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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Comments (9)

  • Derek Reply

    Seems like Schiff is being responsible here in disclosing it, even if they are making a labeling mistake saying that it is “no gluten”. I wonder how many other enzyme/probiotic products are cultured on gluten-containing media and do not disclose it?

    September 30, 2020 at 8:47 pm
    • Tricia Thompson Reply

      Agree, responsible in reporting but irresponsible in not knowing labeling laws/rules. My guess is lack of reporting is more prevalent when the growth media includes barley because it isn’t one of the top 8 allergens. Manufacturers appear fairly well-versed in FALCPA and the requirement to declare wheat (although some manufacturers may have no idea about the growth media used to grow/develop their ingredients).

      October 2, 2020 at 7:37 pm
  • Carol asher Reply

    Is the lactose defense formula available anywhere

    March 18, 2021 at 5:19 pm
    • Kathleen Reply

      Not that I can find either! I have been looking for weeks. I did find ONE site where it said that the product will be back on April 17. So, maybe it was just temporarily pulled or halted so that they can address the issue above? We can only hope! I am suffering without my lactose defense capsules!

      March 26, 2021 at 1:44 pm
  • Anita Reply

    Thanks for destroying the availability of a product that millions of people depend upon. The box is clearly labeled as containing wheat and soy and the FDA should have much more important issues to research. My tax dollars hard at work?

    April 6, 2021 at 9:20 pm
    • Tricia Thompson Reply

      Hi Anita, This product can’t be labeled gluten-free if it contains an enzyme cultivated on growth media containing wheat. This may not be an issue for you but it is for those who have celiac disease. If it is widely out of stock my guess is it is undergoing a formulation change or labeling change.

      April 8, 2021 at 5:57 pm
  • Mike Reply

    For anyone who is uncomfortable…there is Lactaid. It is more tedious to use but it’ll get you through. It works for me anyway.

    April 30, 2021 at 12:54 pm
    • Daniel H. Stansberry Reply

      Lactaid is nowhere near as effective in the daily treatment of lactose intolerance. We ordered The Schiff Lactose Defense Formula, and it is not effective. Suppose I have had my last dairy meal, and have to be very cautious with many other foods. Thank you very much. I had used this product for years, and will miss it greatly. Please don’t try to coddle us.

      July 27, 2021 at 9:01 pm
  • Suzanne Rutan Reply

    I am new this past year to eating gluten free due to a change in my body post gallbladder removal. I went gluten free after doing an elimination diet for my symptoms and found wheat to be quite problematic when reintroduced. I became SO much better without wheat but was just not able to stop the daily on and off nausea…the other most unpleasant symptoms almost all gone. I couldn’t figure out how I might still be getting gluten/wheat or IF that was the case. Three weeks ago I checked the label on my Digestive Advantage lactose formula probiotic that I’ve taken for years. It just hadn’t occurred to me it could be a pill I was taking. I stopped this probiotic immediately when I saw it contained wheat. 1 1/2 weeks after stopping this probiotic I had my first day with NO NAUSEA in nine months! I have been nausea free for 5 days in a row now. I am SO happy! I firmly believe this product was causing my low grade nausea.

    I really does matter to some of us. I will be much more careful checking labels on medications from here on out.

    June 25, 2023 at 7:46 pm

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