Updated statement from FDA on soy sauce

For years Gluten Free Watchdog (GFWD) has been asking FDA to clarify for manufacturers that soy sauce made from wheat can NOT be included in foods carry a gluten-free claim. We were advised that the agency would not be providing additional guidance until the publication of the final rule on gluten-free labeling of fermented and hydrolyzed foods and ingredients. FDA was true to its word and on August 13, the same day the rule was published in the Federal Register, GFWD was advised that the Q&A on gluten-free labeling had been updated to include a section on fermented and hydrolyzed foods and ingredients. See https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-gluten-free-food-labeling-final-rule

“Can soy sauce be labeled “gluten-free” or used as an ingredient in a product making a “gluten-free” claim?

It depends on the ingredients and processing of the soy sauce. Soy sauce is a food ordinarily made by fermenting a mixture of soybeans and wheat. However, some soy sauces are not made using wheat. In general, when soy sauce is made from soybeans and wheat, or any other gluten-containing grain, it may not bear a “gluten-free” claim. If soy sauce is not made using wheat or any other gluten-containing grain then it can bear a “gluten-free’ claim. Also, if the soy sauce is made using a gluten-containing grain that is processed to remove gluten resulting in the presence of less than 20 ppm gluten prior to the fermentation process, then it can bear a “gluten-free” claim. Soy sauce produced in this manner could also be used as an ingredient in a food bearing a “gluten-free” claim, provided that the use of the soy sauce does not result in the presence of 20 ppm or more gluten in the food.

As with other foods, if the soy sauce is made using wheat that has been processed to remove gluten, bears a “gluten-free” claim, and declares “wheat” in the ingredient list or in a separate “Contains wheat” statement, then it must also comply with the disclaimer statement requirement in 21 CFR 101.91(b)(3) indicating that the wheat has been processed to allow the food to meet FDA requirements for “gluten-free” foods.”

According to FDA:

• Wheat starch is considered and ingredient processed to remove gluten.
• Fermentation is not considered a process to remove gluten.
• Hydrolysis is not considered a process to remove gluten.

After publication of the rule, GFWD reached out to FDA to ask whether it was necessary to resubmit product complaints for the facially misbranded products not yet subject to enforcement action. We were advised that we did not need to resubmit a claim at this time. We impatiently await action on the following products:

Gourmet Warehouse Ernest Hemingway Feast and Rum Runner marinades. Reported to FDA via CAERS on June 8, 2020. Report acknowledged by CAERS on June 8, 2020. Both products are labeled gluten-free yet list wheat as a sub-ingredient in the soy sauce. Feast marinade was first reported to FDA via CAERS on September 4, 2019. 

Chef Myron’s Sauces. Chef Myron’s sauces were first reported to FDA in 2014. These sauces were again reported to FDA via CAERS on August 18, 2020. Sauces carry a gluten-free claim and include wheat-based soy sauce. The following statement is included on product labels, “*The wheat has been processed (converted to amino acids during the fermentation process) to allow this food to meet the Food and Drug Administration (FDA) requirements for a “gluten-free” food.” These sauces are sold retail and to various food service outlets, including schools, hospitals, military, and restaurants. UPDATE: Chef Myron’s sauces containing wheat-based soy sauce were recalled in late 2020.