Action Alert: Notifying the FDA about Misbranded Gluten-Free Products

Action Alert: Notifying the FDA about Misbranded Gluten-Free Products

Last week the following question was posted on Gluten Free Watchdog’s Facebook page, “How will mislabeled foods be policed?” My answer to this question was, “By you, and me, and the entire Gluten Free Watchdog community (aka Gluten Free Watchdog Posse).”

A former consumer safety officer with the Food and Drug Administration (FDA) indicated during an Academy of Nutrition and Dietetics Webinar that it would take a pattern of complaints (ie more than one) before the FDA would investigate a product. As a community, we must make sure that the FDA receives as many complaints as possible for every product we believe is misbranded.

Labeling issues

To this end, now that August 5th 2014 has almost arrived, there are a few labeling issues to start thinking about in earnest. Once this date is upon us, foods labeled gluten-free and regulated by the Food and Drug Administration (FDA) must be in compliance with the gluten-free labeling rule.

There are three main areas where misbranding of labeled gluten-free foods may occur:

  1. Incomplete wording
  2. Use of ingredients not allowed
  3. Gluten content at or above 20 parts per million

The Gluten Free Watchdog community can help provide information to the FDA in all three areas. After August 5th, if you come across any of the scenarios detailed below under “Incorrect Labeling” or “Use of Ingredients not Allowed,” please email me (you will NOT be publicly identified). Please provide the name of the product, photos of the product that include the gluten-free label and ingredients list, and the name/location of the store where you purchased or came across the product.  Product information will be posted on Gluten Free Watchdog’s Facebook page and instructions on how to contact the FDA will be provided.

In general if you feel a product has made you sick, please contact the Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System at 240-402-2405.

If you come across a food you feel may be misbranded please contact a Consumer Complaint Coordinator http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/.

When a Consumer Complaint Coordinator is contacted, a lot of information will likely be requested. More will be posted about this later but it is best to record as much information as possible, either in writing or pictures or both. This information should include:

  • UPC bar code number
  • Best by date
  • Date of purchase
  • Place of purchase

Specific areas of misbranding

Please watch for the following:

Incomplete Wording

Please notify Gluten Free Watchdog if you come across the following:

  1. A product that includes the word “wheat” in the ingredients list (eg, wheat starch) or “Contains” statement IF the word “wheat” is not immediately followed by an asterisk (or other symbol) and the following wording is NOT included on the product packaging, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”
    1. Note: The above does NOT apply to “May Contain” statements. HOWEVER, please let Gluten Free Watchdog know about these products as they may need to be tested for gluten contamination.

If a product is incorrectly labeled, consumers can report this information to an FDA Consumer Complaint Coordinator in the state where the food was purchased or is being sold.

A list of FDA Consumer Complaint Coordinators is posted at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/

To help Gluten Free Watchdog notify consumers regarding who to contact, please send photos of the product clearly showing the ingredients list and the gluten-free label (note: photos will be posted to Facebook but your personal information—name, etc–will remain confidential). Please also include the store name and location (city and state) in your email. If you purchased the product, please send along a copy of the receipt clearly showing the date of purchase.

Use of Ingredients NOT Allowed

Please notify Gluten Free Watchdog if you come across a food labeled gluten-free that includes any of the following in the ingredients list:

  1. “Malt”
  2. “Malt syrup”
  3. “Malt extract”

Please also contact Gluten Free Watchdog if you come across any product with the following ingredients (clarification may be required from FDA regarding whether these ingredients are allowed):

  1. Extracts of rye
  2. Extracts of barley
  3. Hydrolyzed wheat protein
  4. Hydrolyzed barley protein

Note: This section will be updated once FDA releases information on how they plan to handle foods/ingredients that are hydrolyzed/fermented.

If a product contains ingredients not allowed in gluten-free foods, consumers can report this information to an FDA Consumer Complaint Coordinator in the state where the food was purchased or is being sold.

A list of FDA Consumer Complaint Coordinators is posted at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/

To help Gluten Free Watchdog notify consumers regarding who to contact, please send photos of the product clearly showing the ingredients lists and the gluten-free label (note: photos will be posted to Facebook but your personal information—name, etc–will remain confidential). Please also include the store name and location (city and state) in your email. If you purchased the product, please send along a copy of the receipt clearly showing the date of purchase.

Gluten Content at or above 20 ppm Gluten

Subscribers to the Gluten Free Watchdog testing site (www.glutenfreewatchdog.org) will be notified of products testing at or above 20 ppm gluten via weekly product reports. In addition, an email will be sent out letting subscribers know who to contact if they feel a product made them sick. This email will also let subscribers know where the product was purchased so that a Consumer Complaint Coordinator can be notified.

FOR ALL OF THE ABOVE MISBRANDING ISSUES, GLUTEN FREE WATCHDOG WILL CONTINUE TO CONTACT THE FDA DIRECTLY. BUT THIS IS NOT ENOUGH. IF WE WANT FDA TO ACT AND ACT QUICKLY WE ALL MUST MAKE OUR VOICES HEARD AS LOUDLY AS POSSIBLE.

Examples of gluten-free labeling misbranding

What follows are two examples of labels that will be considered misbranded after August 5, 2014. These examples are based on actual products available before the FDA’s compliance date. However, the ingredients list of each product has been changed slightly for simplicity.

Example 1:

Labeling Claim: Gluten-Free

Ingredients: Glucose syrup, Sugar, Gelatin, Citric acid, Natural flavors, Vegetable oil (coconut), Carnauba wax, Turmeric oleoresin, Vegetable juice, Paprika extract, Wheat starch

Contains: coconut, wheat

What this label should look like:

Labeling Claim: Gluten-Free

Ingredients: Glucose syrup, Sugar, Gelatin, Citric acid, Natural flavors, Coconut oil, Carnauba wax, Turmeric oleoresin, Vegetable juice, Paprika extract, Wheat starch*

Contains: coconut, wheat*

*The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”

NOTE: WHEAT STARCH IS AN ALLOWED INGREDIENT IN FOODS LABELED GLUTEN-FREE AS LONG AS THE FINAL FOOD PRODUCT CONTAINS LESS THAN 20 PARTS PER MILLION OF GLUTEN (AND ALL OTHER CRITERIA FOR GLUTEN-FREE LABELING ARE FOLLOWED).

NOTE: FOODS LABELED GLUTEN-FREE AND CONTAINING WHEAT STARCH AND INGREDIENTS MADE FROM WHEAT STARCH, SUCH AS “GLUCOSE SYRUP (WHEAT),” “MALTODEXTRIN (WHEAT),” AND “DEXTRIN (WHEAT)” MUST INCLUDE AN ASTERISK (OR OTHER SYMBOL) AFTER THE WORD “WHEAT” IN THE INGREDIENTS LIST OR CONTAINS STATEMENT THAT REFERS TO ANOTHER ASTERISK THAT IS FOLLOWED BY THE FOLLOWING WORDING, “THE WHEAT HAS BEEN PROCESSED TO ALLOW THIS FOOD TO MEET THE FOOD AND DRUG ADMINISTRATION REQUIREMENTS FOR GLUTEN-FREE FOODS.”

Example 2:

Labeling Claim: Gluten-Free

Ingredients: Potatoes, Sunflower and/or safflower oil, Malt vinegar powder (maltodextrin, food starch modified, malt vinegar), Fructose, White vinegar powder (maltodextrin, distilled white vinegar), Sea salt, Citric acid, Malt extract.  (emphasis added)

What this label should look like:

Labeling Claim: There should NOT be a gluten-free labeling claim on this product.

NOTE: ACCORDING TO THE FDA THE INGREDIENTS MALT, MALT EXTRACT, AND MALT SYRUP ARE NOT ALLOWED IN FOODS LABELED GLUTEN-FREE.

© Copyright July 8, 2014 by Gluten Free Watchdog. All Rights Reserved.

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