Encouraging the FDA to investigate when products labeled gluten-free appear misbranded

Encouraging the FDA to investigate when products labeled gluten-free appear misbranded

I recently reached out to subscribers to Gluten Free Watchdog to ask for ideas regarding how best to attract the attention of the FDA when foods labeled gluten-free appear to be misbranded due to ingredients (e.g., barley malt, hydrolyzed wheat protein) or gluten level. The response was overwhelming. Here is a portion of the follow-up email sent to subscribers this morning:

Taking into consideration all of your ideas, I have developed an action plan. Before presenting my thoughts, it is probably useful to provide some background on what we typically do (or have done) when a product appears misbranded due to either ingredients or gluten content.

  • First an email is sent or a phone call is made to the manufacturer and the test results/ingredient information is shared. It often takes multiple phone calls and emails to get manufacturers to understand why a certain ingredient cannot be included in a food labeled gluten-free. On rare occasions they never understand. If the product tests at or above 20 ppm of gluten conversations with manufacturers often focus on testing and whether raw ingredients and final product are tested for gluten. We have only had a few instances when manufactures did not make changes to their suppliers and/or testing protocols.
  • Second, a number of contacts at FDA are notified by email and sometimes via voice mail when a product appears to be misbranded due either to the ingredients or gluten content and the manufacturer appears unwilling to rectify the situation. Up until this year and the change in administration, these emails were generally acknowledged. However, it is unclear whether any action was taken by the agency (to find out a FOIA request must be filed).

A portion of one of my latest emails to FDA reads, “I know you are tired of hearing from me about malt, malt extract, malt syrup, and malt vinegar. Consumers are tired of finding products on store shelves labeled gluten-free that contain malt ingredients. I am tired of contacting manufacturers about this issue. Because nothing appears to be changing, many in the gluten-free community are coming to the conclusion that the FDA is not responding to reports of possible misbranding of gluten-free labeled foods containing barley malt and barley malt ingredients.”

It is important to stress that many folks at FDA who are involved with labeling are hard-working people. Rhonda Kane, who was very involved in writing the gluten-free labeling rule, is a perfect example. Prior to her retirement, she was the hardest working dietitian I knew. The gluten-free community was fortunate to have her in our corner. Unfortunately, from my perspective no one at the agency has stepped in to fill her shoes.

FDA Action Plan

To try to get the attention of FDA, Gluten Free Watchdog will be doing the following:

  1. Encouraging a (hopefully) massive social media campaign directed at FDA:
  • Both a blog page and video will be posted on Gluten Free Watchdog (GFWD)

o   Target audience will be FDA

  • Products that are labeled gluten-free and appear misbranded based on the ingredients list will be named

o   Products will include those containing barley malt, barley malt extract, barley malt syrup, and hydrolyzed wheat protein

o   Certain products testing at/above 20 ppm of gluten will also be included

  • GFWD community will be asked to send a specific tweet to FDA that links to the blog page and @mentions the FDA

o   Tweet will include wording such as “Please RT, it takes a gluten-free village”

NOTE: Above social media steps will be taken only if a manufacturer refuses to change labeling (e.g., either removes the offending ingredient or the gluten-free labeling claim) or refuses to take immediate steps to decrease gluten content of the product AND does not take immediate steps to either remove the product from the marketplace or cover the gluten-free labeling claim.

  1. Encouraging a (hopefully) massive phone campaign directed at FDA:
  • When a product is identified that appears to be misbranded due either to ingredients or gluten content and the manufacturer refuses to make changes (or it is discovered that the manufacturer stated they would make changes and then did not), the GFWD community will be encouraged to contact the FDA Consumer Complaint Coordinator in their state
  • This listing will be posted on GFWD
  • A sample script will be provided
  1. Alerting the news media:
  • GFWD will contact members of the media starting with those who have already covered (or shown interest in covering) GFWD and labeling issues

o   Please let me know your media contacts, especially if you know them personally or know they will be sympathetic to the cause

o   If you work for a gluten-free magazine or support group, it would be great if you covered this story too. Please contact me!!

  1. Posting a petition on change.org:
  • GFWD will be asking the FDA to enforce the gluten-free labeling rule
  1. Writing an Op-Ed:
  • I will be writing Op-Ed about this issue and submitting it to national newspapers one at a time until accepted (smile).

Other steps we may take:

  • Contacting Congress: There were a lot of comments both in favor and not in favor of taking this step. Some folks believe it simply is not the right time to reach out to Congress.
  • Organizing marches at FDA field offices: I really like this idea but it will require a dedicated team of organizers.

All of these actions will require a lot of work. It will truly take a gluten-free village to make any of them successful.

Thanks everyone. I will keep you posted.

Kind regards,

Tricia Thompson, MS, RD

Founder, Gluten Free Watchdog, LLC


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Comments (6)

  • Helen Weems Reply

    Wow, Tricia. Thank you so much! Let us know our role as this develops.

    July 6, 2017 at 11:30 pm
    • Tricia Thompson Reply

      Will do, Helen! More information will post next week.

      July 7, 2017 at 12:08 pm
  • Lara Reply

    Wouldn’t it be great if the FDA required companies to label all products as “Not Gluten Free” until tested and established otherwise? I bet that there would suddenly be a lot more GF products on the market.

    July 11, 2017 at 12:45 am
  • Jeanine Reply

    Tricia, my understanding is that hydrolyzed wheat protein IS gluten free as the manufacturing process removes all traces. In Europe legislation allows it to be considered GF. Up to us to decide whether we want to eat it or not (it is in my hair conditioner), but I think it sould be incorrect and misleading to complain to the FDA about it.

    July 11, 2017 at 2:24 pm

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