Soy Sauce: More insightful news from FDA based on Gluten Free Watchdog FOIA requests

Soy Sauce: More insightful news from FDA based on Gluten Free Watchdog FOIA requests

We recently filed 3 Freedom of Information Act requests with FDA for products containing hydrolyzed/fermented protein. All products had been reported to FDA for facial misbranding by Gluten Free Watchdog. What follows is a summary of the information received from FDA to date. A huge thank you to Adam, one of GFWD’s pro-bono attorneys for filing these requests.

FOIAs were submitted for the following products:

Three Crabs Fish Sauce. Ingredients list reads, “hydrolyzed vegetable protein.” This ingredient declaration hasn’t been allowed since 1993. The protein source MUST be declared. Per the materials received as part of the FOIA request, the source of hydrolyzed protein is corn, and the label will be corrected.

Sugar Plum Sesame Soy Vegetable Seasoning Blend. This product contains undeclared wheat. Sub-ingredients list for soy sauce is not included on product packaging. Ingredients per manufacturer: “Soy Sauce (soybeans, wheat, salt).” This product was recalled.

Chef Myron’s sauces. These products contain wheat-based soy sauce yet are labeled gluten-free. Nine sauces were recalled.

What we’ve learned:

It appears that FDA is compelling recalls when products are labeled gluten-free yet contain wheat-based soy sauce or undeclared wheat from soy sauce. General speaking and according to FDA, when soy sauce is made from wheat, it may not be labeled “gluten-free.”

The Center for Food Safety and Applied Nutrition (a branch of FDA) conducted a health hazard assessment on Chef Myron’s sauces. This assessment was conducted because the products were labeled gluten-free yet contained wheat that was not processed to remove gluten prior to the fermentation process. This health hazard assessment also helped to inform FDA’s response to the complaint for Sugar Plum seasoning blend.

Health hazard assessment bottom line: There is some evidence to suggest that there are low to absent levels of gluten in most commercial soy sauces. In addition, because soy sauce is a condiment it is likely to be consumed in small amounts. Regardless, it is not possible to know the concentration level of wheat gluten or gluten residues in final product soy sauce due to limitations in current testing methodologies for fermented foods. Therefore, gluten levels must be assessed prior to fermentation.

Health hazard assessment details: The assessment provides a window into FDA’s thinking on soy sauce (paraphrased from the health hazard assessment):

  1. Soy sauce is generally made via the fermentation of wheat and soybeans.
  2. Fermentation is not considered a process to remove gluten.
  3. Fermentation may break apart gluten protein into smaller gluten protein fragments.
  4. Current testing methods may not accurately measure the amount of gluten in fermented products.
  5. The part per million level of gluten in soy sauce after fermentation can’t be reliably estimated.
  6. Gluten levels in fermented foods must be assessed before fermentation.
  7. A literature review found some evidence to suggest that wheat-containing soy sauces may be tolerated by wheat-allergic individuals.
  8. The health hazard posed by undeclared wheat gluten or immunogenic gluten residues depends on the exposure amount in the final product consumed per meal.
  9. Wheat gluten/gluten residues at levels above 20 ppm are likely to pose a risk to individuals with celiac disease and wheat allergy.
  10. Wheat gluten/gluten residues at levels below 20 ppm could pose a “remote hazard” for some highly sensitive consumers with wheat allergy.
  11. Based on published data analyzing soy sauce using ELISA and Western Blot methodology, soy sauce fermentation may remove a substantial amount of wheat protein peptides.

Please reach out with any questions.

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Comments (9)

  • Dick Lunde
    Reply

    Has any research been done to see if celiacs actually have any tolerance for wheat-based soy sauce? Is there much anecdotal evidence of celiacs having reactions to wheat-based soy sauces?

    October 4, 2022 at 9:23 pm
    • Tricia Thompson Reply

      To the best of my knowledge, research has focused on testing soy sauce for residual gluten protein versus feeding trials.

      October 5, 2022 at 12:02 pm
  • Jocelyn Reply

    Thank you for this. I recently dined at HuHot Mongolian BBQ and they listed soy sauces that contain wheat as gluten free. The menu states that the products have been processed to meet FDA standards to be labeled gluten free. Doesn’t seem right to me.

    October 4, 2022 at 10:32 pm
    • Tricia Thompson Reply

      Hi Jocelyn, Thanks for reaching out about HuHot. This issue has been going on for years. Gluten Free Watchdog reached out to them about 4 years ago. This was their response at the time, “We try to provide as much information about our products as possible so guests can decide for themselves if they are comfortable dining with us. Several in the HuHot family live with Celiac disease and enjoy dining with us. Thank you for your interest in this important topic.”

      October 5, 2022 at 12:07 pm
  • Max Rathgeber Reply

    Great article. I stopped using “gluten free” tamari soy sauces about a year after being diagnosed because I was still experiencing effects. Felt much better after cutting this out. To this day I’m still not sure if it’s because of soy itself or low level contaminants of gluten.

    October 5, 2022 at 3:49 pm
    • Tricia Thompson Reply

      Thanks, Max. If a soy sauce is made using wheat, then wheat must be declared in the ingredients list under the Food Allergen Labeling and Consumer Protection Act. Fortunately, most manufacturers of soy sauce properly label their products.

      October 5, 2022 at 5:01 pm
  • joseph poole Reply

    Has anyone used FIG food is good app? If you filter nothing but gluten free diet and skip everything else, there’s 3 rates. Minimum: I try to avoid gluten, Average: I must avoid gluten but cross-contamination is ok, Maximum: I must avoid gluten and cross-contamination is not ok. If you use the minimum, wheat starch (common) won’t apply as anything. If you use the maximum, wheat starch, caramel color, and brown rice syrup will apply YELLOW as ingredients to limit. It’s weird that even though wheat (as extract term) in common soy sauce isn’t gluten removed, It only applies as an ingredient to limit and it only has anything to do with a product being symbolized Yellow as: (you may be able to eat). Some will be symbolized red as: (you cannot eat) if it at all has wheat ingredients (flour, gluten, protein), all 3 of these wheat ingredients will apply RED as ingredients to avoid. Not to depend on whether contamination is permitted or avoided completely, Common malt (barley) terms will always apply as ingredients to avoid, And unless it depends on gliadin part being removed, it’s unclear how wheat (as extract term) can only apply as an ingredient to limit and not as an ingredient to avoid without being furthur processed to remove gluten.

    October 5, 2022 at 7:15 pm
    • Tricia Thompson Reply

      This is the first time I’ve heard of this app. Does the app provide references/sources for information on ingredients?

      October 6, 2022 at 12:11 pm
      • joseph poole Reply

        If you’re looking at any product, you can select the underlined ingredients to read about them. There’s profile next to saved at the bottom and within it, You can browse through the overall ingredient list, there’s 2443 total existing ingredients. You can even search any ingredient you’re curious about. It’s of surprise that just the artificial flavors from the gluten source grains even (artificial malt vinegar flavor) are symbolized as anything to do with products allowed. Not to mention (Hydrolyzed wheat) which is just as surprising. Gluten free notes (positive, neutral, negative) are so fixed changing the symbols can’t affect it. Though Fermentation, Germination, and Hydrolyzation usually process those grains just to break the gluten and leaves it shattered but not remove it.

        October 8, 2022 at 2:27 am

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