Running List of Potentially Misbranded Gluten-Free Products Reported to FDA & USDA by Gluten Free Watchdog in 2020
This list is updated when necessary to include additional misbranded products and recall status. Thank you to the consumers who have reported products to Gluten Free Watchdog. It takes a gluten-free village to do this work.
Rainbow Light Prenatal One Multivitamin. Reported to FDA via CAERS on February 17, 2021. Product packaging includes a gluten-free claim along with the statement Contains wheat traces from enzyme fermentation media. The FDA declined to exempt enzymes from the gluten-free labeling rule for fermented and hydrolyzed foods and ingredients.
Tattooed Chef plant-based sausage breakfast bowl. Reported to FDA via CAERS on January 6, 2021. Product packaging includes a gluten-free claim yet wheat flour and malt extract are included in the ingredients list. This product was purchased January 2, 2020 at a Sam’s Club. The manufacturer has confirmed that the gluten-free claim is a packaging error. According to the manufacturer COO, this product has been removed from the shelves at Sam’s Club.
RECALL NOTICE: Chef Myron’s sauces containing soy sauce made from wheat have finally been recalled. Recall notices for several sauces were posted to FDA’s enforcement report page the week of December 16, 2020.
The reason given for all recalls: “Product utilized a gluten-free claim but has as an ingredient a fermented soy sauce that is produced from wheat which was not processed to remove the gluten prior to fermentation.”
It is huge that these recalls are happening. Finally, the FDA appears willing to recall foods labeled gluten-free containing wheat-based soy sauce as an ingredient. This is a first in recent memory for an FDA-regulated food. These recalls also serve as precedent and a deterrent to other manufacturers using wheat based soy sauce in labeled gluten-free foods.
These recalls are a long time coming. Gluten Free Watchdog first reported Chef Myron’s to the FDA in 2014. We last filed a complaint on August 18, 2020. Unfortunately, these sauces are sold to various food service outlets, including schools, hospitals, military, and restaurants.
Gluten Free Watchdog also has been in contact with Chef Myron’s since 2014 advising them about their misbranded products. Most recently, in May 2020, the manufacturer advised Gluten Free Watchdog that the gluten-free statement appearing on product packaging “is from our quality team who works closely with the proper authorities to ensure everything is correct and testing is done.”
As of January 4, 2021, there is no mention of the recalls on Chef Myron’s website. Products are still represented as containing wheat with the following statement, “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.”
To view the recalls, see https://www.accessdata.fda.gov/scripts/ires/index.cfm. Select year 2020 and search the week of December 16th under the category food.
Alessi Gluten-Free Gnocchi. Reported to FDA via CAERS on November 25, 2020. This product is labeled gluten-free on front packaging but the ingredients list on back packaging includes wheat flour. From the manufacturer: “Our Gnocchi is a product of Italy, and packed for us there under the Alessi label. There are two versions: Gluten Free and Regular with Gluten. The two are packed on different lines and have different package weights. We had someone notify us of this issue, and was informed by our supplier that the Gluten free Gnocchi had the correct front label, however, the wrong back label was applied to some of the packages. We did verify the error and assure the product is gluten free. The error was in the back label with the incorrect ingredient statement. This error has since been corrected.” GFWD reached back out to the manufacturer to ask if the mislabeled product had been tested for gluten to make sure it was gluten-free. They have not yet responded.
The Fine Cheese Co Olive Oil and Sea Salt Crackers. Reported to FDA via CAERS on November 19, 2020. FDA was first made aware of this product in December 2019. This product is labeled gluten-free yet contains “gluten-free malted barley.” Malted barley (labeled gluten-free or otherwise) is not allowed in foods labeled gluten-free in the US.
Smart for Life Banana Chocolate Chip Square. Reported to FDA via CAERS on November 16, 2020. UPDATE: This product is also sold in Canada and was reported by GFWD to Health Canada. According to an email received Jan 21, 2021, the cultured wheat flour has been removed from the product and the gluten-free claim retained. There is still no word from FDA. This product is labeled gluten-free yet includes the ingredient, “cultured wheat flour.” While this product includes a Contains statement, wheat is not listed (in violation of FALCPA). The manufacturer has been contacted but they have not responded. Update: GFWD is in contact with Smart for Life. It is unclear what steps this manufacturer will be taking.
Howe’s Oktoberfest Bratwurst (Beer Flavor). Reported to USDA on November 13, 2020. This product is labeled gluten-free yet includes the ingredient “beer.” There is no sub-ingredients list as would be expected if the beer was gluten-free and made using a substitute for malted barley. GFWD reached out to the manufacturer but they have not responded. There have been ongoing issues with the same formulation of product sold under different brand names.
Rainbow Light Women’s One Multivitamin. Reported to FDA via CAERS on November 2, 2020. This product is labeled gluten-free yet includes the statement, “Contains wheat traces from enzyme fermentation media.”
Pots & Co. Flourless Chocolate Cake. Reported to FDA via CAERS on September 18, 2020. This product is made in the UK and sold in the US. It is labeled gluten-free yet contains the ingredient “gluten-free barley malt extract (barley malt, water).”
Schiff Digestive Advantage Lactose Defense Formula. Reported to FDA via CAERS on September 15, 2020. Report acknowledged by CAERS September 15, 2020. Product packaging includes a “no added gluten” claim yet contains an enzyme cultivated on growth media containing wheat per the manufacturer.
Dandy Blend Instant Herbal Beverage (Organic). Reported to FDA via CAERS on July 14, 2020. Report acknowledged by CAERS July 15, 2020. First reported to FDA in 2014 (6 1/2 years ago). Product packaging includes a gluten-free claim. The ingredients list reads, “extracts of roasted barley, rye, chicory root, dandelion root and sugar beet.”
Restructure Protein Powder. Second complaint. Reported to FDA via CAERS on July 10, 2020. Report acknowledged by CAERS July 10, 2020. After GFWD’s first complaint the product was recalled but because of undeclared milk only. The gluten-free claim remains on product packaging and “germinated barley seed powder” remains in the ingredients list. The label now includes a sticker that reads, “Contains Milk, Soy.”
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.
So Nourished Gold Alternative Sweetener. Reported to FDA via CAERS on May 26, 2020. Report acknowledged by CAERS on May 28, 2020. Product packaging includes a gluten-free claim. The ingredients list reads, “Erythritol, Tagatose, Malt extract, Monk fruit extract, Glycerol.”
Dandy Blend Instant Herbal Beverage. Reported to FDA via CAERS on May 18, 2020. First reported to FDA in 2014 (6 1/2 years ago). Report acknowledged by CAERS on May 19, 2020. Product packaging includes a gluten-free claim. The ingredients list reads, “extracts of roasted barley, rye, chicory root, dandelion root and sugar beet.”
Kroger Simple Truth Gluten-Free Chicken Nuggets (animal shapes). Reported to USDA on April 23, 2020.
Background information: Kroger Simple Truth Gluten-Free Chicken Nuggets (animal shapes). A consumer reached out to Gluten Free Watchdog about this product. The consumer’s bag contains dinosaur shapes instead of the animal shapes shown on the bag. I spoke with Kroger and their supplier Golden Platter. USDA was also contacted.
From the supplier (email and phone correspondence): Both the dinosaur and animal shape nuggets are gluten-free formulations (it appears that Walmart brand gluten-free dino nuggets were packaged in bags intended for Kroger Simple Truth brand gluten-free animal nuggets). The supplier is a certified gluten-free company. They extend their apologies to consumers who found dinosaur nuggets in their packages. There will be re-training sessions for supervisors and plant personnel to prevent a recurrence.
From the USDA (email correspondence): “We worked with the inspectors at the processing facility where the chicken nuggets were made and, based on the in-plant investigation, the inspectors informed us that the dinosaur shaped nuggets are gluten free.”
Vietti Ancho Chicken Chili with Beans & Porter Ale. Reported to USDA on April 20, 2020. Update May 1, 2020: From the manufacturer: “The “Gluten Free” callout on our Vietti Artisan Ancho Chicken Chili with Beans is indeed an error. We have identified the source of the error and we have been working with the USDA on the next steps to ensure the safety of our consumers.” Update May 7, 2020: From the manufacturer: “After review by the USDA, the Vietti Artisan Ancho Chicken Chili with Beans contains less than 10 parts per million of wheat. This does not constitute a recall in accordance with the regulation. However, we do recognize the importance of proper labeling and have taken corrective action.” GFWD asked the manufacturer for more information about the corrective action. They have yet to respond. GFWD also asked USDA to elaborate on the corrective action. On May 12, 2020, the agency responded that they: “determined that the label was in compliance with less than 20 ppm to be labeled gluten free. However, the establishment is voluntarily removing the “gluten free” from that label.” GFWD has provided USDA with more information about the gluten-free labeling rule, including the fact that regular malt based can’t be labeled gluten-free and can’t be added to foods labeled gluten-free.
Background: At least some cans include a gluten-free claim. The ingredients list includes, “Porter Ale” with the sub-ingredients list, “Water, Malts (Contains wheat), Salt, Hops).” Regular malt-based beer containing barley (and in this case wheat) is not allowed in foods labeled gluten-free under the FDA’s gluten-free rule (USDA adheres to FDA’s gluten-free labeling rule). The manufacturer has been contacted by phone and email. A complaint has been filed with the USDA (this food is regulated by the USDA versus the FDA).
Nature’s Earthly Choice Lentil Trio. Reported to FDA via CAERS on March 3, 2020. Report acknowledged by CAERS on March 3, 2020. Product RECALL posted under Enforcement Reports (it isn’t clear when the recall posted but it was classified by FDA on April 3). This product contains numerous errant grains. Test results suggest the grains are a mix of oat and wheat/barley. The certifying organization–GFCO was notified about this product issue. UPDATE: GFCO has issued a safety alert for this product https://gfco.org/safety-alerts/
Bart’s Chocolate Chip Cookie Dough Ice Cream. Reported to FDA via CAERS on February 26, 2020. Report acknowledged by CAERS on February 26, 2020. Product RECALL posted under Enforcement Reports for the week of March 18, 2020. This product includes a GF on front packaging (used by Bart’s to indicate that a product is gluten-free). This ice cream isn’t gluten-free. It contains wheat flour-based cookie dough. GFWD spoke with the manufacturer. This is a labeling error and they will be contacting retail outlets that carry this product.
Sweet Bourbon Crunchers Pretzels sold through Beef Jerky Outlets. Reported to FDA via CAERS on February 25, 2020. Report acknowledged by CAERS on February 25, 2020. Product RECALL posted under Enforcement Reports for the week of April 1, 2020. GFWD spoke to both the manufacturer and the distributor. Due to an error in the labeling process, this product includes a gluten-free claim. However, the pretzels contain wheat flour as confirmed by the manufacturer. The manufacturer has instructed all Beef Jerky Outlet stores to remove product from the shelf. Regardless, this product was purchased at a Beef Jerky Outlet February 22/23.
Grow Girl Hair Growth Dietary Supplement. Reported to FDA via CAERS on January 28, 2020. Report acknowledged by CAERS on January 29, 2020. The product is labeled “no gluten” which FDA considers a synonym for “gluten free” yet it includes “malt syrup” in the ingredients list. Under the FDA’s Code of Federal Regulations for malt syrup, this ingredient is “barley malt syrup.” Barley malt syrup is not allowed in foods labeled gluten-free per FDA. Manufacturer alerted to this issue via email.
Pike Place Chowder, smoked salmon chowder. Reported to FDA via CAERS on January 16, 2020. Report acknowledged by CAERS on January 23, 2020. Product RECALL posted under Enforcement Reports for the week of January 29, 2020. Outer packaging includes a gluten-free claim and the ingredients list does not include a gluten-containing ingredient. The inner plastic pouch that contains the chowder includes a stamp that reads, “Smoked Salmon Chowder. Contains: Fish (Salmon), Milk, Shellfish (Lobster, Shrimp), and Wheat. GFWD spoke to the manufacturer. The wrong outer packaging was used. The chowder contains wheat flour.
Restructure Protein Powder. Reported to FDA via CAERS on January 5, 2020. Report acknowledged by CAERS on January 8, 2020. RECALL March 3, 2020 posted on FDA’s Recalls, Market Withdrawals, & Safety Alerts page BUT because of undeclared milk only. It appears the gluten-free claim will remain on new product packaging and the ingredient “germinated barley seed powder” will not be removed. The product is labeled gluten-free yet includes “germinated barley seed powder” in the ingredients list. In addition, the ingredients list includes “whey protein concentrate” but “milk” is not declared in either the ingredients list or separate Contains statement. GFWD spoke at length to the manufacturer.
Sierra Soups Pasta e Fagioli. Reported to FDA via CAERS on January 4, 2020. Product RECALL February 24, 2020 posted on FDA’s Recalls, Market Withdrawals, & Safety Alerts page. The product is labeled gluten-free yet includes durum semolina flour in the ingredients list. Wheat is not declared in the ingredients list or separate Contains statement.
Sticky Fingers Bakeries Gluten-Free Scones Mix Reported to FDA via CAERS on January 4, 2020. Product Recall posted under FDA’s Enforcement Reports page for the week of March 11, 2020. Report acknowledged by CAERS on January 8, 2020. A second report was filed on February 8, 2020. Product is labeled gluten-free yet enriched wheat flour is included in the ingredients list.