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)
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.
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!
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.
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
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.
Christopher S. Murphy
United States Senator
United States Senator
Edward J. Markey
United States Senator
Update: 6/26 – here are links to coverage about the above:
In January 2013 I first became involved in the Center for Science in the Public Interest (“CSPI“)’s efforts to petition the FDA to require labeling of sesame in a manner similar to labeling requirements of the “top 8” allergens under FALCPA. By November 2014 when their petition was lodged, they had put together a solid argument and gathered support from allergists as well as families impacted by the lack of sesame labeling under current law. The Citizen Petition specifically requests that the Food and Drug Administration issue a rule that would:
1) require sesame-based ingredients to be listed by name (“sesame”) in the ingredient lists of all foods and;
2) add sesame to FDA’s list of allergens in Sec. 555.250 of its Compliance Policy Guides Manual, “Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens” to address both labeling and cross contact issues related to food manufacturing practices.
In March of this year, Laura MacCleery, Chief Regulatory Affairs Attorney for CSPI reached out and inquired about my availability to attend a proposed meeting with the FDA near Washington, D.C. I didn’t know any particulars but I discussed the expense of the plane ticket with my husband, knew I could find a friend’s (comfy) couch on which to crash, and just needed the date to put everything in motion (and secure my mother in law to watch the kids). By the time I did buy the ticket to D.C., I was able to fly for an approximately $11 fee each way, plus the $99 annual fee for the credit card that afforded me the bonus points I needed to fly. That helped a great deal when it came to justifying a trip that put me in Washington for about only 28 hours.
Unlike other advocacy opportunities I’ve had in the food allergy arena when I wanted to make my voice heard regarding an issue, I wanted to make listening my priority (instead of speaking) on this trip. Coming from a standpoint of believing disclosure of allergens is not remotely partisan, I wanted to know why there might be resistance to the idea of labeling for the presence of sesame in food products. I’m not sure I have an answer at this point but I know where and with whom to start looking (I’m hoping to update on those efforts soon). I also now understand the long process we may be in for.
I landed in Washington at about 3:30 p.m. on Tuesday, May 12th, and navigated the Metro to CSPI’s office to meet my friend (and possessor of the above-referenced comfortable couch) Jessica Almy, who is the Senior Nutrition Policy Counsel at CSPI though we met a while before that role as a result of her website Vegbooks.org (where I’m a contributing reviewer). She introduced me to Laura and we went over the itinerary for the next day. We’d all have folders with information about everyone in our group as well as the individuals we’d be meeting. I’d brought a teal scarf for Laura as a gift – she knew it was Food Allergy Awareness Week so it was neat that the upcoming “Lobby Day” fell during that time.
I got to have a lovely dinner with Jessica, her family, my friend Jennifer from college and Chris from high school that evening on the rooftop of a pizza place in Adams Morgan. I should have been tired but there is something electrifying about the capitol even after a day of travel. There’s a line in Jane Austen’s “Persuasion” that comes to mind:
‘My idea of good company…is the company of clever, well-informed people, who have a great deal of conversation; that is what I call good company.’
‘You are mistaken,’ said he gently, ‘that is not good company, that is the best.’
And so, I had an evening with the best of company, not to mention yummy pizza!
The next morning I had made plans to meet my sister in law – we had never met in person before so I was thrilled to be able to coordinate breakfast on short notice. My brother introduced us over the phone right before he deployed last year (he won’t be back stateside until late 2015). She was incredibly sweet and our breakfast together breezed by at a place near the Senate office buildings where my first meeting had been set. She even gave me a ride to the Hart Building which was great because we got to visit a little longer that way.
Once inside the Hart Building, I navigated the marble halls to find the office of Senator Murphy of Connecticut. Laura was waiting along with Rachel Clark, the legal fellow for regulatory affairs at CSPI, and two other parents of a child with sesame among his allergies, Rob and Christine (Rob asked me to just use their first names in my post, I’m happy to oblige though it feels very informal). Brian Heller, who operates a change dot org petition started 9 months ago seeking sesame labeling and which was cited in CSPI’s Citizen Petition to the FDA, had e-mailed to indicate he’d skip the morning meetings (and lunch) but link up with us at the 3 p.m. FDA meeting later in the day.
Laura handed me a small red cloth bag, remarking “one good turn deserves another,” and inside was a turquoise ring she’d handmade. I know it may seem off topic to mention these details but each time I try to write this post without the personal aspects it just doesn’t match the way my brain processes experiences. I think understanding people as both professionals and as people has always been a crucial part of advocacy to me. I love that so many aspects of ourselves can co-exist in a given person. We can be mothers and crafters and lawyers all rolled into one. Her personal connection to food allergy is that her husband has an allergy to shellfish – I think if we include just one degree of separation with the 1 in 13 affected by food allergy, we’d have a very big portion of the population included, indeed.
At any rate, we met with Senator Murphy in his office and told him our stories. My story focused on label reading and touched upon when E was diagnosed, but Rob and Christine’s story of their son got to the heart of the issue. Encouraged by a pediatrician to expose their approximately 8 month old son to other flavors when he wasn’t interested in solid foods, they’d touched the tiniest bit of hummus (which contains tahini, derived from sesame) to his lips when he began vomiting, breaking out into hives, and swelling. He thankfully survived the experience but their lives were forever changed.
Senator Murphy was gracious and attentive, but also compassionate especially since his own family had been touched by food allergy in the past. (He did ask about the support of other food allergy groups which has spurred me since to contact AAFA’s Kids With Food Allergies and FARE to see where they stand regarding sesame labeling. Responses are still pending and I’ll update when I hear back with something official.) I managed to tweet after each meeting at the Hart building though the day became so much more fast paced afterwards that I didn’t get much documented online.
Next we were able to meet with staff at Massachusetts Senator Markey’s office – it felt strange to tell our stories again but each time we’d find more of a rhythm. Christine had to run an errand so Rob and I took turns sharing our history with sesame allergy and food allergies in general.
The response we got was inquisitive and receptive. I was really enjoying getting to see all the offices and take in the questions that people were offering. I had a printed picture of my kids with me at Laura’s suggestion – it was from a recent comic book convention we’d attended so they were in costume as Gandalf and Galadriel from Lord of the Rings. I so closely guard their identities online that it felt strange to be showing off their picture but I think they would have liked that they were there with me in that way. Plus, my mother in law is pretty great at making costumes!
Our final meeting “on the hill” (see, I’m using the lingo!) was with staff from (CT) Senator Blumenthal’s office. I had to snap a picture of the Lego display in the waiting area!
For this round of storytelling I took out the expired Auvi-Q set I carry in my purse (I always carry the most recently expired auto-injector set we have just in case it is of use) and offered information about needing not one, but two doses and how that related to emergency service response times. I wanted to convey the seriousness of exposure and how lack of disclosure puts us all at risk. Rob also was sure to share the fact that even restaurants trying to do the right thing for food allergic patrons would often have to correct themselves when they learned that bread items could contain sesame even if the familiar seeds were not seen on their exteriors.
The group that headed to the Metro to go to the FDA’s Center for Food Safety and Applied Nutrition included myself, Laura, Rachel, Rob, Christine, and Michael. Unfortunately we didn’t get to meet Brian in person as planned as we discovered he’d mapped his way to a different FDA office location 20 minutes away just as we were being called into the meeting room by April Kates and Carol D’Lima with the FDA. We were able to get Brian on his cell using the speaker phone system in the conference room so he could participate, however.
Laura talked about the Citizen Petition from November and stated our purpose in being present was to find out what the FDA thought of it and to learn if there was anything we could do to assist in processing it. We were informed that there were other petitions ahead in line and that responses were of late in excess of 40 pages (some even 70(!) pages) – the implication being a response takes time to get to and time to draft even when its time has come. We pressed on. I knew from the packet we’d been given that Carol D’Lima, FDA Compliance Officer, had a background that included work researching undeclared food allergens and their impacts. From the discussion it sounded like she had already began researching data from which to prepare the FDA’s response so it is encouraging that she understands the interplay between labeling and hidden allergens.
There were two points of confusion that I made note of during the over one hour meeting. One was the distinction between the change dot org petition administered by Brian and the Citizen Petition filed by CSPI. A few times the FDA representatives looked confused when a piece of information was referenced regarding the change dot org petition because that same request or information was not a component of the Citizen Petition before them for review.
The other issue was that it seemed as though the FDA wanted to find out if they needed certain forms of data to support adding sesame to labeling – the law doesn’t seem to mandate it but they referenced needing information for a preamble a few times. The resolution ended up being that they would verify what data may be needed, if any, before efforts are made to mobilize and provide the information. They seemed concerned about putting anyone through the trouble of marshaling resources before they’d verified what they may (or may not) need. So no call to action at this particular instant, though they kept circling back to the concept of showing the harm that not labeling for sesame would be causing.
Some other takeaways from my notes… Though many arguments for labeling sesame begin with pointing up north (Canada) and across the point (the UK) for the proposition that it would not be burdensome for many manufacturers to comply if the FDA mandated sesame labeling stateside, the suggestion was met with the remark that the FDA has to look at US data/needs. Which I understand, though I don’t think it negates the extent to which worldwide impacts are instructive, especially since one of the things implicated by increasing US sesame allergies is exposure to ethnic foods featuring the seed and its derivatives. There’s also immigration and international travel to consider to a much lesser extent.
Finally, I got the feeling that the pending response to the Citizen Petition wasn’t what it promised with the term “response.” What I mean is that I had envisioned that the FDA was preparing to dispute or agree with points in CSPI’s filing when instead they were trying to anticipate push-back depending on whatever position they take and address that commentary in advance. I get into that trap when I draft legal briefs, I anticipate the response to my words and try to head off those arguments while also making my own. It is a tough spot to be in but I can see how wanting to get something right would benefit an underlying cause even if it front loads a lot of the waiting time. And let’s hope we’re not talking about 10 years like labeling carmine, especially with “Dear Colleague” letters hopefully coming from the legislative branch voicing support for sesame labeling.
By the end of the meeting, as we were being walked to the exit to return our security badges/stickers, our hosts had warmed up considerably and thanked us for our time. My first thought as we walked out was that as encouraging as the Capitol Hill meetings had been, receiving resistance on the issue with the FDA made taking the effort to have the meeting all the more important. Better to know now what concerns there are and how to counteract them (even if their basis seems more related to industry than to being legally enabled to make the regulation).
People have asked me how the day went and I’d say it was fascinating and amazing. I feel like I made new friends and connected with existing ones. I made it to my plane on time for my trip home and arrived in the wee hours of the morning on Thursday so that I could be there for my daughter’s school musical debut as a member of the ensemble – keeping that promise to my baby girl was incredibly important to me.
I’m sorry it took so long to get something online about the whole day. I wrote notes and typed drafts of this post and would put them away. I’d return and tinker and tinker again. I sent emails to KFA and FARE, I messaged back and forth with other advocates. I had no idea what to expect from a “Lobby Day” and now feel like I’ve learned a great deal – hopefully some of it has been of interest!
Even with listening as the theme of my trip, I did find myself honing my story as May 13th progressed. For example, some don’t even realize that not all ingredients have to be listed for a given food. Sesame can hide under alternative names (tahini and the like) but the scarier situation is one where sesame hides as “natural flavor” or “spice.”
Also, there’s the idea that my daughter, at almost age 7, is reading labels for herself and I want, I need, for those labels to tell her the truth. I will not always be here for her and traveling across the country to talk about labeling is an outgrowth of the fact that I can’t actually keep her safe now or in the future.
I can’t guarantee that she won’t be exposed to her allergens, or that in my efforts to keep her safe I’m not opening her up to censure from her peers. In the same way that I didn’t know if I’d always be around to make meals for her (this blog was meant to chronicle recipes she could actually eat), I won’t be there to call companies or ask questions on her behalf. I need to teach her what I can but also see what I can do to change the world around her.
My mother often told us that the reason she worked to teach her fellow nurses was because she wouldn’t always be around and she wanted to help the next generation of nurses so they’d be effective caregivers for her children even as adults. I feel the same way about access to affordable epinephrine, stock epinephrine, labeling, and disability rights for those with food allergies. And to be honest, much like hand washing is beneficial for the health of all students, not just those with food allergies, disclosure on labels benefits so many. Even those who may react to foods for the first time and have no way to even begin to inquire whether something like sesame is the culprit because it simply isn’t on the label.
When someone leaves an allergist’s office with a food allergy diagnosis, they are given a prescription for (often costly) epinephrine but they’re also given a prescription that is harder to fill – allergen avoidance. In that sense it is fitting that regulation of both foods and drugs come under one organization’s control, because they are entwined. I’ve referenced this quote before, but it continues to be apt:
‘Let food be thy medicine and medicine thy food.’ – Hippocrates
Avoiding certain foods is a minute to minute prescription when you live with food allergies and knowing where sesame may lurk is a medicine whose time has come.
We have 8 planets and 8 top allergens – that’s about to change! Well, we’re hoping it will change and a fantastic organization called CSPI (the Center for Science in the Public Interest – a Washington, DC based non-profit health advocacy group) has taken a major lead in doing so. No, Pluto isn’t coming back (at the moment) but CSPI and many other folks would love to see sesame added to FDA labeling requirements for allergens.
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.
The sesame seed (Sesamum indicum) is an oilseed crop and edible seed that is used in many food and consumer products. It is used in an increasing number of foods and might be listed in the ingredient list under an unfamiliar name, such as benne, benne seed, benniseed, gingelly, gingelly oil, gingelly seeds, gomasio, halvah, seed paste, seed oil, sesamol, sesamolina, sesamum indicum, sim sim, tahini, and teel or til.
This is part of the background research that Janna and others were involved with when they reached out to food allergy families – where and how does sesame, one of the top 10 allergens labeled for in Canada already, hide and endanger an at-risk population? Sesame also hides under terms like “spices” or “natural flavorings” in food.
My statement in support of the petition is featured on page 13 as pictured below, I’ll also paste it in for easier reading but it gives a better idea of why I think this is such an important step:
September 21, 2014 H. W. Las Vegas, Nevada My daughter was diagnosed with multiple food allergies shortly after turning 1. She’d had reactions before the confirmation of her condition but it took time to isolate her triggers. She was initially allergic to peanut, tree nut, oat, sesame, corn, milk, egg, wheat, soy, and grape. This made cooking and shopping a challenge and it still is a challenge even though she did narrow her list after outgrowing a few allergies to peanut, tree nut, oat, and sesame. Having a “mainstream” allergy mixed with a “non-top-8” allergy makes a life of constant vigilance that much more challenging. You could say “just avoid the allergens” but when companies don’t have to disclose the presence of sesame or use the commonly understood name of sesame, things get tricky. 5+ years into our allergy journey I know how to pick up a product and hunt for the clues that tell me about the presence of something like sesame but even my food allergy mama sleuthing skills can’t see into the mind of a manufacturer that just lists “spices” as an ingredient. “Tahini,” or ground sesame paste, is another nebulous ingredient that I try to work on with my budding reader but which inhibits the ability of others to assist in keeping her safe. Which is to say that I may know that tahini equals sesame but a teacher or other parent may not know that. It really boils down to disclosure for our family – sesame is a fairly major allergen not being labeled for. No one is asking companies to stop using sesame in their products, just to let the consumer know that it is there. The precedent set by adding to labeling requirements will open the door for more transparency and safety for consumers in the United States. How do I teach my child to be responsible about her allergies if companies that make food products aren’t required to tell her the ingredients of their “spices” or that tahini lurks within. I distinctly remember buying tomato sauce and seeing that one variety had sesame. I was shocked and wondered if the absence of sesame on the other brands’ labels meant it was present and they didn’t feel obligated to tell anyone. The broader issue is not whether I’m going to walk out of the store with tomato sauce, it is that if we’re consenting to have food production so removed from the end user, we should be heard when we ask for assistance knowing whether we can safely provide a food product to our families.
What can you do?
Be sure to share the press release with others to raise awareness of non top 8 allergens. You can even share your own story of dealing with sesame or another allergen that isn’t mandated for labeling. More disclosure benefits all of us and may put companies on notice that they should take a step further than what is legally mandated already by FALCPA.
My daughter is reading labels as her reading skills improve, it is exciting and scary for me at the same time because she believes the things she reads (this goes back to the other work CSPI does about children and marketing) and relies on them. She does know that the next step is calling the company or emailing them to find out about other allergens and manufacturing practices and that will still be our norm, but maybe things can change.
Keep sharing also your own stories about living with food allergies with people in your community. Just as there are “teaching moments” when you spend time with a child, there are teachable moments in everyday conversation with others. We may each only be one person but you never know how far a message can spread!