Product Alert: Schiff Digestive Advantage Lactose Defense Formula labeled no added gluten contains an enzyme cultivated on growth media containing wheat

Product Alert: Schiff Digestive Advantage Lactose Defense Formula labeled no added gluten contains an enzyme cultivated on growth media containing wheat

A concerned consumer reached out to Gluten Free Watchdog about this product. GFWD contacted the manufacturer asking about the source of wheat. The manufacturer reply stated: “The product does not contain any wheat or gluten. The enzyme used in our product is grown on fermented wheat so we are required to add it to our label.”

HOWEVER, under FDA’s newly released rule on gluten-free labeling of fermented and hydrolyzed ingredients, FDA has declined to exempt enzymes. This means that enzymes in a product labeled gluten-free must be in compliance with the rule. The media used to grow the bacteria that produce the enzymes should be gluten-free prior to fermentation.

A summary of why FDA is not exempting enzymes from the rule

  1. If bacteria grown on media that contain wheat, barley, or rye are used to produce enzymes, gluten may be present in an enzyme ingredient due to the lingering presence of growth media. 
  2. If gluten is present in the growth media, it may have been broken down into protein fragments. 
  3. FDA does not know at this time if gluten fragments produced during fermentation of growth media can cause an immune response in people with celiac disease. 
  4. FDA also does not know if it is possible to accurately test for the presence of any residual gluten in enzymes produced on growth media containing a gluten source.

FDA considers “no gluten” to be a gluten-free claim.

Gluten Free Watchdog has filed a product complaint with FDA via CAERS.

Consumer photos posted with permission.

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