Currently viewing the tag: "Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)"

Congress_purple-nightA bill named the “Food Labeling Modernization Act of 2015” was simultaneously introduced last week into the House as HR4061 and Senate as S2301. The legislation, sponsored by Rep Frank Pallone Jr (D-NJ) and Sen Richard Blumenthal (D-CT), is intended to “amend the Federal Food, Drug, and Cosmetic Act to strengthen requirements related to nutrient information on food labels, and for other purposes.”

One of the “other purposes” is to amend how allergens are treated with respect to labeling requirements. There are two specific changes that will help families better understand the allergen content of foods they buy.

First and foremost, the bill adds sesame to the list of the FALCPA Top 8 allergens: peanuts, tree nuts, milk, eggs, wheat, soy, fish, and crustacean shellfish. This implies that sesame – when an ingredient of a product – will need to be disclosed in plain English and may not be hidden in ambiguous terms like “spices” or “natural flavoring”.

Second, the bill mandates that for non-packaged foods, retailers must provide signage with the allergen disclosures that would normally be mandated on the package.

Taken together, these mandates are of enormous importance to the food allergy community. We at see anecdotal evidence that sesame allergy is skyrocketing amongst our readers based on the questions and feedback we receive, and better disclosure of the allergen content of foods is always welcome (though we continually caution our readers with severe food allergy to avoid unpackaged foods.)

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cspiAfter conducting an investigation into how sesame-allergic consumers can protect themselves, The Center for Science in the Public Interest (CSPI) issued a scathing report entitled “Open Sesame: Why Sesame Must Be Disclosed As an Allergen on Food Labels” and renewed calls upon the US Food and Drug Administration (FDA) to include sesame in their list of allergens that require special labeling.

Some background: An estimated 300,000-500,000 people in the US suffer from sesame allergy. Robert Wood, MD, Director of Pediatric Allergy and Immunology at Johns Hopkins University School of Medicine, is cited in the report as saying: “Sesame allergies have probably increased more than any other type of food allergy over the past 10 to 20 years. They’re now clearly one of the six or seven most common allergens in the U.S.”

The Food Allergy Labeling and Consumer Protection Act (FALCPA) mandates manufacturers clearly label when any of eight allergens (peanuts, tree nuts, eggs, milk, wheat, soy, fish, shellfish) are ingredients of a food product. Others, like sesame, can be listed under obscure names such as  “spices” or “natural flavoring”.

CSPI enlisted the help of families affected by sesame allergy to compile a list of companies that do not disclose sesame in ingredient lists or voluntary allergen statements. The organization then contacted companies on the list to inquire about their sesame disclosure practices.

The results were shocking: many of the companies contacted would not disclose the sesame content of their products even when responding to direct inquiries. The report states:

The prevalence of nondisclosure among food-makers we contacted suggests a pervasive and dangerous lack of information about a life-threatening risk for consumers. Indeed, of the dozens of food makers contacted, only three – Kraft, General Mills, and Mondelez – include sesame currently in allergen labeling for products. Some companies, like Frito-Lay, do not warn of sesame content on product packaging but will disclose sesame content if a consumer calls to request information. But many companies – including major food manufacturers that make dozens of products – do not disclose the presence of sesame on labels and will not tell a consumer if they ask for that information. The task of conducting meticulous research to determine whether foods are safe to eat is a risky system that should not be imposed upon the public.

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We received many questions regarding those “May contain…” type messages you find on labels after our Time article yesterday. With that in mind, here’s a 10 second quiz to see how well you know what those warnings really mean:

The following are allergen warnings you might find on a product that does not contain the allergen as an ingredient. Simply put them in order of safest to most risk that the product contains traces of the allergen:

A – May contain allergen
B – Manufactured in a facility that also processes allergen
C – Manufactured on equipment that also processes allergen
D – May contain traces of allergen
E – [No statement]

You have 10 seconds while we bring you this graphic. Go!

10sec test

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Time ArticleAn article by Markham Heid posted on Time’s website yesterday seeks to answer whether you can rely on those voluntary “May contain…” and “Manufactured on equipment that also processes…” warnings that appear on food products. We say voluntary because the FDA only requires that manufacturers disclose when a Top-8 allergen is an ingredient of a product, not when there is a danger of cross-contact with an allergen that is processed on the same equipment or in the same facility as the product.

While the article is well written, it may mislead the reader by giving the impression that you can rely on labels to determine whether a food product is safe because “no one is trying to hoodwink consumers—or expose someone with an allergy to a potentially harmful ingredient.”

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FDA BuildingOn Wednesday, three senate democrats issued a letter to the Food and Drug Administration (FDA) urging the authority to issue a rule requiring manufacturers to label for the presence of sesame.

Sesame – though it is estimated that several hundred thousand Americans are allergic to the seed – is not recognized as an allergen under current FALCPA labeling rules, and so is often hidden under other ingredient names such as “tahini” or “natural flavoring”.

To quote the letter issued by Senators Chris Murphy (D-CT), Richard Blumenthal (D-CT) and Edward Markey (D-MA):

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 (the Food Allergen Labeling and Consumer Protection Act of 2004), accurate and comprehensive allergen labeling is essential.

We at wholeheartedly endorse the senators’ efforts to have sesame added to the list of eight allergens recognized by FALCPA, currently peanuts, tree nuts, milk, eggs, wheat, soy, fish and shellfish.  We urge the FDA to also consider adding mustard and corn to the list as these are also major allergens that concern many families coping with food allergy.

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homawoodrumWe often receive questions regarding sesame labeling. Sesame is not considered an allergen under current FALCPA regulations and so is often hidden as “natural flavoring” on the ingredient label.

Considering how lax US label disclosures of the FDA’s “Top 8” allergens can be, those with sesame allergies have a much harder time finding foods that are safe for their dietary restrictions. And if feedback from our blog is any indication, the incidence of sesame allergy is skyrocketing.

Lobbying congress to modernize food labeling regulations is a long, involved process. Homa Woodrum, attorney, blogger, co-founder of the Food Allergy Bloggers Conference,  and mom to a daughter with numerous food allergies, wrote about her recent excursion to Washington DC as part of the Center for Science in the Public Interest’s campaign to require manufacturers to label for sesame as they do for the Top-8 allergens.

Her posting provides a wonderful day-in-the-life recount of an advocate fighting the good fight for changes to benefit the allergic community. If you ever wondered how the process works or considered joining the efforts currently underway to promote a more comprehensive allergen labeling regime, Homa’s article is well worth the read.

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One question we often field generally reads something like this:


This product has a statement that says “Contains: Wheat” but doesn’t mention anything about the peanut oil listed as an ingredient! If I wasn’t such a careful label reader I would have missed it entirely! Should I report them?

Irate in Indiana

To answer questions like Irate’s, we need to take a close look at a clause in Section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004 – often referred to as FALCPA, the law that mandates how food products must be labeled with regard to allergens.

Here’s the clause in question (with the emphasis ours):

The term `major food allergen’ means any of the following:

(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.

(2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following:

(A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil.

(B) A food ingredient that is exempt under paragraph (6) or (7) of section 403(w).”.

So highly refined oils are exempt from the allergen labeling regulations mandated by FALCPA.

VioletWell, we know the Dowager Countess of Grantham (our favorite character from Downton Abbey) is highly refined, but what exactly are highly refined oils and why are they treated differently from the foods from which they are derived?

In a nutshell, highly refined oils are edible oils “resulting from a process that involves de-gumming, neutralizing, bleaching, and deodorizing the oils extracted from plant-based starting materials such as soybeans and peanuts.”

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The label… although it provides important nutritional data, it’s wholly unreliable as a source of potential allergen information due to lax, ineffectual FALCPA labeling guidelines.

Complete disclosure of the potential for allergen cross-contact is a necessity for the millions of Americans suffering with food allergies and celiac disease. But in light of FALCPA’s shortcomings, assembling that kind of information means ignoring the label, rolling up our sleeves, and working directly with responsible manufacturers who are as concerned for the food allergy community as we are.

That’s why we established the Manufacturer PartnershipWe’ve assembled more than 40 manufacturers that provide us with detailed information regarding the processing of 11 allergens and 4 industry recognized certifications, and we provide that information to you in turn via Allergence, a free service.

Here’s an example listing of a peanut butter alternative from Don’t Go Nuts, one of our featured partners:


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FDA Logo

Earlier this week, the US Food and Drug Administration (FDA) published a consumer update entitled “Finding Food Allergens Where They Shouldn’t Be“, a must read if you have food allergies or care for someone who does. (Click here to see the publication.)

The update warns that “undeclared allergens” – allergens that are not listed on the label as an ingredient but should be – are the leading cause of food recalls initiated by the FDA.

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As the start of the school year approaches, we receive many inquiries about the Safe Snack Guide from parents, teachers, school nurses and PTA organizations as they search for solutions to help implement nut-free classroom policies.

Here follows a collection of the most frequently asked questions complete with answers.

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