Gluten-Free Claim Removed from KA-ME Hong Kong Express Rice Noodles
In May 2022, Gluten Free Watchdog (GFWD) reported KA-ME Hong Kong Express Rice Noodles to the Food and Drug Administration (FDA) via the Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS). At the time, product packaging included a gluten-free claim yet barley amylase was declared in the ingredients list.
In February 2023, GFWD submitted a Freedom of Information Act (FOIA) request with FDA to find out what action was taken on our complaint. One of the main reasons for filing the FOIA was to help inform us of FDA’s thinking on barley amylase—were they or were they not allowing this ingredient in foods labeled gluten-free.
While we did not receive any internal FDA discussions about barley amylase, we did receive summary statements of FDA communications with the manufacturer. Based on these communications, the manufacturer was planning to remove the gluten-free claim from product packaging. They expected to have updated packaging by the end of 2022 and estimated that packaging carrying a gluten-free claim would be “depleted” by May of 2023. It is the interpretation of Gluten Free Watchdog that the above actions suggest that the FDA is not allowing barley amylase in foods labeled gluten-free.
It is interesting to note that the Federal Register notice on the FDA’s rule on gluten-free labeling of fermented and hydrolyzed ingredients and foods, clarified that enzymes produced by bacteria grown on gluten-containing growth media were not exempt from the rule. However, barley amylase is not produced in this manner; rather it is extracted and purified from barley.
At Gluten Free Watchdog we hope that FDA will publicly clarify their position on barley amylase. Because barley is not an allergen under the Food Allergen Labeling and Consumer Protection Act, barley is not required to be declared on the food label. As a result, some manufacturers list barley amylase simply as amylase. In addition, some manufacturers appear to believe that enzymes from barley do not require label declaration. For example, based on email correspondence, Rice Dream rice beverage uses enzymes in their rice base and the enzymes are derived from barley. However, nowhere on the label are amylase, barley amylase, or even enzymes declared.
At Gluten Free Watchdog we very much appreciate the work FDA does behind the scenes related to the complaints filed by GFWD. It is our hope however, that at some point in the future information that is currently available only via a FOIA, will be routinely included in a public FDA database.
We are indebted to Adam Rapp, pro bono attorney for Gluten Free Watchdog. He is behind all FOIAs submitted to FDA on behalf of GFWD. His expertise in filing these requests has provided us with information we would not otherwise have access to. Thank you, Adam!
Comments (3)
Is there any improvement in the “oats” GF situation? Such as oatmeal?
Thank you for the update on barely amylase being used in a supposed GF rice noodles. I’m just flabbergasted that FDA allows the manufacturer to use up all the product before making changes and not even notifying the public. Wow! Glad that product is not offered in my area.
Again thank you for all you do.
It appears that there are certain ingredients that may not be allowed in foods labeled gluten-free yet are deemed to be less problematic than for example wheat flour, barley flour, etc. The presence of the ingredient would not lead to a class I or class II recall. Regardless, FDA appears to be compelling manufacturers to either remove ingredients or remove the gluten-free claim. It is the case that barley amylase may not contain any appreciable barley hordein (depending on how purified it is). We worked with a lab in Australia to test amylase. A brief report is available at https://www.glutenfreewatchdog.org/…/gluten-free…/. This work is also being presented at a conference in a few months. When the abstract and poster are available, they will be posted.