Welcome to our September research update! Getting involved with research is an important way to impact food allergy treatments, education, and awareness.

This month, we are highlighting clinical trials, interviews, focus groups, and news on:

• FDA decision on neffy® epinephrine nasal spray
• New stock epinephrine and inhaler toolkits
• Intranasal powder epinephrine spray clinical results
• Eosinophilic gastroenteritis
  
  

Latest News on Food Allergies

AAFA Releases Statement on FDA Decision on neffy® Epinephrine Nasal Spray
On Sept. 19, the FDA rejected neffy, an epinephrine nasal spray to treat anaphylaxis, a severe allergic reaction. The FDA has asked for another study. The Asthma and Allergy Foundation of America (AAFA) released a statement about the FDA’s decision.

New Stock Epinephrine and Stock Inhaler Toolkits Improve Safety of Students with Anaphylaxis and Asthma
The American Academy of Allergy, Asthma & Immunology (AAAAI) has created new stock epinephrine and stock inhaler toolkits to help schools keep kids safe. The toolkits are designed to work in different states and schools to help prevent dangerous asthma and allergy emergencies and keep students safe. The epinephrine toolkit has information on what to do during a severe allergic reaction, training for non-medical staff, and videos to help students with allergies. The inhaler toolkit has resources on understanding state laws, how to help students having trouble breathing, and how to train staff.

Nestlé Divests Peanut Allergy Treatment Palforzia to Stallergenes Greer
Nestlé has sold its peanut allergy drug, Palforzia, to Stallergenes Greer, a Swiss biopharma company. Palforzia is an oral therapy that helps reduce peanut allergies by gradually exposing patients to small amounts of allergenic proteins. It was approved for children aged 4 to 17 and adults following a peanut-avoidant diet. This will expand Stallergenes Greer’s portfolio, which already has treatments for various allergies like grasses, mites, and trees.

Nasus Pharma Announces Publication of Positive Clinical Results for Its Epinephrine Intranasal Powder Spray
Nasus Pharma has shared positive findings from a study on their new epinephrine intranasal powder-based spray. This device, called FMXIN002, aims to provide quick and effective relief for severe allergic reactions caused by food, medicine, or insect bites. The study compared it to traditional epinephrine auto-injectors that deliver medicine through the muscle. The study found that FMXIN002 performed well, especially in simulating nasal congestion during allergic reactions. It delivered epinephrine quickly and effectively, with no significant side effects. This powder-based approach also offers better stability and longer shelf life compared to liquid forms of epinephrine. These results suggest that the new intranasal powder could be a promising and user-friendly solution for life-threatening allergies.

TAMA Corporation Issues Allergy Alert for Undeclared Wheat, Soy and Yellow #5 in "Cachapas de Maiz PAISA"

For Immediate Release

September 21, 2023

Contact Information

TAMA Corporation
305-592-1717

Company Announcement

Tama Corp. of Doral, FL, is recalling its 24-ounce packages of "Cachapas de Maiz Paisa" because they contain undeclared wheat, soy and Yellow #5. People who have allergies to any of these run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled "Cachapas de Maiz Paisa" were distributed nationwide, in retail stores.

The product is packaged in a 24-ounce, clear plastic package.

Recalled lot numbers are: 31082301, 07092301, 06092301, 05092301, 04092301, 29082301, 30082301, 28082301, 31072301, 01082301, 02082301, 03082301, 08082301, 09082301, 10082301, 14082301, 15082301, 16082301, 17082301, 21082301, 22082301, 23082301, 24072301, 25072301, 26072301, 31072301, 28082301, 21072301, 27072301, 17082301, 14082301, 20072301, 21072301, 26072301, 07082301, 08062301, 30082301, 24082301, 12072301.

Lot codes can be found on the bottom right corner of the package, next to the Best if Used by Date. Product UPC: 838795000109.

No illnesses have been reported to date in connection with this problem.

The recall was initiated after it was discovered during an inspection that the allergens-containing product was distributed in packaging that did not reveal the presence of them, due to a labeling error.

Consumers with questions may contact the company at 305-592-1717 Monday to Friday, from 9:00 AM to 5:00 PM EST.

On Sept. 19, the Food and Drug Administration (FDA) requested another study on neffy®, a epinephrine nasal spray to treat anaphylaxis, a severe allergic reaction. This will delay approval of neffy by at least a year.

The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted on May 11 to recommend the approval of neffy for both adults and children over age 6. On Sept. 19, the FDA delayed approval and asked for a study on neffy in people with allergic rhinitis.

If you or your child is at risk for anaphylaxis and has a fear of needles, there are ways you can become more comfortable with injecting epinephrine.

Practice using your epinephrine auto-injector trainer to help you and your child become more comfortable with the process. This will help you understand how the auto-injector works. Follow the instructions for your device and push the trainer against your thigh. After you hear a click, hold the device for a few seconds (you only need hold most devices for two or three seconds). If you have expired epinephrine injectors, you can practice using them on an orange or a grapefruit.

Remember that for many auto-injectors, you won’t see the needle at all. After you press the device on your thigh, a needle will release. Once you remove the device, that needle will likely retract back into the device.

Ask your doctor for an Anaphylaxis Action Plan. This will outline how to recognize symptoms of anaphylaxis and help you feel more confident about when to use your epinephrine.

Talk with your doctor about any concerns you have about using epinephrine. Epinephrine is safe and effective. Your doctor can answer your questions and address any concerns you have about using it.

KFA is the food allergy division of AAFA.

Allergen Alert on Undeclared Peanuts in "Cake"

For Immediate Release

September 19, 2023

Contact Information

David’s Cookies
800-500-2800

Company Announcement

David’s Cookies is recalling 960 units of “Marketside Chocolate Chip Explosion Cake” lot # BS23212 that has been sold in Walmart retail stores across the country.

This recall is due to that the 960 units of “Marketside Ultimate Peanut Butter Chocolate Cake” ware mislabeled with a label as “Marketside Chocolate Chip Explosion Cake” a name that does not depict peanut as a key ingredient and does not declare the peanut allergen warning on the label.

The product is in a 7-ounce, clear plastic package marked with lot # BS23212 on the top of the package. Photo below:

No illnesses or injuries have been reported to date in connection with this mislabel. If there are any consumers with concerns about illness or injury associated with this product, please contact a physician immediately.

Subsequent investigation indicates the problem was caused at the labeling & packaging stage.

In coordination with Walmart, they have blocked all Marketside Ultimate Peanut Butter Chocolate Cake and Marketside Chocolate Chip Explosion Cake from their distribution centers and store registers, so no consumer is able to purchase either of these products until further investigation and resolutions have been completed by David’s Cookies and Walmart.

Consumers who have purchased the 7.9 oz Marketside Chocolate Chip Explosion Cake, lot # BS23212, are urged to return them to the location of purchase for a full refund. Consumers with questions may contact David’s Cookies at 800-500-2800. Business hours are from 8:30 am to 5:00 am, DST Eastern time zone.

The Walmart distribution center distributing the mislabeled product has been identified and David’s Cookies and Walmart will continue to work to correct the situation and prevent further shipments to stores.

FSIS Issues Public Health Alert for Kirkland Signature Chicken Tortilla Soup Product Due to Misbranding

For Immediate Release

September 13, 2023

Contact Information

Customer Relationship Manager at Kettle Cuisine
Jacqui Valerio
619-409-1100
jvalerio@kettlecuisine.com

Company Announcement

WASHINGTON, Sept. 13, 2023 - The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) is issuing a public health alert for a ready-to-eat (RTE) Kirkland Signature chicken tortilla soup product due to misbranding. The label declares the product as gluten-free, a false negative claim. FSIS is issuing this public health alert to ensure that consumers with reactions to gluten are aware that these products should not be consumed. A recall was not requested because the affected products are no longer available for purchase.

The ready-to-eat chicken tortilla soup items were produced on July 26, 2023. The following products are subject to the public health alert [view labels]:

• 2-lb. tubs containing "KIRKLAND Signature CHICKEN TORTILLA SOUP WITH WHITE CHICKEN MEAT" with "USE BY: 11/23/23" and lot code 1394066 printed on the side of the cup just below the lip.

The products bear establishment number "P-18468" inside the USDA mark of inspection. These items were shipped to retail locations in Alaska, California, Idaho, Montana, Nevada, Oregon, Utah, and Washington.

The problem was discovered when the establishment notified FSIS that laboratory testing found gluten in the chicken tortilla soup, which is labeled as gluten-free.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

FSIS is concerned that some product may be in consumers' refrigerators or freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Members of the media with questions regarding the public health alert can contact Andrew Hearns, EVP of Quality and Food Safety at Kettle Cuisine, at 617-409-1100 or ahearns@kettlecuisine.com. Consumers with questions can contact Jacqui Valerio, Customer Relationship Manager at Kettle Cuisine, at 619-409-1100 or jvalerio@kettlecuisine.com .

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854)or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

Knickerbocker 365 Issues Allergy Alert on Undeclared Milk in “Homestyle Hamburger Buns”

For Immediate Release

September 14, 2023

Contact Information

Sandra Sokana
248-217-1942

Company Announcement

Knickerbocker 365, Inc. of Madison Heights, MI, is recalling its 16-ounce packages of "Homestyle Hamburger Buns" because they contain undeclared milk. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled "Homestyle Hamburger Buns" were distributed in southeastern Michigan retail stores, restaurants and foodservice. Retail stores that received recall product include: All Season’s Market, John’s Market, Main Party Store, Nino Salvaggio, Steiner Meat Market and Van Dyke Liquor Beer & Wine.

The product comes in a 16 ounce, labeled clear plastic package marked with the following lot codes: I31C, J01C, J02C, J06C, J07C, J08C, J09C and J11C.

A complaint of illness was reported to the Michigan Department of Agriculture and Rural Development (MDARD).

The recall was initiated after it was discovered that the milk-containing product was distributed in packaging that did not reveal the presence of milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

The problem was corrected immediately.

Consumers who have purchased 16-ounce packages of "Homestyle Hamburger Buns" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Sandra Sokana at 248-217-1942. She will be available Monday through Friday, 9:00am – 3:00pm.

Sheng Kee of California, Inc. Issues Allergy Alert on Undeclared Egg in the Following Traditional Mooncake Products

For Immediate Release

September 11, 2023

Contact Information

1-877-580-8000

Company Announcement

Sheng Kee of California, Inc. is voluntarily recalling varieties of Mooncake Gift Boxes for customers that have any issues because they may contain undeclared egg wash. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled Mooncakes were distributed nationwide in retail stores and through mail orders. We are working with our wholesalers and retailers to relabel and refit the current boxes.

The products come in Glossy Paper Gift Boxes in Various Colors with an expiration labeled on the bottom of the box.

No illnesses have been reported to date in connection with this problem.

The voluntary recall was initiated after it was discovered that the egg-containing products were distributed in packaging that did not reveal the presence of egg. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

Consumers with Egg Allergies who have purchased with the affected Mooncake Gift Boxes are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company M-F 9:00AM-5:00PM PST Toll Free at 1-877-580-8000.

• Small 12 – 3 Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 2UJ4N, 2UJ8N, 1UJ4L, 2UJ5N
• Small 12 – 4 Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 2UJ8N, 3UJ0N, 0UJ1L, 0UJ2L, 1UJ2L, 2UJ7L, 2UJ9N
• Small 12 – 6 Flavor Assorted Mooncake Tin Gift Box (Expires 10/29/23)
  • Batch Number(s): 0UJ7L
• Small 12 – Tea Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 0UJ5L, 0UJ6L
• Small 6 – 3 Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 2UJ1N, 2UJ3N, 2UJ7L, 2UJ2N
• Small 9 – 3 Flavor Assorted Mooncake Gift Box (Expires 10/29/23)
  • Batch Number(s): 2UJ1N, 2UJ3N, 2UJ4N, 2UJ7L, 2UJ2N
• Assorted Large 4 Mooncake Gift Box (Expires 10/7/23)
  • Batch Number(s): 1UJ9L
• Large 4 – Date Mooncake Gift Box (Expires 10/7/23)
  • Batch Number(s): 1UJ9L
• Large 4 – Lotus Pine Nut Mooncake Gift Box (Expires 10/7/23)
  • Batch Number(s): 1UJ9L
• Large 4 – Red Bean Mooncake Gift Box (Expires 10/7/23)
  • Batch Number(s): 1UJ9L

Many children with food allergies have asthma. It is a leading chronic disease in children. Both conditions are part of a progression of allergic diseases called the “allergic march.”

Genetics, exposure to tobacco smoke, and illnesses can be involved in the development of asthma. But location may influence if a child develops asthma and how well it can be managed.

If your child has asthma, September is a critical month. Children are the most vulnerable to the effects of Asthma Peak Month, also known as the September Asthma Epidemic.

To bring awareness to Asthma Peak Month, the Asthma and Allergy Foundation of America (AAFA) has released its 2023 Asthma Capitals™ report. This report analyzes data from the 100 largest cities in the U.S. to identify the most challenging places to live with asthma. Allentown, Pennsylvania, is #1 for 2023.

Asthma Capitals report ranks each city based on these factors:

• Asthma prevalence (or occurrence)
• Asthma-related emergency room visits
• Asthma-related deaths

The report also highlights risk factors that can affect asthma outcomes:

• Poverty
• Lack of health insurance
• Air pollution
• Pollen counts
• Smoking laws
• Lack of access to asthma specialists

How Can I Learn More About Managing My Child's Asthma?

Managing asthma involves a multi-step approach. This involves taking asthma medicine and limiting exposure to your child's asthma triggers. Work with an asthma specialist to come up with the best plan for you. AAFA offers free resources to help:

• Online support community
• AAFA's School Zone
• List of CERTIFIED asthma & allergy friendly® products to help you make your indoor air healthier
• Opportunities to participate in research to improve future asthma treatment

The 2023 Asthma Capitals report is an independent research project of AAFA and is made possible by a grant from Sanofi and Regeneron.

An important part of managing your child’s food allergy is teaching them how to choose safe foods for themselves. This helps prepare them for times when you won’t be available to help them read labels or decide if a food is safe to eat. It also gives them a solid foundation for managing their allergy as they grow into adulthood.

Start by teaching them how to manage their food allergy at home. They can learn how to choose their own snacks on the weekends and school breaks. This will also foster independence and confidence – important skills your child will need when it comes to making food choices on their own.

Teach Your Child to Read Food Labels

The only way to prevent allergic reactions is to make sure your child avoids the foods they are allergic to. To do so, you need to know how to identify those foods. And you need to know how foods are labeled. Once you know how to read labels, you can start teaching your child once they are old enough to read.

Here are some important label-reading basics to teach your child:

1. Tell them to read every label every time. Food makers can change ingredients and the way the food is made at any time.
   
   
2. If it doesn’t have a label, don’t eat it, even if it looks like something they’ve eaten before.
   
   
3. Food makers are only required to label the most common allergens in plain language: milk, egg, peanut, tree nut, sesame, soy, wheat, fish, and shellfish. This rule does not apply to certain types of foods like foods prepared in a restaurant or deli.
   
   
4. Because there are some cases where foods (or products) do not have to label allergens in plain language, be aware of your allergen’s other or “hidden” names. For example, milk might be labeled as “casein.” Use our food allergen management guides to see the list of alternate names for top food allergens.
   
   
5. Different size packages of the same foods may have different ingredients.
   
   
6. Allergy warning statements like “may contain” or “processed in a facility with...” may not be correct or helpful. They are not always a good way to tell if a food contains your child’s allergen. Talk with your allergist to decide if you need to avoid foods with these statements.
   
   
7. If a package says, “allergy free” or “allergy safe,” it doesn’t mean it’s safe. It might contain your child’s allergen.

Review these tips with your child using labels from foods in your home. Or take them grocery shopping with you so they can practice picking out foods with your help.

Even though young readers won’t be able to read full ingredient lists yet, they can still get into the habit of looking at labels before they eat a food. They can also learn to identify top allergens in bold in or under the ingredients list (although some labels may not bold the names of allergens).

Place Snacks Within Reach

Put your child’s safe snacks in an area they can reach. You can even let them decorate a box or small container so they know those snacks are just for them. This will allow them to easily and quickly grab a snack on their own time. (Just remind them to read the label!)

Prepare Allergy-Friendly Snacks Together

Kids with food allergies also need to learn basic food prep skills so they can learn to make their own safe foods. Set aside time for you and your child to make some allergy-friendly snacks for the week. They can learn age-appropriate food skills while helping you prepare for the week ahead.

You can find many snack recipes on our Safe Eats® Allergy-Friendly Recipe Collection. You can also search our Allergy-Friendly Foods Collection for snacks you can buy. You can search for snacks free from the allergens you are avoiding.

Teach Your Child How to Choose Nutritious Snacks

Not all snacks are created equal. While teaching your child how to choose their own snacks, teach them how to pick healthy foods too. Good nutrition is important for a child’s growth and general health. And if your child has multiple food allergies, you’ll want to make sure they are getting a balanced diet.

High nutrition foods – like fruits and vegetables – come with another benefit. They tend to be more allergy friendly since they don’t contain multiple ingredients.

These steps are great ways to start your child on the path to independence when it comes to managing their food allergy. Expand on these skills as your child grows to help them successfully manage their food allergy as teenagers and into adulthood.