food allergies

may-contain-nuts:-precautionary-allergen-labels-lead-to-consumer-confusion

May contain nuts: Precautionary allergen labels lead to consumer confusion

can i eat this or not? —

Some labels suggest allergen cross-contamination that might not exist.

May contain nuts: Precautionary allergen labels lead to consumer confusion

TopMicrobialStock, Getty Images

When Ina Chung, a Colorado mother, first fed packaged foods to her infant, she was careful to read the labels. Her daughter was allergic to peanuts, dairy, and eggs, so products containing those ingredients were out. So were foods with labels that said they may contain the allergens.

Chung felt like this last category suggested a clear risk that wasn’t worth taking. “I had heard that the ingredient labels were regulated. And so I thought that that included those statements,” said Chung. “Which was not true.”

Precautionary allergen labels like those that say “processed in a facility that uses milk” or “may contain fish” are meant to address the potential for cross-contact. For instance, a granola bar that doesn’t list peanuts as an ingredient could still say they may be included. And in the United States, these warnings are not regulated; companies can use whatever precautionary phrasing they choose on any product. Some don’t bother with any labels, even in facilities where unintended allergens slip in; others list allergens that may pose little risk. Robert Earl, vice president of regulatory affairs at Food Allergy Research & Education, or FARE, a nonprofit advocacy, research, and education group, has even seen such labels that include all nine common food allergens. “I would bet my bottom dollar not all of those allergens are even in the facility,” he said.

So what are the roughly 20 million people with food allergies in the US supposed to do with these warnings? Should they eat the granola bar or not?

Recognizing this uncertainty, food safety experts, allergy advocates, policymakers, and food producers are discussing how to demystify precautionary allergen labels. One widely considered solution is to restrict warnings to cases where visual or analytical tests demonstrate that there is enough allergen to actually trigger a reaction. Experts say the costs to the food industry are minimal, and some food producers across the globe, including in Canada, Australia, Thailand, and the United States, already voluntarily take this approach. But in the US, where there are no clear guidelines to follow, consumers are still left wondering what each individual precautionary allergen label even means.

Pull a packaged food off an American store shelf and the ingredients label should say if the product intentionally contains one of nine recognized allergens. That’s because in 2004, Congress granted the Food and Drug Administration the power to regulate labeling of eight major food allergens—eggs, fish, milk, crustaceans, peanuts, tree nuts, soybeans, and wheat. In 2021, sesame was added to the list.

But the language often gets murkier further down the label, where companies may include precautionary allergen labels, also called advisory statements, to address the fact that allergens can unintentionally wind up in foods at many stages of production. Perhaps wheat grows near a field of rye destined for bread, for instance, or peanuts get lodged in processing equipment that later pumps out chocolate chip cookies. Candy manufacturers, in particular, struggle to keep milk out of dark chocolate.

The FDA offers no labeling guidance beyond declaring that “advisory statements should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading.”

Companies can choose when to use these warnings, which vary widely. For example, a 2017 survey conducted by the FDA and the Illinois Institute of Technology of 78 dark chocolate products found that almost two-thirds contained an advisory statement for peanuts; of those, only about four actually contained the allergen. Meanwhile, of 18 bars that carried no advisory statement for peanuts specifically, three contained the allergen. (One product that was positive for peanuts did warn more generally of nuts, but the researchers noted that this term is ambiguous.) Another product that tested positive included a nut warning on one lot but not on another. Individual companies also select their own precautionary label phrasing.

For consumers, the inconsistency can be confusing, said Ruchi Gupta, a pediatrician and director of the Center for Food Allergy & Asthma Research at Northwestern University’s Feinberg School of Medicine in Chicago. In 2019, Gupta and colleagues asked around 3,000 US adults who have allergies or care for someone who does about how different precautionary allergen label phrases make a difference when they are considering whether to buy a particular food. About 80 percent never purchase products with a may contain warning. Less than half avoid products with labels suggesting that it was manufactured in a facility that also processes an allergen, even though numerous studies show that the wording of a precautionary allergen label has no bearing on risk level. “People are making their own decisions on what sounds safe,” said Gupta.

When Chung learned that advisory labels were unregulated, she experimented with ignoring them when her then-toddler really wanted a particular food. When her daughter developed a couple of hives after eating a cereal labeled may contain peanuts, Chung went back to heeding warnings of peanut cross-contact but continued ignoring the rest.

“A lot of families just make up their own rules,” she said. “There’s no way to really know exactly what you’re getting.”

May contain nuts: Precautionary allergen labels lead to consumer confusion Read More »

new-fda-approved-drug-makes-severe-food-allergies-less-life-threatening

New FDA-approved drug makes severe food allergies less life-threatening

Taking the edge off —

Injections over several months allowed people to tolerate larger doses of trigger foods.

Peanuts

Enlarge / Peanuts

Living with food allergies can be a fraught existence. There is no cure, and the standard management is to be ever vigilant of everything you eat and have an emergency shot of epinephrine constantly handy in case an accidental ingestion leads to a swift, life-threatening reaction. But, for the millions of people in the US who live with such allergies, a new drug may dull the threat.

On Friday, the Food and Drug Administration approved the antibody drug omalizumab (brand name Xolair) as an injection to lessen allergic reactions to foods in people ages 1 and up. In a trial of 168 children and adults with multiple food allergies, participants who received shots of omalizumab for 16 to 20 weeks were much more likely to tolerate a test dose of allergy-inducing foods at the end than those who received a placebo.

Omalizumab—which was previously approved to treat asthma, hives, and nasal polyps—works by binding to a class of antibodies in the body called immunoglobulin E (IgE) that are specifically involved in allergic responses. The monoclonal antibody drug binds IgE, blocking it from binding to its target receptor, thus preventing it from triggering the immune responses that lead to allergy symptoms.

“This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, said in today’s announcement. “While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

The trial began in 2019 and was run by the National Institute of Allergy and Infectious Diseases and is still ongoing. But an interim analysis of early data was enough to convince the FDA of the drug’s benefit.

More tolerance

For the trial, researchers recruited people who had an allergy to peanuts, as well as at least two other food allergies, including milk, egg, wheat, cashew, hazelnut, or walnut. Those assigned to get omalizumab received shots every two to four weeks for 16 to 20 weeks. Afterward, researchers looked at whether participants could handle 600 milligrams or more of peanut protein, which is equivalent to eating about 2.5 or more peanuts. Of those who got the shot, 68 percent (75 of 110 subjects) handled the peanut doses without moderate to severe allergy symptoms, such as whole-body hives, persistent coughing, or vomiting. In the placebo group, only 6 percent (3 of 55 subjects) managed this.

As secondary tests, the researchers tried other allergy-triggering foods at the higher dose of 1,000 milligrams or more. For cashews, 42 percent (27 of 64) of participants who received omalizumab tolerated the challenge without moderate or severe allergic reactions, compared with 3 percent (1 of 30) in the placebo group. For milk, 66 percent (25 of 38 subjects) who received the drug tolerated the dairy, while only 11 percent (2 of 19) of the placebo group did so. For egg, 67 percent (31 of 46 subjects) on the drug tolerated the dose, compared to 0 percent of the 19 who received placebo.

The benefits of omalizumab were not universal. The FDA notes that 17 percent of the people who received the drug had no significant improvement in their sensitivity to allergy-triggering food. As such, the FDA cautions that even if people receive Xolair, they should still avoid the foods that trigger their allergies.

The trial is ongoing, and researchers plan to look at the longevity of the drug’s effectiveness and whether it can be paired with another strategy to ratchet down food allergies: oral immunotherapy (OIT), which uses small, daily doses of an allergen to build tolerance over time. For the look at longevity, some trial participants will get shots for an additional 24 weeks, followed by more food challenges to see if the drug remains useful at easing allergic responses over the prolonged time period. For the OIT part of the trial, participants will get another 16 weeks of injections and, halfway through that, some will undergo multi-allergen OIT. They will then be followed for 44 additional weeks.

The FDA says the most common side effects of omalizumab are injection site reactions and fever, but the agency also warns of the possibility of joint pain, rash, parasitic infections, malignancies, and abnormal laboratory tests.

New FDA-approved drug makes severe food allergies less life-threatening Read More »