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Complying to the FDA Gluten-Free Labeling Rule

Complying to the FDA Gluten-Free Labeling Rule

With the FDA gluten-free labeling rule in place, manufacturers must comply with the definition of “gluten-free” if they choose to label their products as gluten-free. Manufacturers who do not comply with the ruling can face consequences from the FDA.

You play a role in ensuring manufacturers are meeting the definition of “gluten-free.” If you come across a product that is mislabeled as gluten-free (sometimes referred to as facial misbranding), or that you believe made you sick because of gluten content, follow the steps below to notify the FDA of the problem.

Reporting a Problem

The FDA gluten-free labeling rule does not require manufacturers to test their final products. Here’s what to do if you believe you have been made sick due to gluten by a product that was labeled gluten-free:

  • To report a problem with an FDA-regulated product labeled as gluten-free, use the FDA’s Consumer Complaint System. FDA Consumer Complaint Coordinators (CCC) will listen, document your complaint and follow up as necessary. CCCs vary by location and a list of the appropriate phone numbers to call can be found here. Consumers and manufacturers can make a complaint through CCCs.
  • The MedWatch form should be used to report adverse events for medical products, like prescription or over-the-counter medications, cosmetics and food and beverage . Learn more about which products should be reported through MedWatch or begin a report here.
webinar icon Free Webinar: Understanding the FDA Gluten-Free Labeling Rule Part 2: Focusing on Compliance

Product Recalls

To learn if a product has been recalled and for what reason, visit the FDA’s product recall section.

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