Food Allergy Support

Specific Food Allergies => Seed Allergy => Topic started by: AdminCM on August 22, 2011, 01:46:15 PM

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Title: sesame seeds labeling: US specific (laws, loopholes)
Post by: AdminCM on August 22, 2011, 01:46:15 PM
This thread has been transferred from our former location.

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Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on June 02, 2013, 01:29:46 PM
This is an important thread for those with sesame allergy to read:

Other names for Sesame


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on June 02, 2013, 02:08:58 PM
www.regulations.gov

Request of Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds

FDA-2012-N-0711-0053


Quote
FARRP would assert that the FDA does not have compelling scientific data on the prevalence, severity and potency of other foods to consider any additions to the existing FALCPA list. In fact, if the three factors of prevalence, severity and potency are examined together, several of the existing foods may not belong on the list. Soybean allergy appears to be less prevalent than any of the others on the FALCPA list, soybean is not an especially potent allergenic food, and soybean has caused very few severe reactions. Much the same could be said for wheat allergy (not for celiac disease which does have higher prevalence). Crustacean shellfish allergy is very prevalent but the potency and severity of crustacean shellfish appear to be rather low. FARRP would encourage FDA to develop an algorithm based upon prevalence, severity and potency to determine which foods belong on the priority allergens list. The decisions should be based upon science. FARRP would note that ILSI-Europe is working on the development of an algorithm for possible use in the EU and FDA should monitor this ongoing activity. FARRP would further note that the U.S. does not really have good data on prevalence. This is also true on a worldwide basis (Rona et al., 2007), although the EU has funded the EuroPrevall project that should, when published, fill that gap for the EU. U.S. estimates are based mostly on telephone surveys (Sicherer et al., 1999; Sicherer et al., 2004; Sicherer et al., 2010). Telephone surveys are not supported by clinical confirmations. Thus, FARRP would encourage FDA to work with other federal agencies to obtain better estimates of the prevalence of various specific food allergies in the U.S. based upon unselected populations and clinical confirmations.


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http://www.foodallergy.org/about/leadership/advisors

Quote

Steve Taylor, PhD
Professor, Department of Food Science and Technology
Director, Food Allergy Research and Resource Program
University of Nebraska-Lincoln
Lincoln, NE


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on June 02, 2013, 02:22:04 PM
http://fdatransparencyblog.fda.gov/2009/07/02/how-can-fda-use-its-website-to-improve-transparency-at-the-agency/
Karen P
Quote
Thank you for this opportunity to suggest ways in which FDA can improve its transparency. I have several things I’d like to say so I may post a couple of times.

My first suggestion would be for FDA to publically post “individual consumer” comments on the regulations.gov site. I recently submitted two comments for docket FDA-2008-N-0429 (Food Labeling; Current Trends in the Use of Allergen Advisory Labeling: Its Use, Effectiveness, and Consumer Perception; Public Hearing; Request for Comments).

Although “individual consumer” comments are available for FDA to review, I feel the voices of individual consumers were largely silenced since those comments could not be viewed by others like food manufacturers and the larger international community (where, for instance, they might have influenced changes being considered for the VITAL system).

I think it would be entirely reasonable to perhaps post “individual consumer” comments last after other comment categories and I would not object to them being stored at regulations.gov for less time than other comment categories, but I do think they should see the light of day.

I ended up having to file a FOIA request and have begun posting some of the “individual consumer” comments at websites like about.com. I think consumers had some good ideas and I would like the voices of consumers to be heard. I also think the posting of these comments will make FDA more responsive and accountable to the public.


http://www.fda.gov/AboutFDA/Transparency/PublicDisclosure/default.htm
Quote
Phase II Transparency Report
On May 19, 2010, the Transparency Task Force released a report containing 21 draft proposals about expanding the disclosure of information by FDA while maintaining confidentiality for trade secrets and individually identifiable patient information.


Docket Management Process - Draft Proposal 2
http://tinyurl.com/lmqaz9u
Quote
FDA should change its current practice so that comments submitted at [url=http://www.regulations.gov]www.regulations.gov[/url] from people self-identified as individual consumers are posted on that Web site in the same manner as other comments.


We could push this issue and start a FOIA "individual consumer" write-in campaign, but really we would be wasting FDA resources and we aren't going to do that.

If we submit a sesame labeling petition, we want our voices heard. 


------------------------------

http://fdatransparencyblog.fda.gov/2009/06/16/response-to-some-comments/
Quote
June 21, 2011 at 3:18 pm
I heard a while back that Dr. Sharfstein left FDA. I’d just like to thank him for the work he did to further FDA transparency. Is Afia gone now also?

Is FDA planning on continuing this blog? Is it to serve more of a public relations and announcement purpose? Are you still interested in hearing general ideas and concerns from the American public?

A lot has been on my mind lately regarding FDA, but I am hesitant to post as those ideas don’t fit neatly into any recent blog post categories. It would be nice to have an open-ended “Tell us what is on your mind” post.


Quote
The Agency is still committed to the Transparency Initiative, and we hope that the blog will increase the dialogue between the Agency and stakeholders. We are always looking for new ways to increase transparency and to improve FDA Basics and the blog. We appreciate your recommendation and will discuss it with the Task Force.


Just noting that as of today (5/4/14), the last Transparency blog post was from 9/17/13.   :-/



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 21, 2013, 07:01:46 PM
http://fdatransparencyblog.fda.gov/2009/07/02/how-can-fda-use-its-website-to-improve-transparency-at-the-agency/

Quote
The following language is found in the official notice language for Docket ID: FDA-2008-N-0429:

“II. Purpose and Scope of the Hearings FDA is developing a long-term strategy to assist manufacturers in using allergen advisory labeling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs allergic consumers and their caregivers. To that end, FDA is soliciting comments and information to assist the agency in determining how manufacturers currently use advisory labeling, how consumers interpret different advisory labeling statements, and what wording is most effective in communicating to consumers the likelihood that an allergen may be present in a food. …
The scope of this hearing is determined by this document.


However, in the transcript of the public meeting for this docket, an FDA employee uses different language:

“the purpose of the meeting today is for F.D.A. to gather information that will help us develop a long term strategy that can assist manufacturers in using allergen advisory labeling that is truthful and not misleading and conveys a clear and uniform message and adequately informs food allergic consumers and their caregivers to the potential presence of a major food allergen.”


I am admittedly not a lawyer, but it does appear to me that FDA attempted to change the stated scope of the hearing from dealing with “allergens” to “major food allergens”. I do not know if this is legal, but I do not believe it is fair. What I think probably happened is that FDA was surprised that a large percentage of the public comments submitted for this docket mentioned allergens other than those covered under the FALCPA.


FDA should consider all of the comments we consumers submitted as part of the FDA advisory docket, including the "sesame" ones.

--------------------------------------


Regulations.gov - Docket FDA-2008-N-0429

In the "Notice" document, one of the FDA's questions was:
Quote
Question 2. If we decide to develop guidance for using advisory labeling, should we incorporate any of the guidelines from the Food Allergy Issues Alliance or the principles of the VITAL system? If so, why?


One of the "individual consumer" comments stated:
Quote
One feature of the VITAL system that should definitely be incorporated into any future FDA advisory labeling guidance is to include sesame among the allergens falling within the scope of the guidelines.

Here is some information about sesame:

• The foods most likely to cause anaphylaxis are peanuts, tree nuts, shellfish, and sesame.

• Sesame may be one of the top five most prevalent allergies in the United States

• “Sesame is included in the allergen list of both the EC and Canadian Food Inspection Agency”

• “sesame allergy may be rarely outgrown”

I realize that sesame is not considered a “major food allergen” under the FALCPA, but that should not be used as a justification to exclude sesame from the current advisory labeling standardization efforts. In fact, I would recommend going a step farther, and using this opportunity to close other labeling loopholes with regards to sesame so that USA regulations can catch up to other nations regarding this issue. The following passages from the FALCPA make it clear that FDA already has the authority needed to make the necessary changes through regulation:

‘‘(x) Notwithstanding subsection (g), (i), or (k), or any other law, a spice, flavoring, coloring, or incidental additive that is, or that bears or contains, a food allergen (other than a major food allergen), as determined by the Secretary by regulation, shall be disclosed in a manner specified by the Secretary by regulation.’’.
(b) EFFECT ON OTHER AUTHORITY.—The amendments made by this section that require a label or labeling for major food allergens do not alter the authority of the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or labeling for other
food allergens.

It is my hope that the FALCPA will eventually be amended to take USA allergen law from a “big eight” focus to a “big nine” with the addition of either sesame or of the general food group of seeds. Until that happens, however, I strongly urge FDA to treat sesame as a “de facto” major allergen. The current manufacturing and labeling practices of many companies are unnecessarily putting those of us with a sesame-allergy at an increased risk of having a serious allergic reaction.

Perhaps many at FDA share the sentiment expressed by the 2005 Policy Advisor to CFSAN’s Director of the Office of Regulations and Policy, when she stated that “We’ve got enough to deal with right now with the eight major allergens.” It is clear from the following prepared remarks of Dr. Eschenbach’s March, 2008 FDLI conference speech, that the FDA faces challenges:
“today I wish to focus my remarks not on the Promise of the Future but the Peril of the Present – the risk that the FDA you have known and in many ways have helped make what it is – that this FDA that during the 20th Century has been the world's gold standard – will in the 21st Century fail in its mission to protect and promote the health of every American.”

FDA has a noble mission to protect the public health. I am asking FDA to fulfill this mission by requiring the labeling of sesame and by developing a strong long-term strategy for dealing with the complex issues of allergen cross-contamination and advisory labeling.

Thank you for considering my suggestions and for the hard work you have done on behalf of those of us with food allergies.


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 21, 2013, 07:14:35 PM
Severity:

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"Tourist dies of allergic reaction to tahini"
Apr. 1, 2014
http://www.haaretz.com/news/national/1.583210

Quote
The woman, who was allergic to sesame, did not know that tahini (“tehina”) was made from sesame seeds and developed a severe allergic reaction shortly after her meal.


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"Allergy Led To Death Of Popular Teenager"
http://www.burnleyexpress.net/news/local/allergy-led-to-death-of-popular-teenager-1-1670926
Quote
An inquest into the death of 16-year-old Paul Derrick Howard, of Thursfield Road, Fulledge, found that the keen footballer suffered from an allergy to sesame seeds, which had caused his death.


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"Sesame allergy: a growing food allergy of global proportions?"
Venu Gangur, DVM, MVS, PhD*†; Caleb Kelly, BS*; and Lalitha Navuluri, DVM*

Thanks to Dr. Gangur for giving me a copy of his paper years ago.  :heart:

Quote
A recent study on food allergy among Israeli children (n = 9,070) found food allergy prevalence to be 1.7%, with sesame the third most common food causing sensitization (0.18% prevalence), following egg (0.5%) and cow’s milk (0.3%) and more than that of peanut sensitization (0.04%).12 Furthermore, sesame was second only to cow’s milk as a leading cause of anaphylaxis.12,20


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Food Allergy: Is Sesame Seed the “Middle Eastern Peanut"?
http://allergynotes.blogspot.com/2011/05/food-allergy-is-sesame-seed-middle.html
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Although specific IgE to peanut were higher than for sesame, peanut-induced allergic reactions were mild, in contrary to sesame where anaphylaxis was the only clinical manifestation.


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Food Allergies For Dummies
Robert A. Wood, MD

Page 49

Quote
While any food allergen can cause anaphylaxis, a few are particularly skilled at doing so.  The most sinister of the bunch are peanuts, tree nuts, sesame, and shellfish.


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"Sesame allergy in Britain: a questionnaire survey of members of the Anaphylaxis Campaign."
http://www.ncbi.nlm.nih.gov/pubmed/15787876
Quote
One in six (17%) had suffered potentially life-threatening symptoms, with 65% of severe reactions happening on first known exposure.


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"The Allergens to Watch – Sesame to Lentils and More"
http://allergicliving.com/2010/08/30/the-allergens-to-watch/
Quote
So why did Health Canada choose to add a food like mustard seed to its list? According to Food Allergen Program Manager Michael Abbott, the government agency not only looks at which allergens are the most common, but which ones are mostly likely to produce the most severe reactions, because they especially need to be clearly labeled on food packaging.


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on January 10, 2014, 10:00:07 PM
Prevalence:

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"Prevalence Of Food Allergy To Uncommon Foods Based On Oral Food Challenges"
Gita Ram, Christina Gustafson, Jonathan M. Spergel, MD PhD FAAAAI, Antonella Cianferoni, MD PhD
https://aaaai.confex.com/aaaai/2014/webprogram/Paper11869.html

CHOP

Quote
Methods: Retrospective chart review of all children undergoing OFC to any food excluding milk, egg, peanut, wheat and soy from 2004-2012.


Quote
Patients aged 1-18 years (median 6) underwent 366 OFCs. Challenged foods included tree nuts (36.6%), meats (15.8%), seeds (11.7%), shellfish (9%), fish (6.8%), fruits and vegetables (6%), grains excluding wheat (5.7%), legumes excluding peanut (4.9%), and miscellaneous foods (3.2%). 90.7% of patients had other FA, 71.6% asthma, and 48.1% eczema. Overall, 81.1% of children passed OFC with similar pass rates within each food category.


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http://www.aaaai.org/global/latest-research-summaries/Current-JACI-Research/outpatient-open-oral-food-challenges-feasible-an.aspx

Mount Sinai

Quote
The authors reported results of 701 challenges over the 22 month period. 18.8% of the challenges were positive, i.e. elicited a reaction. The challenged foods were common food allergens (in descending order of frequency: peanut, tree nuts, egg, milk, soy, fish, sesame, shellfish, wheat, and others).


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“Food Allergy in Kids Not Being Optimally Diagnosed”  11/14/2011
By Fran Lowry


Quote
Ruchi Gupta, MD, from Northwestern University Children's Memorial Hospital in Chicago


Quote
Formal diagnoses were most frequently confirmed by oral food challenge for milk allergy (22.4%), soy (19.2%), peanut (16.1%), wheat (15.5%), shellfish (14.4%), tree nut (12.6%), egg (12.4%), sesame (11.2%), and fin fish (9.1%).


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http://www.webmd.com/allergies/news/20090316/sesame-allergies-on-the-rise-in-us
Quote
“Sesame allergies have probably increased more than any other type of food allergy over the past 10 to 20 years,” says Robert Wood, MD, director of the division of pediatric allergy and immunology at Johns Hopkins University School of Medicine in Baltimore.

“They’re now clearly one of the six or seven most common food allergens in the U.S.,” he tells WebMD.



http://www.livingwithout.com/issues/4_8/sesame_seed_allergy-2025-1.html
Quote
“It’s remarkably common to see sesame allergy and to see severe reactions to it,” says Robert Wood, MD, chief of pediatric allergy and immunology at the Johns Hopkins University School of Medicine in Baltimore. Wood estimates it’s the fourth or fifth most common allergy in his patient population of 4,000 kids with severe food allergies.


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on January 27, 2014, 08:13:26 AM
"Sesame seed food allergy."
http://www.ncbi.nlm.nih.gov/pubmed/22610362

Quote
Based on the available data, we estimate that SFA affects 0.1-0.2 % of the population, in areas where the food is available. Albeit this prevalence appears to be relatively low, it is approximately one-half of that of persistent cow's milk allergy. While only one fatality has been reported, the significant number of SFA patients presenting as anaphylaxis indicates the potential risk.


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US prevalence of self-reported peanut, tree nut, and sesame allergy: 11-year follow-up. Published in the Journal of Allergy and Clinical Immunology, June 2010.
http://www.jacionline.org/article/S0091-6749(10)00575-0/abstract

Quote
We sought to determine the US prevalence of self-reported peanut, TN, and sesame allergy in 2008


Quote
A total of 5,300 households (13,534 subjects) were surveyed (participation rate, 42% vs 52% in 2002 and 67% in 1997).


Quote
Sesame allergy was reported by 0.1% (95% CI, 0.0% to 0.2%).


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"Reported adverse food reactions overestimate true food allergy in the community."
http://www.ncbi.nlm.nih.gov/pubmed/11840177
Quote
There was little agreement between self-reported perceived illness to food(s) known to contain the food allergen of interest, and positive SPT, suggesting that most reactions are not due to IgE mediated food allergy.


"1 in 10 Americans report food allergies, but questions linger"
http://www.thedoctorschannel.com/view/1-in-10-americans-report-food-allergies-but-questions-linger/
Quote
Nearly 1 in 10 American adults report food allergies, but many of them regularly eat what they say they are allergic to, according to data from the National Health and Nutrition Examination Survey (NHANES).

Quote
Dr. Keet concluded. “Hopefully in the future we can come up with combinations of questionnaires and laboratory measures that will give us a more accurate estimate of prevalence.”



Just my opinion ... but my guess is that a lot of people think they have a peanut/nut allergy who don't, making sesame look less significant than it really is in the phone survey.  Most people don't usually think "sesame" for reactions unless a doc is involved because this is not a well-known allergen among the general public ... so my guess would be that sesame is not as prone to overestimation in a phone survey as nuts/peanuts are.


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Quoting a friend who I think won't mind
Quote
Yeah-- I'd go with the top allergists' honest appraisal of incidence within their own clinical practices over a phone survey.  {sigh}


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on January 27, 2014, 08:13:49 AM
"Hard to uncover sesame seeds for those with the growing allergy"
BY KATE SILVER
http://www.suntimes.com/lifestyles/23680924-423/hard-to-uncover-sesame-seeds-for-those-with-the-growing-allergy.html
Quote
To further complicate matters, sesame can appear under a number of different names — benne, gingelly, sesamol, sesamolina, sesamum indicum, sim sim, tahini, til or simply “seeds” — so no matter how closely you read the a label, you may not be aware of its presence.


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What do companies tell you about their labeling practices for sesame?

My dd is growing up being taught that we can only trust the labels of some companie s.  She knows GM well  :heart:


I still like GM, but I'm taking away the heart

FDA-2012-N-0711-0053
Quote
FARRP would assert that the FDA does not have compelling scientific data on the prevalence, severity and potency of other foods to consider any additions to the existing FALCPA list.


FDA-2012-N-0711-0062 (GM)
Quote
In addition to our direct comments, we fully endorse comments submitted by the Food Allergy Research and Resource Program.


How nice it would be if, for once, companies didn't fight some additional regulations.  It would be so nice if they said - you know, we support mandatory sesame labeling because we care about our customers and we are committed to their safety.  No company likes complicated or excessive regulations, but requiring the labeling of sesame makes sense.  Instead of fighting us, why not be true partners with us FA consumers?


2 Strikes.
General Mills now requires disputes to be resolved through binding arbitration

Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on January 27, 2014, 08:14:09 AM
FDA-2011-N-0259-0001


Quote
In accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation. The goal of this review of existing regulations, as with our other reviews, is to help ensure that FDA's regulatory program is more effective and less burdensome in achieving its regulatory objectives. FDA is requesting comment and supporting data on which, if any, of its existing rules are outmoded, ineffective, insufficient, or excessively burdensome and thus may be good candidates to be modified, streamlined, expanded, or repealed. As part of this review, FDA also invites comment to help us review our framework for periodically analyzing existing rules.


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ID: FDA-2011-N-0259-0046


Quote
As a consumer, I do not find FDA’s existing regulations easy to understand and my experience is that there is not much help for consumers when they have a need for assistance in understanding those regulations.

As part of the transparency initiative, when communicating with industry,
“FDA will also aim to respond to general questions about an existing policy,
regulation, or the regulatory process that are submitted via email, whenever
practicable, within 5 business days or acknowledge receipt of the inquiry and
provide an estimated time for response.”
[url]http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencytoRegulatedIndust%20ry/PhaseIIITransparencyReport/UCM239088.pdf[/url]
(page 4)

That is good, but consumers with serious questions have no such guarantee that I am aware of.
I have many very detailed examples of regulatory questions that I have had, but I’ll just go over one here. When trying to figure out if sesame could be labeled as “spice” on the food label, I could not get a straight answer. One FDA representative told me no, one FDA representative said it could be labeled as spice in certain forms (ex – crushed), I have heard of some companies that do label sesame as spice, whereas another company told me that FDA regulations prohibit the labeling of sesame as spice. This was not an academic question for me. I had a very real need to know in order to keep my daughter safe. I have given up trying to figure it out and only rely on the labels of companies like General Mills which voluntarily treat sesame as an allergen

Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on January 27, 2014, 08:14:27 AM
FARE
http://www.foodallergy.org

I love things like your FAAP/ECP, but unless I'm missing it, I can't find a
"How to Read a Label for a Sesame-Free Diet" or other "non top 8" diet.

http://www.foodallergy.org/document.doc?id=133


Why?


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on January 27, 2014, 08:14:49 AM
Anaphylaxis and Food Allergy Association of Minnesota (AFAA)

ID: FDA-2012-N-0711-0047

Quote
Adding Additional Allergens. In addition to the traditional “8 major allergens” in the U.S. (milk, egg, wheat, soy, fish, shellfish, treenut, peanut), it behooves the FDA and the food industry to begin recognizing other allergens that are becoming increasingly common rather than keeping the list of major allergens static. (Recognizing this, other countries label for additional allergens such as mustard, sesame, and other foods.)2 For example, in the 2011 study3 among children with food allergies, strawberries and wheat and soy were equally prevalent. Deciding what additional allergens to include on U.S. labeling should be based on medical and statistical information, and possibly also including items showing increases that are likely in the future to be significant.

Quote
Uncommon Allergens. Consumers allergic to foods that are not of the “major 8” are at a distinct disadvantage in determining whether manufactured food products are safe for them or not. Manufacturers should be able to provide answers to consumers about product ingredients even if labeling for those ingredients is not mandated. All consumers deserve easy-to-find company contact information and clear answers when inquiring about the safety of food.

Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 01, 2014, 09:20:21 AM
Food Allergy Research & Education (FARE)

ID: FDA-2012-N-0711-0059

Quote
Although the “major allergens” include 8 foods/food groups accounting for most of the allergic reactions affecting consumers, many persons with food allergies must avoid additional foods. It is also recognized that over 170 foods have triggered allergic reactions, including anaphylaxis caused by many foods not considered “major allergens” (e.g., seeds). Additional foods should be considered in discussions about thresholds.

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"Why isn’t Sesame a Top Allergen in the U.S.?"
Dr. Scott Sicherer
https://allergicliving.com/index.php/2013/11/13/why-isnt-sesame-a-top-allergen-in-the-u-s/
Quote
Sesame allergy can be a severe and it certainly could be argued that it should be regulated. We should continue to advocate for improvements in the laws.




Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 02, 2014, 10:03:36 PM
Hmmmm, I can't seem to find an equivalent FDA document ...

"The Canadian Criteria For The Establishment of New Priority Food Allergens"
http://www.hc-sc.gc.ca/fn-an/pubs/label-etiquet/crit/index-eng.php

--------------------

Well, yeah ...

http://fdatransparencyblog.fda.gov/2009/06/04/the-transparency-task-forces-first-question/
Quote
1) The 2005 Policy Advisor to CFSAN’s Director of the Office of Regulations and Policy stated that “We’ve got enough to deal with right now with the eight major allergens.” (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 141 (2006).)




Quote
October 12, 2009 at 1:36 pm Reply | Quote

I read the 6/15/09 article “New commissioner aims to open FDA’s ‘black box’”, [url]http://findarticles.com/p/articles/mi_hb4365/is_12_42/ai_n32147623/[/url] , where Dr. Hamburg was reported as saying “If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions”.

I am writing as a citizen who has already filed a FOIA request and is considering submitting a petition asking FDA to regulate the allergen sesame. I know FDA is not considering individual issues like the regulation of sesame here in this blog, but I am using this issue as an example of how FDA could better explain its operations, processes, and decision making.

From a scientific standpoint, it is clear that sesame should be regulated:

1) The foods most likely to cause anaphylaxis are peanuts, tree nuts, shellfish, and sesame. (Reference: Robert A. Wood, MD and Joe Kraynak, Food Allergies For Dummies (Hoboken: Wiley Publishing, Inc., 2007), p. 49.).

2) Sesame is “clearly one of the six or seven most common food allergens in the U.S.”.
(Reference: Sesame Allergies on the Rise in U.S.: Sesame Seed Allergy Now Among Most Common Food Allergies, by Charlene Laino, available at [url]http://www.webmd.com/allergies/news/20090316/sesame-allergies-on-the-rise-in-us[/url] ).

3) The European Commission (EC) and the Canadian Food Inspection Agency both include sesame in their allergen lists. (Reference: Gangur V., Kelly C., Navuluri L. (2005). Sesame allergy: a growing food allergy of global proportions? Annals of Allergy, Asthma and Immunology. 95, 5.).

Looking in at the FDA from the outside, it appears that FDA has not decided on standardized criteria that will be used to determine when additional allergens will be regulated using the authority granted in the FALCPA. Instead, from the references below, it seems that FDA is not prioritizing the risk that different allergens pose to the public health, and is too overworked and underfunded to do so.

1) The 2005 Policy Advisor to CFSAN’s Director of the Office of Regulations and Policy stated that “We’ve got enough to deal with right now with the eight major allergens.” (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 141 (2006).)

2) In the prepared remarks of Dr. Eschenbach’s March, 2008 FDLI conference speech, it is explained that there are significant problems at FDA like a lack of “planning, precision, or prioritization”, a workforce that is “aging, volatile, overextended, and equipped with inefficient tools”, and that FDA may “fail in its mission to protect and promote the health of every American”. (Reference: Andrew C. von Eschenbach, M.D (Commissioner of Food and Drugs), Prepared remarks for “The FDA Amendments Act: Reauthorization of the FDA” speech, Annual Conference of the Food and Drug Law Institute (March 26, 2008), available at [url]http://www.fda.gov/NewsEvents/Speeches/ucm051550.htm[/url] ).

In many cases in which FDA is given authority by Congress, it would be both possible and helpful for FDA to explain to the public the criteria and decision-making processes FDA plans to use as it decided decides whether and when to use such authority.




Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 04, 2014, 01:56:54 PM
https://www.facebook.com/KyleDineMusic/posts/10151447134802267
Quote
What allergen would you like to see become a priority allergen?



http://www.linkedin.com/groups/My-son-is-allergic-Sesame-166193.S.128673496?_mSplash=1
Quote
How can we get the US Government to join Canada and the EU in recognizing this



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 04, 2014, 06:09:27 PM
I know we FASers can be a little feisty and critical, but largely, it is because we care deeply about the FA community ... we want good education, good labeling, good medical care, safe schools, etc.

We want the FDA & FA orgs to act on issues like sesame labeling.


***********************************


Food Allergy Awareness Week

http://www.foodallergy.org/food-allergy-awareness-week#.U0CIZn-9KSM

May 11 - May 17

My wish for this week is that one of the major allergy organizations makes a commitment to try and get sesame added to the USA list of "major food allergens".


Food Allergy Awareness Week 2014



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 04, 2014, 10:20:09 PM
http://www.aseanfoodsafetynetwork.net/CurrentIssueDetail.php?CIId=110

Quote
Japan’s Consumer Affairs Agency (CAA) issued a notice to add “cashew nut” and “sesame” to the ingredient list for a recommended allergy labeling.


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 05, 2014, 10:42:27 AM
 :disappointed:


As far as I know, FDA never improved its educational material for sesame or for "non top 8" allergies in general.


http://fdatransparencyblog.fda.gov/2009/09/16/fda-101-curriculum/
Quote
What do I need to know about food allergies?

FDA has already partially answered this question in its educational material titled “Food Allergies: What You Need to Know” available at [url]http://www.fda.gov/Food/ResourcesForYou/Consumers/ucm079311.htm[/url] .

However, the “About Other Allergens” section, where FDA advises consumers to “read the food label’s ingredient list carefully to avoid the food allergens in question” is both disingenuous and dangerously misleading.

FDA is well aware that consumers with allergies not covered under the FALCPA do “not receive sufficient information from food labels to protect their safety”.  (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 109 (2006).)



FDA says it cares about those of us with less common illnesses - for example:
http://fdatransparencyblog.fda.gov/2010/06/21/new-fda-basics-video-available-about-orphan-drugs-and-the-fight-against-rare-diseases/


The simple step of improving educational materials could save lives so why hasn't it been done?

------------------------

Look what this woman with corn allergy goes through to try and avoid her allergen.

http://www.cornallergens.com/list/corn-allergen-list.php
Quote
The FDA, at this time, does not regulate corn to the extent that it does, say, peanuts, so we corn allergy sufferers are truly on our own.


You think that advice to just read the label helped much?  At least give them/us a fighting chance with a little better education, if not better allergen regulation.  Let's minimize the amount of "learning" that consumers/patients are doing the hard way by having reactions.




Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 07, 2014, 08:21:13 AM
Ok.

Fair warning.

We've patiently waited and watched for years, hoping that a major allergy organization would act on this issue (to get sesame labeled in the USA).  They have the resources - $, expert allergists, lawyers, connections, regulatory experience - to do this the right way.  We didn't want to make things worse for the allergy community by pushing ahead without their support.

However, at this point, we FASers are seriously considering submitting a petition ourselves.  As a group, we have many talents (some of us are good at writing, some have a scientific/medical background, we understand the law pretty well thanks to FDLI (A special  :heart: to James Kelly - I will never forget his kindness), some are extremely persistent  :P, some can get feedback for refinements before submitting, etc.).  We have also reached out to people outside our group who have the (respected/likeability/social media/good image) qualities that we sometimes fall short on - some are already on board if we should move forward.

Soooooo .... this is the time to communicate with us if there is a good reason why we should hold off on doing this.  We are really hoping that one of you allergy orgs will save us a lot of work.

We are willing to work together with any of the main allergy orgs on this.



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: Macabre on April 08, 2014, 06:34:26 AM

--------------------

Well, yeah ...

[url]http://fdatransparencyblog.fda.gov/2009/06/04/the-transparency-task-forces-first-question/[/url]
Quote
1) The 2005 Policy Advisor to CFSAN’s Director of the Office of Regulations and Policy stated that “We’ve got enough to deal with right now with the eight major allergens.” (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 141 (2006).)





And we don't have  enough to deal with?  Sheesh. Clearly these people are not living with sesame allergy.
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: Macabre on April 08, 2014, 06:36:31 AM
Now I'm regretting not sending several products to FAARP.  There was a flatbread and other breads. My sesame reactions have gotten worse, so in not inclined to buy things to try them out just to see if they're okay.
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 08, 2014, 08:27:03 AM

--------------------

Well, yeah ...

[url]http://fdatransparencyblog.fda.gov/2009/06/04/the-transparency-task-forces-first-question/[/url]
Quote
1) The 2005 Policy Advisor to CFSAN’s Director of the Office of Regulations and Policy stated that “We’ve got enough to deal with right now with the eight major allergens.” (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 141 (2006).)





And we don't have  enough to deal with?  Sheesh. Clearly these people are not living with sesame allergy.



We could always tweet to them also.    :)

https://mobile.twitter.com/US_FDA

I doubt that they would respond to less than a petition, but hey, you never know.   :P

-----------------------


Related topic:
FDA


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: Macabre on April 08, 2014, 08:53:53 AM
Buena idea! We follow them. :)
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 10, 2014, 09:46:04 AM
If you tweet specifically to them, does it show up on our FAS twitter feed?

I guess it's time that I learn more about how Twitter works.    :hiding:   


If the TweetQueen has any tips, feel free to share them with me.  :)


Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 11, 2014, 03:36:55 PM
http://cheatthewheat.com/2014/03/29/a-response-from-falcpa/


Quote
Sesame is an allergen that appears to be increasing in prevalence, and FARE has received questions before about what is needed to update a “top allergen” list. More research studies would need to be done that confirm any other allergens outside the currently recognized Top 8 have enough prevalence in order to be added, and we have no information that leads us to believe such a change will be taking place in the very near future.

Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: twinturbo on April 11, 2014, 03:49:33 PM
Links, you ever ask any of the FDA people why coconut and not sesame? In response to the where's the numbers, blah, blah, blah.
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 11, 2014, 07:10:27 PM
Links, you ever ask any of the FDA people why coconut and not sesame? In response to the where's the numbers, blah, blah, blah.



Well, it seems like industry would like to whittle away at some of those allergens like coconut.


Re: Survey on Thresholds from FARE
Quote
Another interesting comment

The International Dairy Foods Association (IDFA)

ID: FDA-2012-N-0711-0046

Quote
Definition of Tree Nuts Should be Reviewed
We would also request that FDA review comments regarding the list of tree nuts included in the Q&A document, previously submitted by Grocery Manufacturers Association to Docket No. 2005D-0490 on May 14, 2007. These comments identified some concerns with categorizing ten nuts including coconut as a major food allergen, due to the botanical classification and the lack of incidence of severe allergic reactions. IDFA strongly agrees with GMA’s comments that review of the scientific literature establishes there are insufficient data to support the inclusion of beech nut, butternut, chinquapin, ginkgo nut, hickory nut, pili nut, sheanut, chestnut, coconut, and lichee nut in a list of major food allergens. Inclusions of “tree nuts” that have either no history of sensitization and elicitation of allergic reactions (beech nut, butternut, chinquapin, ginkgo nut, hickory nut, pili nut, and sheanut), or only a few cases of mild and non-life threatening reactions (chestnut, coconut, and lichee nut) contradict the intent of FALCPA and leads to an unnecessary elimination of food choices that are enjoyable, nutritious and convenient to allergic consumers




---------------------


Really, I'm done talking to the FDA.  I'm not a good talker anyway.

For matters like this, I much prefer written communication.    :evil:

I don't know, I just feel like it's time to make a decision, one way or the other ... do we do this or not? Eventually (maybe in like 10 or 15 years  :P) sesame will probably get added without our FAS involvement if we decide to drop the issue.  You all know that I'm personally fine at this point with whatever we decide.  I would give my allergist a chance to talk us out of this also.



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on May 05, 2014, 08:28:13 AM
Well, FDA has been tweeted, but no response as was to be expected.

------------------------

Sooooooo ...


In the words of Yoda  :) :
"Do or Do Not"

We can decide together soon.  I'm fine with whatever we decide to do.



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on May 07, 2014, 02:26:21 PM
[url=http://www.regulations.gov]www.regulations.gov[/url]

Request of Comments and Information on Initiating a Risk Assessment for Establishing Food Allergen Thresholds

FDA-2012-N-0711-0053

Quote
The decisions should be based upon science.




This is not directed at anybody in particular (just speaking in general terms):

Yes, the decisions should be based on science ..... but let us not forget the real people that are unnecessarily at an increased risk of having a severe allergic reaction because of inadequate labeling.  Do not get too detached from the faces behind the science.

How many people at risk does it take to justify labeling for an allergen?



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on May 16, 2014, 04:25:24 PM
Tweeted by @DrLindaMD & @AllergyKidsDoc

----------------------

http://blog.sermo.com/2014/05/16/kids-and-food-allergies-infographic/

Foods that bring kids to the ER:   16% tree nuts & seeds

I wonder if I could find the source later.

----------------------


I have a nice new info stream for links  :evil:
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on June 03, 2014, 01:54:14 PM
Quick update.  I hear another org has also been working on this ... I'm just going to wait and see what they decide to do.  I'm not going to post details in this thread.
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on June 23, 2014, 09:28:29 AM
A very important tweet today:

Quote
Sesame labeling advocates with issues in the lack of sesame labeling, shoot me an email at homa@woodrumlaw.com. Neat opportunity to share.


Send her a tweet or contact her on this blog ASAP :)

http://ohmahdeehness.wordpress.com/about-2/

 :heart: Homa  :heart:

 :smooch:

Spread the word.
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on July 02, 2014, 11:11:27 AM
Docs helping patients to surf the internet


Quote
How many people are willing to stand up and say loudly that it is time to label for sesame?  Is our community independent & brave enough?  Are our intentions pure?



Not All “Patients” Are Created Equal
http://sellingsickness.com/not-all-patients-are-created-equal/
Quote
We need to make sure the patient safety voice is not only represented, but can be heard over the noise of money, politics, and power.



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on August 10, 2014, 09:46:35 AM
"The FDA, ConAgra, Coca-Cola Share Food Allergen Control Strategies"

http://www.foodmanufacturing.com/articles/2014/06/fda-conagra-coca-cola-share-food-allergen-control-strategies


Quote
To clarify allergen-related policy and practices, industry experts from the FDA, Johns Hopkins University, ConAgra and the Coca-Cola Co. presented in a Food Safety Summit workshop, “Food Allergen Control Update,” April 10 at the Baltimore Convention Center.


Quote
The most common allergens, by prevalence, are milk, eggs, peanuts, tree nuts, fish and shellfish. Sesame is increasingly being recognized as a common allergen, Keet said.



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on August 26, 2014, 02:19:52 PM
Another sesame petition
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on September 24, 2014, 11:42:14 AM
Food Allergen Labeling: Using "common sense" when assessing safety
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on October 14, 2014, 09:37:09 AM
”The Power of Cases"
http://www.6seconds.org/2014/10/07/power-cases/


Quote
Don’t be afraid to tell the compelling story first and then back it up with data!
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 18, 2014, 12:18:11 PM
CSPI Sesame Petition filed!!!



 :happydance:
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 19, 2014, 09:36:57 AM
I was thinking about this today ... what is my role now ...

it is not to be a promoter or a face of this thing ...

no no, a FA-Jedi works more behind the scenes, sometimes you hardly know that they are there at all.

------------------------------


First, take a small break.

Then, start preparing your regulations.gov comment ... this task I am well prepared for ... it actually will be quite fun I think.    :evil:


(Yes, I know ... I have to get more of a life ... but would like to do this first.)

------------------------------


Am so glad that all those docs got on board with this.   :heart:



Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:08:48 PM
Tweeted by @woodrumlaw

"CSPI Files Sesame Labeling Regulatory Petition"
http://ohmahdeehness.wordpress.com/2014/11/19/cspi-files-sesame-labeling-regulatory-petition/


Quote
In January 2013 Jessica connected me with Janna dePorter, a research associate at CSPI, about CSPI’s work on a petition for the FDA to get sesame labeling going.  I was able to reach out to my own networks so that Janna could speak with other great individuals that wrangle sesame allergies in their life.
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:13:27 PM
I'm going to save some spots for the news articles that we'll likely start seeing more of (so I don't have to keep bumping).

-----------------------------------------------------


"CSPI asks FDA to add sesame to list of allergens, mandate labeling"
http://www.foodnavigator-usa.com/Regulation/CSPI-asks-FDA-to-add-sesame-to-list-of-allergens-mandate-labeling

By Elizabeth Crawford, 20-Nov-2014

Quote
FDA should protect the estimated 300,000 to 500,000 Americans who are dangerously allergic to sesame by mandating the ingredient be labeled clearly when in foods and when products are made on the same machinery as foods with the ingredient, the Center for Science in the Public Interest argues.


-----------------------------------------------------


"Allergy experts support group’s call for allergen labeling for sesame"
https://www.agra-net.net/agra/food-chemical-news/food-safety/allergens-contaminants/allergy-experts-support-groups-call-for-allergen-labeling-for-sesame-461792.htm

Quote
Sesame should to be added to the Big 8 list of allergens that must be identified on food labels, say several prominent allergy experts who joined the Center for Science in the Public Interest (CSPI) in a petition filed Tuesday (Nov. 18) with the Food and Drug Administration.




Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:14:38 PM
Food & Beverage Litigation UPdate
http://www.shb.com/newsletters/Current/FBLU.pdf


"purported"    (Italics mine)


 :toothbrush:


Let the games begin.   :evil:


There is a time for nice.  This is not that time or my role.






Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:15:35 PM
"The Impact on Food Manufacturers if FDA Adds Sesame to List of Allergens"
http://www.stoel.com/shownews.aspx?Show=11791





Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:16:09 PM
Tweeted by @bmarler

"FDA Urged to Require Allergen Labeling for Sesame Seeds"
http://www.foodsafetynews.com/2014/12/fda-urged-to-list-sesame-seeds-as-allergens/#.VH5mV3-9KSN

Quote
In a news release, CSPI highlighted the case of a 10-year-old boy in Virginia who was rushed to the emergency room after eating a meal at a restaurant, despite his parents getting the assurance of the staff before ordering that the meal contained no sesame seeds.




Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:16:41 PM
Tweeted by @AcademicsSay


Quote
I have no special talents. I am only unreasonably persistent.



 :)





Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:17:17 PM
AAFA/KFA


"Food Labeling Modernization Act of 2015"

http://tinyurl.com/zgyxr9u


Quote
Updates to food labeling requirements are overdue; the list of major food allergens has not been updated since 2004.

Help us support this important legislation. Input your information below to tell your members of Congress to support the Food Labeling Modernization Act!







Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:17:37 PM
Tweeted by @woodrumlaw


"Sesame Gains Traction in Push for Food-Labeling Require"
http://www.foodsafetynews.com/2015/11/sesame-gaining-traction-in-congressional-push-for-food-labeling-requirements/#.VlxQw3o8KrU


Quote
Section 8, which would require sesame to be placed on the list of major food allergens

Quote
Section 9 of the proposed legislation goes one step further and requires that, within three years of enactment, signs listing the major food allergens be placed adjacent to non-packaged foods being offered for sale at retail outlets.

Quote
Just this past week, four members of Congress — U.S. Reps. Frank Pallone Jr. (D-NJ) and Rosa DeLauro (D-CT), and U.S. Sens. Richard Blumenthal (D-CT) and Edward J. Markey (D-MA) — introduced the Food Modernization Act of 2015



--------------------------------------



H.R. 4061, the “Food Labeling Modernization Act of 2015”
November 23, 2015

http://tinyurl.com/ot6wefy

--------------------------------------



"RE: Support for the Food Labeling Modernization Act of 2015"
January 27, 2016
http://www.aafa.org/media/Food-Labeling-Modernization-Act-Support-Letter.pdf

Quote
It is imperative that we add sesame to the list of major food allergens

Quote
Additionally, we support other revisions to the food labeling regulations






Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:17:59 PM
"One tiny sesame seed was all it took"
https://www.washingtonpost.com/national/health-science/one-tiny-sesame-seed-was-all-it-took/2015/11/16/8e14f120-6301-11e5-9757-e49273f05f65_story.html?postshare=2991447699195270&tid=ss_tw

Quote
“There is a fairly broad consensus among those of us who see people with sesame allergy that sesame allergy is comparable [to] and as prevalent as [allergies to] some of the individual tree nuts,” said Wayne Shreffler, director of the Food Allergy Center at Massachusetts General Hospital.





Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:18:20 PM
"Understanding and Managing Sesame Allergy (Webinar Recording and Recap)"
http://blog.foodallergy.org/2015/10/22/understanding-and-managing-sesame-allergy-webinar-recording-and-recap/#_ga=1.251041477.23381587.1434562410

Quote
On Wednesday, October 14, FARE was joined by Dr. Robert Wood, for a webinar titled Understanding and Managing Sesame Allergy.

Quote
Mr. Riccio encouraged webinar attendees to share their sesame allergy stories with FARE, sign up for advocacy alerts, and let their congressmen/women know that adding sesame FALCPA is an issue important to their families.






Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:18:40 PM
http://www.regulations.gov/#!documentDetail;D=FDA-2015-N-3230-0001

Quote
All comments submitted to any FDA docket on or after October 15, 2015, will be publically posted, unless otherwise determined not to be subject to posting as described in the SUPPLEMENTARY INFORMATION section.


-------



DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration [Docket No. FDA–2015–N–3230]
Consumer Comments—Public Posting and Availability of Comments Submitted to Food and Drug Administration Dockets
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

Quote
SUMMARY: The Food and Drug Administration (FDA or Agency) is changing the Agency’s long standing practice of not publically posting on [url]http://www.regulations.gov[/url] comments submitted by individuals in their individual capacity. These are generally comments from people who self-identify as an ‘‘individual consumer’’ under the field titled ‘‘Category (Required)’’ on the ‘‘Your Information’’ page on http:// [url=http://www.regulations.gov]www.regulations.gov[/url]. Changing FDA’s practice to routinely post these comments, as we do other comments, will increase the transparency and public utility of FDA’s public dockets.
It will better enable our public dockets to function as intended: To share information and encourage an open exchange of ideas.

Quote
This change fulfills a recommendation from the 2010 FDA Transparency Initiative




  :)





Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on November 20, 2014, 12:18:55 PM
Tweeted by @parisreview


"Alice Munro, The Art of Fiction No. 137"
http://www.theparisreview.org/interviews/1791/the-art-of-fiction-no-137-alice-munro


Quote
There should be a point where you say, the way you would with a child, this isn't mine anymore.





Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: briheller on December 08, 2014, 07:40:20 AM
Please sign this petition to the FDA requiring better labeling of sesame https://www.change.org/p/fda-add-sesame-seeds-as-an-allergen-to-us-product-labeling-laws-require-them-to-be-disclosed-on-us-food-labels  Anyone can sign this informal petition on Change.org, but the more signatures, the more they will take notice. 

FYI:  This informal petition led to a more formal "citizen's petition" by CSPI, which is not the type that take signatures, but rather, is the type the FDA must reply to by law!  http://cspinet.org/new/201411181.html

Again, here's where to sign the original petition that started it all:  https://www.change.org/p/fda-add-sesame-seeds-as-an-allergen-to-us-product-labeling-laws-require-them-to-be-disclosed-on-us-food-labels 
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on December 08, 2014, 07:50:20 AM
Brian,

Most of us sesame folks at FAS have already signed your petition.  I support it & the CSPI petition.  Thank you for your efforts to help those with sesame allergies.
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on May 24, 2015, 09:48:26 PM
Lobbying for Sesame Labeling in Washington, D.C.
MAY 18, 2015

https://ohmahdeehness.wordpress.com/2015/05/18/lobbying-for-sesame-labeling-in-washington-d-c/





Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: GoingNuts on May 25, 2015, 07:48:29 AM
Thank you for sharing that Links.  :)
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on April 26, 2016, 02:46:40 PM
Sesame Allergy
http://www.foodallergy.org/allergens/sesame

Quote
Sesame is not currently included in the list of major allergens that must be declared by food manufacturers as part of the Food Allergen Labeling Consumer Protection Act (FALCPA), although FARE supports the addition of sesame to the list of “major food allergens” that are required to be identified on ingredient labels of processed foods.

Quote
The list below includes information about ingredients to avoid if you have a sesame allergy, including uncommon names for the ingredient.



------


Linking ...

Efforts to add Sesame as Top Allergen







Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on September 18, 2017, 09:13:31 PM
Although I'm not too active at FAS anymore, I do read here sometimes, and I saw that somebody was asking about the current status of the sesame labeling efforts .... so I thought that I would update this thread.

---------------------------------

I was a sesame labeling advocate from 2008-2015 ... my comment was included with the 2014 CSPI petition (K.P. - Page 16)

https://www.regulations.gov/document?D=FDA-2014-P-2035-0001

https://cspinet.org/sites/default/files/attachment/11-18-sesame-petition.pdf

I tried lots of tactics over the years trying to get that allergen labeled .... some clever imo ... some naive and kind of embarrassing at this point ... I don't want to rehash everything ...

My daughter has now fully outgrown her sesame allergy ... in fact, she no longer has any IgE allergies ... so I'm not involved in food allergy advocacy anymore.  However, since I did invest so much of myself into this issue, I keep an eye on it from a bit of a distance.

---------------------------------


KFA & AAFA now support efforts to improve sesame labeling:


"Tell the FDA to List Sesame as a Major Food Allergen on Food Labels"
3/6/17
https://community.kidswithfoodallergies.org/blog/aafa-supports-labeling-for-sesame
Quote
The Asthma and Allergy Foundation of America (AAFA) is standing up for people allergic to sesame. We joined with a consumer advocacy group to ask the Food and Drug Administration (FDA) to add sesame to the list of ingredients that must be disclosed on food labels.


-----

http://www.aafa.org/media/CSPI-AAFA-Comments-Sesame-Labeling.pdf

Quote
We urge the FDA to include sesame among the list of ingredients that must be disclosed


-----

Comment from Center for Science in the Public Interest CSPI and Asthma and Allergy Foundation of America AAFA
https://www.regulations.gov/document?D=FDA-2014-P-2035-0034

---------------------------------


FARE is also on board now ...


"FARE Supports Calls for Addition of Sesame as a Major Food Allergen"

July 1, 2015

https://www.foodallergy.org/about-fare/blog/fare-supports-calls-for-addition-of-sesame-as-a-major-food-allergen

Quote
As the leading advocacy organization representing the 15 million Americans with food allergies, FARE supports the addition of sesame to the list of “major food allergens” that are required to be identified on ingredient labels of processed foods.


---------------------------------


So you might be thinking that things are looking pretty good ... the allergy orgs are backing sesame labeling ...
but keep reading, if you would ...






Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on September 19, 2017, 07:12:55 AM
"Food Allergy Research & Education Joins with National Academies of Sciences, Engineering and Medicine in Call for Sweeping Changes to Improve Health, Quality of Life of Individuals With Food Allergies"

November 30, 2016

https://www.foodallergy.org/about/media-press-room/food-allergy-research-education-joins-national-academies-sciences

Quote
Food Allergy Research & Education (FARE) is the lead sponsor of this report

Quote
In discussing the need for improved policies regarding labeling of packaged foods, the expert committee is recommending that the priority list of food allergens in the U.S. be periodically reviewed, noting that evidence of allergy prevalence and reaction severity to sesame may warrant inclusion on this list.


----------------------------------------


"National Academies Consensus Study"

https://www.foodallergy.org/research-programs/national-academies-consensus-study

Quote
FARE and other groups nominated the members of the expert panel and the volunteer patient advisory panel.

Quote
FARE also assisted in securing diverse co-sponsors to provide funding support for the study.


------------------------------------------------------


"Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy"
Released: November 30, 2016
http://nationalacademies.org/hmd/reports/2016/finding-a-path-to-safety-in-food-allergy.aspx

Click on the "Committee Members" & "Sponsors" sections ...

Two of the things that jumped out immediately to me were that Dr. Stephen Taylor was on the committee & there seemed to be a lot of sponsors from industry.

If FARE had so much influence in setting this up and if FARE is a patient org representing patient interests ... why such heavy industry involvement?  Yes, all stakeholders need to be at the table ... but for instance if Dr. Taylor is going to be included, why not also have a food science expert that is more closely associated with patients/consumers to balance things out, to help with potential COI & bias issues?  Am I mistaken (sincere question)?  Is there such an expert on the committee that I'm not recognizing?

For some more background that might help explain why I am concerned, see:

Re: sesame seeds labeling: US specific (laws, loopholes)

&

Re: sesame seeds labeling: US specific (laws, loopholes)

-------------


I was pleased to see that the:
Quote
committee had the unique opportunity to hear directly from an advisory panel made up of nine parents of children with food allergies and one individual with food allergy

https://www.nap.edu/read/23658/chapter/1  (Page x) .

However, I didn't see any patients on the committee itself or listed as reviewers (please feel free to correct me if I am wrong).

This sentence from Rosamund Snow came to mind:
Quote
We’re allowed to remind the researchers why they went into the job in the first place, but we’re not supposed to be able to comment on methodology, even if the methodology is flawed because the researchers aren’t aware of their own biases.


"Rosamund Snow: What makes a real patient?"
July 19, 2016
http://blogs.bmj.com/bmj/2016/07/19/rosamund-snow-what-makes-a-real-patient/


Another thing that came to mind was power & influence ... being on the committee is much different than being on an advisory panel.

-------------

Back to the main report ... the recommendation that I feel is probably most relevant to the topic of sesame labeling is this:

"Finding a Path to Safety in Food Allergy: Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy"
Released: November 30, 2016
Page 312
https://www.nap.edu/read/23658/chapter/9#312

Quote
For example, in the United States, some foods listed by the FDA as tree nuts (i.e., beech nut, butternut, chestnut, chinquapin, coconut, gingko nut, hickory nut, lichee nut, pili nut, shea nut) could be removed from the current priority list based on the paucity of data or low frequency of allergic reactions. In addition, evidence of the allergy prevalence and reaction severity to sesame seeds may warrant their inclusion on the priority allergen list in the United States.



What this reminds me of is the general political talk of taking away more regulations than you add:
Re: FDA

but instead of maybe "Two-for-One", is it going to be something like "Ten-for-One" with food allergen labeling?

My opinion is that sesame will eventually get labeled in the USA (as I think it should be), but the real question, the
upcoming "battle" imo, is at what cost?  Will it be one of those cases where even if patients "win", we lose?





Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on September 19, 2017, 12:55:03 PM
Before I continue ... let me put this here:

"Are the National Academies Fair and Balanced?
One in Five Scientists on NAS Issue Panels Tied to Firms Involved in Issue"
July 24, 2006
https://cspinet.org/new/200607241.html

Quote
CSPI doesn’t dispute the high quality of reports produced by the National Academies (which include the National Academy of Sciences, the Institute of Medicine, the National Academy of Engineering, and the National Research Council). But it says that the NAS should strengthen its policies for avoiding and disclosing conflicts of interest and for maintaining balance if the NAS is to maintain the credibility it currently enjoys.


It's something to think about.
 
-------------------------------------------------------------------



ok, back to that report ... I think this is the latest (final?) version ... 2017:


"Finding a Path to Safety in Food Allergy:
Assessment of the Global Burden, Causes, Prevention, Management, and Public Policy (2017) "
https://www.nap.edu/catalog/23658/finding-a-path-to-safety-in-food-allergy-assessment-of

https://www.nap.edu/read/23658/chapter/1

Page 288:
Quote
Insufficient evidence exists on the prevalence and severity of allergies to other foods on the lists of priority allergenic foods in other countries, including molluscan shellfish, mustard, celery root, and buckwheat, to warrant their addition to the priority list in the United States.


Page 312:
Quote
in the United States, some foods listed by the FDA as tree nuts (i.e., beech nut, butternut, chestnut, chinquapin, coconut, gingko nut, hickory nut, lichee nut, pili nut, shea nut) could be removed from the current priority list based on the paucity of data or low frequency of allergic reactions.



Coming from a patient/consumer background, I think that existing data and studies could have been used to make different policy recommendations.

For instance, I think that there may be enough data/evidence to make a good argument that mustard should be included in the USA priority list as it is for Canada:
https://www.canada.ca/en/health-canada/services/food-nutrition/reports-publications/food-safety/mustard-priority-food-allergen.html

Or ... for the addition of the category "Seeds":  sesame, mustard, sunflower, etc.

Some were arguing against the addition of sesame to the priority list before the CSPI petition was filed ... did the science change or the politics? 

When I was active in the food allergy community, I met several people dealing with coconut allergy ... I feel badly because that allergen is going to be a nightmare to avoid imo if it is again allowed to "hide" on the food label under terms like "natural flavor".  Many food products will probably become off-limits for the coconut-allergic if that allergen is removed from the priority list.  Coconut may not have a high prevalence, but do patient quality-of-life considerations count for nothing?

Like I said before, I'm no longer involved in food allergy advocacy ... it does not affect my family ... and if the food allergy patient community is satisfied with the proposed "Ten-for-One" deal ... fine.  I just wanted to make sure that the patient community understood that this may be where things are headed.

Deciding on the appropriate level of regulations is often sort of a dance/game between consumers/patients and industry imo ... a negotiation ... $$$, power, influence, media/PR, lobbying & voting all come into play ... but consumers/patients have to remain informed & active if they want a government that is responsive to the needs of "the people", regular citizens.

-----------------

Something Jimmy Kimmel said the other day resonates with me ...

"Jimmy Kimmel: Sen. Bill Cassidy ‘failed’ his own test on health care"
By DAN DIAMOND, 09/20/2017 12:16 AM EDT
http://www.politico.com/story/2017/09/20/jimmy-kimmel-bill-cassidy-obamacare-242913

Quote
“Health care’s complicated [and] it’s boring; I don’t want to talk about it [and] the details are confusing,” Kimmel said in his monologue. “And that’s what these guys are relying on. … They’re taking care of the people who give them money, like insurance companies.”


The same kind of thing imo ... FDA regulations can be kind of boring and complicated ... but if regular citizens/patients don't pay
attention, public health can be negatively affected.




Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on September 20, 2017, 09:58:41 AM
"Report from the National Academies of Sciences, Engineering and Medicine: Recommendations to the Food Industry and Regulatory Agencies on the Management of Food Allergens"
By Steve L. Taylor, Ph.D., and Maria Oria, Ph.D.
February/March 2017

https://www.foodsafetymagazine.com/magazine-archive1/februarymarch-2017/report-from-the-national-academies-of-sciences-engineering-and-medicine-recommendations-to-the-food-industry-and-regulatory-agencies-on-the-management-of-food-allergens/

-----------------------------


"Critical Issues in Food Allergy: A National Academies Consensus Report"

Scott H. Sicherer, Katrina Allen, Gideon Lack, Steve L. Taylor, Sharon M. Donovan, Maria Oria

July 2017

http://pediatrics.aappublications.org/content/early/2017/07/19/peds.2017-0194

Quote
Dr Taylor received grant support for research from the National Institute of Food and Agriculture and from the Food Allergy Research and Resource Program consortium of over 90 food manufacturers and/or suppliers as well as royalties from Neogen Corp.








Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on September 20, 2017, 10:16:12 AM
.
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: gvmom on September 20, 2017, 10:52:18 AM
Will it be one of those cases where even if patients "win", we lose?

Yes.  Of course.  Naturally.  Unless there is more money and less regulation, implementation & enforcement, in anything that might be an actual win.

I probably should have asked if you were really being rhetorical......
Title: Re: sesame seeds labeling: US specific (laws, loopholes)
Post by: LinksEtc on September 20, 2017, 12:22:47 PM
Will it be one of those cases where even if patients "win", we lose?

Yes.  Of course.  Naturally.



Naturally.   Yeah.    :)


I really don't want to be a cynical person ... but that's really hard these days.


------------------------------------------------------------------------------------------


ETA



Re: American healthcare - patient-centered?


Obviously, I've collected a lot of negative examples in this thread ... mostly to encourage people to critically think about what is really in our (patients') best interest ... sometimes, if we don't look out for our needs, nobody else will ... we can get complacent if we blindly trust that others (docs, patient orgs, government, etc.) always have genuine concern for our well-being.

Yes, I'm feeling somewhat depressed and disheartened ...

at the same time, I still think that things have the potential to get better ...

whether talking about patients & healthcare ... or citizens and government ...

for instance, there are drugs that have been developed that save lives, there are docs who truly care, there are
patient orgs where patient needs are the primary focus, etc. ...

maybe we have to find that right balance between hope & critical thinking ...

-----------------------------------------------------------------


"Hope, Cynicism, and the Stories We Tell Ourselves"
By Maria Popova
[url]https://www.brainpickings.org/2015/02/09/hope-cynicism/[/url]

Quote
Critical thinking without hope is cynicism. Hope without critical thinking is naïveté.

Finding fault and feeling hopeless about improving the situation produces resignation — cynicism is both resignation’s symptom and a futile self-protection mechanism against it.