Tagged With "FDA"

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Proposed Federal Bill Adds Sesame to List of Major Allergens

Kids With Food Allergies ·
An important bill in Congress adds sesame to the list of major allergens that must be declared on a food label. Currently, only eight allergens - milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soy - are listed on food labels . Allergens not on that list - such as sesame – are sometimes called non top-8 allergens. The Food Labeling Modernization Act of 2015 (HR 4061) would make sesame the ninth allergen regulated by the Food and Drug Administration (FDA). In addition, the...
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Think Your Dark Chocolate is Dairy Free? Better Call the Company

Kids With Food Allergies ·
The Food and Drug Administration is warning consumers that the dark chocolate you purchased may likely have milk in it – even, in two cases, products labeled “dairy free.”   The FDA study tested 100 dark chocolate products and...
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AAFA Responds to FDA Cumin Warning

Kids With Food Allergies ·
This week, the Food and Drug Administration issued a warning to people with peanut allergies, advising them to consider staying away from all food products containing ground cumin or cumin powder after a wave of recalls. Ground cumin, apparently...
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FDA Allows Peanut Immunotherapy Treatments to Advance

KFA News Team ·
  The Food and Drug Administration (FDA) agreed to expedite the review of a specially formulated peanut product. The peanut product, called AR101, is being studied as a potential allergy treatment. The status was granted after the company...
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FDA: Foods Must Contain What Label States

Kids With Food Allergies ·
FDA: Foods Must Contain What Label SaysFebruary 4, 2013 As someone who cares about what your family eats, you make it a practice when shopping to read the labels on food packages.  And you have the right to expect that the information on the...
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FDA Gives Experimental Peanut Allergy Patch Special Status Designed to Speed Review

Kids With Food Allergies ·
The Food and Drug Administration agreed to review a skin patch for peanut allergy on an expedited basis following positive results of recent clinical trials, the company said Thursday.   DBV Technologies said that the FDA granted its Viaskin...
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FDA Study Finds Milk in Most Dark Chocolate, No Matter What Label Says

Kids With Food Allergies ·
This FDA Consumer Update sheds further light on the results of an FDA study on milk in dark chocolate shared previously . For more detail,  read the study results .   In This Update: Read ‘May’ as ‘Likely’ Not Quite...
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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?
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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.
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Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

texasgirl ·
I have learned of a company that uses non toxic chemicals and is transparent with the ingredients. They actually support labeling for the cosmetic industry.
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Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

Jen ·
What company?
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Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

StephC ·
There's also www.KissFreely.com, free from top 8.
Blog Post

FDA Modernizes Nutrition Facts Label for Packaged Foods

Kids With Food Allergies ·
Kids With Food Allergies is providing this information from the FDA so you can stay informed about changes in the Nutritional Facts label on packaged foods. Be aware this redesign does not change how allergens are labeled . Stay up-to-date on breaking news about food allergies, nutrition updates and allergy-friendly recipes and join or login to our community today! For Immediate Release May 20, 2016 Today, the U.S. Food and Drug Administration took a major step in making sure consumers have...
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U.S. Updating Rules for Food Manufacturers With Food Allergies in Mind

Kids With Food Allergies ·
Have you read about changes to U.S. food manufacturing practices? Are you confused? In this post, we explain some of the changes and what it means if you have food allergies. What Are Good Manufacturing Practices? The U.S. has rules that establish “Good Manufacturing Practices” (GMP) for food manufacturers to follow. These practices help to lessen the risk of danger to the public. They require manufacturers to follow good food hygiene and handling methods. Most facilities that manufacture...
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Re: U.S. Updating Rules for Food Manufacturers With Food Allergies in Mind

Katie D ·
It is encouraging to see these changes being made, and I hope we start to see a decline in the number of recalls we see along with better management and education of allergens within manufacturing facilities. I did not know that the FDA didn't have the ability to force a recall for mislabeled products and that it was up to the manufacturer, this is a move in the right direction for sure. To the facilities have to have procedures in place to ensure that their products are not cross...
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FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

Kids With Food Allergies ·
The FDA announced changes to the labeling for epinephrine auto-injectors to help patients and caregivers use the medication appropriately in the event of anaphylaxis (anna-fih-LACK-sis). Anaphylaxis is a serious allergic reaction. Epinephrine is always the first treatment for serious allergic reactions . For all epinephrine auto-injectors: Hold the patient's leg and keep the leg steady while you inject the epinephrine This will help prevent the needles from cutting the thigh or becoming...
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Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

LSK ·
thanks! really helpful to get this update
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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.)
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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 -...
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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...
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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.
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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.
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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.
Blog Post

Do the Food Allergen Labeling Laws Apply to Cosmetics?

Kids With Food Allergies ·
From lip balm and shampoo to moisturizers and eye shadow, cosmetics are overseen by the Food & Drug Administration (FDA). Even though these products go on our lips and skin, the FDA provides a lot less oversight than you might expect. In fact, most of the time the government does not get involved until there is a problem. Here’s what you need to know. What are “cosmetics”? The government defines “cosmetics” based on how the product is meant to be used. Cosmetics are meant to be rubbed,...
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Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

JoyceZ ·
Is the training device a device regulated by FDA? any safety issues?
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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.
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Re: Do the Food Allergen Labeling Laws Apply to Cosmetics?

K8sMom2002 ·
@texasgirl Just wondering what the company name was you had found ... DD has to avoid corn, and that can be hard for a girl who likes makeup as much as she does!
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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 .
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Re: FDA Updates Instructions for EpiPens and Other Epinephrine Auto-Injectors

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

FDA Approves Eucrisa for Eczema

Kids With Food Allergies ·
The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.
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Re: How to Report Foods After an Allergic Reaction

Will Way ·
Useful information. Thanks!
Blog Post

How to Report Foods After an Allergic Reaction

Kids With Food Allergies ·
If you suspect your child had an allergic reaction to a mislabeled food, you can report it. By doing so, you can help play an important role in public health.
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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?
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Re: How to Report Foods After an Allergic Reaction

Will Way ·
K8sMom2002 posted: Leslie, has your son ever had a reaction to a food that wasn't properly labeled? 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...
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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.
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