Dandy Blend Instant Herbal Beverage: Where is the enforcement FDA?

This herbal beverage is labeled gluten-free and lists as ingredients “extracts of roasted barley, rye”. After seven years of reporting this product to FDA, it remains on store shelves. What follows are the nitty-gritty details.

Initial correspondence with FDA

• Gluten Free Watchdog first made FDA aware of this product via email on January 10, 2014—over SEVEN years ago!
• FDA’s initial email response received January 17, 2014:
  • “As far as the product, “Dandy Blend Instant Herbal Beverage”, we do not have enough information to be able to decide if the product meets the requirements of the Gluten-free labeling regulations or not.  We would need more details as far as the processing steps and we are also not sure what extracts are being referred to in the description.” 
• GFWD responded stating:
  • “The product contains extracts of roasted barley and extracts of roasted rye. If malt extract is not an allowed ingredient in a labeled gluten-free food then it would seem these extracts would not be allowed either.”
• Follow-up email from FDA received January 24, 2014:
  • “As I explained in my earlier email, we are not certain what exactly the extracts of roasted barley and roasted rye contain so we cannot make a decision on labeling as yet.”
  • FDA went on to say that they “are aware of what malt extract is” and that it is “simply a water extract that contains plant constituents (including gluten protein); therefore as we stated in past correspondence, we would consider it to be an “ingredient not processed to remove gluten”. 

So how does Dandy Blend describe their process?

• From the Dandy Blend website (https://dandyblend.com/faqs/):
  • “How can there be no gluten in Dandy Blend if it contains Barley and rye?
    • It does not contain barley and rye. It contains the water extracts of barley and rye, and that is a big difference. Gluten and Gliadin proteins are not water soluble. That means that all gluten and gliadin are left behind in the grounds, and get thrown away (usually composted).”

So how does FDA describe malt extract?

• FDA’s Code of Federal Regulations states about malt extract (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=184.1445):
  • “Malt syrup and malt extract are interchangeable terms for a viscous concentrate of water extract of germinated barley grain, with or without added safe preservative.”

So Dandy Blend is made from a water extract of barley (and rye). Malt extract is a water extract of barley. BUT because the ingredient in Dandy Blend is listed as extract of roasted barley FDA doesn’t know what it is???

Gluten Free Watchdog has continued to report this product to FDA

• Our latest complaint filed July 14, 2020 to FDA via CAERS reads:
  • This is Tricia Thompson from Gluten Free Watchdog. We’ve once again tested Dandy Blend Instant Herbal Product. Product packaging includes a gluten-free claim. The ingredients list reads, “extracts of roasted barley, rye, chicory root, dandelion root and sugar beet.”
  • Gluten Free Watchdog has formally tested this product:
    • January 2014: 116 ppm gluten using the competitive R5 ELISA.
    • November 2014: 30 ppm and 47 ppm gluten using the competitive R5 ELISA.
    • September 2019: 22 ppm and 29 ppm gluten using the competitive R5 ELISA
    • June 2020: < 5 ppm using the sandwich R5 ELISA;  < 10 ppm using the competitive R5 ELISA
    • July 2020: < 5 ppm using the sandwich R5 ELISA; 43 ppm and 24 ppm using the competitive R5 ELISA
  • Gluten Free Watchdog has reported dandy Blend to FDA on numerous occasions, beginning in 2014.
  • A consumer filed a formal complaint via MedWatch in September 2019. 
  • After 6 ½ years, this product remains on store shelves labeled as gluten-free. 

• FDA, as required, was provided with all the information necessary to follow-up with the manufacturer
  • Image of product label: (see attached)
  • Name and place of business identified on product label: Goosefoot Acres, Inc., Valley City, Ohio
  • UPC code of the product (a/k/a bar code): 6 18825 15030 7
  • Lot number (and best by or expiration date, if there is one): 02/17/2023
  • When and where purchased (or observed): Amazon; June 2020
  • Ingredient list (including name of the suspected gluten-containing ingredient): “extracts of roasted barley, rye, chicory root, dandelion root and sugar beet.”

So has there been any FDA enforcement?

• A search of FDA’s recalls, market withdrawals, and safety alerts page (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts) on February 17, 2021 resulted in no mention of Dandy Blend or the parent company Goosefoot Acres.