When a regulatory agency (USDA) actually enforces the gluten-free labeling rule and recalls a product containing wheat-based soy sauce

When a regulatory agency (USDA) actually enforces the gluten-free labeling rule and recalls a product containing wheat-based soy sauce

On August 30, 2019, the United States Department of Agriculture announced the recall of Heatherfield Foods Inc. pork sausage products due to misbranding. The sausage is labeled gluten-free yet contains wheat. https://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2019/recall-088-2019-release?permalink=35A47FAFA869093A250D7843C3A55B6D5ADD2BFB5919576B6453B59930E6CE26

Why is this recall particularly significant?

  1. It took place because of a consumer complaint received by USDA.
  2. Based on consumer photographs sent to Gluten Free Watchdog, the source of wheat in the sausage is soy sauce.
  3. USDA doesn’t have an agency defined gluten-free labeling rule.
    1. Instead they require manufacturers under their labeling jurisdiction to adhere to the gluten-free labeling rule established by the FDA.
  4.  In 2017 Gluten Free Watchdog contacted USDA about another product labeled gluten-free yet containing wheat-based soy sauce.
  5. Because soy sauce is under the labeling jurisdiction of FDA, USDA reached out to FDA for clarification about the gluten-free status of wheat-based soy sauce.
  6. The USDA shared the FDA’s response with Gluten Free Watchdog.
    1. “If a soy sauce is made from wheat and soybeans, “wheat” is a gluten-containing grain, and, therefore, cannot make the gluten-free claim.”
  7. Many products labeled gluten-free and containing wheat-based soy sauce have been reported to FDA by Gluten Free Watchdog, including sauces made by the manufacturer Chef Myron’s.
  8. Chef Myron’s sauces were first reported to FDA in 2014.
  9. Chef Myron’s sauces continue to be represented by the manufacturer as “gluten-free” and continue to contain wheat-based soy sauce. These sauces are sold retail and to various food service outlets, including schools, hospitals, military, and restaurants. For more information see https://chefmyrons.com/information-sheets/

We should all be asking why USDA enforces FDA’s gluten-free labeling rule when it comes to wheat-based soy sauce but the FDA does not.

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Comments (9)

  • Al
    Reply

    Seriously? What is going on? Grrrr

    September 3, 2019 at 1:25 pm
  • Jan Lee Reply

    In response to your point that the USDA issued a recall based on an FDA rule governing the use of “gluten free” branding: I suspect the reason this action fell under the USDA’s jurisdiction is that it was a meat product that was labeled incorrectly. While the USDA can issue recalls for other foods as well, it is its FSIS office that oversees recalls of meat products. Politics being what it is in the US regulatory system, I imagine it fell to the USDA to issue the bad news to the pork producer.

    But your point about Chef Myron’s soy sauce not being recalled due to wheat ingredients highlights a loophole that manufactures seem able to access now: Chef Myron boldly admits that its soy sauce has wheat in its manufacturing process, at the level of less than 10 ppm, which is below the FDA’s regulated threshold of 20 ppm. But because the amount in one bottle falls below 20 ppm, it feels it doesn’t have to to print that admission on its label and further, can declare its product “gluten free”

    What about the consumer in this case? According to Canadian regulatory literature (I haven’t found this in the FDA’s explanation yet), the “threshold level” established by the FDA of 20 ppm (and, coincidentally, Health Canada) is based on research that concluded that a person with Celiac disease can in most cases, safely ingest up to a maximum of 50 mg per day of gluten. According to its interpretation of the 2007 paper by Catassi et al (see below), Some signs of damage to the intestinal villi were found in the 50 mg/day group, whereas 10mg/day appeared safe for most of the subjects studied.” Health Canada indicates that this stated threshold has been used to establish the 20 ppm maximum definition of gluten-containing foods (although the Canadians have other rules enforcing whether a manufacturer can “intentionally” add wheat to a product as well).

    Chef Myron’s assumption that it can slip under the radar legally because its soy sauce is only half the legal maximum threshold should still be a huge concern for consumers. If I use two of Chef Myron’s sauces in my dinner party preparation because I assume they are “gluten free,” and two other products on the market with a similar claim that has say, 10 ppm, then I am actually at risk of ingesting sufficient gluten to do harm. What’s worse, is I am complicit in subjecting my gluten-free guests to a Celiac flare as well.

    The answer here is that Chef Myron needs to be honest and print a disclaimer on its bottles (i.,e, wheat used; less than 20 ppm present) or some such explanation. It doesn’t because it knows that on face value, it will still drive away customers. It will also draw criticism for printing the much-coveted claim of “gluten free” on its products.

    Thanks for bringing this follow-up to your readers’ attention. It’s valuable information.

    Research noted above:
    Catassi, C., Fabiani, E., Iacono, G., D’Agate, C., Francavilla, R., Biagi, F., Volta, U., Accomando, S., Picarelli, A., Vitis, I. de, Pianelli, G., Gesuita, R., Carle, F., Mandolesi, A., Bearzi, I.,Fasano, A. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr. 2007;85(1):160-166

    Health Canada literature on the definition of Gluten Free:
    https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-allergies-intolerances/celiac-disease/health-canada-position-gluten-free-claims.html

    September 3, 2019 at 3:38 pm
    • Tricia Thompson Reply

      Hi Jan,
      Yes, this is a USDA-regulated product and it is the responsibility of FSIS to regulate the product and issue corrective action.
      Under the FDA’s gluten-free labeling rule, wheat-based soy sauce is not allowed in foods labeled gluten-free. It doesn’t matter how the product tests. There is more to the gluten-free labeling rule than a food having a level of gluten below 20 ppm. Certain ingredients simply aren’t allowed. For a more complete explanation on soy sauce see https://www.glutenfreewatchdog.org/news/make-no-mistake-about-it-wheat-based-soy-sauce-is-not-allowed-in-foods-labeled-gluten-free/.
      Also, please keep in mind that ppm is a proportion. To know the amount of gluten consumed you have to know both the ppm level of a food and the amount of the food consumed. For example a one ounce slice of gluten-free bread containing just under 20 ppm gluten contains approximately 1/2 milligram of gluten.
      Hope this helps.

      September 3, 2019 at 3:52 pm
      • Jan Lee Reply

        Excellent points. Interesting that Chef Meyron’s managed to overlook that distinction and figures it can take advantage of a “gluten free” status.

        Yes, I am aware that it is a proportion. You illustrated my concern perfectly: Just because the manufacturer can claim its product has less than 20 ppm doesn’t mean that the consumer should be reassured or is out of the woods when it comes to avoiding unseen gluten in their meal.

        September 3, 2019 at 7:23 pm
  • Ellen Reply

    Good. This needs to be enforced. People’s health and well-being are at steak. Now, if only we could get accurate food labeling!!! If GMO’s are so healthy, why not label it?????

    September 4, 2019 at 3:26 pm
  • Kerry Carlson Reply

    Why don’t they just use wheat free tamari soy sauce?

    September 4, 2019 at 7:33 pm
  • Thomas Miller Reply

    Yes, all we are asking for is the truth.

    September 5, 2019 at 8:30 am
  • Joy Reply

    Interesting, I never knew where to report something if I thought it was mislabeled. Also, I have a question, is Chef Meyron’s simply labeled “gluten free” or “certified gluten free”? Any products not certified cause me pause and probably have cross contamination amounts of gluten. Just curious. Thank you!

    September 5, 2019 at 1:40 pm
    • Tricia Thompson Reply

      Chef Myron’s is labeled gluten-free. When we last compared gluten content of labeled gluten-free versus certified gluten-free approximately 5% of labeled gluten-free foods contained a level of gluten at/above 20 ppm. Approximately 4% of certified gluten-free foods contained a level of gluten at/above 20 ppm. The percentage of products labeled gluten-free and containing a level of gluten at/above 20 ppm dropped to around 4% in a recent assessment. It is likely the percentage dropped for certified gluten-free foods as well (although this wasn’t assessed).

      September 5, 2019 at 1:52 pm

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