On Aug. 9, 2024, the Food and Drug Administration (FDA) approved neffy®, an epinephrine nasal spray to treat anaphylaxis, a severe allergic reaction. It has been approved for adults and children who weigh about 66 pounds or more (30 kilograms).

Neffy is a single-dose nasal spray to be given in 1 nostril. You can give a second dose (using a new nasal spray to administer neffy in the same nostril) if symptoms don’t get better or get worse. You may need to get emergency medical care to monitor the allergic reaction in case you need more treatment.

Until now, epinephrine has only been available in devices that use needles. A nasal spray gives people managing allergies more options. And as we told the FDA in May of last year, people at risk of anaphylaxis deserve to have a choice in treatment.

On Sept. 19, 2023, the FDA asked for another study on neffy that focused on adults. This approval follows that study. A study of neffy in children weighing more than 66 pounds showed that epinephrine amounts in children were similar to adults who received neffy.

Epinephrine is the first-line treatment for severe allergic reactions. But far too often, people are not using or getting epinephrine when needed. In a study the Asthma and Allergy Foundation of America (AAFA) conducted in 2019, almost 3 out of 4 people said they didn’t use epinephrine for their most recent severe allergic reaction.

Epinephrine nasal spray may remove some of the barriers that prevent people from using epinephrine. The needle-free device removes the fear of needle-based injections and may be easier to use. This may increase confidence among people managing life-threatening allergies.

Innovation is one of our foundation’s core values and we are excited by this new treatment for severe allergic reactions. We will continue to advocate for research that supports our community.

Read the FDA press release to learn more about neffy.

Here are some answers to common questions about neffy.

When will I be able to get neffy?

The epinephrine nasal spray should be available around mid-October. Starting September 4, 2024, you can preorder neffy by visiting neffy.com and clicking the “Getneffy now” button at the top of the homepage. The company expects to start shipping pre-orders at the end of September.

How much will neffy cost? Will it be covered by insurance?

If you have commercial insurance (for example, through your job), you can pay $25 for each filled prescription of 2 devices using ARS Pharma’s copay savings program.

If you don’t have insurance coverage, your plan doesn’t cover neffy, or if you have a high-deductible plan, you can pay a cash price of $199 for 2 doses of neffy using BlinkRx. BlinkRX is a digital pharmacy service that is available to you at no added cost.

This cash price is also available if you use retail pharmacy discounts through GoodRx.

The ARS Pharma Patient Assistance Program (PAP) may provide neffy at no cost if you:

• Are a U.S. resident
• Don’t have enough insurance
• Don’t have insurance
• Meet certain eligibility criteria
• Have tried all other options to help pay for neffy

Visit neffy.com or call 1-877-696-3339 for more information.

How many doses does 1 neffy device have?

Each device offers a single dose. Each prescription comes with 2 single-use devices.

Does neffy still work if my nose is congested or if I have a cold?

Clinical tests suggest that upper respiratory tract infections, allergic rhinitis, and infectious rhinitis do not affect how much epinephrine you get or how much you absorb after giving neffy.¹

Talk with your doctor for more information on conditions that may affect how well neffy works. You can also visit neffy.com for more information.

Is neffy as effective as an epinephrine auto-injector?

Yes. Four tests in adults showed that the epinephrine nasal spray works as well as an auto-injector for anaphylaxis. The FDA approved neffy after more testing confirmed how well it works.

• neffy affected systolic blood pressure within 1 minute of dosing.²
• People who gave themselves neffy had responses that were the same or higher than injected epinephrine given by health care providers.³
• In a study of 90 patients, 100% correctly gave neffy to themselves or someone else.⁴
  
  

Is neffy affected by temperature?

Neffy should NOT be frozen. If frozen, neffy will not deliver epinephrine while frozen. These devices can temporarily handle heat up to 122 F. But it is best to keep neffy between 68 - 77 F. The nasal spray is good for 30 months. Studies showed it was still good after thawing if accidentally frozen.^2,5

How quickly does neffy expire?

The expiration date of a medicine is based on when that medicine was made. The expiration date of the device you pick up at your pharmacy will depend on how long ago it was manufactured. The nasal epinephrine spray is good for 30 months.²

Who can use neffy?

Neffy has been tested in adults and in children weighing 66 pounds or more. ARS Pharma plans to file another application with the FDA for neffy for children who weigh between 15 to 30 kilograms later in 2024.

Medical Review: August 2024 by Mitchell H. Grayson, MD

References
1. Oppenheimer J et al. Pharmacokinetics/Pharmacodynamics of Intranasal Epinephrine in Subjects with and without Upper Respiratory Infections Presented at the American College of Allergy, Asthma and Immunology (ACAAI); November 9-13, 2023; Anaheim, CA.
2. ARS Pharma Data on File.
3. Casale TB et al. Pharmacokinetics of Self-Administration of ARS-1 (neffy® Nasal Spray) 2.0 mg Versus Manual Intramuscular (IM) Epinephrine 0.3 mg by Health Care Provider (HCP). Presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting; February 24, 2023; San Antonio, TX.
4. Lowenthal R et al. Self-Administration of Intranasal Epinephrine (neffy) Using the Aptar Unit Dose System Compared to EpiPen and Symjepi. Presented at the Annual Meeting of the American Academy of Allergy, Asthma and Immunology; February 25-28, 2022; Phoenix, AZ.
5. neffy Epinephrine Nasal Spray Full Prescribing Information. ARS Pharma. 06-2024.

Niitakaya USA Inc. Issues Allergy Alert on Undeclared Allergen of Fish (Bonito) in #3700 Shiso Katsuo Ninniku/#3701 Miso Katsuo Ninniku

For Immediate Release

September 05, 2024

Contact Information

323-720-5050

Company Announcement

Niitakaya USA Inc. of Montebello, CA, is recalling All Best By dates of its 5.2 ounce (147 gram) packages of #3700 Shiso Katsuo Ninniku /#3701 Miso Katsuo Ninniku because they may contain undeclared Allergen of Fish (Bonito). People who have allergies to fish run the risk of serious or life-threatening allergic reaction if they consume these products.

The recalled #3700 Shiso Katsuo Ninniku /#3701 Miso Katsuo Ninniku were distributed nationwide to retail stores and through distributors.

The product comes in a 5.2 ounce (147 grams), clear plastic package marked with Niitakaya logo on the top. The product images are below. The Best By date will be located in the top back part of the package.

No illnesses have been reported to date.

The recall was initiated after it was discovered that product containing Fish (Bonito) was distributed in packaging that did not reveal the presence of “Containing allergen: Fish (Bonito)”.

Distribution of the product has been suspended until the company is certain that the problem has been corrected.

Consumers who have purchased 5.2 ounce (147 grams) packages of #3700 Shiso Katsuo Ninniku and #3701 Miso Katsuo Ninniku are urged to return them to the place of purchase for a full refund, if allergic to fish. Consumers with questions may contact the company Monday to Friday 7AM-3PM PDT at 323-720-5050.

Hammond’s Candies Issues Allergy Alert on Undeclared Milk in Hammond’s Dark Chocolate Filled Mini Waffle Cones

For Immediate Release

September 06, 2024

Contact Information

Devon DeVries (Hammond’s Candies)
1-888-226-3999 or at 303-333-5588 x 180

Company Announcement

Hammond’s Candies of Denver, CO is recalling 4-ounce bags of Dark Chocolate Filled Mini Waffle Cones because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Hammond’s Dark Chocolate Filled Mini Waffle Cones were distributed to AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OK, OR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Washington, D.C., through retail stores and mail order via https://www.hammondscandies.comExternal Link Disclaimer and https://www.amazon.comExternal Link Disclaimer.

The recalled Hammond’s Dark Chocolate Filled Mini Waffle Cones are packaged in a 4-ounce stand-up, resealable bag, with UPC -6 91355 90513 5. Hammond’s item number for this product is FC23212. The recalled product codes LN0525453 Use By: 03/20/2025 and LN0525453 Use By: 05/20/2025 can be found printed on the lower-center region of the back of the bag. See below photos for example.

One report of an allergic reaction has been reported in connection with this problem to date.

The recall was initiated after the firm received one consumer report of an allergic reaction experienced after consuming the product. As part of the firm’s ongoing investigation, the product was tested and found to contain more than trace amounts of milk proteins, which is not indicated on the packaging. The firm’s investigation into the cause is ongoing.

Consumers who have purchased Hammond’s Dark Chocolate Filled Mini Waffle Cones are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Devon DeVries at Hammond’s Candies at 1-888-226-3999 or at 303-333-5588 x 180 Monday-Friday, 8am-4pm MST.

If you’re a teacher or serve as a staff member at a school, you’ve probably had students with food allergies. Food can be a common part of the learning experience – whether it’s during class events, snack times, or even arts and crafts.

Reading labels is a vital part of helping prevent food allergy reactions at school. Anyone who works with students who have food allergies can benefit from knowing how to recognize food allergens on labels.

Here are 8 label reading tips for teachers, school staff, and volunteers to help prevent food allergy reactions:

1. Read every label. The Food Allergen Labeling Consumer Protection Act (FALCPA) states foods that have any of the 9 most common allergens must list them on the label in plain language. These foods are:

• Egg
• Fish
• Milk
• Peanuts
• Sesame
• Shellfish
• Soy
• Tree nuts
• Wheat

If a student has an allergy to a food that is not on the list above, read the entire ingredients list carefully for their food allergen. Allergens that aren’t on this list may not be clearly labeled. Work with their parents or caregivers on what ingredients to watch for.

2. Read the entire label. Don’t only look for bold print or a “contains” statement. Companies do not have to use a bolded font for all food allergens. You must always read the entire ingredients label.

Kids with Food Allergies (KFA) has food allergy management guides for many of the most common food allergens.

3. Understand precautionary allergen labels (allergy warning statements).
Statements like “may contain...” or “processed in a facility with...” may not be accurate or consistent. They are not always a good measure of whether a food contains an allergen. Follow the child’s school health care plan to know if they can eat foods with these types of labels.

4. Check for “natural flavors.” If a natural flavor contains one of the top allergens, it will be in the ingredients list or in a “contains” statement in plain language. Other allergens, like corn, sunflower, or banana may hide in natural flavors.

5.  “Non-dairy” and “dairy-free” do not always mean there are no milk ingredients. A food can use the term “non-dairy” on the packaging even if the product contains casein, a milk protein. Creamers and whipped toppings that contain sodium caseinate are often labeled as “non-dairy.” Even some cheeses may be labeled as “non-dairy” but actually contain milk protein. The term “dairy-free” is not regulated but will sometimes be used by manufacturers to describe lactose-free products. Read the entire ingredient label to check for milk ingredients.

Some foods may also include animal-free milk. It may be listed as non-animal whey protein. Even though it did not come from an animal, people with a milk allergy can still react to it. The FALCPA requires food makers who use this type of milk to list milk as an allergen on ingredient labels.

6. Don’t rely on terms like “school safe,” “classroom safe,” “allergy free” or “allergy safe.” The food may still contain an allergen of a child in your classroom – even one of the most common allergens. Read the entire ingredient label of every food.

7. Some non-food products contain food allergens. You can find food allergens in other items that might be in your classroom, such as personal care items (like lotions and soaps), pet food, toys, craft supplies and play dough. These items may not have an ingredient list or may list allergens by their botanical names.

8. Remember to read every label every time. Food companies can change ingredients and manufacturing processes at any time. Even different sizes or packages of the same food can have different ingredients and advisory labels. And if the food doesn't have a label, don't allow the child with food allergies to eat the food.

Sri Lakshmi Narasimhar Overseas LLC Issues an Allergy Alert on Undeclared Milk and Sesame Seeds in Bliss Tree Butter Snacks

For Immediate Release

August 23, 2024

Contact Information

1-732-675-7935
sales@srilno.com

Company Announcement

Sri Lakshmi Narasimhar Overseas LLC of Edison, New Jersey is recalling the following products because Bliss Tree Butter Snacks may contain undeclared milk and/or sesame seeds. The presence of undeclared milk and/or sesame were discovered during the FDA review of the product labels. People who have an allergy or severe sensitivity to milk and sesame run the risk of serious or life-threatening allergic reaction if they consume these products., which is not listed as an ingredient on the label.

The recalled snacks were distributed nationwide via retail stores, through online orders at www.bliss-tree.us and through Amazon (www.amazon.com)

• Bliss Tree Ragi Butter Murukku 200g Box
  • UPC: 8906087451754
  • Best By: May 2025 or earlier
  • Allergen: Milk
• Bliss Tree Ragi Butter Murukku 400g Pouch
  • UPC: 8906087452829
  • Best By: May 2025 or earlier
  • Allergen: Milk
• Bliss Tree Millet Butter Murukku 200g Box
  • UPC: 8906087451631
  • Best By: May 2025 or earlier
  • Allergen: Milk & Sesame
• Bliss Tree Millet Butter Murukku 400g Pouch
  • UPC: 8906087452850
  • Best By: May 2025 or earlier
  • Allergen: Milk
• Bliss Tree Millet Butter Ribbon Pakoda 200g Box
  • UPC: 8906087451624
  • Best By: May 2025 or earlier
  • Allergen: Milk
• Bliss Tree Millet Butter Ribbon Pakoda 400g Pouch
  • UPC: 8906087452843
  • Best By: May 2025 or earlier
  • Allergen: Milk
• Bliss Tree Moringa Butter Murukku 400g Pouch
  • UPC: 8906087452836
  • Best By: May 2025 or earlier
  • Allergen: Milk
• Bliss Tree Curry Leaves Butter Murukku 400g Pouch
  • UPC: 8906087452867
  • Best By: May 2025 or earlier
  • Allergen: Milk
• Bliss Tree Millet Butter Karasev 200g Box
  • UPC: 8906087451686
  • Best By: May 2025 or earlier
  • Allergen: Milk

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

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

Production and distribution of the product has been suspended until FDA and the company are certain that the problem has been corrected.

Consumers who have purchased these products are urged to return them to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-732-675-7935 or sales@srilno.com. Available Mon-Fri, 8am – 5pm ET.

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

This month, we are highlighting research opportunities and news on:

• Palforzia® approval for young children
• Clinical trial for children with peanut allergy
• Community advisory panel opportunity
• FDA approval of neffy® epinephrine nasal spray
• Parent experiences during oral food challenges for infant and toddler

Note: The links below will take you to external websites.

Surveys

Join Our MomLife Panel!

MomLife is looking for food allergy moms to join our group of community advisors to major brands. Our next study in MomLife, which will post within the week, will be for caregivers of kids with severe allergic reactions. This study will involve 30 minutes of your time answering fun, creative questions. So sign up for MomLife today so you can take part!

Participation in any study is completely voluntary and you can opt out at any time. Please note: we will never attempt to sell you anything or market to you and all your information is kept private and confidential. This is a market research opportunity and you will be compensated for your time.

LEARN MORE

Medical Review: August 2024 by John James, MD

Too Good Gourmet Issues Allergy Alert on Undeclared Milk in Meijer Dunking Cookies Chocolate Chip 10oz

For Immediate Release

August 09, 2024

Contact Information

Too Good Gourmet, Meijer
510-317-8150, 800-543-3704

Company Announcement

August 9, 2024 – Too Good Gourmet of San Lorenzo, CA is announcing a recall of Meijer Dunking Cookies Chocolate Chip because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reactions if they consume these products.

The recalled Meijer Dunking Cookies Chocolate Chip were sold at Meijer stores in Michigan, Indiana, Illinois, Ohio, Kentucky, and Wisconsin.

The recalled Meijer Dunking Cookies Chocolate Chip were sold in a 10 oz. tall clear container with a blue and white label, UPC 713733712972. All Best if Used By codes are included in this recall.

Neither Too Good Gourmet or Meijer have received any customer complaints or claims of illness associated with this recall to date.

The product contains a milk allergen that was mistakenly not listed in the ingredient declaration and Contains statement. Meijer was not notified of the label inaccuracy.

Customers that have impacted products should discontinue use and return the product to the customer service desk at any Meijer store for a full refund. Customers with questions regarding this recall can contact Meijer at 800-543-3704 from 7 a.m.-1 a.m. EDT daily. You can also reach Too Good Gourmet at 510-317-8150 from 8 a.m.-5 p.m. PST M-F. Customers with questions or concerns about their health are encouraged to contact their primary care provider.

Prime Food Processing LLC Issues Allergy Alert on Undeclared Sesame in Steam Buns with Egg Custard Added and Steam Buns with Egg Custard and Coconut Added

For Immediate Release

August 09, 2024

Contact Information

718-963-2323

Company Announcement

Prime Foods Processing LLC of Brooklyn, NY is recalling 477 cases of 2 varieties of Egg Custard Steamed Buns because they may contain undeclared Sesame. People who have an allergy or severe sensitivity to Sesame run the risk of serious or life-threatening allergic reaction if they consume these products.

The items were distributed in 27 states (AZ, CA, CO, CT, FL, GA, HI, IL, KY, KS, LA, MA, MD, ME, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TX, UT, VA, WA) through Asian grocery stores. These products were distributed between May 30, 2024 and June 28, 2024.

The Prime Foods products being recalled are:
Item #PD4180 Steam Buns with Egg Custard Added Lot Codes #24149, and #24150. Expiration on 10/2025. UPC Code 797803704050
Item #PD4190 Steam Buns with Egg Custard and Coconut Added Lot Codes #24149. Expiration on 10/2025 UPC Code 797803704869

The products are Frozen items packaged in bright yellow packaging. The Code Date information can be found on the bottom of the le side panel.

The mislabeling was identified internally. No customer complaints or illnesses have been reported to date. The recall was initiated after it was discovered that 6 cases of Sesame Steamed Buns may have been packaged in Egg Custard Steam Bun packaging. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's packaging processes, which has been corrected.

Consumers should return the affected product to the store where they purchased it with the uneaten buns and packaging for a full refund.

Consumers with questions may contact the company at 718-963-2323. Monday-Friday 8:00am-5:00pm Eastern Standard Time.

Perrigo Issues Voluntary Recall of One Batch of Premium Infant Formula with Iron Milk-Based Powder Due to Elevated Levels of Vitamin D

For Immediate Release

August 08, 2024

Contact Information

Perrigo Consumer Affairs Contact Information
1-800-538-9543

Company Announcement

Dublin, Ireland and Allegan, MI – August 8, 2024 – Perrigo Company plc is issuing a voluntary recall at the retailer and warehouse level of three lots within one batch, or 16,500 cans, of store brand Premium Infant Formula with Iron Milk-Based Powder due to levels of Vitamin D above the maximum level permitted. The recalled product was shipped to H-E-B Grocery Company, LP in TX ; and CVS in the following states: TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO. No other products or retailers are impacted by this recall.

The Company is initiating this voluntary recall in consultation with the U.S. Food and Drug Administration (FDA). There have been no reports of adverse events to date attributed to the elevated levels of Vitamin D in the product subject to this recall, which was determined through routine testing.

For the vast majority of infants, short-term consumption of the affected lot codes is unlikely to cause adverse health implications. In a small subset of physiologically vulnerable infants (e.g., impaired renal function), there is the potential that consumption of the recalled product could result in health complications. Parents and caregivers who may have purchased the product should look for the lot codes below with “use by” dates, which can be found on the bottom of the package and should contact their health care provider if they have any concerns.

Perrigo has taken immediate action by notifying H-E-B Grocery Company, LP and CVS directly and asking them to examine their retail and warehouse inventory and isolate the product.

Product shipped to CVS beginning February 6, 2024, being recalled:

T11LMYC – USE BY 11NOV2025
(Material: 975261, UPC: 050428318034)

Product shipped to H-E-B Grocery Company, LP beginning February 2, 2024, being recalled:

T11LMXC – USE BY 11NOV2025
T09LMXC – USE BY 09NOV2025
(Material: 788362, UPC: 041220164578)

No other lot codes are impacted by this recall.

If infants experience any symptoms while using the product, report them to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Additionally, please contact your healthcare provider.

Any questions or concerns regarding the recall or adverse events associated with these lot codes can be communicated to Perrigo Consumer Affairs at 1-800-538-9543, M-F from 8:00am-5:00pm EST.

Yummy Foods Issues Allergy Alert on Traces of Milk Allergen in Non-Dairy Ices

For Immediate Release

August 07, 2024

Contact Information

yummyfoodsrecall@gmail.com

Company Announcement

Yummy Foods, In Edison, NJ is recalling their Yummy Swirly Ices line because it may contain traces of milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

THIS IS NOT A KASHRUS CONCERN AND THE PRODUCTS ARE ALL CONSIDERED KOSHER PARVE AS CONFIRMED BY THE CRC KASHRUS AGENCY.

The products were distributed through retail supermarkets in New York, New Jersey, Maryland, Ohio, Chicago, Florida, California.

The products are packaged in printed boxes with the Yummy logo and can be found in the freezer aisle in independent kosher supermarkets.

The recall was initiated after an allergen sensitive consumer complained about feelings of discomfort after consuming the Swirly Ices. The reason for the cross contamination is still under investigation.

Do not consume this product if you have a sensitivity or are allergic to milk. It can be returned to the original point of purchase for a full refund.

If you have questions or concerns, please email to yummyfoodsrecall@gmail.com.

The recalled products include:

Swirly Tropical melon- Swirly Berry Blast - Swirly Tropical Tornado - Swirly Churning Cherry - Swirly Variety Pack.

Product are numbered with lot numbers 68/2 and 69/1 and expiration dates 5/28/2026 and 5/30/2026 but the entire line is being recalled notwithstanding the lot number.

Bonbon - A Swedish Candy Co.. Issues Allergy Alert on Undeclared Almonds, Wheat and Nuts in Marabou Sea Salt 200g Chocolate Bar

For Immediate Release

August 02, 2024

Contact Information

BONBON - A SWEDISH CANDY CO.
212-786-0094

Company Announcement

BonBon - A Swedish Candy Co. of New York, NY is recalling every Marabou Sea Salt chocolate bar, because it may contain undeclared almonds, wheat, and nuts. People who have an allergy or severe sensitivity to almonds and wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

Marabou Sea Salt was distributed in BonBon retail stores located at 130 Allen St, 1220 Lexington Ave and 705 Driggs Ave in New York City and was sold alongside other imported packaged goods.

The product can be identified by the ‘Marabou’ trademark font and logo, yellow plastic packaging and the word ‘havvsalt:’ the Swedish word for ‘sea salt.’ The product is a flat chocolate bar (9” x 4”) and weighs 185g. The expirations and production codes of the implicated inventory is 04.09.2024 and 09.11.2024 as well as OUV0134912 and OUV0140643.

No illnesses have been reported to date.

The recall was initiated after it was discovered that batches of Marabou Sea Salt contained almonds, wheat and nuts outside of its allergen profile. The packaging disclosed the product contained “traces of nuts and wheat.” On May 8, 2024, BonBon was informed of the recall by our distributor, Ert Godis, and the product was removed from the sales floor and subsequently destroyed at every retail location.

Consumers who have purchased Marabou Sea Salt are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 212-786-0094, Monday through Sunday from 10am-12am.