Survey on Thresholds from FARE

[LinksEtc]

Comment from Food Allergy Research and Education FARE

FDA-2012-N-0711-0059

FARE has decided to answer questions 1, 2 and 7 posed by the FDA; we feel that
our areas of expertise are best suited to those questions.

FARE urges FDA to first engage in outreach to the food allergy community to explain how
thresholds would affect families who live with food allergies, and then engage in notice and
comment rulemaking to establish any thresholds.

FARE urges FDA to use its authority under the misbranding provisions of Sec. 403 of the Food Drug and Cosmetic
Act to publish regulations that protect food allergic consumers from confusing and misleading
statements about allergens on food labels.

FDA should specify a small number of cautionary statements
with clearly defined, consistently-applied meanings to indicate whether a processed food that is
not intended to contain major food allergens may contain them due to manufacturing
processes. FARE would be pleased to work with FDA to develop specific language suggestions,
because accurate labeling is critical to allow consumers managing food allergies to make an
informed and safe choice about the products they purchase and feed to their families.

FARE encourages rigorous application of
preventive controls to eliminate the unintended presence of allergens in foods which might
reduce the need for cautionary labeling.

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

ETA this link also

"Can we establish safe allergen thresholds in foods? What does the current science say?"
http://foodallergysleuth.blogspot.com/2013/02/can-we-establish-safe-allergen.html

I especially like the conclusion.

[CMdeux]

Grocery Manufacturers Association GMA

FDA-2012-N-0711-0063

Moreover, GMA and the food associations who have joined this letter believe that the Agency should not require any recalls for packaged food products that may contain trace amounts of an undeclared allergen at or below the established threshold as the risk to human health would be extremely low.

This comment alone ought to give the FDA pause in considering any other commentary from GMA.

Because they are quite deliberately sidestepping any responsibility to allergic consumers by conflating risk to the GENERAL population ('extremely low') and that to highly sensitive allergic consumers (moderate to very high).

This suggests that they genuinely have no compunction about killing allergic consumers-- that some people don't, I don't know-- deserve (?) to be able to rely upon food safety and labels.



The notion that oils are hypoallergenic is also based on sampling methodology which is highly suspect, as the working group tasked with threshold determination back in 2004 rapidly discovered.  Those with the lowest thresholds are at greatest RISK OF FATALITY-- not just in a dose dependent manner, as one might anticipate, but in a non-linear fashion as well.

For those people, there may really not be a threshold above the current limit of determination.  I daresay that with sesame, cashew, and peanut in particular, there may not be a threshold above the limit of detection. 

What is problematic about ANY establishment of threshold for 'food safety/labeling' requirements is that it is based upon a confidence interval. 

That means that SOME of the most vulnerable population (that is, those very low-threshold allergic consumers) is going to be thrown under the bus.  The only real question is-- how many of them?

We don't even know the answer to this-- because there has never been a systematic effort to determine threshold for a wide enough swathe of clinical patients.  Those WILLING to undergo DBPCFC's are not necessarily a good population sample for the whole population, and good luck getting an IRB approval to do an oral challenge on a child who has been intubated after a skin prick test.

THAT end of the sensitivity spectrum is an unknown and undefined population.  It just is.  There's no way to get a good profile of those people without risking death for a few of them in the process.

So the real question is...

how badly do we want to know?  What's it worth to us as a community?

[LinksEtc]

Those with the lowest thresholds are at greatest RISK OF FATALITY-- not just in a dose dependent manner, as one might anticipate, but in a non-linear fashion as well.

Another FARRP quote

Previously, we have demonstrated for peanut that patients with
histories of severe allergic reactions do not have lower thresholds by comparison to peanut-allergic
patients without such histories (Taylor et al., 2010).

[CMdeux]

Ahhhhh-- but that isn't the same thing.


Low threshold = severe reactions

is not the same as saying

severe reactions == low thresholds.

Those can be independent statements.  The reason is that very few people are on that 'highly sensitive' tail of the allergic population to start with.

  That is, those with very low thresholds for reactivity MAY be a different group which is composed of "severe reacting" individuals, and it still wouldn't skew the overall distribution if you looked at the larger group "people who have had severe reactions" since that group of people is VERY much larger than the 2-3% of lowest threshold individuals...

and it seems to be true that those people have really severe reactions to traces and have drifting thresholds  (I'll dig out source material later, but it's in the FDA's working group's report), but they are a very difficult group to study. 

There may well be those with severe reaction history who require higher thresholds... but I'm suggesting that they are the minority in the 'regular' allergic populations.  That is, that they may be "average" in threshold dose but not in terms of reaction severity... but that doesn't make them typical of the low-threshold group that is impacted by threshold decisions in food labeling.

We really DO NOT know much about that group.

But-- again, the sampling conundrum.  In any such study, you are required to do informed consent, and the participants have to be informed of RISKS.  If you can't sample randomly and include everyone you select, then your sample is not exactly representative to begin with.



People who have really severe histories from really tiny trace exposures are simply not going to get approval to participate in challenges, and they probably aren't going to volunteer, either.  They'll self-select OUT of such studies, which just goes to demonstrate that the Taylor study was a tremendous waste of resources, frankly.  But I suppose on the one hand it was a success, since it showed exactly what the prinicipal investigator has always hoped is true.



 

[Janelle205]

I took benadryl and pain killers, so I'm worried that this is going to seem mangled, but I'm trying.

Going along with what CM said:

I know that I am a statistical outlier.  My doctor and I laughed yesterday when he said "What is it like to be you?"

Not only does threshold level and reaction severity not necessarily correlate among the population, it also doesn't necessarily correlate within a person.

I have had severe reactions to tiny amounts of one allergen - anaphylaxis from what we assume was contact ingestion.  I have also had severe reactions to a different allergen which I directly ingested a lot more before I started reacting.


I'm not sure what that means for the population overall, but I just wanted to share.  I can have skin exposure to a small amount of very processed apple and have a serious reaction.  I could probably eat a pan of scrambled eggs and just end up with a few hives, eczema, and a stomach ache.  (Ok, I might throw up, but that is probably more because I think that eggs are gross.)

[CMdeux]

The reason that throwing THAT population of food allergic people under the bus makes me so mad?

(Aside from the fact that my DD is probably in that group with peanut, anyway.)

Because they are the group that already faces the greatest limitation and risk in their daily lives.  Nothing like having their own patient advocacy group and government tell them "you're outliers.  Your safety doesn't matter."

How many of those people is it okay to give the giant kiss-off to, anyway?

Are only some allergens special that way?

Like I said-- we. don't. know.

As long as we don't know the answer to that question, this strikes me as being much like the treatment that sesame allergy has gotten by the FDA.  If they don't have the data, then it must not be important, right? 

 

[Janelle205]

Are only some allergens special that way?

Like I said-- we. don't. know.

I doubt it.  Apples are on almost every 'least allergenic foods' list out there.  And I react to them in ways that really do not seem possible, except that it has happened, so it has to be.

[CMdeux]

I doubt it, too.  The very very few studies that exist on 'how little is enough' suggest that some allergens have thresholds that are really, really, really low for some individuals...

but the N's are so small in those studies that it could quite easily be true that they only capture the central two standard deviations, and not the actual tails of the sensitivity distribution.  The ones that I'm familiar with that use good experimental design tend to report that some individuals report subjective symptoms from the lowest doses in the range.

Clinicians know that these people exist.  They know because they see them.  Not every outlier gets a write-up in a medical journal, because their doctors are busy being-- well, clinicians.

Besides, the extant studies do NOT include many common allergens that are-- just anecdotally-- thought to not be life-threatening at trace levels-- things like soy, wheat, and non-seed allergens outside of the top 8.  Obviously they ARE life-threatening for some people, as you do occasionally hear reports of fatalities, particularly outside the top 8.  One of the saddest allergy fatality tales I've ever heard is of the young mum in the UK who died after opening a can of tomatoes in order to make her children a meal.  SHE clearly had a pretty low threshold-- and was possibly taken by surprise by just how low?-- and to an allergen that "shouldn't" be possible.

[twinturbo]

Apple as an allergen is almost always associated with birch sensitivity, which while not a food allergen is a major or common environmental allergen, and even with environmental allergy immunotherapy there is a risk for anaphylaxis as most places won't deliver the interval 'shots' without the patient bringing their EAI with them in conjunction to a 30 min office wait post-injection.

Whereas peanut, milk, etc tend to be primary stand alone allergens fruits seem to start with common pollen allergens. Janelle and I happen to be a couple of outliers that anaphylax and even then there's a couple standard deviations between my reactions and Janelle's. Our birch sensitization may be similar, however.

But yeah, highlight and underscore everything CM wrote better than I could about when papers become unread, unquestioned, misinterpreted absolute truth.

[LinksEtc]

An older related thread:

http://allergy.hyperboards.com/action/view_topic/topic_id/17461

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http://allergicliving.com/index.php/2013/12/30/is-peanut-oil-safe-or-not/

If your allergist is comfortable with you consuming refined peanut oil, then you will need to take great care to ensure that you use only products with this type of oil. This will likely involve contacting a manufacturer or restaurant chain, and checking each time.

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Food Allergy Research & Resource Program, University of Nebraska
FDA-2012-N-0711-0053

In the passage of FALCPA, Congress wisely exempted highly refined oils likely because of good evidence that highly refined peanut and soybean oils were safe for ingestion by peanut- and soybean-allergic individuals (Hourihane et al., 1997; Bush et al., 1985). Highly refined oils contain virtually no detectable protein with the protein being largely removed by the refining process (Rigby et al., 2011).

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Peanut Threshold Study

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http://www.namamillers.org/wp-content/uploads/2013/06/4-Stephen-Taylor-2013.pdf

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http://ohmahdeehness.wordpress.com/2014/03/12/shared-equipment-facilities-and-food-allergy/

This month's Food Allergy Buzz Blog Carnival theme is cross contamination

Somewhere between a company deciding whether a trace amount is too small to disclose (see above) or a company that makes a blanket warning on a single ingredient item (see above also), I think there needs to be a real discussion about labeling and disclosure not just for the benefit of food allergic families but all who wish to know what they're eating.

[spacecanada]

Great finds, Links! Nowhere, though, does it mention what would happen if a sensitive individual ate multiple servings of a product containing 0.1 mg of peanut, pushing that dose up to 1+ mg, which could cause a reaction.  Someone eating a whole box of cereal in a day, for instance, or half a box of cookies.  (I'm guilty of both!)  Or simply various foods throughout the day that may have 0.1 mg in them, but combined over the day create a much higher dose?  Why is this simple real world situation being ignored?

[rebekahc]

Or, to piggyback on SpaceCanada's example...  What if I get all the contaminated pieces of cereal (or whatever) in my one serving?  How do they determine the level of contamination per serving?  There's X mg of contamination per batch, a batch = Y servings therefore there's Z mg contamination per serving? That may work mathematically, but that's not the way contamination works.  One peanut per batch is very low contamination per serving but I'd hate to get the serving that actually has the peanut.  I'm thinking the food industry will treat contamination the same way they do trans-fat (manipulating the math to say there's 0g trans-fat when that's not really true -especially if you eat more than one serving).

[LinksEtc]

I am up too late tonight 


"Precautionary labelling of foods for allergen content: are we ready for a global framework?"
http://www.waojournal.org/content/7/1/10

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