Warning: This column may, or may not, result in an allergic reaction
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 in December, the Italian eatery began adding sesame flour to its recipe.
The goal 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, they’re potentially subject to recalls, fines and 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.
Over 170 foods have been identified as producing allergic reactions in humans. Reactions can range from minor (an itchy mouth) to more serious (hives and diarrhea), to life threatening. The problem is growing, with debate over why. Today, food allergies likely affect 10% of American adults and 8% of American children. The Centers for Disease Control and Prevention has estimated that food allergies are responsible for 30,000 emergency room visits and 150-200 deaths a year.
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 (so long as they don’t sell packaged food), but many outlets create allergen lists, anyway.
The problem is that the FDA doesn’t offer guidance on what 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.
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.
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 (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; if not, a single standardized advisory label 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. 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.
The concept is gaining acceptance.
The World Health Organization and the Food and Agriculture Organization of the United Nations have spent years reviewing food allergen thresholds and risk assessments. Backing from these organizations would be helpful in creating a scientifically grounded, universal allergen label.
The FDA shouldn’t wait. 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.
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.