FDA outlines when firms do not need to label major food allergens

By Elizabeth Crawford contact

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FDA outlines when firms do not need to label major food allergens

Related tags: Food allergy

Manufacturers do not need to label major food allergens if they can prove to FDA prior to distribution that the production process eliminates allergenic proteins from the product or that the allergen is in such a low amount that it does not pose a risk, the agency says in guidance published June 18.

The guidance​ outlines two options for obtaining an exception for labeling a major food allergen: a petition and a notification. If the agency does not approve either of these then, according to the Food Allergen Labeling and Consumer Protection Act of 2004, manufacturers must label with the common name the presence of milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. 

FDA acknowledges that labeling already is unnecessary if an ingredient from a major food allergen does not contain protein from the allergenic food. For example, highly refined oil from a major allergen does not need to be labeled. If, however, protein is present, manufacturers should consult with FDA about whether a petition or notification is the best way to obtain an exemption and what specific scientific evidence should be included.

Generally speaking, manufacturers seeking an exemption should opt for a petition if allergenic proteins are present, but are in such low doses that they do not pose a threat, according to the guidance.

A notification is a better bet if the ingredient contains proteins from a major food allergen, but not the allergenic proteins, the guidance says.

What to include

Regardless whether a manufacturer chooses to submit a notification or petition, both methods must describe:

  • The ingredient, including its name, the food allergen from which it is sourced, chemical and biological properties, related food standards, its compensation and batch-to-batch variations and methods for determining its composition.
  • The preparation of the ingredient, such as physical, temperature and chemical treatments, growth conditions and bioengineering process.
  • The protein’s characterization, including the amount present and variation amounts.
  • The ingredient’s application, such as the amount to be used in products.

Petitions also must include expected consumption levels by different consumer groups and clinical evidence via oral provocation studies, skin prick tests or in vitro studies that show there is no allergenic reaction risk.

Notifications also must include proof the ingredient does not contain the allergenic protein, according to the guidance, which suggests in vivo or in vitro clinical data.

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6 comments

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FDA News.. states more available foods, if manufactures can develop products that do not have allergens by scientific evidence that has been since 2004? Both links are below.. Sorry Concerned and Confused..?

Posted by Julianne DeNicola,

Same as prior link is folling this one... very confusing to me, might be to others.. the actual news states the same as the Act 2004? they have to prove with scientific evidence that the allergen is removed to even get an exemption..

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm446273.htm

see #15 and 16 these have been part of the act all along... ?

Link below.. I just need to understand what your article is about that is NEW information..

http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/allergens/ucm106890.htm

They would have to provide proof of scientific fact that there is an allergen. What I know about the current FDA measures, they are still asking for guidance in reviewing allergens themselves.

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Sources of your article.. you are not the FDA or governing agency just an opinion or FACT Please Concerned Parents need clarification PLEASE !!!

Posted by Julianne DeNicola,

I am having a hard time finding any such information as you are outlining that would be New ? The only information that I see regards to the labeling of foods are set dates? Rulings on the changes for Trans Fats but nothing regarding allergens, the allergens on their website is of the same safety act as they had been, can you clarify the source of your data and the base of your article? If we shout that they are leading us in the wrong direction and complain, to the FDA as a food allergy mom, I would like sound solid facts from the source of you information, since I do not see such when reviewing the FDA regulations and final acts... I know media can post as they feel but when it comes to such type of articles and it can be a NEW act and change, To alarm parents and their children, I would ask for facts, not opionon based on all along procedures.. Where is the new compliance I o not see it anywhere, the last was back in Dec 2014 in which only states trans fats.. thank you.. I just want to get facts before we have our mothers and fathers fighting for safer labels when nothing but an article, written might be of old source data... http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm425647.htm

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Unacceptable, dangerous practice that needs to change

Posted by Jennifer,

The fact is that ANY amount of an allergen, regardless of how small, is allowed to be present without requiring declaration on the label is a dangerous practice that leaves room for major errors which threaten the health of an allergic person who may have relied on labeling to determine the safety of a particular product. Consumers have the right to make an educated decision about a product, especially when their health, and often times their life, is at stake. The "safe" amount of an allergen is a threshold that varies person to person, and differs from one reaction to the next. The threshold should be zero, AND if the allergen is present in the facility of any manufacturing facility (including the sources of the listed ingredients), then the label should indicate that so that the decision of whether a product is safe or not is up to the actual consumer and their physician, NOT the government and manufacturer whose common interest is the money to be made off a product. Bottom line is that, with food allergies on the rise, if a company cannot be forthcoming about manufacturing conditions and practices due to a technicality in the law that allows them to be evasive about cross contamination (easily determined by calling or emailing any mfg customer service and asking a few simple questions), then they lack integrity and won't get my business. At least the ones who do label well allow me to make the decision for myself whether a product is safe for my allergic children or not.

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