FDA, please investigate labeled gluten-free foods containing wheat-based soy sauce and enforce your own rule

FDA, please investigate labeled gluten-free foods containing wheat-based soy sauce and enforce your own rule

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FDA Action Alert #1

Dear FDA,

Please investigate labeled gluten-free foods containing wheat-based soy sauce and enforce your own rule.

  • FDA, you state the following in the online document, “Questions and Answers: Gluten-Free Food Labeling Final Rule” available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm362880.htm#Compliance:
    • Compliance
      • How will FDA check that food manufacturers labeling their foods gluten-free comply with the requirements of the final rule?
        The agency will use the full range of its routine post-market monitoring activities to enforce the final rule on gluten-free food labeling. These activities include sampling, periodic inspections of food manufacturing facilities; food label reviews; follow-up on consumer and industry complaints reported to the agency; and when needed, gluten analyses of food samples.
  • FDA, please review the food labels of the following labeled gluten-free products that appear to contain wheat-based soy sauce as an ingredient:
    • Chef Myron’s Teriyaki Sauce and all Myron’s sauces containing shoyu (i.e., soy sauce): Information on their website reads, “Our Chef Myron’s Aged Shoyu (all purpose soy sauce) is one of the base ingredients of many of our sauces. The soy sauce contains soy beans, wheat, water, and salt. Therefore, the products that contain the Aged Shoyu also contain wheat. However, they are still certified as gluten free. Here is why:” For the rest of their statement see http://www.chefmyrons.com/images/stories/pdfs/gluten_free_statement.pdf
      • Product purchased by Gluten Free Watchdog on July 6, 2017 from Amazon (Best By 08/25/18):
        • A gluten-free claim is included on the front label.
        • Ingredients: Naturally aged shoyu (water, soybeans, wheat, salt), Evaporated cane juice, Sake (rice, koji rice, water), Water, Fresh garlic, Rice starch, Rice vinegar and Spices
        • Label also states, “About gluten and wheat: all gluten from the wheat in this product is converted to amino acids during the fermentation process. More information and certifications are on our website.”
        • Label also states, “Contains wheat and soy.”
      • Salamida State Fair Big Hawaii Teriyaki Marinade:
        • Product purchased by Gluten Free Watchdog on July 6, 2017 from Wal-Mart (Best By 12/14/18):
          • A gluten-free claim is made on the neck tag; the back label includes the claim, “No Gluten.”
          • Ingredients: Pineapple juice (water, pineapple juice concentrate), Soy sauce (water, soybeans, wheat, salt), Water, Vinegar (distilled, cider, water), Brown sugar, Sugar, Salt, Dehydrated garlic, Raisin juice concentrate, Spices, Orange peel, Caramel color, Natural flavor, Dehydrated onion, Vegetable gums (for consistency), Potassium sorbate & Sodium benzoate (preservatives).
  • FDA, this is what you state in the online document, “Proposed Rule for Gluten-Free Labeling of Fermented or Hydrolyzed Foods” available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm472735.htm:
    • What additional requirements does FDA propose to verify a “gluten-free” claim on hydrolyzed or fermented foods?
      • Because the current gluten tests do not adequately detect and quantify gluten in fermented and hydrolyzed foods or ingredients, FDA proposes that, in order to make a “gluten-free” claim, manufacturers of these foods would have to make and keep records to show all of the following:
        • The food meets the definition for “gluten-free” in 21 CFR 101.91(a)(3), including that the food had less than 20 ppm gluten, before fermentation or hydrolysis.
      • What is an example of a hydrolyzed or fermented food product that would still not be permitted to bear the “gluten-free” claim in its labeling under this proposed rule?
        • Fermented or hydrolyzed soy sauce made from gluten-containing grains would not be permitted to bear a “gluten-free” claim, unless the grains were processed to remove gluten and the use of the ingredient resulted in the presence of less than 20 ppm gluten in the food.  If, however, the soy sauce was made using a roasted grain that does not contain gluten, then it would be permitted to bear the “gluten-free” claim if it meets the other requirements of the gluten-free labeling rule.
  • FDA, have you changed your policy on the use of wheat-based soy sauce in labeled gluten-free foods?
  • FDA, If you have not changed your policy, please reach out to the manufacturers listed above and assess whether they are in compliance with the gluten-free labeling rule.
  • FDA, Gluten Free Watchdog is more than happy to send you the products we have in our procession for label verification.
  • FDA, protect the health of people with celiac disease and enforce your own rule.


The Gluten Free Watchdog community

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Comments (3)

  • Marianne Schorer Reply

    We need the FDA to do their job–one that requires accountability, transparency and vigilance as their job is to protect, regulate, and safeguard the health and well being of all people. Protections for people with autoimmune issues; namely, celiac are critical. Helping them navigate the marketplace with “truthful” labeling of products is necessary to ensure their health and safety. We need the FDA to serve these needs first and foremost.

    July 10, 2017 at 9:26 pm
    • Tricia Thompson Reply

      Thanks so much for sharing your thoughts, Marianne. FDA, please enforce your own rule!

      July 11, 2017 at 7:46 pm
  • Helen Weems Reply

    Yes, we need the support of the FDA. Nearly 1 in 100 taxpayers have Celiac Disease, and those with Gluten Sensitivity and Intolerance only add to that ratio. An informed advocate is showing the FDA some glaring regulatory failures. All the FDA has to do is act. Please, FDA, act on your mission and your constituents’ behalf.

    July 11, 2017 at 1:41 am

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