Trust and Food Allergies

The candles are off the cake, slices served to eager children.  A little girl has her fork by her mouth, a small bite of cake hovering and awaiting a response.  She was dropped off to the party, so there’s no one in particular for her to ask, so her tentative voice asks no one in particular. . .

“Does this have tree nuts?”

I ask her if she’s allergic, she says she is.  I ask her if she has her EpiPen and she pauses and then reveals she does not.  She really wants the cake.  She seems to regret asking the question.

I can’t get it out of my mind, what would I want another mom to tell my child?  How can I frame this in a way that doesn’t come off as judgmental because I am not in that other family’s shoes and I don’t know what advice they follow to manage allergies?  As I contemplate the situation a few things converge – food allergy awareness week, whether I’m quick to discount lay advice online, and community generated parenting advice.

First, we’re almost upon “Food Allergy Awareness Week” – I will actually be away from my own family for a few days to present at a conference in Orlando as a one-third representative of the Allergy Law Project (“ALP”).  I was invited because of ALP and will be reimbursed for my air travel and will have a room provided (see, there’s my disclosures at work). That has me contemplating audience – who are we trying to reach in an awareness context – could it be diagnosed individuals as much as people who may not know about allergies except for seasonal ones?

Second, a friend has made some very cogent points about a concept floated in an ALP post where we discussed non-lawyers dispensing legal advice.  She cautioned me that in law, medicine, and the like, we can’t discount the power of community information shared by informed individuals who have lived a given scenario.

Third, I’ve been reading the book “Parent Hacks” by Asha Dornfest – I pre-ordered a copy of my own but also received a review copy and Asha’s site and book have elements of empowerment and community based information that had me thinking about the tips, recipes, and more that food allergy parents share on social media and elsewhere.  (I reviewed the book on Amazon, so you can see my specific thoughts there via this affiliate link.)

Does anyone recall the part in Donald in Mathamagic Land where Donald Duck is advised to tidy his mind?  I’ve viewed my mind that way often – jumping to and fro – so blogging is often a way to achieve some organization.

Source: The Encyclopedia of Disney Animated Shorts
Source: The Encyclopedia of Disney Animated Shorts

Unrelated aside, well, aside, these things connect for me but they probably appear hodge podge to anyone else.  I promise I’m going somewhere with this.

A few things I know, in relation to the thoughts above:

  1. Communities have power, especially through the internet, to share useful and even life saving information.
  2. There are awareness battles to fight within a community as well as without.
  3. Bringing together 1 & 2 is a matter of safe spaces, supporting one another, and cogent discourse.

When there was nowhere else for me to go, there were blogs and other forms of social media.  Perhaps my law license gives me a little more ability to dig deeper into what I read, but I absolutely am sure the first place I heard about 504 plans was on a food allergy mom blog.  The first book about food allergy I read was Robyn O’Brien’s The Unhealthy Truth from our local library.  Who am I to discount parent based medium when it helped me so directly?  Well, there’s a balance, much like when I rambled on about FTC dot com disclosures.  Common sense comes into play with any information you read about online, in the news, or elsewhere – but the scaffolding we each build upon is different.

I was at a self help center “ask a lawyer” meeting and the prospective client had some bad experiences with attorneys.  She wanted my advice as an attorney but not representation by anyone because of her bad experiences.  I can’t fault her.  The same would go for a person who had a bad experience with an allergist or professional who was not an adequate shepherd of their trust.  Which all goes to say that I don’t fault people for looking elsewhere when they may have reason to believe they aren’t getting the truth from a segment of professionals.  But we can’t move from one extreme to another.  I wouldn’t presume to say a food was “safe” for another child, I can only know what works for our family – and yet you’ll find people posting online “we have x, y, and z allergies – is food abc okay?” and relying on the responses.  Is the asker or the answerer more at fault in that scenario (if any fault were to be placed)?

We have a responsibility to share accurate information about food allergies because we live it every day, but with the appropriate caveats we can share as well as protect one another.  For example, let someone know the limits of advice (“this worked for us, your mileage may vary” versus “this is how it is done”).  Community message boards, forums, and even facebook can all be very effective awareness and advocacy tools but we should disclaim and warn wherever appropriate.  I do see this form of appropriate disclosure quite a bit, but there are some situations where people become defensive and hostile if asked to clarify their experience or acknowledge the limits of their advice.

This leads me to thinking of my presentations next week at the FARE Food Allergy Conference in Orlando.  Mary and Laurel both have conflicts and can’t attend so it was up to me to carry the Allergy Law Project banner, so to speak, and take this great chance to reach others within our allergy community to share our resources and mission.  I know, however, that these are well informed individuals at different stages in their out advocacy journey and I would not presume to imply that their personal experiences are diminished in the face of the letter of the law.  On the flip side, I do think I want to address how to recognize when one is maybe out of their depth and needs more resources.

Just as physicians bemoan the snake oil salesmen of the world, lawyers do get frustrated at the harm that can be done when someone gets bad advice.  That said, bad advice can come from lawyers just as it comes from lay people, but professionally there are remedies for people harmed by bad advice from a lawyer.  You have reason to believe a higher expertise is at play, after all.  The next layer of complication though comes from giving a presentation as a lawyer, or writing an article, and the recipient changing the message or making it their own.  If I talk about 504 plans or rights under the ADA, I do want people to feel empowered to advocate for themselves.  I really do.  But I wouldn’t ideally want them to claim some authority if they share that information with another person.

Back to the little girl at the party, a lot of this comes down to trust.  Who we trust and how.  Whether trust is enough – we can trust that we won’t get in an accident or we can also wear a seatbelt.  We can trust that a label is accurate or we can also carry epinephrine.  We can trust that a school administrator is on the side of our child’s safety or we can advocate for a 504 to supplement what are hopefully already sound school policies.  What we should avoid is implying that something is a safeguard when it is just a shared experience -the audience doesn’t always have the ability to tell the difference so it is up to the speaker to relay that to the listener proactively.  That is simply being a responsible person.

At the outset of any business relationship, I tell clients, there’s a point where everything is going to be great – you and your business partner get along great, you trust each other, it is simply going to be awesome.  And then down the line people change and circumstances change.  At that point there’s an appreciation for the operating agreement that seemed so specific and pessimistic.  If you’re the one to point out to a fellow allergy parent, for example, that maybe they shouldn’t send their kid to a birthday alone and without epinephrine, you have a situation ripe for conflict.  Allergy Awareness Week is a time and a chance to share information and perhaps reach people within the community who have received poor advice or who are relying on sources who are not responsible about the effect of the information they provide.  People should absolutely have access to resources to represent themselves, they just shouldn’t be effectively representing someone else outside of their own sphere.

While I’m in Orlando, by happenstance, Asha from Parent Hacks will be stopping on her book tour and I really hope I can make time to go meet her because her community based website has been such an inspiration to me as a blogger.  She always keeps her own voice, even if something is sponsored, because she discloses whenever a concern could be raised and is not afraid to spark discussion.  I remember when she wrote about the pressure parents can feel about Valentine’s Day.  She suggested that we remember what our children feel about what may simply be a Hallmark holiday.  But she made no apologies for not being a fan of the day when her kids were small.  She didn’t claim that her approach was better or worse, she just offered her personal insight.  That is the power of blogging and community based information.  Putting something out into the world without judgment but so that someone else maybe sees their own struggle put into another’s words.

I hadn’t really looked through the Parent Hacks book when my ordered copy arrived because because I’d been in the middle of some health issues at the time and everything about life and the universe pretty much managed to put me in tears.  And then I saw this…

To Caron Arnold, Sara Carlstead Brumfield, Kara Hagen, Tracy Hengst, Adrienne Jones, Jim Jones, Elana Kehoe, Stu Mark, Rob Monroe, Duane Morin, Heather Petit, Jill Pohl, Kendra Riemermann, Marjorie Wheeler, Homa Woodrum, and the readers of ParentHacks.com. This book and my gratitude are yours. We made this together.
“To Caron Arnold, Sara Carlstead Brumfield, Kara Hagen, Tracy Hengst, Adrienne Jones, Jim Jones, Elana Kehoe, Stu Mark, Rob Monroe, Duane Morin, Heather Petit, Jill Pohl, Kendra Riemermann, Marjorie Wheeler, Homa Woodrum, and the readers of ParentHacks.com. This book and my gratitude are yours. We made this together.”

And I teared up anyway.  There’s something amazing about feeling like you are friends with someone you’ve never met in person and then somehow having your life weave into theirs in something so concrete as a book you can hold in your hands.  A book that is about bringing a parenting community together with tips, tricks, and “hacks” to make taking care of kids a little easier.

There’s this larger parent community with islands of compassion and support like ParentHacks.com and I think there are those islands similarly in the food allergy world in the form of in person support groups, conferences, meetings, KFA, FARE, social media groups, and more.  The tone we set is important and the information we give is as well.

Like Asha, my gratitude is this community’s.  I can’t wait to meet some of you next week and share my hopes for continued legal safeguards, labeling, and the strong food allergy community at large.  Hopefully I’ll figure out what to do about the little girl from the party in the process – I need advice on that front for certain.  Thank you to FARE for this upcoming opportunity and for embracing the independence that is at the heart of the Allergy Law Project‘s mission.

Dreamy Desserts: Las Vegas Storefront Kickstarter Campaign

Dreamy Desserts was founded by Penny Redlin and has been doing awesome custom orders for a number of years so when I found out she was launching a Kickstarter campaign to open a storefront I was so excited!  Here’s the cake she made for my son’s birthday last year – it was free of my daughter’s allergens as well as vegan!

11855783_923057901098927_3632186542132946080_n

My reasons for why this is an awesome idea:

  1. Las Vegas is an International City – visitors come from all over and many of them deal with food allergies.  How cool would it be for them to stop by an allergy friendly bakery?
  2. Allergy Friendly on the Fly – Friends ask me all the time where they can get safe treats for my kids.  Sometimes a gathering comes up last minute and you can’t plan ahead, being able to grab some fresh cookies or beautiful cupcakes would be great!
  3. Dreamy Desserts is already part of the allergy community – Penny’s son cannot have peanuts or tree nuts so she knows what we go through.
  4. Dreamy Desserts is ready to grow – this is not an idea that came out of thin air, Penny has been successfully operating an online bakery and she is already a seasoned businesswoman with the frameworks in place to hit the ground running.
  5. You’ll brighten someone’s day – the campaign just started, put a smile on Penny’s face with even a small pledge!

Penny has made several things for my kiddos’ birthdays, look at these vegan, nut, oat, and sesame free cupcake push pops!  They tasted lovely and made every guest feel included.

11880581_929807290423988_1652066752381637355_n

Click here to check out her campaign and support it – just 24 days to go!

 

Food Allergy Labeling Woes

I never used to be a label reader until food allergies.  Now I find myself reading labels even when I’m not with my daughter.  As dependent as I’ve become on labels, there are situations where we have to accept what we’re told about a food or go without any indication of ingredients at all.

There’s a sliding scale of comfort – if I can talk to a chef or baker I can feel out their level of awareness of food safety.  I recall talking to  Chef Keith Norman at the South Point and learning once that someone with celiac disease can’t even assume shredded cheese is gluten free because flour can be used to make pre-shredded cheese not stick together.  They’re cautioned to ask for freshly grated cheese.  Or someone with a dairy allergy can’t just order hummus because maybe food service has added milk powder.  Still, these details can be teased out the closer you get in the hierarchy to the person who actually made the food in question.

I’ve been trying to put together a draft of a piece about a fairly recent food allergy case involving the grocery store Publix.  I have the pleadings printed out and on my desk and keep reading and re-reading them.  The ultimate goal was to discuss the case on the Allergy Law Project but the time doesn’t feel quite right as the case is still playing out.

It is incredibly difficult to even write out the facts of what happened in the case because when an allergic individual or their family demands better treatment and uses the law for assistance, invariably there are those who would pick the facts and pass judgment.  I’ve written before about the dangers in doing so. Further, it is simply heartbreaking to consider the loss of a loved one, let alone to anaphylaxis.  That said, I’ll try because I think this highlights the complexity of the road ahead for labeling.

Derek Landon Wood died after eating an unlabeled cookie at a Publix grocery store after being assured that it did not contain nuts.  In the family’s complaint filed in the Middle District of Tennessee Nashville Division, they do not simply ask for compensation for the negligence alleged against Publix, they seek “to raise awareness of potential fatal food allergies in American children.”  (See the Complaint at pg. 1).

Derek, along with his mother and aunt, was at a Publix Store in Clarksville, Tennessee when his aunt purchased a cookie for him at the bakery counter on June 3, 2014.  He requested the Chocolate Chew cookie and, given his diagnosis of a tree nut allergy 7 years prior, his aunt inquired of the store clerk whether or not the cookie of Derek’s choice had tree nuts.  Assured that it did not contain tree nuts, she purchased the cookie.  Breaking off a piece and eating it, she saw there were no nuts and gave the cookie to Derek but shortly thereafter he experienced anaphylaxis and ultimately (and tragically) died.

Derek was 11 years old.

A suit in Tennessee Federal court ultimately ensued, brought by Derek’s legal guardian (his grandfather) as well as his aunt and mother.  Publix attempted to have claims brought dismissed by stating that the case was one meant to attack the unlabeled nature of bakery counter products while Derek’s family had alleged that the misrepresentation of the clerk was what they had to rely on for lack of ingredient information.

Disturbingly, the case implies that though Publix creates the illusion that products are baked on site, products like the cookie Derek consumed are not baked on site.  It bears repeating, though the sales clerk purported to know about ingredients in the cookie based on the implication that they were backed in that area, “no Publix bakery products offered for retail sale are made fresh or prepared in the store locations where they are offered for sale.”  Id. at 3.  Even the batter used to prepare the few items that are made to order is mixed at a bakery plant. Id. at 3-4.

What does this mean?  When Publix takes a product that may be sold elsewhere in the store and places it in the bakery display, they are removing any ingredient information and simply placing the item in an unmarked bag when selected by a customer.  Id. at 4.

Derek’s mother carried epinephrine but despite best efforts of his mother and medical professionals, 11 year old Derek was pronounced dead at 10:19 p.m., about 4 hours after he and his family had entered the Publix store in Clarksville.

The suit alleged negligent training of the employee that assured the family that there were no tree nuts present, failure to warn consumers of allergens, violation of the Tennesse consumer protection act, as well as strict liability claims and a breach of implied warranty of fitness.  The suit also sought declaratory relief under FALCPA.

It is still ongoing but the encouraging thing for advocates has been that the judge in the case could see something concerning about taking a labeled good and removing it from its immediate packaging to effectively package it under the guise of an on-site bakery.

Going back to the way we tend to trust communication the closer we get to a perceived source such as a chef or baker, it is one thing to have an unlabeled good.  Most people would pass on that.  It is another thing to remove labeling information and substitute it with verbal assurances.

 

Yesterday I came across a cookie that had me snapping a photo because instead of an actual ingredient list they just had a “may contain” statement.

IMG_20151120_121609

The label reads: “May contain the following: flour, sugar, brown sugar, margarine, butter, oatmeal, eggs, cream, chocolate chips, raisins, craisins, eggs [sic], vanilla chips, peanut butter, peanuts, almonds, walnuts, pecans, coconut, cocoa, baking powder, baking soda, salt, vanilla, and various extracts.”

First of all, the kind part of me sees this as interesting because they’ve gone to the trouble of letting us know everything they use in their kitchen.  This is just a small local bakery and they don’t have the FALCPA requirements at play.  I also chuckled at the fact that eggs made an appearance twice.  The skeptic (aka lawyer) in me wonders if this is not a label but a disclaimer.  A label tells us something about the product, a disclaimer tries to make it our fault if we eat it anyway and come to harm.

The cookie looked like a sugar cookie with frosting, sprinkles, and a candied cherry of some sort.  I showed a photo to my daughter (aged 7) and asked her what she thought it was made of.  She said “I think it is flour, sprinkles, sugar, jam, and water.”

IMG_20151120_121612

I read the label to her and she looked concerned.  “May contain?” she asked, her brow furrowed, “Not good.”  She went on to say it wasn’t good because “it has all the allergies.”

Even in commercially labeled products “may contain” statements aren’t regulated or mandated but this cookie made me think of Derek.  How delicious the cookie must have looked, how his family asked questions and even checked the cookie.  How they might have turned away from the counter if the employee had said “I don’t know what is in our cookies, we don’t make them.”

Allergy advocates talk a lot about epinephrine, I know I have spent my fair share of time doing that, but reactions are what we want to avoid in the first place.  Sometimes epinephrine fails.  Sometimes epinephrine isn’t given in time.  Sometimes epinephrine isn’t nearby.

Allergen avoidance isn’t a perfect strategy, true, but I find communication one half of so much in the allergy world.  Working with a school to keep your child safe, the label on a food, the assurances of a waitress at a restaurant. . . .  The other half is a disparity of power.  The look of an enticing treat, the pressure of a social situation, the clout of organizations trying to downplay the allergic storm, and even the cost of epinephrine.

Where does all of this leave us in the day to day?  Sometimes I think things are getting better but perhaps I’m just brushing off the things I’m used to – like all the food fundraisers at school (I can’t fathom how cookie dough sales are more helpful than buying some paper and pencils for the classroom directly, for example, or how being invited to buy McDonald’s products served by teachers is as useful as volunteering in the classroom).  I’m laughing at labels like the one I featured above as a coping mechanism because it just is a signal of a greater disregard for the complex relationship between people and food.

There’s so much more to food than nourishment.  It can comfort, welcome, and include.  It can also be a part of anxiety, dysfunction,  and exclusion.  We can’t rely on those who have the upper hand, be it drug or food companies, to “do the right thing.”  We can’t prepare for all contingencies but we can work together and not judge one another in our own personal battles.  We can speak softly.  We can push for labeling of one allergen while knowing there are many more in need of disclosure.

Most of all, we can try to be compassionate and inclusive of others outside our allergy sphere.  As usual, I don’t have answers.  I can share how I frame the question to unpack ways to help any way I can.  The irony of fighting for labeling of allergens while not wanting people to label my child simply as food allergic is not lost on me.  However, the example of consideration and kindness we show will shape the next generation and the balance of the bargains they must make.

10/28/15 – All Auvi-Q Epinephrine Autoinjectors Recalled

Today Sanofi US announced a large scale recall of their .15 and .3 mg epinephrine autoinjectors.  A few folks subscribe to this blog because of the pricing and expiration date updates I’ve provided about autoinjectors so I wanted to link to their announcement right away: http://www.news.sanofi.us/2015-10-28-Sanofi-US-Issues-Voluntary-Nationwide-Recall-of-Auvi-Q-Due-to-Potential-Inaccurate-Dosage-Delivery

auviqrecall

I’m disturbed that I learned about this via twitter even though I’ve registered for emails from Sanofi about the Auvi-Q and received an email from them on October 22 reminding me to use discount cards before they expire.

auviqemailoctober22

Questions folks have right now include:

  • What autoinjector do we get in the meantime if we’re returning recalled ones?
  • Do we need a new prescription?
  • Will Sanofi reimburse for replacements and if so, do they have to be of the same brand or can they be for a competitor model?
  • Will the failures as reported be confirmed and if so, how?
  • Will the expense and public relations fallout mean even higher prices for Auvi-Q in the future?
  • Are expired Auvi-Q models affected or those only within the current expiration date range?

Also, the wording of the announcement has a lot of people confused because it talks about specific expiration dates and then also says all injectors on the market are impacted.  The announcement also talks about hypersensitivity which is odd wording.

You could view the recall as being in an abundance of caution and therefore showing how sensitive Sanofi is being to consumers or you can wonder about the timing and the lack of actual clear instructions for how to handle the issue.  People who have relied on EpiPens may be saying “told you so” while those who embraced Auvi-Q may be wondering about making a switch, we still don’t know enough at this point except that how this is handled going forward will certainly impact consumer perceptions.

The costs of replacing medication, between new doctor’s appointments for prescriptions, potentially missing work or school to sort matters out, and more are factors that Sanofi can’t control.  I have preferred the Auvi-Q in form and function since it was released but will be sending my daughter to school tomorrow with a set of EpiPens.  The sheer expense of a mid-year replacement (ie, replacing the EpiPen with an Auvi-Q if new batches ship) make reverting back to the Auvi-Q another year away for us.

No matter what take we have as the story develops, safety is always a priority.  Though I’m no medical expert or professional, my standard operating procedure for food allergies is: Avoid allergens and respond appropriately in the event of known ingestion or a reaction.  Always carry two autoinjectors and practice your allergy action plan.  If all you have is an Auvi-Q in the event of a reaction before you can replace it, use it.  The same goes for using an expired autoinjector – if it is all there is and there’s no time to waste, use what you can safely use.

Letter from Senator Dean Heller Regarding Sesame Labeling

I know, another post about sesame!  I have some research still pending about the epinephrine expense issues I’ve written about here previously but with an influx of new cases and adding a partner at the firm (to find out more about them, check out our redesigned website!) and putting in time with Mary and Laurel at the Allergy Law Project, I haven’t been able to get much else done.

At any rate, I reached out recently to the Senators here in Nevada, Harry Reid and Dean Heller, via their respective website contact forms to let them know how important sesame labeling is to our family.  Of course, there is no pending legislation, but as you can see from my last post, there are ways that the legislative branch can voice support on an issue even if it isn’t technically before them for debate or decision.

If you’re reaching out to influencers regarding sesame labeling feel free to use some of these talking points:

  • While some allergens have to be disclosed, a major allergen does not have to be: sesame
  • Sesame can disguise itself as “natural flavoring” or “spices” on labels and put people very much at risk
  • Sesame can also be called “tahini” or “gingelly” on labels if it appears at all
  • Those with sesame allergy who are exposed can experience potentially fatal anaphylaxis
  • Robert Wood, director of pediatric allergy and immunology at Johns Hopkins University School of Medicine notes sesame allergies are “now clearly one of the six or seven most common food allergies in the US”
  • The mandatory labeling for food allergens looks at the “top 8” in the US, so if FALCPA was being written today, sesame would almost certainly be included in mandatory labeling
  • FDA-2014-P-2035 filed by CSPI and including prominent allergists and concerned families asks that the FDA require labeling of sesame using regulatory powers under 21 USC (s) 343(x)

My message to my state’s Senators talked about the letter from Senators Blumenthal, Markey, and Murphy to the FDA.  I received a letter in the mail from Senator Dean Heller’s office that I thought was pretty cool and I wanted to share it here since I so appreciated it:

Letter from Nevada Senator Heller
Letter from Nevada Senator Heller

Ms. Homa Woodrum
3470 E. Russell Rd Ste 212A
Las Vegas, NV 89120-2201

Dear Ms. Woodrum:

Thank you for contacting me to share your support for labeling sesame in food products. I appreciate your thoughts on this issue and welcome the opportunity to respond.

As you know, nearly 500,000 Americans are estimated to be allergic to sesame seeds. There are currently no federal laws or regulations mandating the label of sesame in food products, and I understand your desire to see this ingredient labeled on food packaging.

Generally, I am supportive of measures that help provide consumers with more information so they can make better choices for their own lives. Although no legislation has been introduced regarding mandatory sesame labeling, rest assured I will keep your support for this measure in mind should related legislation come before the Senate for debate or a vote.

Again, thank you for contacting me. Please continue keeping me informed of issues that matter to you.

Sincerely,

DEAN HELLER
U.S. Senator

____

I have a call this week with representatives at AAFA/KFA to hopefully get a statement from them regarding this issue – the support of the food allergy community is so crucial.  We can’t let CSPI go it alone!

Other posts about sesame labeling on this site:

Sesame labeling related articles elsewhere – commenting on these sites may help show support if you have the time:

Sesame Labeling Update – Senators Support CSPI’s Labeling Efforts

I just received the following via CSPI – we met with Senator Murphy and staff from Senator Blumenthal’s office and Senator Markey’s office in May when I was in Washington, D.C.!   Since then, I’ve been on the lookout for problematic labels so I will share one of my finds here before pasting the release I received via CSPI.

Example of labeling as
Example of labeling as “tahini” instead of the allergen “sesame”

WASHINGTON – Today, U.S. Senator Chris Murphy (D-Conn.), a member of the U.S. Senate Health, Education, Labor, and Pensions Committee, U.S. Senator Richard Blumenthal (D-Conn.), and U.S. Senator Ed Markey (D-Mass.) called on the U.S. Food and Drug Administration (FDA) to take swift action to require labeling of products that contain sesame or sesame seeds. Currently, sesame is not required to be labeled as an allergen on food products, yet sesame allergies are growing in prevalence. The senators heard directly about the dangers and challenges individuals with sesame allergies face from not having accurate information about what is in their food. The senators wrote a letter to FDA Acting Commissioner Stephen Ostroff requesting that the agency require that sesame – one of the most common allergens in the United States – be listed specifically by name on ingredient lists and that sesame be included in inspections for cross-contact. 

“Given the severity and growing prevalence of sesame allergies, we respectfully ask the FDA to move expeditiously under its current authority to require sesame labeling and inspection of sesame cross-contact to help protect the health and safety of our constituents,” wrote the senators. “Without required uniform labeling of the presence of sesame, consumers with this serious allergy have no way of protecting themselves or their family members from its potentially life-threatening consequences. As Congress recognized when it passed FALCPA, accurate and comprehensive allergen labeling is essential.”

“Currently, the inclusion of sesame as a major allergen in processed food is not explicitly regulated by  FALCPA, making it difficult for those with sesame allergy to determine which products may contain this allergen,”said James R. Baker, Jr., MD, CEO of Food Allergy Research & Education (FARE), an organization representing the 15 million Americans with food allergies.  “With a significant documented increase in the prevalence of sesame allergy, which can be life-threatening, we are pleased to see Senator Murphy bring attention to the need and means for improving labeling to help families managing food allergies keep themselves and their loved ones safe.”

The Center for Science in the Public Interest Chief Regulatory Affairs Attorney Laura MacCleery said, “Several hundred thousand Americans are allergic to sesame, and their allergy is no less serious and no less life-threatening than that of those allergic to peanuts, shellfish, or other common allergens. The Food and Drug Administration could easily protect these consumers by including sesame among the so-called Big 8 food allergens for purposes of labeling and education.  We’re grateful to Senator Murphy, Senator Blumenthal, Senator Markey, and others who similarly wish the FDA would follow the lead of Canada, the European Union, Australia, and other nations that require labeling of sesame and sesame-based ingredients.”

The full text of the letter is below:

The Honorable Stephen Ostroff

Acting Commissioner

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Commissioner Ostroff:

We write to urge the Food and Drug Administration (FDA) to take swift action to require sesame seeds and sesame products to be labeled and regulated in a manner similar to the rules that apply to the eight current labeled major allergens.

Sesame is now one of the most prevalent, and most dangerous, food allergies in the United States.  When Congress passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) in 2004 to require the labeling and regulation of allergens then considered the “Big 8” (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soy), it was thought that these categories covered around 90% of all allergies in the United States. However, if FALCPA were enacted today, sesame would be included on this list. Allergists consider sesame to be an emerging allergy concern, affecting an estimated 300,000 to 500,000 people in the United States.  Robert Wood, the director of the division of pediatric allergy and immunology at Johns Hopkins University School of Medicine, notes that sesame allergies “have probably increased more than any other type of food allergy over the past 10 to 20 years” and are “now clearly one of the six or seven most common food allergies in the U.S.”  In addition to its mounting prevalence, sesame poses a particular danger due to the severity of the allergy: for some, sesame exposure can trigger potentially-fatal anaphylaxis.

A recent Citizen Petition—FDA-2014-P-2035, filed by the Center for Science in the Public Interest and a number of prominent allergists and concerned parents—outlines the need for action in this area. We support the petition’s request that the FDA require sesame to be listed specifically by name on ingredient lists of foods and be made part of inspections for cross-contact, to better protect our many constituents who suffer from such allergies.

FDA has the authority to regulate sesame in the same manner as other major allergens under FALCPA.  Under 21 U.S.C. § 343(x), the Secretary may promulgate regulations requiring disclosure of allergens other than the allergens listed in the original statute, and has already done so in the case of the coloring carmine/cochineal. This provision also gives the FDA the authority to determine the manner and extent of such disclosure.

As Congress recognized when it passed FALCPA, accurate and comprehensive allergen labeling is essential to enable allergy sufferers to avoid specific ingredients and potentially fatal reactions.  This need is especially critical for sesame, which is often listed under unfamiliar names, like “tahini” and “gingelly,” and is sometimes not identified at all as a component of “spices” or “natural flavors.”  Without required uniform labeling of the presence of sesame, consumers with sesame allergies, and the families of children with this serious allergy, have no way of knowing whether sesame is present in the foods they are eating, and cannot protect themselves or their family members from its potentially life-threatening consequences.

FALCPA was enacted to improve allergen labeling so that consumers can identify the presence of an ingredient they must avoid.  Given the severity and growing prevalence of sesame allergies, we respectfully ask the FDA to move expeditiously under its current authority to require sesame labeling and inspection of sesame cross-contact to help protect the health and safety of our constituents.

Sincerely,

Christopher S. Murphy

United States Senator

Richard Blumenthal

United States Senator

Edward J. Markey

United States Senator

____

Update: 6/26 – here are links to coverage about the above:

http://thehill.com/regulation/246026-senate-dems-urge-fda-to-make-labeling-of-sesame-products-mandatory

http://www.murphy.senate.gov/newsroom/press-releases/murphy-blumenthal-call-on-fda-to-label-and-regulate-all-sesame-products

snacksafely.com/2015/06/senate-dems-to-fda-label-sesame-as-an-allergen/

Statement From FARE Regarding Sesame Labeling

When I wrote about my experience on May 13, 2015 lobbying for sesame labeling in Washington, D.C. I was still awaiting statements from food allergy organizations in hopes that they would support the Citizen Petition of CSPI on the FDA’s docket.  The Citizen Petition is open for comments until May 25, 2015 from what I’ve heard so if you wish to register support as an individual, you can do so here: http://www.regulations.gov/#!docketDetail;D=FDA-2014-P-2035

What follows is Food Allergy Research and Education‘s statement in response to my inquiry.  My hope was for a resounding statement of support for CSPI’s November 2014 Citizen Petition but there may be interests at play that I don’t fully understand as a layperson in this arena.  It does sound like FARE might have independent plans regarding FALCPA that I will follow with keen interest.

Screen Shot of http://www.foodallergy.org/allergens/other-allergens#seed
Screen Shot of http://www.foodallergy.org/allergens/other-allergens#seed

Special thanks to Anna Luke, Manager of Online Community for FARE for going above and beyond to secure the following statement just after a busy period of time post-FARE conference in California at the end of Food Allergy Awareness Week.  Thank you, Anna!

The title below is mine, but everything after that is unedited and complete as provided to me today via e-mail:

May 22, 2015 Statement from Food Allergy Research and Education Regarding Sesame Labeling

Sesame allergy can be severe — individuals who are allergic to sesame can experience potentially life-threatening reactions such as anaphylaxis. A 2010 survey showed that hundreds of thousands of Americans are affected by sesame allergy, and several reports have shown that sesame allergy has increased significantly in the worldwide population over the past two decades.

Currently, the inclusion of sesame as a stated ingredient in processed food is not explicitly regulated by the U.S. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), making it difficult for those with sesame allergy to determine which products may contain this allergen.

Given the importance of education and awareness about this important health issue, FARE will be releasing new information and resources regarding sesame allergy in 2015, including a webinar dedicated to sesame allergy and a tip sheet on how to read a label to help consumers determine if a product contains sesame.

Improving education and awareness are critical first steps, but FARE is also engaged in advocacy efforts to determine how FALCPA can allow for the addition of new common allergens, including sesame and other seeds. FARE is committed to working directly with law makers, government bodies, and our food allergy community leaders to advance these efforts to help improve the quality of life and health of patients with sesame allergy.​

Update as of 7/1/15:  FARE has issued a statement of support on their blog: http://blog.foodallergy.org/2015/07/01/fare-supports-calls-for-addition-of-sesame-as-a-major-food-allergen/