Is the FDA enforcing the gluten-free labeling rule?

Is the FDA enforcing the gluten-free labeling rule?

Question: How many FDA food recalls have there been since January 1, 2016 and the reason/problem cited by the FDA is gluten?

Answer: Two

A search under “gluten” on FDA’s “Recalls, Market Withdrawals, & Safety Alerts” page resulted in the following:

How many potentially facially misbranded products, including those containing barley malt ingredients and hydrolyzed wheat protein have been reported to FDA staff by Gluten Free Watchdog?

  • 2016: 14 products
  • 2017: 17 products
  • 2018 (to date): 9 products

Note: Some products are included in more than one year as they remain on store shelves.

Note: The above listing does not include foods tested by Gluten Free Watchdog and found to contain levels of gluten of at least 20 parts per million.

Based on the above information, it appears that FDA is not recalling products labeled gluten-free that include in the ingredients list: malt, malt extract, malt syrup, malt vinegar, and wheat as a sub-ingredient in shoyu/soy sauce.

Does this mean FDA allows the above named ingredients to be included in foods labeled gluten-free?

  • FDA on soy sauce: “If a soy sauce is made from wheat and soybeans, “wheat” is a gluten-containing grain, and, therefore, cannot make the gluten-free claim.”
  • FDA on malt extract, and malt syrup: “Malt extract and malt syrup are ingredients derived from gluten containing grains and containing gluten therefore we would consider them as ingredients not processed to remove gluten and they would not be permitted in foods bearing the claim gluten-free.”

Then why isn’t the FDA enforcing the gluten-free labeling rule when it comes to these ingredients? We don’t know.

What recourse does the community have?

  • As many of you know, Gluten Free Watchdog filed an FDA citizen petition requesting that the FDA establish a specific protocol for increased surveillance, investigation and enforcement of potential facial misbranding violations under the gluten-free labeling rule.
    • On February 13, 2018 the FDA issued an interim response stating, “we have not reached a decision on your petition within the first 180 days due to competing priorities. However, be advised that your petition is currently under active evaluation by our staff.”
      • There have been no further public updates from FDA.

Is there legal recourse if the FDA is not enforcing the gluten-free rule? Hmm.

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Comments (2)

  • Jean
    Reply

    Regarding your question about legal recourse if the FDA is not enforcing the gluten-free rule it would be difficult. The FDA is protected like all government entities (federal, state, county, city) by sovereign immunity. However, there is the Federal Tort Claim Act that some have used in federal lawsuits but with limited success because it exempts failure to exercise or perform discretionary function or duty.
    I am not a lawyer or have any legal expertise but have read about the difficulty and expense to sue government agencies.

    June 7, 2018 at 3:59 am
  • nomen nescio Reply

    The recourse with FDA is for a powerful majority party member of Congress to find out that their son or daughter has Celiac disease. Then they will exert pressure on FDA.

    June 13, 2018 at 10:06 pm

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