For years, Olive Garden’s famous breadsticks were considered safe to eat by the more than 1.5 million Americans who suffer from sesame allergies. But that’s no more. In December, the Italian eatery began adding sesame flour to its recipe.
The goal, it turns out, isn’t flavor enhancement. Olive Garden is adding sesame to comply with new Food and Drug Administration regulations requiring labels for foods that contain sesame. That regulation was intended to improve food safety and choices for allergic consumers. But cleaning every last seed and particle from food service equipment isn’t easy — or cheap. If Olive Garden or its contractors miss something, even after spending hours cleaning, they’re potentially subject to expensive recalls, fines and even lawsuits.
So Olive Garden and other food companies are dealing with the uncertainty and risk by adding sesame to previously sesame-free foods and labeling accordingly. It’s often the safest business decision, but one that contravenes the spirit of a regulation designed to provide more — not fewer — safe food options for allergic consumers.
Estimates vary, but food allergies affect tens of millions of Americans. Unfortunately, current FDA labeling practices rely too much on companies to judge the risk that an allergen is present in food. A better approach, grounded in science and an assessment of the actual risks posed by different levels of allergens, would benefit consumers and industry alike. The U.S. can be a leader in the shift.
More than 170 foods have been identified as producing allergic reactions in humans. Reactions can range from the relatively minor, an itchy mouth, to more serious, hives and diarrhea, to life-threatening, including tightening of the airways and shock. The problem is growing, with considerable debate over why. Today, food allergies likely affect 10% of American adults and 8% of American children. Managing those allergies takes a toll. The Centers for Disease Control has estimated that food allergies are responsible for 30,000 emergency room visits and 150-200 deaths a year.
To help address the problem, the FDA has recognized nine major food allergens — milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans and sesame — that must be listed on food packaging. The regulation doesn’t apply to restaurants, as long as they don’t sell packaged food, but many outlets — including Olive Garden — create allergen lists, anyway.
Labels aren’t foolproof. For example, at bakeries, where many products and ingredients are cycled through equipment, there is always the possibility of cross-contamination by ingredients used earlier in the day. In those cases, the FDA expects manufacturers to do their best to avoid the contamination, but it also allows them to add a voluntary advisory label — such as “may contain peanuts” — when they believe they can’t.
The problem is that the FDA doesn’t offer any guidance to food manufacturers on what actually constitutes a dangerous level of an allergen. Instead, the FDA relies upon manufacturers to voluntarily determine if a level of contamination is safe or not. That leaves restaurants like Olive Garden no choice but to make the most risk-averse choice: add sesame flour to the breadsticks!
But even if Olive Garden added the “may contain” advisory label, there is little reason to believe it would protect consumers. Studies find that consumers have trouble distinguishing the risk level described by “may contain.” At best, the confusion keeps allergy sufferers from enjoying meals; at worst, it places them at risk.
Fortunately, there are ways to label foods that reflect actual risks. In 2007, the Allergen Bureau of Australia and New Zealand, a voluntary industry consortium, convened an expert panel to determine the lowest threshold dose for a food that can be eaten without setting off an allergic reaction. The resulting program, VITAL, or Voluntary Incidental Trace Allergen Labeling, publishes those thresholds and an advisory statement that can be adopted by companies. If an allergen is measured below the threshold, no label is needed at all; if it’s above the threshold, a single standardized advisory label, grounded in science and risk assessment, can be used.
These allergen thresholds don’t let manufacturers off the hook. Bakeries and other food producers that adopt the VITAL standard are required to certify and audit that they take reasonable steps to eliminate allergens and cross-contamination in their processes. When allergens can’t be eliminated, the manufacturer must determine how much is present in the final product and whether it exceeds safe volumes — as determined via VITAL’s risk assessments for various allergens. For example, if sesame contamination can’t be eliminated from a bakery, the bakery must determine how much is present, and whether — if it’s incorporated into a product — it exceeds the agreed-upon threshold. If it does, an advisory label must be attached to the product.
Equally important, VITAL requires societal buy-in. Allergenic consumers and their clinicians must have a sense of their own risks to trust the published thresholds. That’s a far better approach than simply relying upon “may contain” without any sense of what it might mean.
The concept is gaining acceptance. The World Health Organization and the Food and Agriculture Organization of the United Nations have spent several years reviewing food allergen thresholds and risk assessments. Backing from these organizations, whenever it comes, would be helpful in creating a scientifically grounded, universal allergen label.
The FDA shouldn’t wait for these drawn out processes. At the direction of Congress, it can embark on establishing U.S. thresholds and risk assessment for use by American consumers and food manufacturers. There is precedent. In 2013, under the direction of Congress, the FDA adopted a regulatory threshold for gluten and gluten-free labeling that used risk assessments similar to what would be required with food allergens. The establishment of those thresholds played a key role in creating the safe, nearly $10 billion gluten-free industry. Allergen-safe foods could be next, with benefits for consumers and industry alike.
The first step in managing risk is knowing the risk. Food allergy sufferers deserve that information, and the FDA can play a large role in providing it.
Adam Minter is a Bloomberg Opinion columnist covering Asia, technology and the environment. He is author, most recently, of “Secondhand: Travels in the New Global Garage Sale.” This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
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