It should be no surprise that attention to detail increases our chances of success in the gluten-free lifestyle. After all, something measured in parts per million rearranges our lives. Talk about little things making big things happen. Coach Wooden’s words take on a whole new meaning for those with a gluten-related disorder.
Knowing what's in our food is probably one of the most important details. President Theodore Roosevelt signed into law the Pure Food and Drugs Act of 1906. Known as the Wiley Act, it gave the federal government the power deem a food “misbranded” if ingredients were “false or misleading,” or deemed “adulterated” if it contained ingredients harmful to health. Sadly, it would take nearly a century before the presence of food allergens would be recognized. A decade later, gluten-free regulations finally make it on the books.
The Protection Agencies
Only a few different governmental agencies regulate food safety. In this article, we’ll be discussing the US Food and Drug Administration (FDA) and the US Dept. of Agriculture (USDA). The US Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates beverage alcohol [as in gluten-free beer]. Sorry beer lovers, we won’t be getting into those regulations in this article.
FDA vs. USDA
The FDA regulates most packaged foods we see on the store shelves. The USDA regulates meat, poultry and egg products, and mixed food products that contain more than three percent raw meat or two percent or more cooked meat or poultry (e.g., soups, chilis, frozen entrees).
While USDA regulated products are encouraged to follow FDA regulations, it is not required. [This is valuable information to know when it comes to reading ingredient lists. More on this later.]
Estimates show that 80% to 90% of USDA products voluntarily comply. If you see a “Contains” statement or other indication of a USDA product, major food allergen will be plainly listed.
FDA & the Top 8 Food Allergens
The FDA’s Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires food labels to clearly identify the food source names of all major food allergens used to make the food. They must use the common or usual name of an ingredient [e.g., Modified Food Starch (wheat)} or use a “Contains” statement next to the ingredient list. [e.g., Contains Wheat, and Milk]
What are the major allergens as defined by the FDA?
- Fish (bass, flounder, cod)
- Crustacean shellfish (crab, lobster, shrimp)
- Tree nuts (almonds, walnuts, pecans)
- Wheat (including all types: durum, spelt, emmer, farina, farro, einkorn)
Source FDA: http://bit.ly/FDA-Big8
You’ll notice the Top 8 list above only includes wheat. It does not include gluten-containing ingredients barley (malt), rye, or oats*. Fortunately, barley is most commonly listed as “barley," "barley malt," or simply “malt”. Rye is rarely used in a form other than flour and would appear in the ingredient list.
*Oats (and products that contain them) that are not explicitly certified or labeled gluten-free are off-limits to anyone following a gluten-free diet. They are a high-risk ingredient because they are exposed to substantial amounts of gluten via cross-contact from field to packagings. Oats require additional knowledge and careful consideration.
The Ingredient Label
The ingredient label is your frontline defense in determining the gluten-free status of a product. An important fact to know: FALCPA labeling regulations do not apply to the potential or inadvertent presence of food allergens resulting from cross contact. Cross-contamination of a food or ingredient can occur at harvest, transport, manufacturing, or packaging. Calling the manufacturer may be required not only for ingredient clarification but also to determine manufacturing practices.
Cross-contact and Good Manufacturing Practices
Manufacturers are encouraged [not required] to follow Current Good Manufacturing Practices (CGMP). Part of CGMP means developing and executing food allergen control plans. The plan must address six elements: training of processing and supervisory personnel, segregation of food allergens during storage and handling, validated cleaning procedures for food contact equipment, prevention of cross-contact during processing, product label review and label usage and control, and a supplier control program for ingredients and labels.
Voluntary Allergen Advisory Statements
Gluten-free experts and third-party testing tell us Food Allergen Advisory statements are not useful in determining the gluten-free status of a product.
You may find a product labeled “Gluten-Free and/or Wheat-Free” or even bears a GFCO gluten-free certification logo that has a Food Allergen Advisory statement that includes wheat. Yes, this product complies with current FALCPA labeling laws.
For products not certified gluten-free, call the manufacturer to ask questions. Ask about the facilities, the production lines, and their policies, procedures for allergen handling, and testing protocols. If they do not answer the questions to your satisfaction, find another manufacturer with a similar product that does meet your needs.
The Definition of Gluten-Free
As we discussed above, FALCPA does not directly address gluten. Before the FDA could create regulations regarding “gluten-free,” they needed to define what “gluten-free” means. It took ten years for the definition to finalize, but the voluntary gluten-free labeling regulation went into effect August 5th, 2014.
The FDA’s definition of “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” is as follows:
“…the food either is inherently gluten free; or does not contain an ingredient that is: 1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.”
Notice the last sentence of the definition: "Also, any unavoidable presence of gluten in the food must be less than 20 ppm.” This means cross-contact.
I hear you…
“Whoa, this is confusing and complicated. Isn't there an App?"
Websites, published lists, and apps that report a product's gluten-free status are excellent tools to help narrow down product selection. Please do not use them as the sole means to determine the gluten-free status.
Companies change product ingredients at will, generally without notice. The product label will reflect any ingredient changes. Most companies will refer you to the ingredient list found on the product for the most up to date information. A published list (on paper or electronic form) is only as accurate as its most recent update.
Reading the label. Finally!
- Look for a third-party gluten-free certification mark - like GFCO's.
- Gluten-Free Certification Organization requires all finished products and individual ingredients using the GFCO logo contain 10 parts per million or less of gluten.
- Know your certification organizations. When companies mark their products as GF it may appear as if they are actually certified. It might simply be a logo from their marketing or package design department.
- Read the ingredient list. Yes, even certified products. If you see any of following ingredients, the product is not gluten-free.
- Wheat (including durum, spelt, emmer, farina, farro, einkorn)
- Oats (unless certified gluten-free)
- Brewer's Yeast
- Ingredients needing verification:
- Yeast Extract - this could be a by-product of the beer brewing process. Verify with manufacturer in non-GF labeled products.
- Vinegar - FDA defines the single word "vinegar" to mean apple cider vinegar. However through the certification process, GFCO has encountered some usages of malt vinegar labeled as "vinegar". Remember barley/malt is not required to be disclosed. Not a large area of concern, but if you are unfamiliar with a manufacturer or product, it might be a good idea to inquire about the source of their vinegar. Better safe than sorry.
- USDA Products - Products are not required to comply with FDA's FALCPA regulations. If you see a "Contains" statement (or some other wording) that a package is complying with FALCPA, you know wheat must be declared. If you do not see a "Contains" statement, you'll need to verify the source of these ingredients (they could come from wheat):
- Food Starch
- Modified Food Starch
You’ve made it! I hope I’ve increased your knowledge on this multi-layered subject.
11/14/18 - Added Confusing Ingredients
04/15/18 - Added AllergicLiving.com article from Gina Clowes
May Contain, Manufactured in a facility, etc
Voluntary Food Allergen Advisory Statements
Updated March 30th 2018
I've added the Allergen Advisory Statements Study that was published in Sept. 2016.
You may find a product labeled “Gluten-Free and Wheat-Free” that bears a GFCO gluten-free certification logo, but, it also has a “May contain traces of” statement that includes wheat. WHOA!
Believe it or not, this product is in compliance with current FDA Food Allergen Labeling and consumer Protection Act of 2004 (FALCPA) labeling laws. “May Contain”, “Processed in the same facility as”, or “Processed on the same equipment as” are known as Food Allergen Advisory statements. They are voluntary and are not regulated, unlike the required “Contains” statement for food allergen ingredients. According to the FDA, companies may use advisory statements as long as they are “truthful and not misleading”.
For years, the gluten-free community has been warned about using advisory statements for determining the gluten-free status. Their usefulness is diminished due to the lack of definition and regulation.
We covered this information in our March 19th 2011 newsletter and meeting, but it bears repeating. In 2010, HealthNow hosted their 2nd Annual Gluten Sensitivity & Celiac Forum. Cynthia Kupper, RD, GIG Executive Director was a featured speaker. She was asked this question during her Q&A session:
Q: The ingredient list contains no gluten, but there's a statement about “Processed in the same facility as...”or “Processed on the same equipment as...” what do you do? A: That’s a voluntary advisory statement designed for people with IgE allergies. Many companies use it as a “CYA”. No meaning for celiacs. A group of RD's determined that it would reckless of them to suggest that statement should be used to determine gluten-free status. If you have an IgE (anaphylactic reaction), you need to think about it.A "Contains..." statement is an allergen statement and required by law. "May Contain" is not an allergen statement.”
Source: 2010 HealthNow Gluten Sensitivity & Celiac Forum DVD
Check out this example of Aldi's Baker's Corner Instant Pudding. After the ingredient list, you'll see a statement that reads: "MANUFACTURED IN A FACILITY THAT USES TREE NUTS, SOY, MILK, AND WHEAT."
Update: While it may still be gluten-free, this product is no longer labeled gluten-free.
I reached out to Aldi's to ask about this product. On May 15th, 2015, the Quality Control Supervisor from Subco Foods in Sheboygan, WI (the company that does the pudding) called me. I asked about the production lines for this product - did they run any gluten products on this line?
Tamela’s answer was very thorough! The pudding lines are dedicated - only pudding is done on them - nothing else - no gluten. They test raw materials for gluten coming into the plant - they test during production and they also send samples out to a private lab for finished product testing. Between pudding flavor runs (vanilla/chocolate/etc), they follow a strict teardown and cleaning process. They are very serious about food allergens.
Also the pudding lines are isolated from their jello lines. She said they do not want dairy getting into the jello lines.
So, what do we do with products like this? Call the manufacturer to ask questions. Ask about the facilities, the production lines, and their policies and procedures for allergen handling. If they do not answer the questions to your satisfaction, find another manufacturer with a similar product that does meet your needs.
Building upon their 2016 paper [see below], Tricia Thompson, Amy Keller, and Trisha B. Lyons published "When foods contain both a gluten-free claim and an allergen advisory statement for wheat: should consumers be concerned?" on March 26, 2018 in the European Journal of Clinical Nutrition.
This retrospective database analysis included a total of 328 gluten-free labeled products previously tested for gluten content by Gluten-Free Watchdog.
Here's what they found…
On the basis of this retrospective data analysis, the use of allergen advisory statements (regardless of type) on foods labeled gluten-free was not indicative that a food was out of compliance with the gluten-free label ing rule. Due to the current lack of federal regulations for allergen advisory statements, consumers with celiac disease and other gluten-related disorders should not make gluten-free purchasing decisions based solely on the presence or absence of an allergen advisory statement for wheat.
One issue that may be causing mistrust among gluten-free consumers when products contain both a gluten-free claim and a precautionary statement for wheat is the lack of required testing for foods labeled gluten-free. In the US,while foods must contain <20 p.p.m. of gluten to be labeled gluten-free, testing is not included in the FDA’s codiﬁed rule.
Increased education is needed to advise consumers that a gluten-free claim applies to gluten that may be in a product due to ingredients and cross-contact. Under the gluten-free labeling rule, a gluten-free claim on product packaging means the food must comply with all criteria of the rule,including containing <20 p.p.m. of gluten. This is true regardless of the presence or absence of an allergen advisory statement for wheat .
When combining the results of both studies…
4/45 (9%) products that DID include an allergen advisory statement for wheat or gluten on product packaging contained quantifiable gluten.
52/384 (14%) products that did NOT include an allergen advisory statement for wheat or gluten on product packaging contained quantifiable gluten.
The FDA should strongly consider regulating allergen advisory statements, especially in light of the Food Safety Modernization Act.
Tricia Thompson, Trisha B. Lyons, and Amy Jones analyzed allergen advisory statements of 101 products previously tested for gluten content by Gluten-Free Watchdog. These products were not labeled gluten-free, however the ingredient list did not include any gluten containing ingredients (no wheat, barley, rye, malt, or brewers yeast).
On September 14th 2016, they published Allergen Advisory Statements for Wheat: NOT a Useful Predictor of Gluten Content.
Here's what they found…
In this database review, precautionary labeling for wheat or gluten on products not labeled gluten-free but appearing to be free of gluten-containing ingredients was NOT a useful predictor of gluten content. In some cases, consumer reliance on precautionary statements for wheat or gluten could have resulted in choosing a product contaminated with gluten.
• 87/101 (86%) products tested for gluten did NOT include an allergen advisory statement for wheat or gluten on product packaging.
• Fourteen products (14%) tested for gluten DID include an allergen advisory statement for wheat or gluten on product packaging.
• Of the 87 products that did NOT include an advisory statement, 13 (15%) contained quantifiable gluten at or above 5 ppm including 4 products (5%) that tested at or above 20 ppm of gluten.
• Of the 14 products that DID include an advisory statement, only 1 (7%) contained quantifiable gluten at or above 5 ppm.
On the basis of this analysis, the current use of allergen advisory statements for wheat or gluten are not useful predictors of whether or not a single or multi-ingredient food product contains 20 or more p.p.m. of gluten. Precautionary statements should be regulated and standardized so that they are helpful to the consumer.
In terms of foods labeled gluten-free, consumers are advised to trust the label regardless of allergen advisory statements for wheat or gluten. This is due to the gluten-free labeling rule applying to both gluten in ingredients and gluten that may be found in a product due to cross contact. However, when it comes to foods not labeled gluten-free but appearing to be "gluten-free" based on ingredients, there are no established guidelines for individuals with celiac disease on whether they should avoid products with allergen advisory statements for wheat or gluten.
Increased education is also required to let consumers know that FALCPA includes ingredients only and does not include allergens that may be in a product unintentionally due to cross contact. Increased education is also needed to let consumers know that a gluten-free label applies to gluten that may be in a product due to ingredients and cross contact and that regardless of the source of gluten the product must contain less than 20 p.p.m. gluten.
To learn more about this confusing matter, please watch these excellent Q&A videos from Gluten-Free Watchdog.
3/30/18 - Updated to include "When foods contain both a gluten-free claim and an allergen advisory statement for wheat…" paper
10/20/16 - Updated to include "Allergen advisory statements for wheat: do they help US consumers with celiac disease make safe food choices?"