The Food and Drug Administration is weighing a major shift in how nutrition labels on packaged foods communicate food allergy risks. The agency wants to replace today’s unreliable array of allergen warnings such as “may contain” or “made in a facility” that manufacturers voluntarily apply.
In their place, the FDA is exploring a standardized warning statement to indicate whether an allergen is likely to be present from cross-contact above a predetermined level. That level is known as an allergen threshold.
“Recent scientific developments … have prompted the FDA to explore how understanding thresholds can improve food safety, enhance labeling practices for transparency and help consumers make informed decisions,” says Kyle Diamantas, the FDA’s Deputy Commissioner for Human Foods.
A Febuary 18 virtual public meeting convened FDA scientists, allergists, food industry representatives, and patient advocates to discuss the idea. A majority backed the concept. Two additional days of listening sessions followed, to gather input from allergy families and manufacturers.
The precautionary labels in use today are “arbitrarily applied,” says Dr. Brian Vickery, chief of the Division of Allergy and Immunology at Emory University. He told the meeting that a threshold-based approach “grounded in the best science and anchored to a risk-based framework” would offer more clarity.
“I see this as a big step in the right direction,” Vickery says.
What Allergen Thresholds Mean
An allergen threshold is the amount of an allergenic protein a person can consume before symptoms occur.
Sensitivity varies from person to person. However, newer food challenge and oral immunotherapy studies allow researchers to estimate a dose at which 95 percent of people with a given allergy are unlikely to react. Also called a “reference dose,” it falls between 1 and 5 milligrams (mg) for most top allergens.
Under threshold labeling, a food would not need to be completely allergen-free to avoid a precautionary label – only below the established limit.
Proposed reference doses are 1 mg for walnut, pecan, cashew, pistachio, and almond; 2 mg for peanut, egg, milk or sesame; 3 mg for hazelnut; 5 mg of wheat or fish; and 200 mg of shellfish. They were developed by the Food & Agriculture Organization (FOA) of the United Nations.
Experts stressed that these are conservative levels, lower than the tolerance of the majority of allergic individuals.
While up to 5 percent of highly sensitive individuals could still react to exposures below those levels, reactions would likely be mild, says allergist Dr. Matthew Greenhawt. The chief medical officer for the Asthma and Allergy Foundation of America noted: “The data suggest even if there is a reaction, it’s of low risk and of low consequence.”
Current System’s Problems
Precautionary allergens labeling, or PAL, is meant to alert consumers when a product may unintentionally contain small amounts of an allergen due to shared equipment or facilities.
The statements are varied and applied at the manufacturer’s discretion. The FDA sets no upper limit for how much allergen can be in a product due to cross-contact.
Companies are expected to be truthful and not use precautionary labels as a substitute for allergen controls, Lynn Szybist, director of the FDA’s Division of Food Labeling and Standards, told the meeting.
In practice, the warning labels are applied inconsistently, says Steve Taylor, PhD, founding director of the Food Allergy Research & Resource Program at University of Nebraska-Lincoln. Studies have shown some products with precautionary allergy labels contain little or no detectable allergen. Yet others lacking a warning can contain amounts that could trigger reactions.
Dark chocolate is one such food, notes Dr. Stefano Luccioli, an FDA senior physician and its Allergen Coordinator. Surveys have found milk in 70 percent of dark chocolate products, but many did not carry allergen advisory statements.
The reverse also occurs: companies add warning labels where risk is negligible. Manufacturers tend to be “risk-averse,” Taylor says, and use warnings as legal protection. “PAL is not currently risk-based,” he says.
Label Confusion Reigns
The inconsistency has left consumers confused, says Dr. Ruchi Gupta, a professor of pediatrics at Northwestern University’s Feinberg School of Medicine.
Her team’s 2016 survey found only about half of consumers managing allergies knew that precautionary allergen labels are voluntary. Many assumed phrases such as “may contain” versus “manufactured in a facility” reflect different risk levels (they don’t). Yet they used that wording to decide whether a product was safe. “Families want labels that clearly state whether a product is safe to eat,” Gupta told the meeting.
Industry is frustrated, too. “Industry abhors uncertainly. They want clarity,” Steven Gendel, PhD, said in an interview. The food safety consultant and former FDA food allergen coordinator, says: “They don’t know where they stand with the FDA in regard to trace amounts and the correct way to label.”
Undeclared allergens are behind up to 40 percent of costly food recalls. Precautionary labels for cross-contact don’t necessarily protect manufacturers from liability or recalls, Gendel notes.
Support for Allergen Thresholds
Representatives from major companies like The Hershey Company and Conagra Brands expressed support for the allergen thresholds concept. Kevin Boyd, who heads Hershey’s regulatory team, said a threshold-based labeling system should be “hopefully more meaningful for those who are trying to make safe food choices.”
Allergists also expressed support for risk-based PAL warnings. “What we have now is the lack of any meaningful labeling,” says Dr. Wayne Shreffler, director of the Massachusetts General Hospital Food Allergy Center.
Vickery acknowledged that allergen thresholds created from population data can’t predict with certainly whether an individual will react. “Patients most likely will not know if they are one of the 5 percent who might still react.…” Vickery says. “So while an informative label is helpful, not all individuals will be reassured by that.”
Australia’s Voluntary Model
Regulators are also looking to Australia, which has pioneered a risk-based framework through its Voluntary Incidental Trace Allergen Labelling (VITAL) program. It uses allergen reference doses to guide precautionary labels, which carry a standardized “May be present” statement.
Industry leads that system, which is voluntary. In the later listening sessions, the nonprofit FARE and a few food allergy advocates stressed the need for a mandatory system in the U.S.
Jill Mindlin, a patient advocate, said that if it remains voluntary, “things will be exactly the same as where we are today, which is a mass of confusion.”
For consumers to trust new, risk-based allergen labels, it has to be applied the same way by every food company, with standard criteria and wording, Gendel says. “The only way to decrease confusion about these [PAL] labels is if everyone is playing on the same field,” he says.
Community’s Mindset Change
For patients and families long told to totally avoid foods containing their allergen, thresholds would represent a new way of thinking about allergy management, says advocate Caroline Moassessi.
Some may welcome expanded food choices, but others may be wary of labels that imply a low – but not zero – risk, noted the vice president of community relations for the Food Allergy & Anaphylaxis Connection Team (FAACT). “This is a complete mindset change for people told to avoid risk,” Moassessi told the meeting.
Patients, healthcare providers, restaurants and other food services providers will all “need to be educated about thresholds and how to read labels,” she says.
During the listening sessions, there were already signs of challenges ahead. “I don’t know that I would trust somebody to put my child’s life at risk with a threshold. And as a consumer I don’t know that I would choose a product with a threshold,” commented parent Jennifer Holley.
For now, the FDA calls the effort “a dialogue.” Diamantas said “this is early in the process and we’re just beginning to chart our path forward.” The FDA has not announced a timeline for developing a new policy or implementing changes.
Have Your Say on Thresholds
Those who didn’t get to attend the mid-February online meetings can still get their views on the record. The FDA invites the public to make comments about food allergen thresholds and labeling here on the Regulations.gov website. Comments are open through May 19.
The FDA will also host an Expert Panel on Food Allergies, February 25, at 1 p.m. ET. The experts will discuss food allergy causes, treatments and food allergy guidelines. Register for the livestream here.
Related Reading:
May 2023: Experts Seek Global Allergy Labeling, Revised Top Allergens List
June 2023: Food Allergy Experts Weigh In on: Global ‘May Contain’ Labels
Comment to FDA: The docket FDA-2026-N-1304 at Regulations.gov is open for submitting comments on thresholds and precautionary warnings until May 19, 2026.
