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Specific Food Allergies > Seed Allergy

sesame seeds labeling: US specific (laws, loopholes)

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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


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

--- End quote ---

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.

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--- 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.
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Docket Management Process - Draft Proposal 2

--- Quote ---FDA should change its current practice so that comments submitted at www.regulations.gov from people self-identified as individual consumers are posted on that Web site in the same manner as other comments.

--- End quote ---

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. 



--- 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.

--- End quote ---

--- 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.
--- End quote ---

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


--- 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.
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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?
--- End quote ---

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.

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