By joining our Manufacturer Partnership, companies are required to disclose precisely how each product is manufactured with respect to 11 allergens, including peanuts, tree nuts, milk, eggs, wheat, soy, fish, crustacean shellfish, sesame, mustard and gluten. Is the allergen an ingredient of the product? Is it processed in the same line or if not in the same facility? Does the manufacturer explicitly market the product free of the allergen? These are questions each manufacturer must answer for every product they submit to us.

We then provide this information to you via our free Allergence service in an easy to understand Allergen Profile table:

The profile allows consumers to research each product to understand exactly how it was manufactured with respect to the allergens we track so they can determine their own comfort level.

We encourage you to register for your free Allergence account, support partner manufacturers that have gone the extra mile to provide you with these additional disclosures, and urge your favorite companies to join us by sending them an e-mail following the directions on this page.

Please share your own experiences and advice when dealing with manufacturers in the comment section below. Your insight helps us as well as the community.