Enjoy Life Natural Brands, LLC Conducts Nationwide Voluntary Recall of Select Bakery Products Due to Potential Presence of Foreign Material

For Immediate Release

June 30, 2022

Contact Information

Laurie Guzzinati
847-943-5678
news@mdlz.com

Company Announcement

CHICAGO, June 30, 2022 (GLOBE NEWSWIRE) -- Enjoy Life Natural Brands LLC announced today a voluntary recall, out of an abundance of caution, of a limited quantity of a select list of baked snacks products due to the potential presence of hard plastic pieces. The company became aware of this issue as a result of internal quality assurance surveillance.

This recall is limited exclusively to the Enjoy Life products and Best By Dates listed in the grid below which are sold in retail stores and online in the United States and Canada. No other Enjoy Life Foods products are affected by this voluntary recall.

The products being recalled are available at: http://ml.globenewswire.com/Resource/Download/c4abd216-e3d9-49aa-94ca-0ca0199f2721

There have been no reports of injury or illness received by Enjoy Life Foods to date related to these products.

Consumers who have this product should not eat it and should discard any product they may have but should keep any available packaging and contact the company at 1-855-543-5335, 24 hours a day to get more information about the recall and how to receive a refund. Consumer Relations specialists are available Monday-Friday, 9 a.m. to 6 p.m. EST.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration and the Canadian Food Inspection Agency.

Blount Fine Foods Voluntarily Recalls a Limited Amount (a Single Lot) of Southwest Corn Chowder Due to Undeclared Wheat Allergen

For Immediate Release

June 24, 2022

Contact Information

Blount Fine Foods Customer Care
1-866-674-4519

Company Announcement

FALL RIVER, MA (June 24, 2022) – Blount Fine Foods announced that it is voluntarily recalling a limited amount (a single lot—2,569 cases total) of 16 oz. Panera at Home Southwest Corn Chowder due to an undeclared wheat allergen. The recall is limited to 1 SKU of 16 oz. Panera at Home Southwest Corn Chowder cups produced with lot number 042122-2K and “Use By” date of 6/30/22. This item is only sold in refrigerated cases in the deli department of select retail grocery stores; it is NOT sold at any Panera bakery-cafe. No consumer complaints or illnesses have been reported in connection with this recall, as this product was discovered at a grocery store during the restocking process. People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reactions if they consume this product.

This voluntary recall is limited only to 16 oz. Panera at Home Southwest Corn Chowder. No other Panera Bread, Panera at Home or Blount products are affected by this voluntary recall.

The recalled product is listed below. Consumers can find lot number and “Use By” date on the bottom of each package.

A limited quantity of this product was distributed across 12 states which include: CA, IA, IL, MA, ME, MI, NH, NY, OH, TX, VA, WA

Consumers can contact Blount Fine Foods Customer Care at 1-866-674-4519 for additional information Monday – Friday from 9 AM to 9 PM Eastern Standard Time. Additionally, consumers who have purchased the specific recalled product are urged to return it to the place of purchase or visit www.blountfinefoods.com/recallExternal Link Disclaimer for product reimbursement.

Creminelli Fine Meats Recalls Mini Parmesan Salami Stick Products Due to Misbranding and an Undeclared Allergen

For Immediate Release

June 28, 2022

Contact Information

Creminelli Fine Meats
Gabriella Graff, Office Manager
801-428-1820

Company Announcement

WASHINGTON, June 28, 2022 – Creminelli Fine Meats, a Salt Lake City, Utah establishment, is recalling approximately 4,207 pounds of ready-to-eat (RTE) parmesan salami sticks due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains egg lysozyme, an egg white protein and known allergen, which is not declared on the product label.

The RTE salami stick with parmesan items were packaged on various dates from October 26, 2021 through April 26, 2022. The following products are subject to recall [view labels]:

2.6-oz. plastic pouches containing “CREMINELLI FINE MEATS salami minis UNCURED ITALIAN SALAMI PARMESAN” with “BEST BY” dates from 06/18/22 through 12/09/22.

The products subject to recall bear establishment number “EST34644” stamped on the back of the product packaging next to the best by date. These items were shipped to retail locations in Arizona, California, Colorado, Florida, Georgia, Illinois, Massachusetts, and Utah, and sold through internet sales nationwide.     

The problem was discovered by inspection personnel during a routine label verification review. Egg white lysozyme, a component of the parmesan cheese ingredient, is not declared on the final product label.

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 in consumers’ pantries. 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.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution lists will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact Gabriella Graff, Office Manager with Creminelli Fine Meats, at 801-428-1820. Members of the media with questions about the recall can contact Chris Bowler, CEO of Creminelli Fine Meats, at 801-428-1820.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday. Consumers can also browse food safety messages at Ask USDA 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/.

Traveling by car when a family member has food allergies can be a success with careful planning. Once you make your vacation plans, you can have a lot of fun and stay safe on the road. Here are eight tips to get you started when you’re planning your next road trip.

1. Plan your meals before you leave home.

Planning your meals ahead of time can save you a lot of stress in the long run. Make a list of heat-and-serve or ready-to-eat snacks or meals you can eat on the road.

Also, look at your trip route to see what foods you can buy along the way. Make note of restaurants and grocery stores that are likely to have foods your child can eat. Then decide what you can buy at your destination or along the way. Research what is available at your vacation spot if you need to pack light.

Here are some ways you can research allergy-friendly restaurants:

• Read reviews on crowdsourcing sites and apps such as Allergy Eats and Find Me Gluten Free.
• Look for restaurant chains with allergy-friendly policies. Allergy Eats publishes lists of the some of the most allergy-friendly restaurants.
• Check out restaurant websites to see if they publish menus and allergy policies.
• Call restaurants in advance to find out if they can accommodate your child’s food allergies. Call during slow times and ask to speak to the general manager or kitchen manager if possible.

Take all this information and research to create a meal plan for each day of the trip.

2. Keep cold foods cold.

Bring a cooler or a portable refrigerator that plugs into your car to keep fresh food cold while you travel. Don’t forget to include zip-top bags of ice or reusable ice packs. You can also pack a portable cooler bag to take snacks with you during activities at your destination.

3. Look for hotel rooms with microwaves and refrigerators or a kitchenette.

Rooms with microwaves and refrigerators are useful if you plan to reheat foods or cook in the hotel room. They come standard in many hotel rooms now. Some hotels may even have rooms with kitchenettes available.

If each room does not have a microwave and refrigerator, many hotels will have a few for rent. Call ahead to find out if a microwave and fridge are available. Tell hotel management you need them for medical reasons. That may put you at the top of the list for availability. The hotel may waive rental fees if you bring a letter of medical necessity from your doctor.

4. Think small.

When you purchase food, try to get as many individually packaged foods as possible. For instance, use your limited refrigerator space to store juice boxes instead of a big bottle of juice. Smaller packages are also easier to take sightseeing. And if you have any leftovers, they are easier to transport home.

5. Shop locally.

Remember that grocery stores are almost everywhere. Bring less perishable food than you think you will need. Instead, bring more non-perishable food than you think you need. You can buy many perishable foods, like fresh fruit, at any standard grocery store. If you created a meal plan like we mentioned in tip #1, create a grocery list using your plan with a list of foods you can buy when you get to where you’re going.

Specialty items, such as wheat-free cookies or your favorite allergen-free brands, may not be available at a regular grocery store. Bring those allergen-free foods that you know are safe and that your child is familiar with eating.

6. Ship ahead.

If you won’t have time to shop when you get to your destination, consider ordering food you will need online or locally. Have the items shipped to your hotel.

7. Don’t forget the dishes.

Bring a small set of dishes, silverware, and kitchen utensils (if you plan to cook). Look at your meal plan to figure out what you’ll need. Pack light – just a few items will do.

8. Bring your medicines and your emergency plans.

Be sure to check expiration dates on epinephrine auto-injectors. Before you leave, practice with an auto-injector trainer and review your child’s emergency plan away from home.

Consider bringing extra medicine in case of an emergency. Inhaled medicines, such as asthma inhalers and nebulizer fluid, tend run out unexpectedly. A duplicate can be a lifesaver.

When traveling, make sure your child's medicines are in their original containers with the prescription labels on the package.

888 Food Company Issues Allergy Alert On Undeclared Egg In Various Ho King and Giai Phat Products

For Immediate Release

June 15, 2022

Contact Information

1-626-443- 9888

Company Announcement

888 Food Company in S. El Monte, CA is recalling Ho King Fish Ball, Ho King Fried Fish ball, Giai Phat Fried Fish Loaf, Giai Phat Fried Fish Cake, Giai Phat Fish Ball, Giai Phat Fried Fish Ball, Giai Phat Featherback Fish Ball, Giai Phat Fried Featherback Fish Ball, Giai Phat Shrimp Ball, and Giai Phat Cuttle Fish Ball because it may contain undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

Recalled products were mainly distributed in California through distributor and direct delivery to retail stores.  Small portions of these products were distributed to retailers in Indiana and Illinois.

The recalled products are:

Lot numbers can be found at the upper right corner of the plastic bag.

A recall was initiated after receiving a consumer complaint of anaphylactic reaction.  Through investigation it was determined that the formulation of an ingredient was changed to include eggs.

Consumers whom have purchased the Ho King Fried Fish Ball are urged to return it to the retailers for a full refund.  Consumers with any questions may contact the company at 1-626-443- 9888, Monday to Friday from 8 a.m. to 4 p.m. Pacific Time.

The Asthma and Allergy Foundation of America (AAFA) is sharing this press release from the Food and Drug Administration (FDA) to bring you the latest research news quickly.

[PRESS RELEASE]

Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

Today, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.

• For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
• For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older.

Key points:

• The FDA’s evaluation and analysis of the safety, effectiveness and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs.
• The agency determined that the known and potential benefits of the Moderna and Pfizer-BioNTech COVID-19 vaccines outweigh the known and potential risks in the pediatric populations authorized for use for each vaccine.
• Prior to making the decision to authorize these vaccines for the respective pediatric populations, the FDA’s independent Vaccines and Related Biological Products Advisory Committee was consulted and voted in support of the authorizations.

The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age.

Information about each vaccine is available in the fact sheets for healthcare providers administering vaccine and the fact sheets for recipients and caregivers.

“As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “In addition to making certain the data for these vaccines met FDA’s rigorous standards, the agency’s convening of an advisory committee was part of a transparent process to help the public have a clear understanding of the safety and effectiveness data supporting the authorization of these two vaccines for pediatric populations.”

Evaluation of the Moderna COVID-19 Vaccine for Individuals 6 Months through 17 Years of Age

Effectiveness

The effectiveness and safety data evaluated and analyzed by the FDA for the Moderna COVID-19 Vaccine to support the EUA for these pediatric populations were generated in two ongoing, randomized, blinded, placebo-controlled clinical trials in the United States and Canada which enrolled infants, children and adolescents.

• Children 6 months through 5 years of age: Among participants 2 through 5 years of age, 72% of whom had blinded follow-up for more than two months after the second dose, the vaccine was 36.8% effective in preventing COVID-19.
• Children 6 years through 11 years of age: In the FDA analysis, the immune response of the children to the vaccine was comparable to the immune response of the adults. An additional analysis pertaining to the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants.
• Adolescents 12 through 17 years of age: In this analysis, among participants 12 through 17 years of age, the vaccine was 93.3% effective in preventing COVID-19. The data for this analysis were obtained before the omicron variant became the predominant circulating strain.

Safety

The safety data to support the Moderna COVID-19 Vaccine EUA in individuals 6 months through 17 years of age are as follows:

• Children 6 months through 5 years of age: In clinical trial participants 6 months through 5 years of age, the most commonly reported side effects across all age subgroups included pain, redness and swelling at the injection site, fever and underarm (or groin) swelling/tenderness of lymph nodes in the same arm (or thigh) as the injection. In clinical trial participants 6 through 36 months of age, the most commonly reported side effects also included irritability/crying, sleepiness, and loss of appetite. In clinical trial participants 37 months through 5 years of age, the most commonly reported side effects also included fatigue, headache, muscle ache, chills, nausea/vomiting and joint stiffness.  
• Children 6 through 11 years of age: The majority of vaccine recipients (98.7%) had at least two months of safety follow-up after their second dose.
• Adolescents 12 through 17 years of age: The majority of vaccine recipients (95.6%) had at least six months of follow-up after the second dose.

The most commonly reported side effects in the clinical trial participants for both the 6 through 11 age group and the 12 through 17 age group who received the vaccine include, pain, redness and swelling at the injection site, tiredness, headache, muscle pain, chills, joint pain, underarm swollen lymph nodes in the same arm as the injection, nausea and vomiting and fever.

Evaluation of the Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months through 4 Years of Age

The effectiveness and safety data evaluated and analyzed by the FDA for the Pfizer-BioNTech COVID-19 Vaccine were generated in an ongoing, randomized, blinded, placebo-controlled clinical trial in the United States and internationally, which enrolled infants and children.

Effectiveness

• The effectiveness data to support the EUA in children 6 months through 4 years of age is based on a comparison of immune responses following three doses of the Pfizer-BioNTech COVID-19 Vaccine in a subset of children in this age group to the immune responses among adults 16 through 25 years of age who received two higher doses of the Pfizer-BioNTech COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19. In these FDA analyses, the immune response to the vaccine for both age groups of children was comparable to the immune response of the older participants. An additional analysis pertaining to the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases that occurred in study participants.

Safety

• The most commonly reported side effects in clinical trial participants 6 through 23 months of age who received the vaccine were irritability, decreased appetite, fever and pain, tenderness, redness and swelling at the injection site. These side effects were also reported for the vaccine recipients 2 through 4 years age, in addition to fever, headache, and chills.

Risks of Myocarditis and Pericarditis

The FDA and CDC safety surveillance systems have previously identified increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following vaccination with the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, particularly following the second dose. The observed risk is highest in males 18 through 24 years of age for the Moderna COVID-19 Vaccine and in males 12 through 17 years of age for the Pfizer-BioNTech COVID-19 Vaccine.

The FDA and the CDC analyses of available safety surveillance data from the U.S. and other countries on myocarditis outcomes continue to strengthen the evidence that most cases of myocarditis associated with the Moderna and Pfizer-BioNTech COVID-19 vaccines are characterized by rapid resolution of symptoms following conservative management, with no impact on quality of life reported by most patients who were contacted for follow-up at 90 days or more after reporting myocarditis. The risks of myocarditis and pericarditis are described in the fact sheets for each of these vaccines.

Ongoing Safety Monitoring

As part of their original EUA requests, both ModernaTX Inc. and Pfizer Inc. submitted plans to continue to monitor the safety of the vaccines as they are used under EUA. These plans for monitoring the overall safety of the vaccines and ensuring that any safety concerns are identified and evaluated in a timely manner, and which include monitoring for myocarditis and pericarditis, have been updated to include the newly authorized populations. In addition, longer-term safety follow-up is ongoing for participants enrolled in the clinical trials for both vaccines. Furthermore, the FDA and the CDC have several systems in place to continually monitor COVID-19 vaccine safety and allow for the timely detection and investigation of potential safety concerns.

It is mandatory for both ModernaTX Inc. and Pfizer Inc., as well as vaccination providers, to report the following to the Vaccine Adverse Event Reporting System (VAERS) for these two COVID-19 vaccines: serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death. It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for vaccine manufacturers to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.

The EUA amendment for the Moderna COVID-19 Vaccine was issued to ModernaTX Inc. and the EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc.

If you’re a parent to a baby that's a few months old, you probably have questions about the best way to introduce solid foods to your child – and if there is a connection to food allergies. With the rise of food allergies, answers to these questions are important.

Kids With Food Allergies (KFA) asked two allergists on our Medical Scientific Council common questions parents have about preventing food allergies and introducing foods. Here’s what allergists Michael Pistiner, MD, MMSc, and David Stukus, MD, had to say.

Question: How do I know if my child is at high risk for food allergies?

Dr. Stukus: There are many factors that have been associated with children who develop food allergies, but the strongest risk factor is whether that infant has developed moderate-to-severe persistent eczema.

Eczema is a chronic skin condition that often presents in the first few months of life and causes dry skin, as well as red, irritated, inflamed patches. It often affects the skin inside the elbows, behind the knees, on the torso, or face. Infants with truly persistent or severe eczema often go on to develop allergies and asthma as they get older.

Targeting early allergen introduction toward this group of infants will likely have the most benefit. This is different than babies who have cradle cap that improves with age or a few mild eczema patches that pop up every so often or improve with moisturizers. Older siblings with food allergy and parental history of allergies or asthma are often considered risk factors, but these aren’t as strongly connected as the eczema risk.

It’s also important to note that some children develop food allergies and don’t have any risk factors at all, but these are the minority. Lastly, individual food allergies are not inherited. There is no gene for peanut allergy. But the predisposition to develop allergies in general is often inherited.

Question: When and how should I introduce solid foods to my child, especially the most common allergens, like egg, milk, peanuts, wheat, soy, sesame, and tree nuts?

Dr. Pistiner: In general, the time to introduce solids is when your baby shows interest. They’ll need to have head control and be able to accept food without thrusting it out with their tongue. Starting with an infant cereal or a pureed fruit or vegetable may be what your primary care doctor recommends. Interestingly, if your child is at risk of developing allergies then considering solid introduction from 4 to 6 months of life will be a good target.

Dr. Stukus: Common food allergens should be introduced beginning around 4 to 6 months of age once babies are showing an interest and ability to swallow pureed and solid foods.

There are a wide variety of foods that contain these allergens that families can offer. Infants should not replace breast milk or formula with drinking cow’s milk until 12 months of age due to risk for anemia. Otherwise, they can try yogurt, cheese, or other forms of dairy.

The key is for parents to actively introduce these various foods AND then keep them in their diet consistently. This is very different than offering a few small bites and not trying again for several months.

Question: What can I do to prevent my child from getting food allergies?

Dr. Stukus: Unfortunately, there is no 100% proven method to prevent food allergies. And there is no single cause as to why some children develop food allergies and other children do not.

But the best path toward preventing food allergies from developing in your child is to have them start eating allergenic foods – such as cow’s milk, egg, wheat, soy, peanut, tree nuts, and seafood – beginning around 4 to 6 months old and then keeping these foods in their diet consistently. This strategy helps their immune system develop a tolerance toward allergenic foods.

It is also helpful to offer your baby a wide variety of foods as diet diversity has been associated with fewer food allergies. The beauty of this approach is that there is no special medicine or supplement involved. It’s based simply on feeding a nutritious diet rich with a variety of foods while parents bond with their infant as they learn to eat.

Question: How do I know if my child is having a food allergy reaction when I start introducing solid foods?

Dr. Pistiner: Signs of an allergic reaction in a baby can vary from child to child.

They can include a rash or hives (red, raised rash/welts) on the skin. The rash or hives can be where the food touches, or in areas where it didn’t also. You can see swelling, including swelling of the face, lips, or tongue. It can cause itching in a baby and you may see them rub, scratch, lick, or mouth objects, depending on where the baby feels itchy.

Reactions can also cause vomiting and diarrhea.

Some symptoms that can be clues of a more severe reaction include:

• Coughing, wheezing (high pitched noise with breathing), trouble breathing that can look like pulling in between the ribs, flaring of the nostrils
• Change in skin color (blue, grey, mottled, pale) especially of and around the lips
• Sudden behavioral change in the baby, including limpness or floppiness, lethargy (difficulty waking up), and unable to stop crying even though all other things that may cause crying have been taken care of
  
  

Question: Should I avoid eating certain foods while pregnant or breastfeeding to prevent food allergies? Or is there a certain type of formula I should give them?

Dr. Stukus: This is a very important question for mothers everywhere as they are often riddled with guilt over these choices or when their child develops food allergies. The good news is that maternal diet during pregnancy or breastfeeding does not cause or prevent food allergies. Mothers should eat whatever they want, guilt free! Evidence also does not support using hypoallergenic formulas for the purpose of preventing food allergies.

Question: Years ago, doctors recommended keeping certain foods out of your child’s diet until they are 1 year old to prevent food allergies. Why did that guidance change?

Dr. Stukus: While flip-flopping guidance may seem frustrating for some, this is actually a really good thing. This means that evidence has changed and, more importantly, the experts who formulate the guidelines recognize this shift and need to support a new approach.

In 2000, the American Academy of Pediatrics specifically recommended avoiding highly allergenic foods until after 1 year of age because this is what the expert opinion and prevailing understanding reflected at the time. Just eight years later, the recommendations were changed to remove the avoidance portion but still didn’t actively recommend feeding allergenic foods to infants.

Then, in 2016, the landmark LEAP trial demonstrated for the first time that early introduction of peanuts to a group of infants with eczema and/or egg allergy between 4 to 11 months of age AND ongoing inclusion in their diet at least three times a week until 5 years of age showed a dramatic reduction in peanut allergy compared with infants who avoided peanut. Other observational and randomized controlled trials have since demonstrated similar benefits for early and ongoing introduction, especially for egg and peanut.

Given this new evidence and understanding of the immune system, as well as significant benefit compared with risk, the recommendations were changed again in recent years to now actively recommend early introduction. When done properly, science should be objective and everchanging. That is how we progress and remain as up to date as possible.

Question: I heard you should give peanut to your baby to try to prevent them from getting a peanut allergy. How do I do that and when?

Dr. Stukus: Yes, current recommendations suggest actively introducing age-appropriate forms of peanut to infants beginning around 4 to 6 months of age AND keeping it in their diet on a consistent basis, ideally at least three times a week.

Nothing we do in medicine is 100% effective, but early introduction is the best path toward preventing peanut allergy from developing. Every baby is different in regard to their readiness for solid foods, and some may not be ready until after 6 months, which is OK as well.

Parents can use peanut butter thinned with water, peanut flour or powder, or peanut puffs. Whole or partial peanuts are a choking hazard and should never be given to children until they are at least 4 or 5 years old. The goal is to give at least two (2) grams of peanut protein each time.

Download, print, and share KFA’s Resource:
Preventing Peanut Allergy: Introduce Peanut Foods Early to Your Baby

The National Institutes of Health also provides excellent instructions for free.

Question: If my child has allergic proctocolitis, how and when should I introduce solid foods?

Dr. Pistiner: Allergic proctocolitis is a non-IgE-mediated food allergy that can cause visible blood in the baby’s stool. This is for the most part outgrown relatively quickly but sometimes can cause delays in the introduction of foods other than the proctocolitis trigger. Babies with proctocolitis triggered by cow’s milk may have a higher chance of also having soy-triggered proctocolitis. Seek guidance from your health care team for managing these and a plan for attempting reintroduction. The introduction of foods like egg, peanut, sesame, wheat, fish, and shellfish should not be delayed.

Question: My older child has food allergies. How can I introduce foods to my baby while preventing food allergy reactions in my older child?

Dr. Stukus: This is a common question and really should involve a discussion with your personal allergist as there are many factors to consider, including:

• Age of the sibling
• What foods they are allergic to
• Their personal risk for reaction from various types of exposures
• Family dynamics

In general, the risk for an allergic reaction from casual exposure to a food being in the home, or even someone else eating during the same meal, is very low. The focus should be on preventing accidental ingestion for the older sibling while also avoiding unnecessary precautions that can be burdensome.

Question: Should I give my child with a food allergy a little bit of the food they are allergic to every day to help them outgrow it?

Dr. Stukus: Absolutely not! The standard of care for food allergy management is avoidance of allergens as any ingestion may cause an allergic reaction to occur. Oral immunotherapy is a highly structured and supervised process that is used in some circumstances as a way to help lower the risk of severe allergic reaction from ingestion of small amounts. But oral immunotherapy should only be done under the close supervision of a board-certified allergist and after families have a full understanding of the risks, benefits, and expected outcomes of treatment. This is a daily treatment that requires close monitoring for allergic reactions, consistency, and structure.

Michael Pistiner, MD, MMSc, is Director of Food Allergy Advocacy, Education and Prevention for the MassGeneral Hospital for Children, Food Allergy Center.

Dr. Pistiner has special interests in food allergy and anaphylaxis education and advocacy, infant food allergy management, health care provider education, facilitating collaborations between the medical home and school health, and maintaining quality of life in children with food allergies and their families.

David Stukus, MD, is a Professor of Clinical Pediatrics in the Division of Allergy and Immunology, Director of the Food Allergy Treatment Center, and Associate Director of the Pediatric Allergy and Immunology Fellowship Program at Nationwide Children’s Hospital and The Ohio State University College of Medicine. He is board certified in allergy/immunology and pediatrics.

Dr. Stukus has devoted his career to communicating evidence-based medicine and best clinical practice to colleagues, medical professionals of all backgrounds, patients, and the general public. In addition to providing clinical care for children with all types of allergic conditions, he participates in clinical research, quality improvement, patient advocacy, and medical education.

Medical Review: May 2022 by Michael Pistiner, MD, MMSc, and David Stukus MD

Gourmondo Cafes and Catering Co. Issues Allergy Alert on Undeclared Egg in Asparagus and Feta Sandwich

For Immediate Release

June 09, 2022

Contact Information

Gourmondo Co.
206-587-0190
gourmondo@gourmondoco.com

Company Announcement

6/9/22, Gourmondo Co. of Seattle, WA is recalling “Asparagus & Feta Sandwiches” Net Weight 11.04 oz / 313 g with best bv dates of 6/5 and 6/7, due to undeclared egg (allergen). People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.

Affected Gourmondo Co. “Asparagus & Feta Sandwiches” were distributed in Washington to Metropolitan Market stores on 6/1 & 6/3. UPC Code: 859266007984. This product has the Gourmondo label and wrapped in cellophane.

No illnesses have been reported to date regarding this issue.

During a routine inspection, WSDA discovered that a printing error on the stickers for the “Asparagus and Feta Sandwich” did not contain the sub ingredients for “mayonnaise”, one of which being whole eggs. Eggs were also omitted in the list of allergens on the mislabeled stickers.

Only 21 of these sandwiches were affected by this error, however, in our over-arching belief in safety and transparency, we are reporting this issue and recalling any product that may remain in inventory. As of the date of this writing, all affected products should show a “best buy” date of, or prior to, today and should already be slated for disposal.

Customers with an egg allergy or sensitivity who have purchased the affected product are urged not to consume the product and dispose of it or return it to their place of purchase for a full refund.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Should you require any further information regarding this recall. Please feel free to contact Gourmondo Co. directly at 206-587-0190 or by email at gourmondo@gourmondoco.com.

Again, a very small sampling of our product was affected by this printing error. We firmly believe that in our partnerships with our customers we provide them with all information that correlates with any products we may provide them. Customer safety is the top priority for our team at Gourmondo and we are happy to discuss this recall any further should you wish more information.

This week, DBV Technologies announced positive results from a clinical trial for Viaskin™ Peanut. Viaskin Peanut is a new type of medicine (a skin patch) being studied for peanut allergy treatment.

The goal of the Phase 3 trial, called EPITOPE (EPIT in TOddlers with PEanut Allergy), was to study the safety and efficacy (effectiveness) of Viaskin Peanut in toddlers ages 1 to 3 years with peanut allergy. A phase 3 clinical trial is used to prove whether a medical approach works.

The EPITOPE study successfully met its “primary endpoint.” A primary endpoint in a clinical trial is the main result or outcome that the study measured.  Participants in the EPITOPE trial were separated into two groups. One group (244 people) received Viaskin Peanut, the new medicine being studied. The other group (118 people) received a placebo, which is a medicine that looks like the new medicine but has no active ingredients.

At the end of the EPITOPE trial, 67% of people in the Viaskin Peanut group responded to the treatment. Only 33.5% of the placebo group met the response criteria. The difference between these two groups means that the medicine studied was found to be effective.

DBV is also talking with the FDA about the design of another Phase 3 clinical trial in response to a Complete Response Letter from the FDA in 2020. The proposed VITESSE trial will study a modified Viaskin Peanut patch, which is circular in shape and approximately 50% larger than the previous patch that the FDA responded to. The VITESSE trial will study Viaskin Peanut in children ages 4 and older.

[PRESS RELEASE]

DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers

Montrouge, France, June 7, 2022

DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers

• 67.0% of subjects treated with Viaskin Peanut 250 µg met response criteria at 12 months, compared with 33.5% of subjects in the placebo arm
• Pivotal trial met primary endpoint: lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 22.4%, exceeding the pre-specified threshold of 15%
• Safety results were generally consistent with safety profile of Viaskin Peanut 250 μg observed in children with peanut allergy ages 4 years and older in prior clinical trials
• High treatment compliance rate observed over trial duration, with low rate of discontinuation due to adverse events
• DBV will hold a conference call today at 5:00 p.m. ET to discuss the results
  
  

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that its pivotal Phase 3 trial EPITOPE (EPIT in TOddlers with PEanut Allergy), assessing the safety and efficacy of Viaskin™ Peanut 250 µg for the treatment of peanut-allergic toddlers ages 1 to 3 years, met its primary endpoint.

Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 67.0% of subjects in the Viaskin Peanut arm meeting the treatment responder criteria after 12 months, as compared to 33.5% of subjects in the placebo arm (difference in response rates = 33.4%; 95% CI = 22.4% - 44.5%).

DBV intends to further analyze the data from EPITOPE and explore regulatory pathways for Viaskin Peanut in children ages 1 to 3 years, given the high unmet need and absence of approved treatments for this vulnerable population. Separately, DBV continues productive dialogue with the U.S. Food and Drug Administration (FDA) on the protocol design of VITESSE, a pivotal Phase 3 trial of the modified Viaskin Peanut patch in peanut-allergic children ages 4 years and older.

“Most peanut-allergic children are diagnosed between 1 to 3 years of age; however, there are currently no FDA- approved therapies for this age group. Furthermore, there is growing evidence on the benefits of treatment from a younger age,” said Dr. Hugh Sampson, Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai, Director Emeritus of the Jaffe Food Allergy Institute and Chairman of the DBV Scientific Advisory Board.“ We believe these positive findings support the potential clinical benefit of Viaskin Peanut in this important, and underserved, population.”

These results represent the second and final part of the EPITOPE trial, which enrolled 362 subjects ages 1 to 3 years, of which 244 and 118 were in the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms. The median subject baseline eliciting dose (ED) was 100 mg in each treatment arm. A double-blind, placebo-controlled food challenge (DBPCFC) was administered at baseline and month 12 to determine a subject’s ED at each timepoint. A treatment responder was defined as either a subject with a baseline ED ≤10 mg who reached an ED ≥300 mg of peanut protein at month 12, or a subject with a baseline ED >10 mg who reached an ED ≥1,000 mg of peanut protein at month 12.

In an additional pre-specified efficacy analysis, treatment response was defined as achieving an ED ≥1,000 mg of peanut protein regardless of baseline ED. Using this response criterion, Viaskin Peanut demonstrated a statistically significant treatment effect (p<0.001), with 64.2% of subjects in the Viaskin Peanut arm meeting this treatment responder criterion after 12 months as compared to 29.6% of subjects in the placebo arm (difference in response rates = 34.7%; 95% CI = 23.6% - 45.7%). The response rate observed in the placebo arm appears consistent with the approximately 22% natural resolution rate in this patient population.¹

The EPITOPE safety results were generally consistent with the safety profile of Viaskin Peanut 250 μg observed in children with peanut allergy ages 4 years and older in prior clinical trials. No imbalance in the overall adverse event (AE) rate was observed in the trial between the active and placebo arms.

Overall, 21 subjects (8.6%) in the Viaskin Peanut arm and 3 subjects (2.5%) in the placebo arm experienced a serious adverse event (SAE). Only 1 of the SAEs (0.4%), which was mild periorbital edema (swelling around the eye) in the Viaskin Peanut arm, was deemed related to treatment.

The most commonly reported adverse events were skin reactions localized to the administration site, the majority of which were mild to moderate in nature. Fifty-five subjects (22.5%) in the Viaskin Peanut arm experienced an application site reaction that was assessed as severe by an investigator compared with 10 subjects (8.5%) in the placebo arm. Based on investigators’ reported observations from examinations of the skin at each study visit, using the skin grading systems defined in the protocol, the severity of administration site skin reactions following patch application decreased throughout the course of the 12-month treatment period.

Four (1.6%) subjects in the Viaskin Peanut arm experienced an anaphylactic reaction determined to be related to, or possibly related to, treatment. Among these anaphylactic reactions, 3 resolved with a single dose of epinephrine and 1 resolved without epinephrine. All anaphylactic reactions were mild to moderate in severity and were characterized mainly by skin and respiratory symptoms.

Eight subjects (3.3%) in the Viaskin Peanut arm discontinued due to adverse events.

In the 12-month treatment period, the trial completion rate was 84.8% and was balanced between the Viaskin Peanut and placebo arms. Mean subject compliance to daily patch treatment was above 95% in both the active and placebo arms.

“We are thrilled by the topline results of EPITOPE, our second Phase 3clinical trial to evaluate the safety and efficacy of Viaskin Peanut,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies.“We are grateful to the toddlers and their parents, caregivers and allergists who are contributing to a brighter future by having participated in this first-of-its kind trial.”

Following the completion of EPITOPE, all eligible subjects had the option to rollover into EPOPEX, a long-term, open-label extension study of Viaskin Peanut. There are currently 304 subjects (88% of all eligible subjects) enrolled in EPOPEX.

DBV plans to present full EPITOPE trial results at future medical congresses as well as submit them for publication in a peer-reviewed journal.

“The EPITOPE data advance our understanding of investigational epicutaneous immunotherapy’s ability to induce an immune response with minimal amounts of allergen,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “These results further inform EPIT’s potential in other food allergies and immunological conditions, which are areas of research DBV remains highly committed to pursuing.”

DBV will host a conference call and live audio webcast on Tuesday, June 7, 2022, at 5:00 p.m. ET to discuss the results. This call is accessible via the below teleconferencing numbers, followed by the reference ID: 23143278#

• United States: 866 374 5140
• Canada: 866 455 3403
• United Kingdom: 808 238 9813
• France: 805 102 712

A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.

About EPITOPE

EPITOPE (NCT03211247) enrolled 413 subjects (51 in Part A and 362 in Part B) in approximately 50 centers across North America (Canada and the United States), Europe and Australia. The EPITOPE trial is a two-part trial: Part A was designed to assess the safety of Viaskin Peanut 100 µg and 250 µg and to determine the highest safe dose, and Part B was designed to assess the efficacy and safety of the selected dose. Based on the results of Part A, the 250 µg dose was selected for Part B. In Part B, subjects were randomized 2:1 to receive Viaskin Peanut 250 µg or placebo.

The primary endpoint was based on a responder analysis after 12 months of treatment with the selected dose of Viaskin Peanut. As a secondary efficacy endpoint, cumulative reactive dose (CRD) was also evaluated in EPITOPE to establish the total quantity of peanut protein that triggers subject reactions at month 12 of active treatment versus placebo. Serological markers were also measured at baseline, 3, 6 and 12 months in order to characterize the immunological changes in subjects.

Following the completion of EPITOPE, all eligible subjects had the option to rollover into EPOPEX, a long-term, open-label extension study of Viaskin Peanut 250 µg. Now that the EPITOPE study results are publicly available, subjects enrolled in the EPOPEX study will be unblinded to their respective treatment group in EPITOPE.

About DBV Technologies
DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients. DBV Technologies’ food allergies programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding DBV Technologies’ Viaskin Peanut, such as the regulatory pathway for approval by the FDA in children ages 1 to 3 years and the planned VITESSE Phase 3 clinical trial in older children discussed in this press release. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. These forward-looking statements may be impacted by market conditions as well as other risks and uncertainties set forth in DBV Technologies’ regulatory filings with the AMF, DBV Technologies’ filings and reports with the SEC, including in DBV Technologies’ Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 9, 2022, and future filings and reports made with the AMF and SEC by DBV Technologies. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.

Investor Contact
Anne Pollak
DBV Technologies
+1 857-529-2363
anne.pollak@dbv-technologies.com

Media Contacts
Angela Marcucci
DBV Technologies
+1 646-842-2393
angela.marcucci@dbv-technologies.com

Katie Hatcher
+1 312-397-6621
khatcher@webershandwick.com

    
^1. Peters RL, Allen KJ, Dharmage SC, et al. Natural history of peanut allergy and predictors of resolution in the first 4 years of life: A population-based assessment. J Allergy Clin Immunol. 2015;135(5):1257-66.e662. doi:10.1016/j.jaci.2015.01.002