sesame seeds labeling: US specific (laws, loopholes)

Started by AdminCM, August 22, 2011, 01:46:15 PM

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This is an important thread for those with sesame allergy to read:

Other names for Sesame



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


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.



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


Karen P
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 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 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 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.
QuotePhase 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
FDA should change its current practice so that comments submitted at 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. 

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.

QuoteThe 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.   :-/


QuoteThe 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.

-------------------------------------- - Docket FDA-2008-N-0429

In the "Notice" document, one of the FDA's questions was:
QuoteQuestion 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:
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.




"Tourist dies of allergic reaction to tahini"
Apr. 1, 2014

QuoteThe 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.


"Allergy Led To Death Of Popular Teenager"
QuoteAn 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.


"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:

QuoteA 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


Food Allergy: Is Sesame Seed the "Middle Eastern Peanut"?
QuoteAlthough 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.


Food Allergies For Dummies
Robert A. Wood, MD

Page 49

QuoteWhile 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.


"Sesame allergy in Britain: a questionnaire survey of members of the Anaphylaxis Campaign."
QuoteOne in six (17%) had suffered potentially life-threatening symptoms, with 65% of severe reactions happening on first known exposure.


"The Allergens to Watch – Sesame to Lentils and More"
QuoteSo 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.




"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


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

QuotePatients 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.


Mount Sinai

QuoteThe 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).


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

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

QuoteFormal 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%).

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.
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.


"Sesame seed food allergy."

QuoteBased 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.


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.

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

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

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


"Reported adverse food reactions overestimate true food allergy in the community."
QuoteThere 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"
QuoteNearly 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).
QuoteDr. 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.


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


"Hard to uncover sesame seeds for those with the growing allergy"
QuoteTo 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.


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

Quote from: LinksEtc on April 09, 2012, 10:49:25 AM
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

QuoteFARRP 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)
QuoteIn 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



QuoteIn 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.


ID: FDA-2011-N-0259-0046

QuoteAs 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."
(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



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.



Anaphylaxis and Food Allergy Association of Minnesota (AFAA)

ID: FDA-2012-N-0711-0047

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.

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.


Food Allergy Research & Education (FARE)

ID: FDA-2012-N-0711-0059

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.


"Why isn't Sesame a Top Allergen in the U.S.?"
Dr. Scott Sicherer
QuoteSesame 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.


Hmmmm, I can't seem to find an equivalent FDA document ...

"The Canadian Criteria For The Establishment of New Priority Food Allergens"


Well, yeah ...
Quote1) 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).)

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

I read the 6/15/09 article "New commissioner aims to open FDA's 'black box'", , 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 ).

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 ).

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.


What allergen would you like to see become a priority allergen?
QuoteHow can we get the US Government to join Canada and the EU in recognizing this

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