Skip to main content

Tagged With "FDA"

Comment

Re: Share Your Allergy Reactions to Sesame With the FDA

Brenda Silvia-Torma ·
Meghan P-K and LISA, thank you both for completing the survey! Your input will definitely help to reinforce the need for sesame to be included on labels. Thank you for sharing your kiddos' stories! Brenda
Comment

Re: Share Your Allergy Reactions to Sesame With the FDA

Lisa ·
Thank you for posting this. When my son was allergic to sesame it was very frustrating to deal with the lack of awareness of sesame as a serious allergen. My son had multiple reactions as a young child and the survey only allowed me to report one reaction. I tried to click again and it would not let me take the survey again so I only reported one of the bunch of reactions to undeclared sesame he had.
Comment

Re: FDA Gives Experimental Peanut Allergy Patch Special Status Designed to Speed Review

Abigail's Mommy ·
How can we find a Phase III trial? I'm interested in doing this.
Comment

Re: FDA Gives Experimental Peanut Allergy Patch Special Status Designed to Speed Review

StephC ·
Same here. And how do we get notified about trials for milk?
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

LSK ·
thanks! really helpful to get this update
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

StephC ·
That's good. It seems like Mylan is recognizing that with the rise of food allergies, a LOT of epi-prescribed folks are children, and they and their parents need extra guidance in using their device safely. (As opposed to an adult patient.)
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

Kids With Food Allergies ·
For more information on the FDA's communications about these changes: EpiPen: New label - http://www.accessdata.fda.gov/...16/019430s061lbl.pdf Letter to Mylan (makers of EpiPen and EpiPen Jr.) http://www.accessdata.fda.gov/...9430Orig1s061ltr.pdf Adrenaclick: New label - http://www.accessdata.fda.gov/...16/020800s034lbl.pdf Letter to Amedra (makers of Adrenaclick and its generic version) http://www.accessdata.fda.gov/...0800Orig1s034ltr.pdf Auvi-Q (removed from market in 2015): New label -...
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

Kids With Food Allergies ·
If you have any questions about the new labels, speak with your healthcare provider. Here is a message from Mylan, the makers of EpiPens: "Mylan offers a library of training and support resources for patients and caregivers which are in the process of being updated to reflect the new labeling. In the meantime, please speak to your healthcare professional or call the Mylan Customer Service team at 800-395-3376 with any questions about the changes. Additionally, each EpiPen 2-Pak® and EpiPen...
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

KellyM ·
Thanks so much for getting this info out! Grateful to Dr. Julie Brown et al for raising some awareness around auto injector issues and Kids with Food Allergies for spreading the word.
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

KellyM ·
Wondering if there is any discussion about "swing and jab" v. press firmly until injector engages? Bruising from overly forceful impact of auto injector on tissues also a commonly expressed concern.
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

Jen ·
Hi Kelly, There is a little more information pertaining to your question re swing/jab in this blog post from last fall. I hope that helps.
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

JoyceZ ·
Is the training device a device regulated by FDA? any safety issues?
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

K8sMom2002 ·
Hi, Joyce, the trainer in an Epi pack is usually a "look alike" that doesn't have a needle. It can be reset to be used over and over again. It's basically a way to teach people which end is up, as with a real Epi, it can be confusing and you want the meds to go in your kid and not in a teacher or staff person's thumb.
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

Rebekah Baharestan ·
This update should be on every news channel and on every epinephrine Epi pen box with a new sticker warning . Please .
Comment

Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

K8sMom2002 ·
Hi, Rebekah and ... what food allergies do you manage?
Comment

Re: What Progress Is Being Made to Improve Sesame Labeling?

Brenda Silvia-Torma ·
This is fantastic news!! Brenda
Comment

Re: What Progress Is Being Made to Improve Sesame Labeling?

Kids With Food Allergies ·
On Nov. 28, 2018, we updated this post to include two new milestones in the timeline: 2018, November – AAFA meets with representatives of Congressional Asthma and Allergy Caucus to garner support for the inclusion of sesame on food labeling. 2018, November – Congressional Asthma and Allergy Caucus sends a letter prepared by AAFA to FDA Commissioner Gottlieb urging the addition of sesame to the list of major food allergens.
Comment

Re: DBV to Resubmit Viaskin Peanut Treatment for FDA Biologics License

Nutfreemama1 ·
Waiting for this! Already tried oit and slit.
Comment

Re: How to Report Foods After an Allergic Reaction

Will Way ·
Useful information. Thanks!
Comment

Re: How to Report Foods After an Allergic Reaction

K8sMom2002 ·
Leslie, has your son ever had a reaction to a food that wasn't properly labeled?
Comment

Re: How to Report Foods After an Allergic Reaction

Will Way ·
He had a reaction to a cereal made by Van's that was labeled as safe for him, but I think it was a cross-contamination issue instead of a mislabeling. If he had a reaction to a mislabeled food, I don't think that it would occur to me to have the food tested. When he reacted to the cereal, I called and there was a cross-contamination risk for tree nuts that was not labeled, so I don't buy their products anymore.
Comment

Re: How to Report Foods After an Allergic Reaction

K8sMom2002 ·
Ouch on the reaction, and good to know. It's also good to know there's a process in place for how to report foods that are mislabeled.
Comment

Re: Generic Montelukast and Singulair Will Now Carry Stronger Warning Label About Possible Side Effects

FineSilver.99 ·
Hi, Thank-you for sending the info. on Singular!! I had told one Dr. many years ago, that it was causing insomnia, and the dosage was too high. I had asked for a children's dosage,but she said , "No, the insurance would not cover it". I quit taking it. Sincerely, Terri
Comment

Re: Generic Montelukast and Singulair Will Now Carry Stronger Warning Label About Possible Side Effects

Will Way ·
Wow! This is frightening! I will be talking to our allergist about taking my son off of this medication.
Comment

Re: What the FDA’s Temporary Food Labeling Guidance Really Means for People With Food Allergies

mc21 ·
I didn't see monosodium glutamate, autolyzed yeast, torula yeast extract, titanium dioxide or turkey listed. Those will directly affect my family. I was glad to see soy and shellfish listed. It's scary to think that our allergens may or may not be listed or masked as something else. I am diligent about checking to make sure food is safe to eat. If in doubt, I don't risk it. I look forward to a day when the food industry has to be more thorough and completely honest about what is in the food.
Comment

Re: What the FDA’s Temporary Food Labeling Guidance Really Means for People With Food Allergies

Kids With Food Allergies ·
On May 28, 2020, AAFA met with the FDA to talk about how these temporary guidelines will affect the food allergy community. After the meeting, we organized a joint letter with other advocacy groups to send to the FDA. In our letter, we have asked the FDA to clarify these guidelines. We are also asking that the FDA require manufacturers to publicly post any substitutions they make. We will keep you updated on this issue. Read our joint letter to the FDA.
Comment

Re: What the FDA’s Temporary Food Labeling Guidance Really Means for People With Food Allergies

Kathy P ·
Thanks for your questions...we are continuing the get more answers and clarity. We'll add those to the list.
Comment

Re: What the FDA’s Temporary Food Labeling Guidance Really Means for People With Food Allergies

Nutfreemama1 ·
Hi thank you for all you are doing. I have a question still...their use of and definition of “should” concerns me that top 8 can be subbed without a label change..as they say they “should be” and not “must be” before describing the safety paragraph on top 8 etc.. can you look at the highlighted usage in the two attachments please? also, in the paragraph describing what it means “ They are not allowed to substitute the top 8 food allergens (egg, milk, wheat, soy, peanut, tree nut, fish and...
Blog Post

Strides in Food Allergy Advocacy

Kids With Food Allergies ·
Even though 32 million Americans have food allergies, protections for people with food allergies are still lacking. The Asthma and Allergy Foundation of America (AAFA) and its division Kids With Food Allergies (KFA) have been advocating for better food allergy awareness and for ways to prevent severe allergic reactions. Engagement With FDA During COVID-19 – AAFA is leading a coalition of 13 other food allergy organizations to respond to the Food and Drug Administration's (FDA) "Temporary...
Blog Post Featured

Letter to the FDA: Require Food Manufacturers to Post Substitutions

Kids With Food Allergies ·
Update: We are pleased to announce that on June 18, 2020, the FDA responded to our joint letter on their temporary labeling guidelines. They released a list of FAQs to help clear up confusion. The FDA is making it clear that: Any substitution that involves a top 8 allergen recognized by law and those identified as “priority allergens” by other countries including sesame, celery, lupin, buckwheat, molluscan shellfish and mustard must require a label change by manufacturers and vendors The...
Blog Post

Study Tests Best Ways to Remove Food Allergens From Surfaces

Kids With Food Allergies ·
Many people are concerned about the food you can’t see – the food left on restaurant tables, school cafeteria tables and in the home kitchen . It’s a valid concern. Some cleaning methods don’t completely remove food allergens. A person with a food allergy may be at risk of having a serious allergic reaction (anaphylaxis) from cross-contact if they eat their food off that surface. The Food and Drug Administration (FDA) has done a study called “ Allergen Removal and Transfer Using Wiping and...
Comment

Re: What the FDA’s Temporary Food Labeling Guidance Really Means for People With Food Allergies

Kids With Food Allergies ·
On July 16, 2020, we updated this blog post to include information on how long the temporary guidelines may remain in effect, as well as a chart to help you better understand the guidelines.
Blog Post Featured

What the FDA’s Temporary Food Labeling Guidance Really Means for People With Food Allergies

Kids With Food Allergies ·
Update – July 16, 2020: The FDA's temporary labeling guidance will remain in effect for the length of the public health emergency (PHE) due to the spread of the new coronavirus (SARS-CoV-2). A PHE is determined and declared by the secretary of the Department of Health and Human Services (HHS). The PHE remains in place during the emergency or 90 days, but may be extended by the secretary. Though the current PHE is set to expire on July 25, 2020, HHS Secretary Azar has said he will extend the...
Blog Post

Viaskin™ Peanut Patch Not Approved in Its Present Form - DBV to Request Meeting With FDA

KFA News Team ·
DBV Technologies, a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the Company’s Biologics License Application (BLA) for investigational Viaskin™ Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
Comment

Re: Viaskin™ Peanut Patch Not Approved in Its Present Form - DBV to Request Meeting With FDA

Juneau ·
We have been looking forward to this patch for years and my kid may be too old by the time it gets approved. So much safer than other peanut allergy treatments.
Blog Post

What Progress Is Being Made to Improve Sesame Labeling?

Kids With Food Allergies ·
Sesame labeling has been a common topic in the news and our community recently. We wanted to give you an update on progress we’ve made advocating for better sesame labeling.
Comment

Re: Advocacy Update: FDA Moves Forward on Sesame Labeling

Penny Wright ·
I’d like to see Sunflower added as well. So many vegan foods use Sunflower oil and my 2 yr old granddaughter is severely allergic. Her allergist said it’s becoming more prevelant
Comment

Re: FDA Issued Guidance on Chocolate and Milk Allergy

FineSilver.99 ·
I believe the most important thing is to read the labels!! And when it says "made in a facility", it means that if you are allergic to something under that statement, you can assume that it will be in that product!! I found that the hard way!!
Comment

Re: FDA Issued Guidance on Chocolate and Milk Allergy

Kathy P ·
Reading labels is absolutely key! It is important to remember that those "shared lines" and "shared facilities" statements are voluntary and not required. They are also not standardized to have the same meaning from product to product.
Blog Post

FDA Issued Guidance on Chocolate and Milk Allergy

Kids With Food Allergies ·
The Food and Drug Administration (FDA) recently published findings about the milk content of dark chocolate bars and chips made in the United States that were labeled “dairy free” or had similar free-from-milk claims. The study found that four of the 52 products tested had enough milk to possibly cause an allergic reaction. According to the FDA : "Milk is the most common undeclared food allergen, responsible for more than a third of all food product recalls caused by undeclared allergens in...
Blog Post Featured

Share Your Allergy Reactions to Sesame With the FDA

Kids With Food Allergies ·
Sesame allergy ranks ninth in prevalence behind the top 8 allergens. But manufacturers are not required to clearly label sesame on their products. It can even go unlabeled under terms like “spices” and “natural flavoring.” This is very distressing as reactions to sesame can be among the most severe for adults and children. We are asking community members who have had an adverse reaction to sesame, or care for someone who has, to share their story with the FDA.
Blog Post

Advocacy Update: FDA Moves Forward on Sesame Labeling

Kids With Food Allergies ·
Updates: On Dec. 9, 2020, the Senate passed the Food Allergy Safety, Treatment, Education, and Research Act of 2020, also called the FASTER Act (S. 3451) . This bill expands the definition of major allergens to include sesame and would increase federal funding for food allergy research. Because this Senate version of the bill is slightly different than the House version (H.R. 2117), the House will need to vote on Senate version before it can be signed into law. If passed by the House, the...
Kids With Food Allergies
A Division of the Asthma and Allergy Foundation of America
1235 South Clark Street Suite 305, Arlington, VA 22202
Phone: 1-800-7-ASTHMA (1.800.727.8462)
-->
×
×
×
×