FDA is acting on complaints filed by Gluten Free Watchdog

FDA is acting on complaints filed by Gluten Free Watchdog

This spring we filed 6 Freedom of Information Act requests with FDA representing 11 products containing malt-based ingredients.* All products had been reported to FDA for facial misbranding by Gluten Free Watchdog. What follows is a summary of the information included in the materials obtained from FDA. A huge thank you to Adam, one of GFWD’s pro-bono attorneys for filing these requests.

*We also filed FOIA requests for three additional products containing wheat. As of July 26, 2022, we have not received any materials from FDA.

FOIAs were submitted for the following products:

  • Kroger salt and vinegar potato chips (labeled gluten-free, malt vinegar powder listed in the ingredients)
  • Walgreens gummy supplements (labeled no gluten, malt syrup listed in the ingredients)
    • Prenatal gummies
    • Elderberry gummies
    • Melatonin gummies
    • Immune Booster gummies
    • Radiant Beauty gummies
  • Welby Aldi elderberry gummies (labeled no gluten, malt syrup listed in the ingredients)
  • Supple Bears quercetin gummies (labeled no gluten, malt syrup listed in the ingredients)
  • Tattooed Chef plant-based bowls
    • Egg roll bowl (labeled gluten-free, malt extract listed in the ingredients)
    • Sausage breakfast bowl (labeled gluten-free, malt extract and wheat flour listed in the ingredients)
  • The Fine Cheese Co. gluten-free olive oil and sea salt crackers (labeled gluten-free, gluten-free malted barley listed in the ingredients)

Important insights from materials obtained from FDA:

  • FDA does investigate complaints filed by Gluten Free Watchdog (GFWD), although sometimes it takes multiple complaints to start the ball rolling.
  • Investigations generally involve outreach to manufacturers asking them why an ingredient such as malt syrup or malt vinegar powder is in a product labeled gluten-free.
  • Manufacturer response generates discussion among FDA staff on how to proceed.
    • Detailed information below.
  • While complaints may not always result in recalls, they do appear to effect change.
    • Kroger removed the gluten-free claim from product packaging. Barley is now declared in the ingredients list (i.e. malt vinegar powder [barley]). Declaring barley is not required under FALCPA but it is very helpful when manufacturers do so voluntarily.
    • Walgreens was asked to change product labeling to reflect the correct ingredient. The ingredient name will be changed from malt syrup to corn syrup.
    • Welby (Aldi) is correcting the label (asked to first sell through inventory) changing the ingredient name from malt syrup to maltose.
    • Supple Bears issued their own recall followed by a voluntary recall through FDA.
    • Tattooed Chef issued a recall for 1 of the 2 products (although for wheat not barley). For the second product, the malt ingredient appears to have been removed.
    • The Fine Cheese Co. gluten-free olive oil and sea salt crackers: This set of product complaints does not appear to have received the same level of attention or follow-through at FDA. UPDATE: We have received yet another complaint for this product. Crackers were purchased in Wisconsin on August 18, 2022. They are labeled gluten-free and list gluten-free malted barley in the ingredients.

Detailed information: Manufacturer responses and resulting FDA comments (Keep in mind that records provided are incomplete and information is sometimes redacted)

Kroger salt and vinegar potato chips

After initial outreach from FDA asking why a product with a malt ingredient is labeled gluten-free…

Kroger:

  • ‘Malt vinegar powder’ ingredient is gluten-free.
  • The product was tested when it launched and no gluten was found.
  • The ingredient ‘malt vinegar powder’ is made by barley fermentation and is distilled.

FDA:

  • Took issue with test results.
  • Manufacturer did not perform adequate testing to conclude the product was gluten free.
  • The firm’s response on testing malt vinegar powder and finding 0.5 ppm gluten is not convincing. There are no scientifically validated methods available for gluten estimation in malt vinegar powder.
  • The compliance of distilled foods should be evaluated by verifying the absence of protein in the distilled component using a scientifically valid analytical method.

While FOIA materials stated this complaint was “flagged for possible action” there doesn’t appear to have been a recall. Regardless, there was a labeling change. This product was found at a Kroger store on July 22, 2022. The gluten-free claim has been removed and barley is called out in the ingredients list. Thank you to Amy Keller for providing the product photo.

Walgreens supplements (Prenatal Gummies, Elderberry Gummies, Melatonin Gummies 10 mg, Immune Booster Gummies, Radiant Beauty Gummies)

After initial outreach from FDA asking why a product with a malt ingredient is labeled gluten-free…

Walgreens:

  • Malt syrup used in the products is derived from corn, not barley.
  • The gluten-free claim is truthful and not misleading and is in compliance with the gluten-free rule.
  • Nonetheless, the label is being revised to change malt syrup to corn syrup

FDA:

  • The products are misbranded because malt syrup is not the appropriate common or usual name of an ingredient made from corn.
  • Didn’t request a recall but did ask for a change in labeling.
    • This was done because of the labeling flexibility guidance due to COVID.
      • The labeling flexibility Guidance due to COVID-19 is still in effect; however, the issues with these products do not meet the eligibility criteria in the guidance.
  • Not sure if the common/usual name should be corn malt syrup or corn syrup.
  • Regarding enforcement discretion, since these are dietary supplements, we defer to ODSP.

Walgreens stated in a letter to FDA in November 2021 that they were changing the ingredients label to read corn syrup instead of malt syrup. We were able to find four of the five supplements in the marketplace on July 22, 2022. One of the four product labels (Elderberry Gummies) has been changed. The other three labels have not yet been changed. Thank you to the consumer who provided this photo.

Welby Aldi elderberry gummies

After initial outreach from FDA asking why a product with a malt ingredient is labeled gluten-free…

Aldi:

  • The supplier accidently listed malt syrup in their ingredient list instead of maltose.
  • Has been in contact with the supplier and the labeling is being corrected.
  • Would like to finish selling through their current inventory.
  • They have enough inventory to sell through May 2022.

FDA:

  • There are no health hazards.
  • Since there is no health hazard, it would be a Class III recall.
  • A few questions came up
    • How large is the remaining inventory that the manufacturer wants to sell?
    • Are they reconditioning the existing stock or only looking to use these new labels in subsequent batches?

We have not yet been able to find this product at an Aldi store to confirm labeling changes.

UPDATE: Sept. 26, 2022: The gummies were spotted at an Aldi store. The ingredients list now reads, “maltose syrup (from corn).” Thank you to the consumer who reached out and provided product photos.

Supple Bears quercetin gummies

After initial outreach from FDA asking why a product with a malt ingredient is labeled gluten-free…

Supple Bears:

  • The sweetener is corn malt syrup
  • Nutritional information on the product page as well as on the physical label for the product is being updated
  • “No gluten” is being deleted as a precaution
  • Units returned and discarded

FDA:

  • Even if the firm removes “no gluten,” the product is still misbranded based on the CPG. In addition, when do they plan to do the label change? How much product is still on the market?
  • Does that mean the firm already completed a recall?
  • Could we reach out to the firm to get the proper documentation so we can enter the recall into RES (FDA Recall Enterprise System)

Tattooed Chef plant-based egg roll bowl and sausage breakfast bowl

Note: Gluten Free Watchdog received limited materials from this FOIA request

Sausage bowl:

  • FDA contacted the company.
  • The label was corrected and the product was withdrawn from marketplace and destroyed.
  • A recall was issued due to the presence of wheat in a labeled gluten-free food. Neither barley nor malt extract was mentioned.
    • Recall information available at https://www.accessdata.fda.gov/scripts/ires/index.cfm#tabNav_advancedSearch

Egg roll bowl:

  • FDA contacted the company.
  • An email response was received.
  • No additional details were provided.

We have not yet been able to confirm labeling changes.

UPDATE: Sept. 15, 2022: Based on additional materials provided to us by FDA, Tattooed Chef has removed malt extract from the product formulation.

The Fine Cheese Co. olive oil and sea salt crackers

Based on materials provided to us, we are unable to determine if contact was made with the manufacturer (this is an imported product) or if there was any FDA follow-up. Information received does not include a record of the most recent (3rd) complaint for this product sent to CAERS on January 4, 2022.

Please reach out with any questions

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Comments (3)

  • Cathy Bischoff
    Reply

    Calling something “corn malt syrup” or even “corn syrup” just
    adds to the confusion. In Europe barley corn is referred to as
    “corn” and in North America maize is referred to as “corn”. I
    recall a conversation between my American uncle and Irish cousin talking about corn. It was funny and I let it go on for a while before I jumped in with the maize and barley information.

    July 26, 2022 at 11:50 pm
    • Tricia Thompson Reply

      Hi Cathy, Thanks for commenting. Calling ingredients by different names certainly adds to the confusion.

      Here are the US definitions/information from the FDA (https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-gluten-free-food-labeling-final-rule):
      Can ingredients such as barley malt and barley malt extract be used in foods bearing a “gluten-free” claim?
      No. Malt syrup and malt extract are interchangeable terms for a viscous concentrate of a water extract of germinated barley, with or without a preservative. The terms barley malt or barley malt extract are used also. Malt extract and malt syrup are ingredients derived from a gluten-containing grain, barley, that has not been processed to remove gluten. Food and ingredient manufacturers should be aware that malt extract and other similar malt-derived ingredients are ingredients derived from gluten-containing grains that have not been processed to remove gluten and, therefore, cannot be used in foods that bear a “gluten-free” labeling claim. The terms “malt extract” or “malt syrup” unqualified should be applied only to products prepared from barley. See FDA Compliance Policy Guide Sec 515.200 Malt Extract; Malt Syrup; Malted Cereal Syrup; Liquid Malt; Dried Malt.

      Corn syrup: See https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1865

      Also from FDA: The terms “malt extract” or “malt syrup” unqualified should be applied only to products prepared from barley. If any other malted grain is used, the extract or syrup may be designated by a specific name such as “extract of malted barley and corn.”

      July 27, 2022 at 1:19 pm
  • Jean lyke Reply

    Thanks for the update. Good to know the FDA does investigate complaints sent by GFWD.
    Plus, the email/photo you sent me regarding the Original, Organic, Enriched Soydream is the product I would like for you to test.
    Thanks.

    July 27, 2022 at 12:58 pm

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