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